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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 44.0
Vaccine: COVID19
Symptoms: Blindness, General physical health deterioration, Glomerulonephropathy, Immune system disorder, Multisystem inflammatory syndrome in adults
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Severe multisystem inflammatory response; Glomerular disease; Progressive respiratory failure; Permanent vision loss; Systemic immune dysfunction; Disabling neurological complications; Permanent organ damage; Experienced a rapid and devastating decline in health; This spontaneous case was reported by a consumer and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) and NERVOUS SYSTEM DISORDER (Disabling neurological complications) in a 44-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response) (seriousness criterion medically significant), GLOMERULONEPHROPATHY (Glomerular disease) (seriousness criterion medically significant), RESPIRATORY FAILURE (Progressive respiratory failure) (seriousness criterion medically significant), BLINDNESS (Permanent vision loss) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Disabling neurological complications) (seriousness criterion medically significant), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health). At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction), NERVOUS SYSTEM DISORDER (Disabling neurological complications), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. It was reported that they never provided full and truthful disclosure of known risks, nor afforded a meaningful opportunity to decline without severe consequences. The patient was at risk for both lung and kidney transplants, dependent on supplemental oxygen, and required coordinated care from over 14 medical specialties and ongoing high-cost treatments. There was no family history or genetic predisposition to the autoimmune and systemic complications that currently faced by the patient. The patient's condition arose in direct temporal proximity to the Moderna vaccine and progressed immediately thereafter. The patient's treating physicians supported this causal link. It was reported that the patient sustained a permanent medical disability, loss of life insurance eligibility, loss of retirement security and earning potential, ongoing costs of care (infusions, transplant evaluation, mobility aids, etc.), and irreversible harm to physical and mental health. Treatment medication name was not 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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Age: 44.0
Vaccine: COVID19
Symptoms: Nervous system disorder, Organ failure, Respiratory failure
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Severe multisystem inflammatory response; Glomerular disease; Progressive respiratory failure; Permanent vision loss; Systemic immune dysfunction; Disabling neurological complications; Permanent organ damage; Experienced a rapid and devastating decline in health; This spontaneous case was reported by a consumer and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) and NERVOUS SYSTEM DISORDER (Disabling neurological complications) in a 44-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response) (seriousness criterion medically significant), GLOMERULONEPHROPATHY (Glomerular disease) (seriousness criterion medically significant), RESPIRATORY FAILURE (Progressive respiratory failure) (seriousness criterion medically significant), BLINDNESS (Permanent vision loss) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Disabling neurological complications) (seriousness criterion medically significant), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health). At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction), NERVOUS SYSTEM DISORDER (Disabling neurological complications), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. It was reported that they never provided full and truthful disclosure of known risks, nor afforded a meaningful opportunity to decline without severe consequences. The patient was at risk for both lung and kidney transplants, dependent on supplemental oxygen, and required coordinated care from over 14 medical specialties and ongoing high-cost treatments. There was no family history or genetic predisposition to the autoimmune and systemic complications that currently faced by the patient. The patient's condition arose in direct temporal proximity to the Moderna vaccine and progressed immediately thereafter. The patient's treating physicians supported this causal link. It was reported that the patient sustained a permanent medical disability, loss of life insurance eligibility, loss of retirement security and earning potential, ongoing costs of care (infusions, transplant evaluation, mobility aids, etc.), and irreversible harm to physical and mental health. Treatment medication name was not 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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Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Illness, Oropharyngeal pain, Pain
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Sore throat; mild upper respiratory symptoms; he walks in the cold or the wind, the faster he walks, it becomes sore; worst sore throat that you can possibly imagine, the 'so-called razor blade; had the hallmark symptom of the nimbus strain; acute illness lasted about a week to a week and a half; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade) and COVID-19 (had the hallmark symptom of the nimbus strain) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 20-May-2025, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade), COVID-19 (had the hallmark symptom of the nimbus strain) and ILLNESS (acute illness lasted about a week to a week and a half). In 2025, ILLNESS (acute illness lasted about a week to a week and a half) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade) and COVID-19 (had the hallmark symptom of the nimbus strain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2025, SARS-CoV-2 test: (Negative) he didn't have a positive test. No concomitant medication was reported. It was reported that around 8 months after patient received the vaccine in September of 2024 in 20-May-2025, he had the hallmark symptom of the nimbus strain. It was the worst sore throat that he could possibly imagine, the 'so-called razor blade, sore throat'. He was highly vaccinated; there was some correlation between that (his symptoms) and being highly vaccinated. Patient didn't had a positive test and the test he did have at home, he did not used because it was past the expiration date. That ever since he started having those symptoms, he had it continuously after. The acute illness lasted about a week to a week and a half. The other symptoms he had were just mild upper respiratory symptoms, sore throat, if he drank alcohol, it became sore, if he drank at 5 in the evening, he would wake up with a sore throat. When he walked in the cold or the wind, the faster he walked, it became sore. If he stopped walking, it went away. These symptoms seemed to be getting better although it was all a sudden onset. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2025: Live significant follow-up received with patient DOB updated.
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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: M
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test
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Sore throat; mild upper respiratory symptoms; he walks in the cold or the wind, the faster he walks, it becomes sore; worst sore throat that you can possibly imagine, the 'so-called razor blade; had the hallmark symptom of the nimbus strain; acute illness lasted about a week to a week and a half; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade) and COVID-19 (had the hallmark symptom of the nimbus strain) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 20-May-2025, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade), COVID-19 (had the hallmark symptom of the nimbus strain) and ILLNESS (acute illness lasted about a week to a week and a half). In 2025, ILLNESS (acute illness lasted about a week to a week and a half) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade) and COVID-19 (had the hallmark symptom of the nimbus strain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2025, SARS-CoV-2 test: (Negative) he didn't have a positive test. No concomitant medication was reported. It was reported that around 8 months after patient received the vaccine in September of 2024 in 20-May-2025, he had the hallmark symptom of the nimbus strain. It was the worst sore throat that he could possibly imagine, the 'so-called razor blade, sore throat'. He was highly vaccinated; there was some correlation between that (his symptoms) and being highly vaccinated. Patient didn't had a positive test and the test he did have at home, he did not used because it was past the expiration date. That ever since he started having those symptoms, he had it continuously after. The acute illness lasted about a week to a week and a half. The other symptoms he had were just mild upper respiratory symptoms, sore throat, if he drank alcohol, it became sore, if he drank at 5 in the evening, he would wake up with a sore throat. When he walked in the cold or the wind, the faster he walked, it became sore. If he stopped walking, it went away. These symptoms seemed to be getting better although it was all a sudden onset. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2025: Live significant follow-up received with patient DOB updated.
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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: COVID19
Symptoms: Arthritis, Blindness, Brain stem haemorrhage, Brain stem stroke, Pain in extremity
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She had a brain bleed on her medulla oblongata, the brain stem; she had a massive stroke; After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm; There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful; She would probably say it's just arthritis; went blind/in and out of blindness; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem), BRAIN STEM STROKE (she had a massive stroke) and BLINDNESS (went blind/in and out of blindness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: smallpox; for Drug use for unknown indication: penicillin (a long time ago as a young girl and hard shot.). Past adverse reactions to the above products included Mobility decreased with penicillin; and No adverse effect with smallpox. Concurrent medical conditions included Blood pressure high (hereditary). On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem) (seriousness criteria hospitalization and medically significant) and BRAIN STEM STROKE (she had a massive stroke) (seriousness criteria hospitalization and medically significant). On 21-Jul-2025, the patient experienced BLINDNESS (went blind/in and out of blindness) (seriousness criterion medically significant). On an unknown date, the patient experienced PIGMENTATION DISORDER (After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm), PAIN IN EXTREMITY (There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful) and ARTHRITIS (She would probably say it's just arthritis). The patient was treated with Lidocaine hydrochloride (Lidocaine) at an unspecified dose and frequency. At the time of the report, BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem) and BRAIN STEM STROKE (she had a massive stroke) had resolved, BLINDNESS (went blind/in and out of blindness), PIGMENTATION DISORDER (After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm) and PAIN IN EXTREMITY (There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful) had not resolved and ARTHRITIS (She would probably say it's just arthritis) outcome was unknown. Concomitant medication was not reported. It was reported that patient did not receive any vaccines 4 weeks prior to her Spikevax Moderna COVID-19 vaccines. She was healthy and mother of 8 children all by natural birth. On 21-Jul-2021, she had a massive stroke. She had a brain bleed on her medulla oblongata, the brain stem. She went blind. And then they transported her. From that vantage, she also had a DNR and then the doctors gave her up, they told she not gonna make it. Patient had been suffering. The 2 injections were put in her left arm. She was dominant in her right arm, she was right-handed. She wanted her Moderna shot in her left arm in case she had some of the same effects of the penicillin vaccine. After receiving her 2 Spikevax vaccines in her left arm, there was a black mark on her arm near her smallpox vaccination and it was never gone away. Her left arm, she had been in pain. It was reported that, there was not a day that goes by where her arm did not hurt, and she can't use it. She was suffering. Patient suffers with her left arm every day, excruciating pain and then it will let up. She could tell the team they can see the black mark on her arm. Her arm hurts so bad, she could not hold it up, it was just hanging on her body and walking was painful. She went blind. She was going in and out of blindness. patient thought it was her glasses. She drove herself to the ophthalmologist and doesn't know how she got there without having a wreck. The doctor told her she was having a brain stroke. Caller was in and out of consciousness then. She went to hospital, and then took an ambulance. The doctor said they will give her something to probably get her there in time. After that, she was in the ICU. It was confirmed that resolved over time and she now still had the symptom of pain in her left arm and a black mark that was never there. It was where the vaccine was injected. There was only 1 black mark.; Reporter's Comments: Concurrent medical condition Blood pressure high is a contributor for the events. In view of the long non-suggestive onset latency the causality of the event blindness was assessed as not related to the vaccine. 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder
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She had a brain bleed on her medulla oblongata, the brain stem; she had a massive stroke; After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm; There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful; She would probably say it's just arthritis; went blind/in and out of blindness; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem), BRAIN STEM STROKE (she had a massive stroke) and BLINDNESS (went blind/in and out of blindness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: smallpox; for Drug use for unknown indication: penicillin (a long time ago as a young girl and hard shot.). Past adverse reactions to the above products included Mobility decreased with penicillin; and No adverse effect with smallpox. Concurrent medical conditions included Blood pressure high (hereditary). On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem) (seriousness criteria hospitalization and medically significant) and BRAIN STEM STROKE (she had a massive stroke) (seriousness criteria hospitalization and medically significant). On 21-Jul-2025, the patient experienced BLINDNESS (went blind/in and out of blindness) (seriousness criterion medically significant). On an unknown date, the patient experienced PIGMENTATION DISORDER (After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm), PAIN IN EXTREMITY (There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful) and ARTHRITIS (She would probably say it's just arthritis). The patient was treated with Lidocaine hydrochloride (Lidocaine) at an unspecified dose and frequency. At the time of the report, BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem) and BRAIN STEM STROKE (she had a massive stroke) had resolved, BLINDNESS (went blind/in and out of blindness), PIGMENTATION DISORDER (After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm) and PAIN IN EXTREMITY (There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful) had not resolved and ARTHRITIS (She would probably say it's just arthritis) outcome was unknown. Concomitant medication was not reported. It was reported that patient did not receive any vaccines 4 weeks prior to her Spikevax Moderna COVID-19 vaccines. She was healthy and mother of 8 children all by natural birth. On 21-Jul-2021, she had a massive stroke. She had a brain bleed on her medulla oblongata, the brain stem. She went blind. And then they transported her. From that vantage, she also had a DNR and then the doctors gave her up, they told she not gonna make it. Patient had been suffering. The 2 injections were put in her left arm. She was dominant in her right arm, she was right-handed. She wanted her Moderna shot in her left arm in case she had some of the same effects of the penicillin vaccine. After receiving her 2 Spikevax vaccines in her left arm, there was a black mark on her arm near her smallpox vaccination and it was never gone away. Her left arm, she had been in pain. It was reported that, there was not a day that goes by where her arm did not hurt, and she can't use it. She was suffering. Patient suffers with her left arm every day, excruciating pain and then it will let up. She could tell the team they can see the black mark on her arm. Her arm hurts so bad, she could not hold it up, it was just hanging on her body and walking was painful. She went blind. She was going in and out of blindness. patient thought it was her glasses. She drove herself to the ophthalmologist and doesn't know how she got there without having a wreck. The doctor told her she was having a brain stroke. Caller was in and out of consciousness then. She went to hospital, and then took an ambulance. The doctor said they will give her something to probably get her there in time. After that, she was in the ICU. It was confirmed that resolved over time and she now still had the symptom of pain in her left arm and a black mark that was never there. It was where the vaccine was injected. There was only 1 black mark.; Reporter's Comments: Concurrent medical condition Blood pressure high is a contributor for the events. In view of the long non-suggestive onset latency the causality of the event blindness was assessed as not related to the vaccine. 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Psoriatic arthropathy
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Psoriatic arthritis; Vaccine overdose; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 062E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 2 milliliter. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criteria disability and medically significant) and OVERDOSE (Vaccine overdose). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) had not resolved and OVERDOSE (Vaccine overdose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had no medical history, concomitant disease, or risk factor. Vaccine had compromised his immune system and had induced psoriatic arthritis. It was reported as 95,000.00 a year as an MRI Technologist, 43-year career gone because the vaccine altered his immune system. It was unknown if the patient experienced any additional symptoms or events. The patient was taking topical steroids. The patient had dermatology biopsy. There were no additional lab data or results available.; 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: M
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. 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500097878 Same reporter/product/event, different patient;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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did not prevent covid or transmission of covid; did not prevent covid or transmission of covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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 "did not prevent covid or transmission of covid". Clinical course: Covid shot did not prevent covid or transmission of covid. 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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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 45-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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2025, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2025) Positive. Additional Information: During an inbound call for financial assistance, the patient stated, she actually tested positive today for COVID, her doctor sent in a prescription for Paxlovid for her because she had a lot of other medical conditions and she just got out the hospital for one of them. Her insurance wasn't approving Paxlovid. She guesses that's stopped or something How do she could get help getting the antibodies, the Paxlovid, because she means, she had been vaccinated. She got the Pfizer vaccines. She was getting sick" Additionally she stated, "she's antigen...she has got two dogs that she need to make sure survive, so she guessed she should probably survive too." Toward the end of the call, she stated, This is the first time she had ever gotten COVID, and she didn't even leave her house. 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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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. An 87-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. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500162422 Same reporter/product/event, different patient;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event
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Accidentally gave subcutaneously instead of intramuscular, but has no known adverse event
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 62.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
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Pt complaining of hot spot, redness, swelling, and heat around injection site. Advised pt to take Tylenol and use ice. Advised pt to monitor over next few days and if it seems to be getting worse, contact her provider.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood creatine phosphokinase increased, Blood potassium decreased, Carbon dioxide decreased, Chest X-ray normal, Chest pain
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During afternoon workout pt developed chest pain and shortness of breath which persisted for 6-7 hours and resulted in ER visit.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram thorax normal, Dyspnoea, Electrocardiogram normal, Full blood count normal
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During afternoon workout pt developed chest pain and shortness of breath which persisted for 6-7 hours and resulted in ER visit.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Throat tightness
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Patient returned to the pharmacy after some shopping complaining of dizziness, feeling weak, and that her throat felt restricted. I offered to use an epipen and call 911, but she declined and said she would call her daughter to pick her up. She accepted 1 tablet of Benadryl 25mg. She was wearing a continuous glucose monitor and her sugar level was at 105. She wanted to check her blood pressure and it was 92/72 which she was was normal for her. We monitored her until her daughter picked her up. I recommended that she went to the emergency room for monitoring and to follow up with her doctor.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Brain fog, Dyspnoea, Feeling of body temperature change, Hyperhidrosis
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the day after the covid vaccine injection, the next day I was extremely sick with the total time being 29 days. 7 of the first days was extremely hard to breathe, fever between 99-104 for the 7 days, hot and cold sweats all day long, little to no sleep, the first 3 days zero food consumption and little to no water, everything kept being thrown up, extreme brain flogged. from day 7-29 extremely sick still but fever was more on and off could hold down food. Extreme amount of bone pain, within knuckles and joints for the whole duration.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vomiting
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the day after the covid vaccine injection, the next day I was extremely sick with the total time being 29 days. 7 of the first days was extremely hard to breathe, fever between 99-104 for the 7 days, hot and cold sweats all day long, little to no sleep, the first 3 days zero food consumption and little to no water, everything kept being thrown up, extreme brain flogged. from day 7-29 extremely sick still but fever was more on and off could hold down food. Extreme amount of bone pain, within knuckles and joints for the whole duration.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cold sweat, Hot flush, Malaise
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Was extremely sick from the prior vaccine that I've made a previous report on that lasted the entire time. I then had to receive this vaccine, which made my fever go back to 99-104 for 5 days, during the first 3 days of this Second round of vaccine I could not hold down any food and barely any water, Extreme cold sweats and hot flashes very little sleep. then for the following 16 days I was very sick with extreme joint pain that still was persisting from the prior vaccine into this vaccine, as well as just overall health feeling sick nauseous, very low and reduced energy. Basically, after getting this vaccine, I got extremely sick, as well as the first round of vaccine making me extremely sick as well.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sleep disorder, Vomiting
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Was extremely sick from the prior vaccine that I've made a previous report on that lasted the entire time. I then had to receive this vaccine, which made my fever go back to 99-104 for 5 days, during the first 3 days of this Second round of vaccine I could not hold down any food and barely any water, Extreme cold sweats and hot flashes very little sleep. then for the following 16 days I was very sick with extreme joint pain that still was persisting from the prior vaccine into this vaccine, as well as just overall health feeling sick nauseous, very low and reduced energy. Basically, after getting this vaccine, I got extremely sick, as well as the first round of vaccine making me extremely sick as well.
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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: COVID19, COVID19, COVID19
Symptoms: Antibody test positive, Deep vein thrombosis, Depression, Hypercoagulation, Post-traumatic stress disorder
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Multiple severe DVTs, consecutive bilateral PEs, enrichment taken from life, debt and depression. PTSD from painful blood thinning injections.
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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: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
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Multiple severe DVTs, consecutive bilateral PEs, enrichment taken from life, debt and depression. PTSD from painful blood thinning injections.
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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: COVID19
Symptoms: Asthenia, Cardiac ventricular thrombosis, Catheterisation cardiac abnormal, Cough, Myocardial infarction
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STARTED with cough then weakness across my whole body 5-25-22 - Heart attack with 3 Blood Clots found.
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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: COVID19, HPV9, TTOX
Symptoms: Emotional disorder, Fatigue, Headache, Hypertension, Mast cell activation syndrome
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She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic,; Shell of herself; headaches; high blood pressure; sensitivity to light; rashes; patient was diagnosed with Raynaud's Disease/Some days are better than others, but no comparison to how she was prior to receiving the three shots; fatigue; This spontaneous report was received from a consumer referring her daughter as a 20-year-old female patient. The patient's medical history was not reported. Her concurrent conditions included Raynaud's disease which was diagnosed on 2 different times, once in middle school and once in high school. Concomitant therapies were unknown. She had not known allergies. On 13-May-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 1 dosage form (dosage regimen, anatomical location, route of administration, batch/lot # and expiration date were not reported) administered as prophylaxis; with elasomeran (COVID-19 VACCINE MODERNA) (reported as "Covid shot [Moderna]") 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported); and with tetanus vaccine (reported as "Tetanus shot"), 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported.) Since 13-May-2024 (reported as "ever since receiving the shots"), she had been a shell of herself (emotional disorder). On unspecified date (s) in May-2024, she experienced high blood pressure (hypertension), rashes (rash), fatigue, sensitivity to light (photophobia), and headaches (headache). The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. It was also reported regarding her Raynaud's disease that patient's fingers were painful and had difficulty opening bottles, with some days better than others, but no comparison to how she was prior to receiving the three vaccines (reported as "shots") (Raynaud's phenomenon) She had been to numerous doctors while in college. She also went to the other facility. The patient underwent bloodwork, Ziopatch for heart monitoring, Gold Standard Potts Diagnosis, but the tests results were not provided. On unspecified date, she had Mast Cell Activation Syndrome (MCAS) by an allergy clinic. At the reporting time, the patient had not recovered from the events and was on unspecified medications. The causal relationship between the events and the suspect vaccines was unknown, and the reporter wanted to know if it was safe to administer the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) along with the "Covid and Tetanus shots", and how to know for sure which vaccine was causing the issues. Upon internal review, the event mast cell activation syndrome was considered to be medically significant. Batch/lot # is being requested and will be submitted if received.
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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: COVID19, HPV9, TTOX
Symptoms: Photophobia, Rash, Raynaud's phenomenon
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She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic,; Shell of herself; headaches; high blood pressure; sensitivity to light; rashes; patient was diagnosed with Raynaud's Disease/Some days are better than others, but no comparison to how she was prior to receiving the three shots; fatigue; This spontaneous report was received from a consumer referring her daughter as a 20-year-old female patient. The patient's medical history was not reported. Her concurrent conditions included Raynaud's disease which was diagnosed on 2 different times, once in middle school and once in high school. Concomitant therapies were unknown. She had not known allergies. On 13-May-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 1 dosage form (dosage regimen, anatomical location, route of administration, batch/lot # and expiration date were not reported) administered as prophylaxis; with elasomeran (COVID-19 VACCINE MODERNA) (reported as "Covid shot [Moderna]") 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported); and with tetanus vaccine (reported as "Tetanus shot"), 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported.) Since 13-May-2024 (reported as "ever since receiving the shots"), she had been a shell of herself (emotional disorder). On unspecified date (s) in May-2024, she experienced high blood pressure (hypertension), rashes (rash), fatigue, sensitivity to light (photophobia), and headaches (headache). The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. It was also reported regarding her Raynaud's disease that patient's fingers were painful and had difficulty opening bottles, with some days better than others, but no comparison to how she was prior to receiving the three vaccines (reported as "shots") (Raynaud's phenomenon) She had been to numerous doctors while in college. She also went to the other facility. The patient underwent bloodwork, Ziopatch for heart monitoring, Gold Standard Potts Diagnosis, but the tests results were not provided. On unspecified date, she had Mast Cell Activation Syndrome (MCAS) by an allergy clinic. At the reporting time, the patient had not recovered from the events and was on unspecified medications. The causal relationship between the events and the suspect vaccines was unknown, and the reporter wanted to know if it was safe to administer the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) along with the "Covid and Tetanus shots", and how to know for sure which vaccine was causing the issues. Upon internal review, the event mast cell activation syndrome was considered to be medically significant. Batch/lot # is being requested and will be submitted if received.
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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: F
Vaccine: COVID19
Symptoms: Insomnia
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Drug-resistant insomnia
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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
Symptoms: Bacterial test, Computerised tomogram, Confusional state, Contrast echocardiogram, Decreased appetite
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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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
Symptoms: Disorientation, Dizziness, Encephalitis, Fungal test, Insomnia
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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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
Symptoms: Laboratory test, Lumbar puncture abnormal, Magnetic resonance imaging, Malaise, Mental status changes
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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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
Symptoms: Product administered at inappropriate site
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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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
Symptoms: Asthenia, CSF lymphocyte count increased, CSF monocyte count increased, Cerebral thrombosis, Cerebrovascular accident
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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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
Symptoms: Computerised tomogram head abnormal, Lumbar puncture abnormal, Pleocytosis, Product administered at inappropriate site
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encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female. The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised. The patient's concomitant medication details were not provided. On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site') On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction. On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night. On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell. On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status. On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space. On an unspecified date, the patient was hospitalized. On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture. On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative. At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'. The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance. Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests. Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.
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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: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pyrexia
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Redness at the injection site; Warm and tenderness at the injection site; Warm and tenderness at the injection site; Chilled fever; Itchiness at at the injection site; This is a spontaneous report received from a Nurse. A 56-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Aug2025 at 12:09 as dose number unknown, 0.5ml single (Lot number: LN4932, Expiration Date: 30Aug2026) at the age of 56 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness at the injection site"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Warm and tenderness at the injection site"; PYREXIA (non-serious), outcome "unknown", described as "Chilled fever"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itchiness at at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site warmth, pyrexia, vaccination site pruritus. Causality for "redness at the injection site", "warm and tenderness at the injection site", "chilled fever" and "itchiness at at the injection site" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Doctor prescribed Doxycycline, Prednisone, Triamcinolone Cream and Pepcid. NDC number of Prevnar 20: 0005200001; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500157347 Same reporter and suspect product different patient/AE;US-PFIZER INC-202500157363 Same reporter and suspect product different patient/AE;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Malaise
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feel very ill; 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) (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 (DOSE 1; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Immunization. The following information was reported: MALAISE (non-serious), 5 days after the suspect product(s) administration, outcome "unknown", described as "feel very ill". Additional information: Patient reported that just got 4th booster and after 5 days felt very ill. No Hospitalization Prolonged. 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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Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
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tested positive for COVID last night/ on like day three of symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underlying health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 vaccination; Bnt162b2 (Dose 2, single), for COVID-19 vaccination. The following information was reported: COVID-19 (non-serious) with onset Aug2025, outcome "unknown", described as "tested positive for COVID last night/ on like day three of symptoms". The event "tested positive for covid last night/ on like day three of symptoms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did three of the boosters in a row, but the last one was in Oct2022. The patient was on like day three of symptoms, and tested positive for COVID last night (12Aug2025). The patient's wife got a tele visit with doctor this morning (13Aug2025). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500098451 same reporter, same drug/event, 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: COVID-19, Drug ineffective, SARS-CoV-2 test
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I did test positive for it; I did test positive for it; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Jan2021 as dose 2, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 07Aug2025, outcome "unknown" and all described as "I did test positive for it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2025) positive. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Clinical Course :Additional Information: The Patient stated last Thursday (07Aug2025), he went to the doctor, and they tested for COVID, and he had strep throat also, double, so it wasn't good. When asked for clarification if he had picked up the medication on Thursday, the patient stated," After he went to a friend's house to borrow the money, he did. He was scared as he never had COVID or the Corona virus or whatever he never had before. The patient got a terrible headache and a cough, and he didn't want to play around with this. The patient stated "for the record, back in Jan2021 he did get the Pfizer Vaccine. Two separate trips to the Hospital down. And he hasn't had any Covid symptoms or signs of anything since then until last week. He must have come in contact with it somehow, because he did test positive for it. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "have COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reason that she was calling is because she have COVID and they prescribed the Paxlovid. Later, she stated, Don't mind me, I'm like delirious with this COVID." Pfizer is the one that gave her the shot. After confirming if the shot was for COVID, stated, "Yes. I took two. Number one and number two. Yeah, with Pfizer." 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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Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Biopsy skin, Cellulitis, Full blood count, Herpes zoster, Macule
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December 28, 2024 Left arm and forearm itchy rash, diffuse red macules, cellulitis, herpetic neuralgia and zoster, redness, swelling, moderate pain, Peau d'orange skin changes, neuralgia C5-C6 dermatome
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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, FLU3
Symptoms: Neuralgia, Pain, Peau d'orange, Rash, Rash pruritic
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December 28, 2024 Left arm and forearm itchy rash, diffuse red macules, cellulitis, herpetic neuralgia and zoster, redness, swelling, moderate pain, Peau d'orange skin changes, neuralgia C5-C6 dermatome
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Multiple sclerosis, Myocardial infarction, Myocarditis
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I had at myocardial infarct the day after I got my booster. I now have Multiple Sclerosis since 2024
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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: COVID19
Symptoms: COVID-19, Headache, Hypoaesthesia, Pain, Palpitations
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Soreness and headache, heart palpitations when lying down to go to sleep. Came down with COVID and then developed Long COVID with numbness in right hand and arm, which then developed with a hand tremor, then developed an internal vibration throughout the whole right arm, The pulsing vibration, will wake me up at night. So I am prescribed Ambien in order to sleep through the night.
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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: COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test positive, Sensory disturbance, Sleep disorder, Tremor
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Soreness and headache, heart palpitations when lying down to go to sleep. Came down with COVID and then developed Long COVID with numbness in right hand and arm, which then developed with a hand tremor, then developed an internal vibration throughout the whole right arm, The pulsing vibration, will wake me up at night. So I am prescribed Ambien in order to sleep through the night.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 65.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site pain, Pain, Sleep disorder
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I had both the flu and pneumonia shot that day. They were both injected into my upper left arm?.i dont know the exact name of the Vaccines?..they warned of some possible injection sight pain, but said it would go away?.it was painful the next day, and now 10 months later my arm is very painful?I can?t sleep on that side?any arm movement causes pain..
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 62.0
Sex: F
Vaccine: FLU3, PNC20, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
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erythema at site edema pruritis, has been getting worse over past few days
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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: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose increased, Brain fog, Dyspnoea, Executive dysfunction
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Palpitations, High BP, Shortness of Breath, Higher than normal Glucose levels, Brain Fog, Loss of Executive Function, Loss of Balance
Treated symptoms, alternative functional treatment (supplements, frequencies, etc.) Improvement after 8 months. However in April of 2025 many of the same symptoms have recurred and are not yet resolved.
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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: M
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
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Palpitations, High BP, Shortness of Breath, Higher than normal Glucose levels, Brain Fog, Loss of Executive Function, Loss of Balance
Treated symptoms, alternative functional treatment (supplements, frequencies, etc.) Improvement after 8 months. However in April of 2025 many of the same symptoms have recurred and are not yet resolved.
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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: Fumbling, Memory impairment
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Neurological. Patient first noticed minor fumbling with their fingers at their laptop the morning after the vax. Patient is a neuroscientist and musician. On the evening after the vax, patient attempted a practice session at the piano and could not remember long passages from pieces previously well-established in memory, including pieces played fluently the night before the vax. Impairment still ongoing today, two days after vax. No other evidence of amnesia or cognitive impairment, brain fog, confusion, etc. Impairment at the piano was/is profound. Patient's speculation as a neuroscientist is that it reflects cerebellar inflammation/neuropathy affecting muscle memory stored in cerebellum.
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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: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Brain fog, Cognitive disorder, Fatigue
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Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
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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: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, General physical health deterioration, Imaging procedure abnormal, Inflammatory marker increased, Laboratory test abnormal
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Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
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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: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Myositis, Neuralgia, Pyrexia
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Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
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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: F
Vaccine: COVID19
Symptoms: Undifferentiated connective tissue disease
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Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Pain, Vomiting
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Body aches, diarrhea, vomiting
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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, SARS-CoV-2 test
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tested positive for COVID last night/ on like day three of symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underlying health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset Aug2025, outcome "unknown", described as "tested positive for COVID last night/ on like day three of symptoms". The event "tested positive for covid last night/ on like day three of symptoms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did three of the boosters in a row, but the last one was in Oct2022. The patient was on like day three of symptoms and tested positive for COVID last night (12Aug2025). The patient got a tele visit with doctor this morning (13Aug2025). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500163075 same reporter, same drug/event, 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, COVID19
Symptoms: COVID-19, Drug ineffective
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got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 2024, outcome "unknown" and all described as "got Covid". Caller mentioned he has been getting the Pfizer Covid-19 Vaccine believed since 2019 or 2020 but then skipped a year and behold last winter him and his wife both got Covid and it was horrible. 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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Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blood test, Burning sensation, Chest X-ray
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Muscle loss, WORMS throughout body, weakness, memory loss, burning throughout body, pain all through her body, Had NEVER been sick BEFORE these shots in ALL her life. She has tried all vitamins and herbs to try to combat all she was feeling. We have gone many, many, many times to 3 hospitals. They ran many tests all these times and thy tell her that all of this is "in her head" never gave much relief. She feels like she is dying, and she LOOKS like she is dying.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Helminthic infection, Muscle atrophy, Pain, Urine analysis
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Muscle loss, WORMS throughout body, weakness, memory loss, burning throughout body, pain all through her body, Had NEVER been sick BEFORE these shots in ALL her life. She has tried all vitamins and herbs to try to combat all she was feeling. We have gone many, many, many times to 3 hospitals. They ran many tests all these times and thy tell her that all of this is "in her head" never gave much relief. She feels like she is dying, and she LOOKS like she is dying.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Anxiety, Coeliac disease, Defaecation urgency, Diarrhoea
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Patient has been health and is a teenager. She has had 3 MRNA Covid vaccines since 2021. She has now been diagnosed with anxiety and new celiac disease in 2025. She has had new GI issues consisting of diarrhea and occasional fecal incontinence due to urgency. Patient also started developing severe headaches in Jan 2022 and had to follow with neurology. They were waking her up at night and she would have several during the week lasting all day. In october 2022 she started to experience frequent dizziness and frequent fainting having once fainted twice in 1 day
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Magnetic resonance imaging head normal, Sleep disorder, Syncope
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Patient has been health and is a teenager. She has had 3 MRNA Covid vaccines since 2021. She has now been diagnosed with anxiety and new celiac disease in 2025. She has had new GI issues consisting of diarrhea and occasional fecal incontinence due to urgency. Patient also started developing severe headaches in Jan 2022 and had to follow with neurology. They were waking her up at night and she would have several during the week lasting all day. In october 2022 she started to experience frequent dizziness and frequent fainting having once fainted twice in 1 day
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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: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
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The patient was accidentally administered the FluAd instead of Flucelvax which is not the recommended dosing for the patient's age.
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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
Symptoms: Dizziness, Dyspnoea, Heart rate increased
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Patient called the pharmacy on 08/15/2025 at around 10am. She stated she received a Flu shot on 8/14/25, and about 20 minutes later, started to experience dizziness, shortness of breath, and increased heartrate. She was not hospitalized and did not see a doctor. I asked her how she was feeling now, and she said fine, but wanted to inform us of what had happened. She asked me which flu vaccine did she receive in the past because she has never experienced any of these symptoms before. Her profile showed that she had Afluria the past 2 years. This was her first time receiving Flucelvax. I annotated this reaction in her profile, and that she may only tolerate Afluria.
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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: Chills, Muscle spasms
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Within 4 to 5 hours patient complained of severe chills that progressed into muscle spasms. Patient also stated that there pretty continuous for the next 2 days. Patient was advised to follow up with doctor.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Swelling
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Local reaction. Redness, pain and swelling. Diameter of reaction 4-4.5 inches.
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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, PNC21
Symptoms: Injection site mass
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knot on her arm where got the IMZ, not hot or anything, about the size of a nickel to a quarter
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness neurosensory, Deafness unilateral
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hearing loss in left ear determined to be neurological
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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, COVID19
Symptoms: Blood test, Hypertension
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High blood pressure
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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: FLU3, PNC20
Symptoms: Erythema, Induration, Limb mass, Pruritus
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The patient states that she had a knot on her arm that was very hard for about a day or so, then that progressed to significant redness around the area along with itchiness that lasted for about 3-4 days. After the 5th day, the patient states that she was fine.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Neurodermatitis, Rash
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Vaccine Details Dose 1: 01-04-2022, Pharmacy Dose 2: 02-08-2022, Pharmacy Timeline of Injury & Medical Negligence Date Event Medical/Legal Significance Apr 8, 2022 First rash appears (within 60 days of vaccination) Direct temporal link to vaccine per *article* 2022-2024 Dermatologist ignored vaccine link; prescribed: Malpractice: - Avoided guideline-backed UV therapy - Reckless steroids with MDD/history - Potent topical steroids (Clobetasol 0.05%, Fluocinonide) - Intralesional triamcinolone injections (high-risk areas: forehead) Aug 22, 2024 Diagnostic biopsy performed Proof of delayed diagnosis: - 28-month delay in biopsy = standard-of-care violation
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Migraine
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Severe migraine lasting several hours and headache lasting two days
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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: M
Vaccine: FLU3, PNC21
Symptoms: Headache, Malaise, Myalgia, Pain
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Patient started to experience headache, malaise, and body/muscle pain at about 9:00AM on 8/17/25. He tried to treat his symptoms with over the counter Tylenol. The symptoms did not fully resolve so he called the pharmacy at about 1:00PM. We talked to the patient and suggested he tried switching to ibuprofen instead of the Tylenol to aid with the muscle pain/aches. We followed up with the patient at 3:00PM and the patient reports feeling a little better than before. The patient states that he does not believe he needs any additional medical attention.
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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: VARZOS
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Headache, Injected limb mobility decreased
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After five days I still have the following symptoms: headache, chest tightness, shortness of breath, lump almost 10 cm in diameter in the right arm, itching in the right arm, back and chest, the lump in the right arm is very hot, burning, painful and difficult to move; I have trouble sleeping and when I sleep I have nightmares or strange sensations
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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: VARZOS
Symptoms: Insomnia, Limb mass, Nightmare, Pain, Pruritus
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After five days I still have the following symptoms: headache, chest tightness, shortness of breath, lump almost 10 cm in diameter in the right arm, itching in the right arm, back and chest, the lump in the right arm is very hot, burning, painful and difficult to move; I have trouble sleeping and when I sleep I have nightmares or strange sensations
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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: VARZOS
Symptoms: Sensory disturbance, Skin warm
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After five days I still have the following symptoms: headache, chest tightness, shortness of breath, lump almost 10 cm in diameter in the right arm, itching in the right arm, back and chest, the lump in the right arm is very hot, burning, painful and difficult to move; I have trouble sleeping and when I sleep I have nightmares or strange sensations
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Joint injury, Loss of consciousness, Syncope
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Flu vaccine administered. Pt then experienced syncopal event approximately 30 seconds after vaccine administered while provider was turned towards the cabinets to complete documentation on the vaccine consent, pt fell from a seated position on the exam table onto the floor hitting her head and knee. Pt regained consciousness within 10 seconds, appeared pale and stated she was okay. EMS was called by the PCT, pt was slowly transitioned to a seated position, bp taken. Pt remained alert and oriented until EMS arrived approximately 5 minutes later and took over evaluation of the pt. Vital signs were stable, pt was advised by EMS that she could be taken by ambulance to the ER for further evaluation but it was not required, pt declined and called her boyfriend to come pick her up and take her to the ER. Pt stated she is in nursing school and notified a friend currently working at ER that she would be driving there with her boyfriend to be evaluated and was told the charge nurse was informed of this. Approximately 10 minutes later, pts boyfriend arrived in the clinic and pt ambulated independently out of the clinic accompanied by her boyfriend.
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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: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Chest pain, Dizziness, Dyspnoea
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Adverse Event(s): ? On July 31, 2025, developed chest pain, shortness of breath, and elevated heart rate within 1?2 days after receiving the COVID-19 vaccine. ? Diagnosed with pericarditis on August 1, 2025. ? Symptoms included chest discomfort, fatigue, lightheadedness, and elevated heart rate reaching the 120s?130s with light activity (walking, climbing stairs). ? Blood pressure has occasionally been low Treatment: ? Initially prescribed ibuprofen 800 mg three times daily for 10 days. ? Due to persistent inflammation, started on colchicine as ongoing treatment, as well as continued ibuprofen for three additional weeks. ? Advised to avoid strenuous activity, monitor heart rate, and rest. ? Scheduled for a follow-up with cardiology on August 25, 2025. Outcome (as of submission): ? Symptoms are gradually improving but not fully resolved. ? Still experiencing elevated heart rate with exertion and occasional fatigue. ? Continuing colchicine therapy and activity modification per physician guidance. ? Concern for possible recurrence or chronic pericarditis remains.
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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: COVID19
Symptoms: Electrocardiogram ST-T change, Fatigue, Heart rate increased, Inflammatory marker increased, Pericarditis
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Adverse Event(s): ? On July 31, 2025, developed chest pain, shortness of breath, and elevated heart rate within 1?2 days after receiving the COVID-19 vaccine. ? Diagnosed with pericarditis on August 1, 2025. ? Symptoms included chest discomfort, fatigue, lightheadedness, and elevated heart rate reaching the 120s?130s with light activity (walking, climbing stairs). ? Blood pressure has occasionally been low Treatment: ? Initially prescribed ibuprofen 800 mg three times daily for 10 days. ? Due to persistent inflammation, started on colchicine as ongoing treatment, as well as continued ibuprofen for three additional weeks. ? Advised to avoid strenuous activity, monitor heart rate, and rest. ? Scheduled for a follow-up with cardiology on August 25, 2025. Outcome (as of submission): ? Symptoms are gradually improving but not fully resolved. ? Still experiencing elevated heart rate with exertion and occasional fatigue. ? Continuing colchicine therapy and activity modification per physician guidance. ? Concern for possible recurrence or chronic pericarditis remains.
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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: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
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red, slightly inflamed rectangular area around the injection site about 3 inches across. pt reports that it is warm and sore and reported to pharmacy day after injection
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Colectomy total, Colitis ulcerative, Colon dysplasia, Condition aggravated, Hernia repair
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Sever inflammation in all areas of body with in a day of second injection. Inflammation ultimately defeated medication providing remission of UC resulting in total Colectomy (Dysplasia Found), Protectomy and Hernia surgeries
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Proctectomy
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Sever inflammation in all areas of body with in a day of second injection. Inflammation ultimately defeated medication providing remission of UC resulting in total Colectomy (Dysplasia Found), Protectomy and Hernia surgeries
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
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warm just below the injection site; had a red reaction just below the injection site; small, puffy, swollen just below the injection site; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves an unknown age female patient who had a red reaction, small, puffy, swollen and warm just below the injection site after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Aug-2025, the patient received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot U8764BB and expiry date: 30-Jun-2026) (strength not reported) via unknown route in unknown administration sit for influenza. On an unknown date in Aug-2025, the patient had a red reaction, small, puffy, swollen, warm just belowthe injection site (vaccination site erythema) (vaccination site swelling) (vaccination site warmth) (latency: Few days approximately). Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: RVX
Symptoms: Cerebrovascular accident
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Stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced stroke (Verbatim: Stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported. It was unknown if the reporter considered the stroke to be related to RSV vaccine. The company considered the stroke to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter stated that more poison they were trying to get to take, husband was in very good health passed heart test with flying colors then got the RSV vaccine and had a stroke. So did not tell vaccines were safe keep believing that nonsense sooner or later they will catch up. The reporter stated all brainwashed if believe that information about vaccines were good let your own body heal you. And if keep getting those vaccines body could not fight.; Sender's Comments: A case of Cerebrovascular accident, an unknown time after receiving RSV vaccine, in a male 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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Sex: M
Vaccine: COVID19
Symptoms: Near death experience
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almost killed him; This spontaneous case was reported by a physician and describes the occurrence of NEAR DEATH EXPERIENCE (almost killed him) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (almost killed him) (seriousness criterion medically significant). At the time of the report, NEAR DEATH EXPERIENCE (almost killed him) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was stated reporter was trying to find someone that offered the Novavax Covid vaccine and he could not find anyone. In other places, he was unable to find it. He was worried about Covid because it was rising to epidemic levels again and it has a real bad impact on him. Patient might like to be vaccinated on this weekend. It was reported that there were 2 seasons for Covid; one was when it was too hot and everyone was inside under the air conditioning, and the other was when it was too cold and people were hiding, and during that time, it was summer season in the reporter's place. It was reported that he did not like the mRNA vaccines and it was reported that Moderna almost killed him, and several of his friends stroke out in different things as well as it seemed to be not very effective. Patient would prefer to be vaccinated with Novavax Covid vaccine or he might would have Pfizer vaccine. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788613 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788613:invalid case for multiple patients
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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
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we both got Covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (we both got Covid) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (we both got Covid). At the time of the report, COVID-19 (we both got Covid) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient and his wife were well vaccinated and so, they took a trip out of the country, and both got covid very mild and came back. Then nothing happened. They did not travel again for a while and then traveled again out of the country with friends. And again, they got covid again, very mild. They had kept up with their vaccines all the way along. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-788543 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788543:wife case
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
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got COVID, but the symptoms were very mild; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (got COVID, but the symptoms were very mild) in an 80-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: tetanus. Past adverse reactions to the above products included No adverse effect with tetanus. 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 COVID-19 (got COVID, but the symptoms were very mild). At the time of the report, COVID-19 (got COVID, but the symptoms were very mild) had resolved. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient had her pneumonia, shingles vaccine already, she was good for a while until any of those come up. It was reported that, patient saw in newspaper that unfortunately, the administration and government was going to withdraw funding for development of Covid and Covid like vaccines and MRNA vaccines in general and wanted to know the status of the current Moderna vaccine. It was reported that, patient received first Moderna dose on 22-Feb-2021, second dose on 22-Mar-2021, third dose on 29-Oct-2021, fourth 26-May-2022, Fifth dose on 04-Oct-2022 sixth dose on 21-Apr-2023, seventh dose on 13-Oct-2023, eight dose on 4-Sep-2024, 9th dose on 07-Apr- 2025 with Batch Number unknown. Her most recent booster Covid vaccine was from Moderna and all covid vaccines had been Moderna. Most recent one was in April, and the consensus patient heard from healthcare provider and others was that seniors like herself and her husband were generally recommended to get a kind of a spring shot to cover the summer surge and a fall shot to cover the winter surge. She had taken covid vaccine as regularly as it was recommended ever since they first came out in January of 2021. She did not travel outside of the country for a couple of years after covid developed, until finally thought it was a bit safer and were well vaccinated and so, they took a trip and they both got covid very mild and came back. Then nothing happened. They didn't travel again for a while and then traveled again with friends. And got covid again very mild. They had kept up with our vaccines all the way along. Patient was planning to get shot of the newest formulation and she likely to call as they get closer to October. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788682 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2025: Follow-up received with non-significant: Historical vaccines were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788682:husband case
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Muscular dystrophy, Weight gain poor
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problems especially with my muscles, in both arms seem to/ but it shrunk; stomach problem; I am not able to gain weight; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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: MUSCULAR DYSTROPHY (non-serious), outcome "unknown", described as "problems especially with my muscles, in both arms seem to/ but it shrunk"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "stomach problem"; WEIGHT GAIN POOR (non-serious), outcome "unknown", described as "I am not able to gain weight". Additional information: Ever since the patient had the shot, the patient had problems especially with muscles, in both arms seem to, it has caused him/her nothing, but it shrunk and had stomach problem. 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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Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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tested positive with covid 19; tested positive with covid 19; 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)), 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 with covid 19". 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Myocardial infarction
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2 heartattacks
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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: M
Vaccine: COVID19
Symptoms: Loss of consciousness
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Patient received vaccine and waited 15 min before leaving facility. Approx 45 min later patient blacked out while driving and have car accident totaling his vehicle. Patient was assessed in the ED.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Gastrointestinal pain, Lip erythema, Nausea
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I was fine, I got my vaccine around Noon, Around 6:30 i started getting gastro pain, I started vomiting and my feet and hands began to tingle and then turned red. My lips turned red and around my mouth. My throat got swollen and it was had to breathe and broke out in a rash all over my body. I then i went to ER they took me right back and they gave me Benadryl something for nauseas, IV fluids and they kept me for observation. They did not keep my over night just until my throat opened up.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Oral mucosal erythema, Paraesthesia, Pharyngeal swelling, Rash, Vomiting
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I was fine, I got my vaccine around Noon, Around 6:30 i started getting gastro pain, I started vomiting and my feet and hands began to tingle and then turned red. My lips turned red and around my mouth. My throat got swollen and it was had to breathe and broke out in a rash all over my body. I then i went to ER they took me right back and they gave me Benadryl something for nauseas, IV fluids and they kept me for observation. They did not keep my over night just until my throat opened up.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Cyanosis, Erythema, Immune thrombocytopenia, Pain, Pallor
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pt says a couple of days later she was in pain from head to toe. Then her toes became really red. Her toes would turn white, and then blue and then red. Then developed sores on them. She has raynaud's disease so had blood work and was sent to the ER. Her platelets were low and she has to have infusions. She is now on hepatitis meds that make her blood sugar go up. She has been diagnosed with ITP. She continues to have these infusions and believes the vaccine caused her symptoms .
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Platelet count decreased, Raynaud's phenomenon, Skin ulcer
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pt says a couple of days later she was in pain from head to toe. Then her toes became really red. Her toes would turn white, and then blue and then red. Then developed sores on them. She has raynaud's disease so had blood work and was sent to the ER. Her platelets were low and she has to have infusions. She is now on hepatitis meds that make her blood sugar go up. She has been diagnosed with ITP. She continues to have these infusions and believes the vaccine caused her symptoms .
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death
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Expired
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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, COVID19
Symptoms: Heart rate irregular, Hypertensive heart disease, Sudden death
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My husband had no heart problem, but after getting the vaccine he had couple of irregular heartbeats. Other then that his heart seemed okay but after 13 month of 2nd Covid Vaccination, he died suddenly due to Hypertension Cardio Vascular Disease. Medical Examiner said it is not related to Covid Vaccine, but as a spouse, I believe this is Vaccine related.
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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: M
Vaccine: COVID19
Symptoms: Death
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resident expired
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Death
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Expired
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 73.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
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No adverse events were reported by patient. This is to report a second dose of RSV given. Database did not show a previous RSV vaccine given on 12/21/2023 therefore the patient was given what turned out to be a second dose.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Other Vaccines: VaccineTypeBrand: fluzone hd; Manufacturer: sanofi; LotNumber: u8800aa; 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
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Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Other Vaccines: VaccineTypeBrand: fluzone hd; Manufacturer: sanofi; LotNumber: u8800aa; 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
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Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 49.0
Sex: F
Vaccine: FLUC4
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, Additional Details: came to pharmacy do discuss adverse reaction, patient gotten same vaccine 8/6/2024 with no adverse effect
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