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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Catheterisation cardiac, Chills, Confusional state, Echocardiogram, Electrocardiogram
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Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Fever-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Her husband called ambulance wednesday few hrs after 2nd shingles dose. she was achy, shivering, vomitting, confused, had a fever, and pain. They thought heart attack- got heart cath, echo, ekg. She said her NSTEMI "kept rising". Transferred to another hospital where cardiologist told her she was ok and discharged sat am. Did diagnose her with UTI.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Pain, Pyrexia, Tremor, Urinary tract infection
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Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Fever-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Her husband called ambulance wednesday few hrs after 2nd shingles dose. she was achy, shivering, vomitting, confused, had a fever, and pain. They thought heart attack- got heart cath, echo, ekg. She said her NSTEMI "kept rising". Transferred to another hospital where cardiologist told her she was ok and discharged sat am. Did diagnose her with UTI.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
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Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Fever-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Her husband called ambulance wednesday few hrs after 2nd shingles dose. she was achy, shivering, vomitting, confused, had a fever, and pain. They thought heart attack- got heart cath, echo, ekg. She said her NSTEMI "kept rising". Transferred to another hospital where cardiologist told her she was ok and discharged sat am. Did diagnose her with UTI.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Nausea, Syncope, Unresponsive to stimuli, Vomiting
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Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Other Vaccines: VaccineTypeBrand: MENVEO; Manufacturer: GLAXOSMITHKLINE; LotNumber: EK7DG; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Anaphylactic reaction, Arthralgia, Asthenia, Autoimmune disorder
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Bell's palsy, Blood disorder, Cardiac disorder, Cerebrovascular accident, Chest discomfort
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Chills, Confusional state, Diarrhoea, Dizziness
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Fatigue, Flushing
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Hyperhidrosis, Hypertension, Hyperventilation, Hypoaesthesia
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Hypotension, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Insomnia, Lethargy, Lymphadenopathy, Mouth swelling
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Multisystem inflammatory syndrome, Myocardial infarction, Nausea, Nervous system disorder, Pain
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus, Pyrexia, Rash, Seizure
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Swollen tongue, Syncope, Tachycardia, Throat tightness
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus, Tremor, Unresponsive to stimuli, Visual impairment, Vomiting
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
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Site: Bruising at Injection Site-Medium
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Rash
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient had whole body rash
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Paraesthesia
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Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt was experiencing tingly sensation radiating from upper left arm [deltoid] down to left hand fingers... Pt reported tingly sensation last 2 eays sat and sun when rph call to follow up on monday after 2 days.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea
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Systemic: Diarrhea-Mild, Systemic: indigestion as well-Mild, Additional Details: Patient says he has a sensitive stomach, and always has these types of issues, but inquired if it could potentially be due to the flu vaccine, and I said that definetly could be a possibility, and if the symptoms persist to see a doctor. Advice in the mean time to eat dry foods, stay hydrated and monitor any worsening. Patient assured me this happens to him regularly, patients wife insisted it was not due to the vaccine, but potentially could be according to patient. Told him will followup., Other Vaccines: VaccineTypeBrand: Flucelvax/Flu vaccine; Manufacturer: seqirus; LotNumber: 406981; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Asthenia, Headache, Nausea, Vomiting
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Systemic: Abdominal Pain-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injection site bruising, Injection site swelling, Pain
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Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: large brusied area around upper portion of arm and slightly swollen-Medium, Systemic: Weakness-Medium
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
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Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt faint
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Presyncope
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Systemic: Dizziness / Lightheadness-Mild, Additional Details: Vasovagal response. Never lost consciousness. Vital sign stayed normal: 128/80, HR 67, 99% Oxygen, RR 16.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: Patientreceived Abrysvo,Boostrix,Prevnar, and Flucelvax on 8-13. Patient reported to technician that her arm was sore. Patient disconnected call before pharmacist was able to get more info. , Other Vaccines: VaccineTypeBrand: Prevnar; Manufacturer: ; LotNumber: LC5485; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: 08/13/2025, VaccineTypeBrand: RSV; Manufacturer: ; LotNumber: LG9829; Route: intramuscular; BodySite: right; Dose: ; VaxDate: 08/13/2025, VaccineTypeBrand: Tdap whooping cough; Manufacturer: ; LotNumber: L5229; Route: intramuscular; BodySite: left; Dose: ; VaxDate: 08/13/2025
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Hypotension
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Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Lethargy, Pain
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Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: patient called and said that injection site from vaccine was bruising and dark. Counseled patient to contact doctor if symptoms do not improve or gets worse. Patient was satisfied with counseling after phone call on 8/13/25
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Seizure
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Systemic: Seizure-Medium, Additional Details: Patient has hx of head injury from MVA 4 years ago. seizure occured within 4 minutes of vaccination. mild seizure lasting approximately 15 seconds. BP and Pulse normal when check 2 minutes later. PT fully recovered in less than 5 minutes, reporting no visual or imbalance problem. PT then was transported to neurologist who cleared PT for normal activities without restrictions, Other Vaccines: VaccineTypeBrand: meningitis(groupb) trumenba; Manufacturer: wyeth/pfizer; LotNumber: hp9987; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 08/14/2025
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Swelling
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REDNESS AND SWOLLEN
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 22.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Loss of consciousness, Seizure
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Patient received 2 vaccines. Patient was sitting in the waiting area and after a few minutes patient passed out then had a convulsion that lasted a few seconds. emergency was contacted, they checked patient out and patient refused transportation to the hospital, patient felt fine and left.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Urticaria
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small bumps/my skin would itch then they appear; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2025, outcome "unknown", described as "small bumps/my skin would itch then they appear". Additional information: It was reported that I keep getting small bumps on my arms, they pop up and then they disappear, sometimes my skin would itch then they appear. 4 months ago it started on my neck, it stopped, it came back 4 days ago and it is just on my arms. Inquired as did it come from the COVID vaccine. Also mentioned patient not on any meds. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nasal congestion, Nausea, Respiratory tract congestion, Wheezing
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The day of the vaccine I experienced nausea but I am not sure if it was related to the vaccine. The next day I experienced fatigue, mild chest and nasal congestion, and a mild expiratory wheeze.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
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Afib
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
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Patient came back on 8/8/25 and showed the pharmacist the bruise , about the size of nickel ,on his injection site . He said this time he bled after the injection . He said the pain has subsided on 8/8/25 when he came in .
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Anxiety, Chest pain, Condition aggravated, Feeding disorder, Hallucination
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Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Inappropriate schedule of product administration, Insomnia, Malaise, Myoclonus, Tinnitus
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Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Tremor, Weight decreased
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Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Anxiety, Chest pain, Condition aggravated, Feeding disorder, Hallucination
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Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Insomnia, Interchange of vaccine products, Malaise, Myoclonus, Palpitations
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Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Tinnitus, Tremor, Weight decreased
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Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Butterfly rash, Lymphadenopathy, Systemic lupus erythematosus
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At time of second vaccination in January 2021, I had extreme bone pain in forearms, thigh bones, and hips. My lymph nodes later enlarged and stayed swollen for months. About 1 year later I developed severe joint pain in multiple joints with a red butterfly rash. 5 years later and I have been diagnosed with SLE.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Cardiac assistance device user, Endotracheal intubation, Fatigue, Impaired driving ability
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Listed in first page of this form, I suffered a life changing cardiac episode.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Resuscitation, Sudden cardiac death
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Listed in first page of this form, I suffered a life changing cardiac episode.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered, Injection site bruising, Injection site discomfort
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Administration error regarding Prevnar 20. Patient received Prevnar 20 on 11/28/23. An additional dose of Prevnar 20 was administered on 08/15/2025. Patient stated she experienced some discomfort and bruising at the injection site that has since improved. No further issues post administration.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Central serous chorioretinopathy, Dermatitis, Eczema, Fluorescence angiogram
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Loss of vision right eye. Central Serous Retinopathy. No treatment available. Severe Eczema, dermatitis. Taking Rinvoq daily indefinitely.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy thyroid gland abnormal, Blood thyroid stimulating hormone decreased, Thyroiditis subacute
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Suffered side effects beginning October 2024 and on December 27, 2024, TSH level dramatically dropped to 0.09. (Note: After 4 previous shots with no noted side effects from the Pfizer vaccine, it is worth noting the FDA approved and updated the mRNA formula for Covid-19 vaccines on August 22, 2024, and nearly one month before I received my 5th Covid-19 vaccine. A vaccine, due to the FDA approved formula change, caused me to experience highly devastating symptoms associated with the condition known as subacute thyroiditis, a rare but potential side effect of the latest and formula-updated Covid-19 vaccine.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Eye pruritus, Eyelid margin crusting
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A week after the second dose, I began experiencing allergies. Although at the time I was not aware it was allergies due to never having allergies. My eyes began itching really bad. I experienced eye crust, difficulty breathing and angioedema on my face. March 2, 2022 I experienced my anaphylactic reaction, followed by another one March 3, 2022. Ever since March, I've experienced multiple idiopathic anaphylactic reactions.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
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A week after the second dose, I began experiencing allergies. Although at the time I was not aware it was allergies due to never having allergies. My eyes began itching really bad. I experienced eye crust, difficulty breathing and angioedema on my face. March 2, 2022 I experienced my anaphylactic reaction, followed by another one March 3, 2022. Ever since March, I've experienced multiple idiopathic anaphylactic reactions.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 53.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Arthralgia, Injection site reaction, Injection site warmth, Rash erythematous
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Patient has a red rash on left arm around injection sites about the size of a fist. Patient also reports a little warmth on touching rash. Patient has not reported any swelling with rash but does have some shoulder pain associated with it
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.5
Sex: F
Vaccine: COVID19, MMR
Symptoms: Immediate post-injection reaction, Infant irritability, Injection site erythema, Injection site rash, Injection site urticaria
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Immediately fussy, within 8-10 minutes started developing rash, pink wheals on left medial thigh concerning for urticaria, pink papules on right buttocks, red patch on dorsum of left toes. Fussiness and rash improved during observation with pink patch remaining on left inner thigh. Observed in clinic for 20 minutes total. No dyspnea, vomiting, or other symptoms of anaphylaxis. Advised home administration of cetirizine which family administered. I (Dr.) followed up 3 hours later with family via phone, she was doing well, rash improving. She had a separate visit to the ER 8/15/25 for high fever, and on 8/18/25 was diagnosed with Roseola.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.5
Sex: F
Vaccine: COVID19, MMR
Symptoms: Papule, Rash, Roseola
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Immediately fussy, within 8-10 minutes started developing rash, pink wheals on left medial thigh concerning for urticaria, pink papules on right buttocks, red patch on dorsum of left toes. Fussiness and rash improved during observation with pink patch remaining on left inner thigh. Observed in clinic for 20 minutes total. No dyspnea, vomiting, or other symptoms of anaphylaxis. Advised home administration of cetirizine which family administered. I (Dr.) followed up 3 hours later with family via phone, she was doing well, rash improving. She had a separate visit to the ER 8/15/25 for high fever, and on 8/18/25 was diagnosed with Roseola.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Fatigue, Flushing, Pain in extremity
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she experienced flushing from her neck to waist; Increased blood pressure; sore arm; Tiredness; This serious case was reported by a consumer via call center representative and described the occurrence of flushing in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included propafenone (Rythmol). On 07-JUL-2025, the patient received the 1st dose of Shingrix. On 09-JUL-2025, 2 days after receiving Shingrix, the patient experienced flushing (Verbatim: she experienced flushing from her neck to waist) (serious criteria hospitalization) and increased blood pressure (Verbatim: Increased blood pressure) (serious criteria hospitalization). In JUL-2025, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: Tiredness). The outcome of the flushing and increased blood pressure were unknown and the outcome of the pain in arm and tiredness were resolved. It was unknown if the reporter considered the flushing, increased blood pressure, pain in arm and tiredness to be related to Shingrix. The company considered the flushing and increased blood pressure to be unrelated to Shingrix. It was unknown if the company considered the pain in arm and tiredness to be related to Shingrix. Additional Information: GSK receipt date: 05-AUG-2025 The reporter was the patient who received her first dose of Shingrix and had a sore arm and felt tired. On Wednesday morning, she woke up with flushing from her neck to waist and an elevated blood pressure of 180/88. She went to the emergency room. She was also admitted to the hospital twice so far for flushing and high blood pressure. The first time was from 14th JUL 2025 to 18th JUL 2025 and the second was from the following Tuesday to Thursday.; Sender's Comments: A case of Blood pressure increased and Flushing, 2 days after receiving Shingrix in a 78-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (age).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Dysstasia, Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities
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Guillain Barre syndrome; There is also a period of time that she does not remember; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). On 23-AUG-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant) and memory loss (Verbatim: There is also a period of time that she does not remember). The outcome of the guillain barre syndrome and memory loss were unknown. It was unknown if the reporter considered the guillain barre syndrome and memory loss to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the memory loss to be related to Shingrix. Additional Information: GSK Receipt Date: 12-AUG-2025 Reporter was the patient who received her second dose of Shingrix on 23rd August 2024. She stated that she was hospitalized from October 2024 to November 2024. She was diagnosed with Guillain Barre syndrome. She could not walk and stand at that time. There was also a period that she did not remember. Today (on the day reporting) she still cannot walk, she cannot put on her shoes, and was in a long term care facility.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a 63-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
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proved to be deathly allergic to the COVID shot; This 69-year-old male subject was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot). No Medical History information was reported. On an unknown date, the patient received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. In 2022, the patient experienced ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot) (seriousness criterion medically significant). At the time of the report, ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot) outcome was unknown. The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown. DCP-ID was reported as withheld id# with DCP name: 2025 Respiratory ATU Tracking Survey - CONSUMER. No concomitant medication was reported. It was unknown if the subject had allergies to medications, food and other products. Reporter stated that the subject provided a vague note that the subject proved to be allergic to the COVID shot when the subject took it. It was unknown if the event caused the subject to seek medical care. It was unknown if there were any other factors that could have led to the adverse event. It was unknown if the subject had experienced a similar event in the past. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-788495 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788495:Same Report, Different patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: Cardiac ventricular thrombosis
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developed a blood clot in his heart caused by the Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) (seriousness criterion medically significant). At the time of the report, CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that patient had developed a blood clot in his heart caused by the Moderna Covid vaccine. He was currently seeing a heart specialist. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Lichen sclerosus
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lichen planus; lichen sclerosis; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis). At the time of the report, LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis) had resolved with sequelae. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Pneumonia
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atrial fibrillation; Pneumonia; This 76-year-old female subject was enrolled in an open label study titled A phase 3b, randomized, open label, multi-country,multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 µg on 14-AUG-2025, for prophylaxis. On 30-DEC-2024, not applicable after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 pneumonia (Verbatim: Pneumonia). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation (Verbatim: atrial fibrillation) on 14-AUG-2025 with serious criteria of hospitalization. The outcome of pneumonia was resolved on 12-JAN-2025. The outcome(s) of the additional event(s) included atrial fibrillation (resolved). The investigator considered that there was no reasonable possibility that the pneumonia and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2025105118 GSK Initial receipt date: 14-AUG-2025, 15-AUG-2025 The end date of event atrial fibrillation was reported as 2-JAN-2025. AE (Adverse event) was not related to study treatment. SAE (Serious adverse event) was not Related to Study Participation Activities other than Study Treatment. Hospital Admission date: 30-DEC-2024 Hospital Discharge date: 12-JAN-2025 Date event became serious for Pneumonia: 30-DEC-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI) Date event became serious for atrial fibrillation: 31-DEC-2024.; Sender's Comments: A case of Atrial fibrillation, Less than a day after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 76-year-old female subject. Report is inconsistent with causal relation to the vaccine product. US-GSK-US2025105118:
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Eye pain, Eye swelling, Eyelid bleeding, Eyelid cyst
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Currently out of the NVX vaccine; My eyes, they were swollen, red, huge; I broke a vessel on my eyelid; Still a bit swollen and sore; They felt strained at worse; They felt strained; I handle Novavax better than Moderna or Pfizer; Very sore arm for a few days; Headache; Legs hurt, my lower legs really hurt like a compartment syndrome type of issue; I really have difficulty in walking/I couldn't drive my car, couldn't walk; My eyes started swelling/My eyes, they were swollen, red, huge/and the eyes were swelling; Then I started sort of feeling a little crappy, like a week later; Didn't feel good and I got so sick; The swellingwediscussedwasso severe and I ended up with a clogged gland in my eyelid/The glands couldn't function..they were closed off and things couldn't. Secrete the way the way they're supposed to; Theswellingwediscussed was so severe and I ended up with a clogged gland in my eyelid/The glands couldn't function. They were closed off and things couldnt. Secrete the way the way they're supposed to; Little lumps that formed in my eyelid/But then I just go another lump; Little lumps that formed in my eyelid; This non-serious initial spontaneous report from (withheld) was reported by a Consumer and concerns a female of unspecified age who experienced VERY SORE ARM FOR A FEW DAYS, HEADACHE, LEGS HURT, MY LOWER LEGS REALLY HURT LIKE A COMPARTMENT SYNDROME TYPE OF ISSUE, I REALLY HAVE DIFFICULTY IN WALKING, MY EYES STARTED SWELLING, CURRENTLY OUT OF THE NVX VACCINE and TODAY WAS MY 3 WEEK APPOINTMENT TO GET MY 2ND SHOT after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). Treatment included prescription ointments and warm soaks. At the time of the report, the outcome of the Pain in extremity, Pain in extremity, Gait disturbance, Product availability issue, Product dose omission issue was Recovered/Resolved, while for Headache was Unknown and Eye swelling was Not Recovered/Not Resolved/Ongoing. On 27-Nov-2024, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV24-00880): The following updates were reported: Patients date of birth was reported. Patient's race, weight and height were reported. First vaccine administration details were provided as follows: Administration date: 10-Oct-2024; Lot number 6024MF012. Second vaccine administration was reported on 31-Oct-2024; Lot number 6024MF016A. Vaccination facility details for both vaccinations were provided. The event Product dose omission issue was removed, since the patient received a second dose on planned date (31-Oct-2024). The event verbatim of MY EYES STARTED SWELLING was updated to My eyes started swelling/My eyes, they were swollen, red, huge. 3 new events were reported as follows: On an unknown date the patient experienced MY EYES, THEY WERE SWOLLEN, RED, HUGE, I BROKE A VESSEL ON MY EYELID, STILL A BIT SWOLLEN AND SORE, and THEY FELT STRAINED AT WORSE after receiving the second vaccine dose. At the time of the report, the outcome of Eye swelling, Ocular hyperaemia, and Eye pain was Not Recovered/Not Resolved/Ongoing while the events of Eyelid bleeding and Muscle strain was Unknown. On 11-Aug-2025 and 13-Aug-2025, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV25-00593 and NOV25-00603): The following updates were reported: The patient's age was updated to 63 years. Cytochrome P450 Deficiency was updated to the current condition with the comment "cytochrome p enzyme deficiency in liver/ genetic diagnosis". Positive Covid-19 test in Sep-2023 was added to the patient's medical history. Concomitant medications, Calcitriol, Calcium, Vitamin D, and Collagen were added. The reported terms for three events were updated as follows: From "My eyes started swelling/my eyes, they were swollen, red, huge" to "My eyes started swelling/my eyes, they were swollen, red, huge/and the eyes were swelling". From "I really have difficulty in walking" to "I really have difficulty in walking"/I couldn't drive my car, couldn't walk". From "Little lumps that formed in my eyelid" to "Little lumps that formed in my eyelid/But then I just got another lump". Five new events were reported as follows: On an unknown date, after vaccination, the patient experienced "I handle Novavax better than Moderna or Pfizer" (PT: Adverse event). On an unknown date in Oct-2024, after vaccination, the patient experienced "Then I started sort of feeling a little crappy, like a week later" (PT: Malaise), "Didn't feel good and I got so sick" (PT: Illness), "The swelling we discussed was so severe and I ended up with a clogged gland in my eyelid/the glands couldn't function..they were closed off and things couldn't secrete the way they're supposed to" (PT: Meibomian gland dysfunction), and "Little lumps that formed in my eyelid/but then I just got another lump. (PT: Eyelid cyst) On an unknown date in Jul-2025, the patient underwent eyelid surgery for the event Eyelid cyst. At the time of the report, the outcomes of the events "Adverse event," Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were unknown.; Sender's Comments: This 63-year-old female experienced Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst is considered Possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Illness, Malaise, Meibomian gland dysfunction
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Currently out of the NVX vaccine; My eyes, they were swollen, red, huge; I broke a vessel on my eyelid; Still a bit swollen and sore; They felt strained at worse; They felt strained; I handle Novavax better than Moderna or Pfizer; Very sore arm for a few days; Headache; Legs hurt, my lower legs really hurt like a compartment syndrome type of issue; I really have difficulty in walking/I couldn't drive my car, couldn't walk; My eyes started swelling/My eyes, they were swollen, red, huge/and the eyes were swelling; Then I started sort of feeling a little crappy, like a week later; Didn't feel good and I got so sick; The swellingwediscussedwasso severe and I ended up with a clogged gland in my eyelid/The glands couldn't function..they were closed off and things couldn't. Secrete the way the way they're supposed to; Theswellingwediscussed was so severe and I ended up with a clogged gland in my eyelid/The glands couldn't function. They were closed off and things couldnt. Secrete the way the way they're supposed to; Little lumps that formed in my eyelid/But then I just go another lump; Little lumps that formed in my eyelid; This non-serious initial spontaneous report from (withheld) was reported by a Consumer and concerns a female of unspecified age who experienced VERY SORE ARM FOR A FEW DAYS, HEADACHE, LEGS HURT, MY LOWER LEGS REALLY HURT LIKE A COMPARTMENT SYNDROME TYPE OF ISSUE, I REALLY HAVE DIFFICULTY IN WALKING, MY EYES STARTED SWELLING, CURRENTLY OUT OF THE NVX VACCINE and TODAY WAS MY 3 WEEK APPOINTMENT TO GET MY 2ND SHOT after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). Treatment included prescription ointments and warm soaks. At the time of the report, the outcome of the Pain in extremity, Pain in extremity, Gait disturbance, Product availability issue, Product dose omission issue was Recovered/Resolved, while for Headache was Unknown and Eye swelling was Not Recovered/Not Resolved/Ongoing. On 27-Nov-2024, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV24-00880): The following updates were reported: Patients date of birth was reported. Patient's race, weight and height were reported. First vaccine administration details were provided as follows: Administration date: 10-Oct-2024; Lot number 6024MF012. Second vaccine administration was reported on 31-Oct-2024; Lot number 6024MF016A. Vaccination facility details for both vaccinations were provided. The event Product dose omission issue was removed, since the patient received a second dose on planned date (31-Oct-2024). The event verbatim of MY EYES STARTED SWELLING was updated to My eyes started swelling/My eyes, they were swollen, red, huge. 3 new events were reported as follows: On an unknown date the patient experienced MY EYES, THEY WERE SWOLLEN, RED, HUGE, I BROKE A VESSEL ON MY EYELID, STILL A BIT SWOLLEN AND SORE, and THEY FELT STRAINED AT WORSE after receiving the second vaccine dose. At the time of the report, the outcome of Eye swelling, Ocular hyperaemia, and Eye pain was Not Recovered/Not Resolved/Ongoing while the events of Eyelid bleeding and Muscle strain was Unknown. On 11-Aug-2025 and 13-Aug-2025, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV25-00593 and NOV25-00603): The following updates were reported: The patient's age was updated to 63 years. Cytochrome P450 Deficiency was updated to the current condition with the comment "cytochrome p enzyme deficiency in liver/ genetic diagnosis". Positive Covid-19 test in Sep-2023 was added to the patient's medical history. Concomitant medications, Calcitriol, Calcium, Vitamin D, and Collagen were added. The reported terms for three events were updated as follows: From "My eyes started swelling/my eyes, they were swollen, red, huge" to "My eyes started swelling/my eyes, they were swollen, red, huge/and the eyes were swelling". From "I really have difficulty in walking" to "I really have difficulty in walking"/I couldn't drive my car, couldn't walk". From "Little lumps that formed in my eyelid" to "Little lumps that formed in my eyelid/But then I just got another lump". Five new events were reported as follows: On an unknown date, after vaccination, the patient experienced "I handle Novavax better than Moderna or Pfizer" (PT: Adverse event). On an unknown date in Oct-2024, after vaccination, the patient experienced "Then I started sort of feeling a little crappy, like a week later" (PT: Malaise), "Didn't feel good and I got so sick" (PT: Illness), "The swelling we discussed was so severe and I ended up with a clogged gland in my eyelid/the glands couldn't function..they were closed off and things couldn't secrete the way they're supposed to" (PT: Meibomian gland dysfunction), and "Little lumps that formed in my eyelid/but then I just got another lump. (PT: Eyelid cyst) On an unknown date in Jul-2025, the patient underwent eyelid surgery for the event Eyelid cyst. At the time of the report, the outcomes of the events "Adverse event," Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were unknown.; Sender's Comments: This 63-year-old female experienced Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst is considered Possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Ocular hyperaemia, Pain in extremity, Product availability issue
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Currently out of the NVX vaccine; My eyes, they were swollen, red, huge; I broke a vessel on my eyelid; Still a bit swollen and sore; They felt strained at worse; They felt strained; I handle Novavax better than Moderna or Pfizer; Very sore arm for a few days; Headache; Legs hurt, my lower legs really hurt like a compartment syndrome type of issue; I really have difficulty in walking/I couldn't drive my car, couldn't walk; My eyes started swelling/My eyes, they were swollen, red, huge/and the eyes were swelling; Then I started sort of feeling a little crappy, like a week later; Didn't feel good and I got so sick; The swellingwediscussedwasso severe and I ended up with a clogged gland in my eyelid/The glands couldn't function..they were closed off and things couldn't. Secrete the way the way they're supposed to; Theswellingwediscussed was so severe and I ended up with a clogged gland in my eyelid/The glands couldn't function. They were closed off and things couldnt. Secrete the way the way they're supposed to; Little lumps that formed in my eyelid/But then I just go another lump; Little lumps that formed in my eyelid; This non-serious initial spontaneous report from (withheld) was reported by a Consumer and concerns a female of unspecified age who experienced VERY SORE ARM FOR A FEW DAYS, HEADACHE, LEGS HURT, MY LOWER LEGS REALLY HURT LIKE A COMPARTMENT SYNDROME TYPE OF ISSUE, I REALLY HAVE DIFFICULTY IN WALKING, MY EYES STARTED SWELLING, CURRENTLY OUT OF THE NVX VACCINE and TODAY WAS MY 3 WEEK APPOINTMENT TO GET MY 2ND SHOT after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). Treatment included prescription ointments and warm soaks. At the time of the report, the outcome of the Pain in extremity, Pain in extremity, Gait disturbance, Product availability issue, Product dose omission issue was Recovered/Resolved, while for Headache was Unknown and Eye swelling was Not Recovered/Not Resolved/Ongoing. On 27-Nov-2024, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV24-00880): The following updates were reported: Patients date of birth was reported. Patient's race, weight and height were reported. First vaccine administration details were provided as follows: Administration date: 10-Oct-2024; Lot number 6024MF012. Second vaccine administration was reported on 31-Oct-2024; Lot number 6024MF016A. Vaccination facility details for both vaccinations were provided. The event Product dose omission issue was removed, since the patient received a second dose on planned date (31-Oct-2024). The event verbatim of MY EYES STARTED SWELLING was updated to My eyes started swelling/My eyes, they were swollen, red, huge. 3 new events were reported as follows: On an unknown date the patient experienced MY EYES, THEY WERE SWOLLEN, RED, HUGE, I BROKE A VESSEL ON MY EYELID, STILL A BIT SWOLLEN AND SORE, and THEY FELT STRAINED AT WORSE after receiving the second vaccine dose. At the time of the report, the outcome of Eye swelling, Ocular hyperaemia, and Eye pain was Not Recovered/Not Resolved/Ongoing while the events of Eyelid bleeding and Muscle strain was Unknown. On 11-Aug-2025 and 13-Aug-2025, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV25-00593 and NOV25-00603): The following updates were reported: The patient's age was updated to 63 years. Cytochrome P450 Deficiency was updated to the current condition with the comment "cytochrome p enzyme deficiency in liver/ genetic diagnosis". Positive Covid-19 test in Sep-2023 was added to the patient's medical history. Concomitant medications, Calcitriol, Calcium, Vitamin D, and Collagen were added. The reported terms for three events were updated as follows: From "My eyes started swelling/my eyes, they were swollen, red, huge" to "My eyes started swelling/my eyes, they were swollen, red, huge/and the eyes were swelling". From "I really have difficulty in walking" to "I really have difficulty in walking"/I couldn't drive my car, couldn't walk". From "Little lumps that formed in my eyelid" to "Little lumps that formed in my eyelid/But then I just got another lump". Five new events were reported as follows: On an unknown date, after vaccination, the patient experienced "I handle Novavax better than Moderna or Pfizer" (PT: Adverse event). On an unknown date in Oct-2024, after vaccination, the patient experienced "Then I started sort of feeling a little crappy, like a week later" (PT: Malaise), "Didn't feel good and I got so sick" (PT: Illness), "The swelling we discussed was so severe and I ended up with a clogged gland in my eyelid/the glands couldn't function..they were closed off and things couldn't secrete the way they're supposed to" (PT: Meibomian gland dysfunction), and "Little lumps that formed in my eyelid/but then I just got another lump. (PT: Eyelid cyst) On an unknown date in Jul-2025, the patient underwent eyelid surgery for the event Eyelid cyst. At the time of the report, the outcomes of the events "Adverse event," Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were unknown.; Sender's Comments: This 63-year-old female experienced Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst is considered Possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Off label use
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She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; This non-serious initial spontaneous report from withheld was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00601) and concerns a 47- year-old Female who reported "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Incomplete course of vaccination) and "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Off label use) after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 22-Mar-2025. At the time of reporting, the outcome of the Incomplete course of vaccination and Off label use was Recovered/Resolved.; Sender's Comments: This 47-year-old Female experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Incomplete course of vaccination and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Computerised tomogram heart, Ear pain, Hypersensitivity
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my allergic reactions; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; This is a spontaneous report received from a Nurse from medical information team. A 72-year-old female patient received BNT162b2 (BNT162B2), in Dec2019 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "elevated cholesterol level" (unspecified if ongoing); "elevated calcium levels" (unspecified if ongoing); "food allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Shingrix vaccine (DOSE 1, SINGLE), administration date: 2019, for Immunization, reaction(s): "blisters and a circle around her left lower leg above the ankle"; Shingrix vaccine (DOSE 2, SINGLE), administration date: 2019, for Immunization, reaction(s): "blister in a circle below the shot in her right arm"; Tetanus toxoid, for Immunization, reaction(s): "Allergic". The following information was reported: ANGINA PECTORIS (medically significant), EAR PAIN (non-serious), NECK PAIN (non-serious) all with onset Dec2019, latency 20 min after the suspect product(s) administration, outcome "unknown" and all described as "I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "my allergic reactions". The patient underwent the following laboratory tests and procedures: Blood test: (Jul2025) Unknown results; Computerised tomogram heart: (unspecified date) showed that she had calcium deposits,; (unspecified date) showed two of the veins in the heart; Lab work: (2025) Unknown results; physicals: (unspecified date) Unknown results. Therapeutic measures were not taken as a result of angina pectoris, ear pain, neck pain, hypersensitivity. Clinical course: The patient reported an adverse event that she experienced from the Pfizer Covid-19 vaccine last Dec2019. It was during the first release of the vaccine and only people in the hospital can have them. The reporter had a reaction to her first shot. She remembered it happened in the hospital where she works, around 5 o'clock in the afternoon. She had to use the stairs in the hospital, and then within 20 minutes after receiving the shot, while she was on the stairs, she sat down and experienced a stabbing pain in her heart, like a knife stabbing her heart. It felt like a knife was stabbing both her ears, going down her neck, similar to a reaction she gets from food allergies. It was like a jellyfish stung her. The patient provided a brief history about the vaccines she had in the past and the reactions she experienced. One of them was the Shingrix vaccine. She had 2 Shingrix shots. The first time, she had blisters and a circle around her left lower leg above the ankle, and then on her second shot, she had another blister in a circle below the shot in her right arm. She also had a reaction with the tetanus toxoid, so she was not allowed to have any of those; she was allergic to tetanus toxoid. She was just telling about the reactions she had with other vaccines; she clarified that it was not related to the Covid vaccine. The patient said she was terrified to have the shot. She even asked her coworkers why she should have the vaccine. She was told to get it so she wouldn't end up in the ICU or on a respirator, so she said that okay, she'll get it. The one that she had with the Covid vaccine, she first reported to VAERS since her side effects were not on the list on the paperwork. She was referred to call Pfizer. She only had a reaction on the first shot, and in the second shot (booster) that she received around January, they were given Tylenol and she did not experience any side effects. They had a calcium CT scan on her heart and it showed that she had calcium deposits, and her husband and daughter have had the vaccines and they have that too, so they're on statins now and that was like 5 years after the vaccine. She had bloodwork last month, and she has her physicals twice a year with her doctor. The reason for the transfer was she was asked if she wants to know what she should do next if she gets the Covid vaccine, so she said sure, so that's why she was transferred to (withheld), so she can find out what to do. Before, she asked what she could have done when she had the reaction to the shot. She was told to call the rapid response team, but she didn't call anybody. She got away and took care of her babies. The patients HCP had not mention for her to have any more vaccines, she did tell her that she had that but she wanted to make sure that her HCP can check her. When probed if consumer took any Pfizer vaccine on the same date or 4 weeks prior, patient stated, her hospital was offering them and she did not want one. She was terrified to get that vaccine because she did not know, She was allergic to the Tetanus Toxoid and may have had an allergic response which she had this after her other vaccine, but was wondering if she could have, the Shingrix she had before, it was in 2019 and so, she had blisters in a circle around my ankle with that vaccine the first shot, the second shot, had blisters in a circle around my right arm which is where she had the vaccine given both times. When clarified if consumer took Pfizer COVID-19 vaccine and Shingrix, consumer stated, "No, I do not have any, I do not take vaccines together. I give them, I am a pediatric RN in (withheld). Pfizer is the one that she had. I have all the paperwork, it is Pfizer and anyway, that was the one that she had. They did not have the (withheld) one quite yet, her daughter had that one, but she had the Pfizer. That was the only one available when she had it. she have not had the Shingles vaccine a year and a half before approximately, she had the COVID vaccines. Yes, they were giving the vaccines to healthcare workers first she was one of those people. Yes, she had the two. She reacted to the first one with that was not on the list on the paperwork that they gave them with the Pfizer vaccine at the hospital and so, she reported it, but she found out and she called VAERS with her allergic reactions. Other medical conditions and other medication: Consumer stated, "At the time no, she was taking statins now, but was not taking them before. Rosuvastatin, elevated cholesterol level, it has gone way down, but she did have a CT scan of her heart a year and a little about a year and a half ago and it showed two of the veins in the heart, widowmaker, and the other one that she had elevated calcium levels and her daughter has it too and so, and her husband (Further details was not available). Patient not had any lab tests in two weeks but had some about a month ago. Patient did not hd any treatments for the events. Consumer stated, "The blisters were from the Shingles vaccine. The COVID vaccine, she had started with in 20 minutes, she had stabbing like knife stabbing in her heart and she had stabbing in both of her ears radiating down her neck and she received no treatment. I called VAERS because they were not on the list, those reactions were not on the VAERS list for the COVID. So, I called them, but I did not know I needed to call you." Anatomical location or site of administration: Consumer stated, "The right arm, they wanted to give it to her left arm, but she only take vaccine shots in her right arm always." Route of administration: Consumer stated, she cannot remember, she was very paranoid of needles. she did not look and see what either she do not ever watch. It was straight in, she did not do it at an angle, it was straight in. If any adverse event resulted in hospitalization: Consumer stated, "No, she had asked them because she was allergic to the Tetanus Toxoid. So, she asked them since she had that vaccine allergy, what should I do because I was working, I was taking care of premature infants, I had my shot and so, I said what do I do if I react to the shot and he says you call for if you have one." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Considering close temporal association, the event of Angina pectoris is assessed as related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Neck pain, Physical examination
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my allergic reactions; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; This is a spontaneous report received from a Nurse from medical information team. A 72-year-old female patient received BNT162b2 (BNT162B2), in Dec2019 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "elevated cholesterol level" (unspecified if ongoing); "elevated calcium levels" (unspecified if ongoing); "food allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Shingrix vaccine (DOSE 1, SINGLE), administration date: 2019, for Immunization, reaction(s): "blisters and a circle around her left lower leg above the ankle"; Shingrix vaccine (DOSE 2, SINGLE), administration date: 2019, for Immunization, reaction(s): "blister in a circle below the shot in her right arm"; Tetanus toxoid, for Immunization, reaction(s): "Allergic". The following information was reported: ANGINA PECTORIS (medically significant), EAR PAIN (non-serious), NECK PAIN (non-serious) all with onset Dec2019, latency 20 min after the suspect product(s) administration, outcome "unknown" and all described as "I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "my allergic reactions". The patient underwent the following laboratory tests and procedures: Blood test: (Jul2025) Unknown results; Computerised tomogram heart: (unspecified date) showed that she had calcium deposits,; (unspecified date) showed two of the veins in the heart; Lab work: (2025) Unknown results; physicals: (unspecified date) Unknown results. Therapeutic measures were not taken as a result of angina pectoris, ear pain, neck pain, hypersensitivity. Clinical course: The patient reported an adverse event that she experienced from the Pfizer Covid-19 vaccine last Dec2019. It was during the first release of the vaccine and only people in the hospital can have them. The reporter had a reaction to her first shot. She remembered it happened in the hospital where she works, around 5 o'clock in the afternoon. She had to use the stairs in the hospital, and then within 20 minutes after receiving the shot, while she was on the stairs, she sat down and experienced a stabbing pain in her heart, like a knife stabbing her heart. It felt like a knife was stabbing both her ears, going down her neck, similar to a reaction she gets from food allergies. It was like a jellyfish stung her. The patient provided a brief history about the vaccines she had in the past and the reactions she experienced. One of them was the Shingrix vaccine. She had 2 Shingrix shots. The first time, she had blisters and a circle around her left lower leg above the ankle, and then on her second shot, she had another blister in a circle below the shot in her right arm. She also had a reaction with the tetanus toxoid, so she was not allowed to have any of those; she was allergic to tetanus toxoid. She was just telling about the reactions she had with other vaccines; she clarified that it was not related to the Covid vaccine. The patient said she was terrified to have the shot. She even asked her coworkers why she should have the vaccine. She was told to get it so she wouldn't end up in the ICU or on a respirator, so she said that okay, she'll get it. The one that she had with the Covid vaccine, she first reported to VAERS since her side effects were not on the list on the paperwork. She was referred to call Pfizer. She only had a reaction on the first shot, and in the second shot (booster) that she received around January, they were given Tylenol and she did not experience any side effects. They had a calcium CT scan on her heart and it showed that she had calcium deposits, and her husband and daughter have had the vaccines and they have that too, so they're on statins now and that was like 5 years after the vaccine. She had bloodwork last month, and she has her physicals twice a year with her doctor. The reason for the transfer was she was asked if she wants to know what she should do next if she gets the Covid vaccine, so she said sure, so that's why she was transferred to (withheld), so she can find out what to do. Before, she asked what she could have done when she had the reaction to the shot. She was told to call the rapid response team, but she didn't call anybody. She got away and took care of her babies. The patients HCP had not mention for her to have any more vaccines, she did tell her that she had that but she wanted to make sure that her HCP can check her. When probed if consumer took any Pfizer vaccine on the same date or 4 weeks prior, patient stated, her hospital was offering them and she did not want one. She was terrified to get that vaccine because she did not know, She was allergic to the Tetanus Toxoid and may have had an allergic response which she had this after her other vaccine, but was wondering if she could have, the Shingrix she had before, it was in 2019 and so, she had blisters in a circle around my ankle with that vaccine the first shot, the second shot, had blisters in a circle around my right arm which is where she had the vaccine given both times. When clarified if consumer took Pfizer COVID-19 vaccine and Shingrix, consumer stated, "No, I do not have any, I do not take vaccines together. I give them, I am a pediatric RN in (withheld). Pfizer is the one that she had. I have all the paperwork, it is Pfizer and anyway, that was the one that she had. They did not have the (withheld) one quite yet, her daughter had that one, but she had the Pfizer. That was the only one available when she had it. she have not had the Shingles vaccine a year and a half before approximately, she had the COVID vaccines. Yes, they were giving the vaccines to healthcare workers first she was one of those people. Yes, she had the two. She reacted to the first one with that was not on the list on the paperwork that they gave them with the Pfizer vaccine at the hospital and so, she reported it, but she found out and she called VAERS with her allergic reactions. Other medical conditions and other medication: Consumer stated, "At the time no, she was taking statins now, but was not taking them before. Rosuvastatin, elevated cholesterol level, it has gone way down, but she did have a CT scan of her heart a year and a little about a year and a half ago and it showed two of the veins in the heart, widowmaker, and the other one that she had elevated calcium levels and her daughter has it too and so, and her husband (Further details was not available). Patient not had any lab tests in two weeks but had some about a month ago. Patient did not hd any treatments for the events. Consumer stated, "The blisters were from the Shingles vaccine. The COVID vaccine, she had started with in 20 minutes, she had stabbing like knife stabbing in her heart and she had stabbing in both of her ears radiating down her neck and she received no treatment. I called VAERS because they were not on the list, those reactions were not on the VAERS list for the COVID. So, I called them, but I did not know I needed to call you." Anatomical location or site of administration: Consumer stated, "The right arm, they wanted to give it to her left arm, but she only take vaccine shots in her right arm always." Route of administration: Consumer stated, she cannot remember, she was very paranoid of needles. she did not look and see what either she do not ever watch. It was straight in, she did not do it at an angle, it was straight in. If any adverse event resulted in hospitalization: Consumer stated, "No, she had asked them because she was allergic to the Tetanus Toxoid. So, she asked them since she had that vaccine allergy, what should I do because I was working, I was taking care of premature infants, I had my shot and so, I said what do I do if I react to the shot and he says you call for if you have one." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Considering close temporal association, the event of Angina pectoris is assessed as related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Mammogram
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lymph node enlargement; Generic flu like symptoms; This is a spontaneous report received from a Nurse. A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node enlargement"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Generic flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500165860 same patient, different dose;US-PFIZER INC-202500165859 same patient, different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "auto immune issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE (All my shots are through Pfizer)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient was just prescribed Paxlovid. Maybe she got crazy symptoms and she not thinking. 5 1/2 years, she has not had COVID and suddenly she was at a wedding, and she thought that's how she got it this weekend. She hasn't had anything for 5 1/2 years thanks to Pfizer. But you know being at a wedding with 5 million people around me and no masks she guess she can see how it happened. All my shots are through Pfizer, every one of them. It's just she was super high risk she have auto immune issues. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
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pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: Feb2017 (ongoing); "Interstitial lung disease", start date: Feb2017 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 31.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Acne, Anorectal discomfort, Erythema, Exercise tolerance decreased, Pelvic discomfort
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Rash on scalp with puss mixed with clear fluid. Rash on both hands on the back of them. Brief flash Rash on forearms.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 31.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Penile burning sensation, Pruritus, Rash
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Rash on scalp with puss mixed with clear fluid. Rash on both hands on the back of them. Brief flash Rash on forearms.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 31.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Rash, Skin discharge
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Rash on scalp with puss mixed with clear fluid. Rash on both hands on the back of them. Brief flash Rash on forearms.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
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Pharmacist gave wrong vaccine; Arexvy in pregnancy; Arexvy in pregnancy; Arexvy at 35 years; anxiety; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of anxiety in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number withheld rx#, expiry date 25-OCT-2025) for prophylaxis. On 07-AUG-2025, the patient received the 1st dose of Arexvy. On 07-AUG-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Pharmacist gave wrong vaccine), vaccine exposure during pregnancy (Verbatim: Arexvy in pregnancy), drug use in unapproved population (Verbatim: Arexvy in pregnancy) and inappropriate age at vaccine administration (Verbatim: Arexvy at 35 years). In AUG-2025, the patient experienced anxiety (Verbatim: anxiety). The outcome of the anxiety was not reported and the outcome of the wrong vaccine administered, vaccine exposure during pregnancy, drug use in unapproved population and inappropriate age at vaccine administration were not applicable. It was unknown if the reporter considered the anxiety to be related to Arexvy. It was unknown if the company considered the anxiety to be related to Arexvy. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Estimated Delivery/Due date: 24-SEP-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 10-AUG-2025 Vaccine not approved for Pregnant women. Pharmacist gave wrong vaccine and administered to 35 years pregnant patient which led to wrong vaccine administered, vaccine exposure during pregnancy, drug use in unapproved population and inappropriate age at vaccine administration. Concerns about premature delivery and concerns about protection for newborn, and her anxiety clear pharmacist error. Had 120-dollar co pay as well and newborn still may need Mab. Swelling concern for her unborn post care follow up.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
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pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 2, single (Lot number: EW0150) at the age of 74 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: Feb2017 (ongoing); "Interstitial lung disease", start date: Feb2017 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 13Mar2021, for COVID-19 Immunization, reaction(s): "tiredness", "pain at injection site", "fever". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: COVID-19: positive. Clinical course: During an inbound call for financial assistance, the patient, stated, "she felt real lousy and for the first time, in her entire life this is the first time she tested positive for COVID. She dodged all the bullets but today. She worked part-time. She left there without the medicine, and she would still like to get it cause she felt really lousy, and she just started feeling sick yesterday." When gathering her demographics to enroll in the program, stated, her voice, she had got another issue with (inaudible) her throat was really, really sore." After playing the patient authorization for electronic income verification recording, stated, "Yes, she did, she was confused but she don't care if she was confused, she would be honest with them, Pfizer has saved her life. She have had all the vaccines that she could possibly get, and She had never caught it until today, in 5 years. She was a little shocked, she thought she was going to get away with not getting it". The coughing was coming in now...she need that Paxlovid, she need the Paxlovid, she need it". Later stated, "as long as she don't feel sick." Towards the end of the call, stated," pretty soon the symptoms just started yesterday so. She wanted to get that drug." When offering to transfer the call to the DSU, stated, "Briefly, her throat was very sore, but she can sing. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Echocardiogram normal, Headache, Hypertensive emergency, Troponin increased, Vision blurred
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she was in a hypertensive emergency/hypertension /headache/ blurred vision; Her Troponin level is elevated; This serious case was reported by a physician via call center representative and described the occurrence of hypertensive emergency in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number D2343, expiry date 31-JAN-2026) for prophylaxis. On 28-JUL-2025 15:00, the patient received Menveo (intramuscular). On 29-JUL-2025 03:00, 1 days after receiving Menveo, the patient experienced hypertensive emergency (Verbatim: she was in a hypertensive emergency/hypertension /headache/ blurred vision) (serious criteria hospitalization and GSK medically significant) and troponin increased (Verbatim: Her Troponin level is elevated) (serious criteria hospitalization). The outcome of the hypertensive emergency and troponin increased were not resolved. The reporter considered the hypertensive emergency and troponin increased to be related to Menveo. The company considered the hypertensive emergency and troponin increased to be related to Menveo. Additional Information: GSK Receipt Date: 05-AUG-2025 and 06-AUG-2025 The Medical Doctor reported that her patient had blurring vision and headaches shortly after receiving the dose of Menveo vaccine. The reporter stated 12 hours after the vaccination she was in a hypertensive emergency at the Emergency Room with hypertension and hospitalized for a week. Her blood pressure had risen from 112/80 to over 200/110 and her Troponin level was elevated but the echogram is normal. The doctor requested as soon as possible any report of hypertension extremely refractory with no response to medication, and blurry vision in adolescent or young adults after Menveo shots. The need to find an urgent cause to this situation; Sender's Comments: A case of Hypertensive emergency and troponin increased, 1 days after receiving Menveo. in a 18-year-old female patient Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Loss of consciousness
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I was knocked out for 2 days; This serious case was reported by a consumer via interactive digital media and described the occurrence of loss of consciousness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced loss of consciousness (Verbatim: I was knocked out for 2 days) (serious criteria GSK medically significant). The outcome of the loss of consciousness was resolved (duration 2 days). It was unknown if the reporter considered the loss of consciousness to be related to Shingles vaccine. The company considered the loss of consciousness to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the 1st shot on Tuesday and it kicked patient's butt. The patient was knocked out for 2 days and would definitely take off from work for the 2nd shot.; Sender's Comments: A case of Loss of consciousness, unknown time after receiving Shingles vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Glucose urine present, Lethargy, Pollakiuria, Thirst
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We collectively obtained the COVID vaccine in preparation of travel from (withheld) to (withheld) on 11/3. During travel around 11/6-11/7 patient began presenting symptoms of extreme thirst and frequent urination and was very lethargic and began losing weight. Unbeknownst to us these are classic signs of diabetes for someone who is in a state of diabetic ketoacidosis. U
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
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We collectively obtained the COVID vaccine in preparation of travel from (withheld) to (withheld) on 11/3. During travel around 11/6-11/7 patient began presenting symptoms of extreme thirst and frequent urination and was very lethargic and began losing weight. Unbeknownst to us these are classic signs of diabetes for someone who is in a state of diabetic ketoacidosis. U
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain
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Patient has redness at injection site and surrounding area about the size of a baseball. Patient states the area is tender to touch. She is also complaining of itching. She is taking tylenol and motrin with minimal benefit. She is also complaining that it is painful to lift the arm. Consulted patient to take benadryl for the itching and try alternating with warm and cold compresses for pain relief. Also let ptnt know let MD know if pain worsens or is not relieved within 72 hours.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: MENB
Symptoms: Immunodeficiency
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Immunocompromised status after Bexsero 2 doses; This serious case was reported by a physician via call center representative and described the occurrence of immunocompromised in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: Immunocompromised status after Bexsero 2 doses) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the immunocompromised to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date :07-AUG-2025 and 08-AUG-2025 Physician reported that a patient had received 2 doses of Bexsero and later became immunocompromised. The reporter wanted to ask should they receive additional dose(s) of Bexsero or not. The reporter consented to follow up.; Sender's Comments: A case of Immunodeficiency, unknown date after Bexsero and Bexsero Pre-Filled Syringe Device, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: Haematological neoplasm
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blood cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOLOGICAL NEOPLASM (blood cancer) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HAEMATOLOGICAL NEOPLASM (blood cancer) (seriousness criterion medically significant). At the time of the report, HAEMATOLOGICAL NEOPLASM (blood cancer) had resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medication was reported. It was stated that patient has blood cancer they did not knew when it started or if the vaccine impacted it in any ways. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Pyrexia, Tremor
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shaking; felt awful and didn't get out of bed; pretty down; feeling feverish; This spontaneous case was reported by a pharmacist and describes the occurrence of TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Pulmonary disorder. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish). In 2024, TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish) had resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient not had other vaccines within the past 4 weeks. The patient was felt feverish, shaky and pretty down for 17 hours. She felt awful and didn't get out of bed but then was back normal. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal neoplasm, Biopsy, Biopsy lung, Borrelia test, Colonoscopy
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have a dark color/On the back side of left thigh it has been dark since the front one was surgically removed; two polyps; same lump in the left side left lung; several very large lumps +6 inches diameter/lump on left thigh, on backside and frontside; few large lumps like 6 inch in diameter/third one is on right side, lower rib cage; few large lumps like 6 inch in diameter/Fourth one is in middle of spine, on her back; few large lumps like 6 inch in diameter that were now into lymph node areas; lymphoma; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID. A 64-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EW0162) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "allergies/Allergy" (unspecified if ongoing); "bones" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral taken for blood cholesterol abnormal, stop date: 2023; LEVOTHYROXIN oral taken for thyroid disorder, stop date: 2023; MONTELUKAST oral taken for drug hypersensitivity, stop date: 2023; CETIRIZINE oral taken for drug hypersensitivity (ongoing); IBANDRONATE SODIUM oral taken for bone disorder, stop date: 2023. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6204, left arm), administration date: 18Mar2021, when the patient was 64-year-old, for Covid-19 immunization. At the end of Apr2021, the patient experienced lumps that were not painful at first and now they were painful. She have several very large lumps +6 inches diameter following receiving the Pfizer covid vaccine. She had few large lumps like 6 inch in diameter that were now into lymph node areas. They have a dark color and now have burning pain. They are also located on backside of left thigh, hamstring. The next one is on left side of the left thigh. Third one is on right side, lower rib cage. Fourth one is in middle of spine, on her back. She also had, two previous ones on left leg front side of thigh lump and these were biopsied and surgically removed. One had two punch biopsied and one surgically removed. On the back side of left thigh, it has been dark since the front one was surgically removed. The patient also have same lump in the left side left lung. She can no longer sleep on her right side. These were burning pain in large lump. As per patient's husband, this seems this is a very serious issue. She has never had lumps before. This was all after the covid shot. She saw the doctor about the lumps in May2022 or Jun2022. She was then sent to her the surgeon in Jun2022 who did original bunch biopsy on one of the lumps. It was inconclusive. She was then sent to a dermatologist who did the second punch biopsy on the same lump. Those results were inconclusive. She was then sent to oncology and oncology ordered the Pet Scan. As a result of the Pet Scan, she was sent to a surgeon who surgically removed the entire second lump on 25Jan2023. The lump was sent and came back like it was lymphoma, or looks like lymphoma. This was during the holiday period of 2022 into 2023. She went through hell for a month and a half waiting for results. Then she got results back like it was not lymphoma, but they do not know what it is. She was sent back to her physician. The patient underwent the following laboratory tests and procedures: Biopsy: (2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; (Jun2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; Biopsy lung: (unspecified date) Unknown results; Borrelia test: (09May2023) negative; Colonoscopy: (21Dec2022) Unknown results; HIV test: (unspecified date) Unknown results; Positron emission tomogram: (08Dec2022) was lit up. On 21Dec2022, patient had removed two polyps. Patient mentioned has a lot of paperwork regarding testing that has occurred. Her doctor was going to send her to a place where test for communicable diseases. They've been to six different physicians and nothing. They have been referring the patient to different physicians and neither one knew what it was. They have run her through so many different test, biopsies, and they scared the mess out of her thinking she had lymphoma. They do not know what it was. After all the test done, they still did not know what it was, what to test for, or what to do. She was told certainly she was not the only one that has these lumps. The patient would like to know what to do or any information about these lumps. Recently, she has been having pain. The lumps were not painful at first. It was just an ugly eye sore. However, now within the last two weeks lumps are painful. The lump on right now, the lump on right rib cage, it is big now. She can no longer tolerate pressure on it. When sleeping, she cannot turn on that side to sleep. It is very painful. After 2.5 years will go ahead and made appointment with doctor will be seeing her doctor on 27Aug2025 at 15:30. Outcome of the darkened skin and polyp was unknown while of the remaining events was not recovered.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Limb mass, Lymphadenopathy, Lymphoma, Neoplasm
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have a dark color/On the back side of left thigh it has been dark since the front one was surgically removed; two polyps; same lump in the left side left lung; several very large lumps +6 inches diameter/lump on left thigh, on backside and frontside; few large lumps like 6 inch in diameter/third one is on right side, lower rib cage; few large lumps like 6 inch in diameter/Fourth one is in middle of spine, on her back; few large lumps like 6 inch in diameter that were now into lymph node areas; lymphoma; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID. A 64-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EW0162) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "allergies/Allergy" (unspecified if ongoing); "bones" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral taken for blood cholesterol abnormal, stop date: 2023; LEVOTHYROXIN oral taken for thyroid disorder, stop date: 2023; MONTELUKAST oral taken for drug hypersensitivity, stop date: 2023; CETIRIZINE oral taken for drug hypersensitivity (ongoing); IBANDRONATE SODIUM oral taken for bone disorder, stop date: 2023. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6204, left arm), administration date: 18Mar2021, when the patient was 64-year-old, for Covid-19 immunization. At the end of Apr2021, the patient experienced lumps that were not painful at first and now they were painful. She have several very large lumps +6 inches diameter following receiving the Pfizer covid vaccine. She had few large lumps like 6 inch in diameter that were now into lymph node areas. They have a dark color and now have burning pain. They are also located on backside of left thigh, hamstring. The next one is on left side of the left thigh. Third one is on right side, lower rib cage. Fourth one is in middle of spine, on her back. She also had, two previous ones on left leg front side of thigh lump and these were biopsied and surgically removed. One had two punch biopsied and one surgically removed. On the back side of left thigh, it has been dark since the front one was surgically removed. The patient also have same lump in the left side left lung. She can no longer sleep on her right side. These were burning pain in large lump. As per patient's husband, this seems this is a very serious issue. She has never had lumps before. This was all after the covid shot. She saw the doctor about the lumps in May2022 or Jun2022. She was then sent to her the surgeon in Jun2022 who did original bunch biopsy on one of the lumps. It was inconclusive. She was then sent to a dermatologist who did the second punch biopsy on the same lump. Those results were inconclusive. She was then sent to oncology and oncology ordered the Pet Scan. As a result of the Pet Scan, she was sent to a surgeon who surgically removed the entire second lump on 25Jan2023. The lump was sent and came back like it was lymphoma, or looks like lymphoma. This was during the holiday period of 2022 into 2023. She went through hell for a month and a half waiting for results. Then she got results back like it was not lymphoma, but they do not know what it is. She was sent back to her physician. The patient underwent the following laboratory tests and procedures: Biopsy: (2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; (Jun2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; Biopsy lung: (unspecified date) Unknown results; Borrelia test: (09May2023) negative; Colonoscopy: (21Dec2022) Unknown results; HIV test: (unspecified date) Unknown results; Positron emission tomogram: (08Dec2022) was lit up. On 21Dec2022, patient had removed two polyps. Patient mentioned has a lot of paperwork regarding testing that has occurred. Her doctor was going to send her to a place where test for communicable diseases. They've been to six different physicians and nothing. They have been referring the patient to different physicians and neither one knew what it was. They have run her through so many different test, biopsies, and they scared the mess out of her thinking she had lymphoma. They do not know what it was. After all the test done, they still did not know what it was, what to test for, or what to do. She was told certainly she was not the only one that has these lumps. The patient would like to know what to do or any information about these lumps. Recently, she has been having pain. The lumps were not painful at first. It was just an ugly eye sore. However, now within the last two weeks lumps are painful. The lump on right now, the lump on right rib cage, it is big now. She can no longer tolerate pressure on it. When sleeping, she cannot turn on that side to sleep. It is very painful. After 2.5 years will go ahead and made appointment with doctor will be seeing her doctor on 27Aug2025 at 15:30. Outcome of the darkened skin and polyp was unknown while of the remaining events was not recovered.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Polyp, Positron emission tomogram, Pulmonary mass, Skin discolouration
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have a dark color/On the back side of left thigh it has been dark since the front one was surgically removed; two polyps; same lump in the left side left lung; several very large lumps +6 inches diameter/lump on left thigh, on backside and frontside; few large lumps like 6 inch in diameter/third one is on right side, lower rib cage; few large lumps like 6 inch in diameter/Fourth one is in middle of spine, on her back; few large lumps like 6 inch in diameter that were now into lymph node areas; lymphoma; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID. A 64-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EW0162) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "allergies/Allergy" (unspecified if ongoing); "bones" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral taken for blood cholesterol abnormal, stop date: 2023; LEVOTHYROXIN oral taken for thyroid disorder, stop date: 2023; MONTELUKAST oral taken for drug hypersensitivity, stop date: 2023; CETIRIZINE oral taken for drug hypersensitivity (ongoing); IBANDRONATE SODIUM oral taken for bone disorder, stop date: 2023. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6204, left arm), administration date: 18Mar2021, when the patient was 64-year-old, for Covid-19 immunization. At the end of Apr2021, the patient experienced lumps that were not painful at first and now they were painful. She have several very large lumps +6 inches diameter following receiving the Pfizer covid vaccine. She had few large lumps like 6 inch in diameter that were now into lymph node areas. They have a dark color and now have burning pain. They are also located on backside of left thigh, hamstring. The next one is on left side of the left thigh. Third one is on right side, lower rib cage. Fourth one is in middle of spine, on her back. She also had, two previous ones on left leg front side of thigh lump and these were biopsied and surgically removed. One had two punch biopsied and one surgically removed. On the back side of left thigh, it has been dark since the front one was surgically removed. The patient also have same lump in the left side left lung. She can no longer sleep on her right side. These were burning pain in large lump. As per patient's husband, this seems this is a very serious issue. She has never had lumps before. This was all after the covid shot. She saw the doctor about the lumps in May2022 or Jun2022. She was then sent to her the surgeon in Jun2022 who did original bunch biopsy on one of the lumps. It was inconclusive. She was then sent to a dermatologist who did the second punch biopsy on the same lump. Those results were inconclusive. She was then sent to oncology and oncology ordered the Pet Scan. As a result of the Pet Scan, she was sent to a surgeon who surgically removed the entire second lump on 25Jan2023. The lump was sent and came back like it was lymphoma, or looks like lymphoma. This was during the holiday period of 2022 into 2023. She went through hell for a month and a half waiting for results. Then she got results back like it was not lymphoma, but they do not know what it is. She was sent back to her physician. The patient underwent the following laboratory tests and procedures: Biopsy: (2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; (Jun2022) inconclusive, notes: two punch bunch biopsy - the first one was done at a clinic. They could not make heads or tails out of it. Clarified, statement as, he was not sure of the results, said had indications of lymphoma; Biopsy lung: (unspecified date) Unknown results; Borrelia test: (09May2023) negative; Colonoscopy: (21Dec2022) Unknown results; HIV test: (unspecified date) Unknown results; Positron emission tomogram: (08Dec2022) was lit up. On 21Dec2022, patient had removed two polyps. Patient mentioned has a lot of paperwork regarding testing that has occurred. Her doctor was going to send her to a place where test for communicable diseases. They've been to six different physicians and nothing. They have been referring the patient to different physicians and neither one knew what it was. They have run her through so many different test, biopsies, and they scared the mess out of her thinking she had lymphoma. They do not know what it was. After all the test done, they still did not know what it was, what to test for, or what to do. She was told certainly she was not the only one that has these lumps. The patient would like to know what to do or any information about these lumps. Recently, she has been having pain. The lumps were not painful at first. It was just an ugly eye sore. However, now within the last two weeks lumps are painful. The lump on right now, the lump on right rib cage, it is big now. She can no longer tolerate pressure on it. When sleeping, she cannot turn on that side to sleep. It is very painful. After 2.5 years will go ahead and made appointment with doctor will be seeing her doctor on 27Aug2025 at 15:30. Outcome of the darkened skin and polyp was unknown while of the remaining events was not recovered.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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tested positive for the covid spike protein which is very high; tested positive for the covid spike protein which is very high; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for the covid spike protein which is very high". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
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came down with COVID/had the flu or something/at home tests, and they both came back positive, and then I had the razor blade sensation in my throat; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Aug2025 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary DOSE SERIES complete (had the Pfizer vaccine in the past and never had a problem)), for COVID-19 immunization, reaction(s): "No adverse reaction ". The following information was reported: COVID-19 (non-serious) with onset 12Aug2025, outcome "unknown", described as "came down with COVID/had the flu or something/at home tests, and they both came back positive, and then I had the razor blade sensation in my throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Clinical course: During an inbound call for additional information regarding eligibility, the patient stated, I was calling regarding a conversation that I had last Friday with a representative from Pfizer regarding the Paxlovid antiviral medication. Later, she stated she received the COVID booster on August 9, and on August 12, this past Tuesday, I came down with COVID. So I was kind of shocked to have that happen to me because I had the Pfizer vaccine in the past and never had a problem. This is the first time I've had COVID ever after confirming she had the booster and then came down with COVID, she stated, "Yeah. 3 days later, she came down with COVID, the Nimbus variant. I was kind of shocked. I thought maybe I had the flu or something, but then I did 2 at home tests, and they both came back positive, and then I had the razor blade sensation in my throat. The severe sore throat, and I looked up the information online, and they said there was a variation called the Nimbus variant. Have you ever heard of anybody getting COVID after they had the vaccine. Later, she stated, she have received like many Pfizer vaccines over the years, and she was totally in shock that 3 days later, after she got the current booster shot, she came down with COVID. So she was not expecting that at all. The information on the batch/lot number for BNT162b2 omicron (kp.2), BNT162b2 will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cerebral infarction, Cerebrovascular accident, Pain in extremity
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multiple strokes; inoperable brain blockage; asthma; a bit of arm pain after vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years. Unknown dose number, Unknown manufacturer.), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "not recovered", described as "multiple strokes"; CEREBRAL INFARCTION (medically significant), outcome "not recovered", described as "inoperable brain blockage"; ASTHMA (non-serious), outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "a bit of arm pain after vaccines". Therapeutic measures were taken as a result of cerebrovascular accident, cerebral infarction, asthma. Clinical information: On 18Aug2025, it was reported that caller stated patient had multiple strokes, had an inoperable brain blockage and asthma. Patient was taking multiple medications for her conditions and has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years, caller indicated a bit of arm pain after vaccines. Created AE due to existing conditions as well as interaction with other medications. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events Stroke and Brain infarction are considered unrelated to the suspect drug, as it is explained by an alternative mechanism unrelated to the pharmacological action of the drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
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Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Other HCP. A female patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization, reaction(s): "Generic flu like symptoms", "lymph node enlargement". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Generic flu like symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node enlargement". Additional Information: Clarified today, 18Aug2025, is day caller made aware of adverse events. Clarified, there were 2 different side effects. Lymph node enlargement: When caller asked when this side effect started, caller states, there were 2 side effects, reporter was saying to caller, that would usually occur every time she got Covid vaccine, back in 2021, 2022, 2023. That is what reporter is guessing. This occurred when getting 2 dose primary series, occurring both with first and second doses. The lymph node enlargement required her to get a mammogram, and lasted about 6 months. Generic flu like symptoms: Clarified second side effect as, just generic flu like symptoms, lasted about 4 days. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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he got Covid after getting the Covid-19 vaccine 2 weeks ago; he got Covid after getting the Covid-19 vaccine 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "unknown" and all described as "he got Covid after getting the Covid-19 vaccine 2 weeks ago". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Fatigue, Musculoskeletal chest pain, Pain
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PATIENT RECEIVED VACCINE FRIDAY AFTERNOON. AT TIME OF VACCINE AND PRIOR PHONE CALL HE SEEMED NERVOUS ABOUT POTENTIAL SIDE EFFECTS BECAUSE HE HAD EXTREMELY SORE ARM AFTER RSV. WE HAD THE OPINION THAT HE MAY HAVE BEEN MENTALLY COMPROMISED DUE TO SPEECH AND BEHAVIOR. HE SAID HE FELT FINE FRIDAY BUT WOKE UP SATURDAY FEELING LOUSY(TIRED, ACHEY AND HAD CHEST PAIN) IN SPEAKING WITH ER THEY NOTED FLU VACCINE ADMINISTERED BUT DID NOT LINK CHESTWALL PAIN SPECIFICALLY TO FLU VACCINE. PATIENT HAS RECEIVED ANNUAL FLU SHOTS FOR MULTIPLE YEARS
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 78.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Erythema
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patient came into pharmacy and showed us that his lower arm was red. it wasnt itchy, swollen, or hot to the touch though. he wondered if the redness couldve been caused by the vaccines. the pharmacist said to take a bendaryl or use benadryl cream if it became itchy or swollen and to contact his doctor.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
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I gave the tetanus shot in the left arm and then proceeded to administer the flu shot in the Right arm. After injecting the flu shot, the patient said" I think you hit a nerve" He fainted. In 2 minutes, he woke up. I gave him orange juice, and water and an ice pack for his neck because he warm to the touch.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: HPV9
Symptoms: Blood pressure immeasurable, Enanthema, Pallor, Rash, Respiratory arrest
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patient fainted and according to the doctor was "unresponsive for about 10 seconds"/patient was pale; not breathing; "some kind of mucosal rash" on the mouth and lips; Caller stated HCP reported patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30; glucocagon for possible low blood sugar; patient had a rash on her chest; This spontaneous report was received from a physician and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by unknown route (lot # and expiration date were not reported) as prophylaxis. On an unknown date, after receiving first dose, the patient fainted and according to the doctor was "unresponsive for about 10 seconds". 9-1-1 was called. She was pale and not breathing. The patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30". HCP gave patient glucagon for possible low blood sugar. HCP stated ambulance finally came, however mother refused her daughter to go to the emergency room, because the patient "seemed to be coming around". The patient's mother called the office and stated patient had a rash on her chest and "some kind of mucosal rash" on the mouth and lips. HCP sent the patient to emergency room where she was given steroids and Benadryl and was sent home. HCP stated both "eventually resolved" and stated that the patient was referred to a cardiologist. Dates of all events were unknown. No additional information provided. At the reporting time, the outcome of blood pressure decreased and sugar blood decreased was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. The reporter considered the all of the events to be life-threatening.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: HPV9
Symptoms: Syncope, Unresponsive to stimuli
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patient fainted and according to the doctor was "unresponsive for about 10 seconds"/patient was pale; not breathing; "some kind of mucosal rash" on the mouth and lips; Caller stated HCP reported patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30; glucocagon for possible low blood sugar; patient had a rash on her chest; This spontaneous report was received from a physician and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by unknown route (lot # and expiration date were not reported) as prophylaxis. On an unknown date, after receiving first dose, the patient fainted and according to the doctor was "unresponsive for about 10 seconds". 9-1-1 was called. She was pale and not breathing. The patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30". HCP gave patient glucagon for possible low blood sugar. HCP stated ambulance finally came, however mother refused her daughter to go to the emergency room, because the patient "seemed to be coming around". The patient's mother called the office and stated patient had a rash on her chest and "some kind of mucosal rash" on the mouth and lips. HCP sent the patient to emergency room where she was given steroids and Benadryl and was sent home. HCP stated both "eventually resolved" and stated that the patient was referred to a cardiologist. Dates of all events were unknown. No additional information provided. At the reporting time, the outcome of blood pressure decreased and sugar blood decreased was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. The reporter considered the all of the events to be life-threatening.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: HPV9
Symptoms: Cervicectomy
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GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) caused a removal of cervix (Hysterectomy) for 2 daughters (This report refers to one of them and the other female patient was captured in case # 2320738) and one daughter developed a "knot" on her breast (Captured in case # 2320739). At the reporting time, the outcome of hysterectomy was not provided. The reporter considered the event of hysterectomy to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). Upon internal review, the event of hysterectomy was considered medically significant. This is one of three reports from the same reporter.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: HPV9
Symptoms: Cervicectomy
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GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) caused a removal of cervix (Hysterectomy) for 2 daughters (This report refers to one of them and the other female patient was captured in case # 2320735) and one daughter developed a "knot" on her breast (Captured in case # 2320739). At the reporting time, the outcome of hysterectomy was not provided. The reporter considered the event of hysterectomy to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). Upon internal review, the event of hysterectomy was considered medically significant. This is one of three reports from the same reporter.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Adrenal insufficiency, Central vision loss, Raynaud's phenomenon, Retinal operation, Retinal tear
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retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Raynauds; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal tear in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced retinal tear (Verbatim: retina tear) (serious criteria GSK medically significant and clinically significant/intervention required), central vision loss (Verbatim: loss my center vision) (serious criteria GSK medically significant), rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), sjogren's (Verbatim: sjogrens) (serious criteria GSK medically significant), systemic lupus erythematosus (Verbatim: lupus) (serious criteria GSK medically significant), adrenal insufficiency (Verbatim: adrenal deficiency) (serious criteria GSK medically significant) and raynauds (Verbatim: Raynauds). The patient was treated with Steroids. The outcome of the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds were not reported and the outcome of the adrenal insufficiency was not resolved. It was unknown if the reporter considered the retinal tear, central vision loss and adrenal insufficiency to be related to Shingrix. The reporter considered the rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds to be related to Shingrix. The company considered the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and adrenal insufficiency to be unrelated to Shingrix. The company considered the raynauds to be related to Shingrix. Linked case(s) involving the same patient: US2021AMR198955 Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient received shingrix vaccine a few years ago (from reporting date) that triggered rheumatoid arthritis, sjogrens, raynauds, lupus and at the time of reporting also had adrenal deficiency that he/she steroid dependent on to live. The patient also developed a retina tear that had three surgeries on and loss his/her center vision. The patient would never tell anyone not to get a vaccine but dang sure would say to do some deep research beforehand.; Sender's Comments: A case of Retinal tear, Central vision loss, Rheumatoid arthritis, Sjogren's syndrome, Systemic Lupus erythematosus and Adrenal insufficiency, unknown time after receiving Shingrix in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GLAXOSMITHKLINE-US2021AMR198955:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Rheumatoid arthritis, Sjogren's syndrome, Systemic lupus erythematosus
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retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Raynauds; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal tear in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced retinal tear (Verbatim: retina tear) (serious criteria GSK medically significant and clinically significant/intervention required), central vision loss (Verbatim: loss my center vision) (serious criteria GSK medically significant), rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), sjogren's (Verbatim: sjogrens) (serious criteria GSK medically significant), systemic lupus erythematosus (Verbatim: lupus) (serious criteria GSK medically significant), adrenal insufficiency (Verbatim: adrenal deficiency) (serious criteria GSK medically significant) and raynauds (Verbatim: Raynauds). The patient was treated with Steroids. The outcome of the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds were not reported and the outcome of the adrenal insufficiency was not resolved. It was unknown if the reporter considered the retinal tear, central vision loss and adrenal insufficiency to be related to Shingrix. The reporter considered the rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds to be related to Shingrix. The company considered the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and adrenal insufficiency to be unrelated to Shingrix. The company considered the raynauds to be related to Shingrix. Linked case(s) involving the same patient: US2021AMR198955 Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient received shingrix vaccine a few years ago (from reporting date) that triggered rheumatoid arthritis, sjogrens, raynauds, lupus and at the time of reporting also had adrenal deficiency that he/she steroid dependent on to live. The patient also developed a retina tear that had three surgeries on and loss his/her center vision. The patient would never tell anyone not to get a vaccine but dang sure would say to do some deep research beforehand.; Sender's Comments: A case of Retinal tear, Central vision loss, Rheumatoid arthritis, Sjogren's syndrome, Systemic Lupus erythematosus and Adrenal insufficiency, unknown time after receiving Shingrix in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GLAXOSMITHKLINE-US2021AMR198955:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Pneumonia
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atrial fibrillation; pneumonia; This 76-year-old female subject was enrolled in an open label study titled A phase 3b, randomized, open label, multi-country,multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV withheld protocol #) study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 µg on 14-AUG-2025, for prophylaxis. On 30-DEC-2024, before receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 pneumonia (Verbatim: pneumonia). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation (Verbatim: atrial fibrillation) on 31-DEC-2024 with serious criteria of hospitalization. The outcome of pneumonia was resolved on 12-JAN-2025. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 02-JAN-2025). The investigator considered that there was no reasonable possibility that the pneumonia and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2025105120 GSK Receipt date: 14-Aug-2025, 15-Aug-2025 and 18-Aug-2025 Hospital admission date of pneumonia and atrial fibrillation was 30-Dec-2024. Hospital discharge date of pneumonia and atrial fibrillation was 12-Jan-2025. Date of event (pneumonia) became serious was 30-Dec-2024. Date of event (atrial fibrillation) became serious was 31-Dec-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI).; Sender's Comments: The company has assessed that it is unlikely that Pneumonia and Atrial fibrillation were caused by the study vaccine. The events occurred prior to vaccine administration. US-GSK-US2025105120:
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Mammogram
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Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Other HCP. A female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for covid-19 immunization, reaction(s): "Generic flu like symptoms", "Lymph node enlargement"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2022, for covid-19 immunization, reaction(s): "Generic flu like symptoms", "Lymph node enlargement". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node enlargement"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Generic flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter had some side effects, to the extent where, she was no longer going to take the mrna vaccine. Clarified, there were 2 different side effects. There were 2 side effects, that would usually occur every time she got Covid vaccine, back in 2021, 2022, 2023. That is what reporter was guessing. This occurred when getting 2 dose primary series, occurring both with first and second doses, with third booster dose, got a little bit of it but, was not as much as first and second primary doses. Guessing about the 2021, 2022 and 2023. They were back to back. reporter were thinking it started with first Covid pandemic, which was back in 2020, did not remember if 2020 or 2021 but put 2021, 2022 and 2023, to the best of their knowledge. The lymph node enlargement required her to get a mammogram, and lasted about 6 months. Believes reporter recovered from it. Clarified second side effect as, just generic flu like symptoms, lasted about 4 days. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500165794 same patient, different dose;US-PFIZER INC-202500165859 same patient, different dose;
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