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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: COVID19
Symptoms: Eye disorder, Fungal infection, Gastrointestinal disorder, Pain, Pruritus
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small nodes were found in lungs and one or two in her trachea; had a fungal infection on hand; GI problems; had a drug reaction on hand. Also one side of hand had eczema; had a problem with eye; taking Bactroban for ear; scalp got extremely itchy/immune response to the vaccine; had a drug reaction on hand. Also one side of hand had eczema; COVID; Last fall after the vaccine had different kinds of pains in back and check and in different places; Last fall after the vaccine had different kinds of pains in back and check and in different places; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand) and GASTROINTESTINAL DISORDER (GI problems) in a 78-year-old female patient 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) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places). On an unknown date, the patient experienced PRURITUS (scalp got extremely itchy/immune response to the vaccine), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID). The patient was treated with Mupirocin (Bactroban) for Ear disorder, at an unspecified dose and frequency and Melaleuca alternifolia oil (Tea tree oil) for Eye disorder, at an unspecified dose and frequency. At the time of the report, PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID) had resolved and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: small nodes were found in lungs and one or two in trachea. Concomitant medication was not reported. It was stated that patient held off on one her boosters and got covid last spring or summer. She had gotten every single COVID vaccine and booster. Either last fall or the fall before HCP stated she had immune response to the vaccine. Her scalp got extremely itchy which went away on it was own. Last fall after the vaccine she had different kinds of pains in her back and check and in different places. It was also reported that she had gastrointestinal problems, and she skipped the vaccine prior the summer because she had a drug reaction on her hand. Also, one side of her hand had eczema. She had a fungal infection on her hand. She had a problem with her eye and used liquid eye drops. HCP did an IG something at one point because of a reaction to medication but she was not sure what medication.
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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: COVID19
Symptoms: Pulmonary mass, Skin reaction
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small nodes were found in lungs and one or two in her trachea; had a fungal infection on hand; GI problems; had a drug reaction on hand. Also one side of hand had eczema; had a problem with eye; taking Bactroban for ear; scalp got extremely itchy/immune response to the vaccine; had a drug reaction on hand. Also one side of hand had eczema; COVID; Last fall after the vaccine had different kinds of pains in back and check and in different places; Last fall after the vaccine had different kinds of pains in back and check and in different places; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand) and GASTROINTESTINAL DISORDER (GI problems) in a 78-year-old female patient 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) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places). On an unknown date, the patient experienced PRURITUS (scalp got extremely itchy/immune response to the vaccine), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID). The patient was treated with Mupirocin (Bactroban) for Ear disorder, at an unspecified dose and frequency and Melaleuca alternifolia oil (Tea tree oil) for Eye disorder, at an unspecified dose and frequency. At the time of the report, PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID) had resolved and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: small nodes were found in lungs and one or two in trachea. Concomitant medication was not reported. It was stated that patient held off on one her boosters and got covid last spring or summer. She had gotten every single COVID vaccine and booster. Either last fall or the fall before HCP stated she had immune response to the vaccine. Her scalp got extremely itchy which went away on it was own. Last fall after the vaccine she had different kinds of pains in her back and check and in different places. It was also reported that she had gastrointestinal problems, and she skipped the vaccine prior the summer because she had a drug reaction on her hand. Also, one side of her hand had eczema. She had a fungal infection on her hand. She had a problem with her eye and used liquid eye drops. HCP did an IG something at one point because of a reaction to medication but she was not sure what medication.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
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Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jul2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset Jul2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset Jul2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset Jul2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500159684 same drug/events, different patient;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
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Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 30Jun2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500159636 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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Vaccine: COVID19
Symptoms: Rash
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Their Covid vaccine gave me a rash; 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: RASH (non-serious), outcome "unknown", described as "Their Covid vaccine gave me a rash". 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: TDAP
Symptoms: Coeliac disease, Rash
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in the 13 years she received Sanofi's Tdap vaccine, she has developed celiac disease; develop a rash; Initial information received on 04-Aug-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp 9healthcare professional). This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Immunization. Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed celiac disease (coeliac disease) and develop a rash (rash) (unknown latency). Reportedly, A female patient reported a 13-year rash from Sanofi's Tdap vaccine, which she reported as an adverse event. Now, her doctor is considering another Tdap vaccine, but she is concerned about the vaccine's gluten content, as she has developed celiac disease. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness Criteria: This event was assessed as medically significant (coeliac disease).; Sender's Comments: Sanofi Company Comment dated 06-Aug-2025,This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding tolerance, allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: MEN
Symptoms: Malaise
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I almost died from the Meningitis jab; This serious case was reported by a consumer and described the occurrence of near death experience in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced near death experience (Verbatim: I almost died from the Meningitis jab) (serious criteria GSK medically significant). The outcome of the near death experience was not reported. The reporter considered the near death experience to be related to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. The company considered the near death experience to be unrelated to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: Additional Information: GSK Receipt Date: 04-AUG-2025 Consumer reported that almost died from the Meningitis jab as a teenager, but we did not know it at the time. This case has been linked with the caseUS2025AMR103054 and US2025AMR101206, reported by same reporter.; Sender's Comments: A case of Near death experience, on an unknown time after receiving Meningococcal B vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK Meningococcal B vaccine and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR101206:Case created for kids US-GSK-US2025AMR103054:Same reporter/kids
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Muscle swelling, Pain in extremity, Paraesthesia, Tenderness
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Arm pain, swollen deltoid, bruising and tenderness, tingling down the arm
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash papular
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SMALL RED RAISED DOTS APPEARED ON THE TOP OF BOTH THIGHS THE NEXT DAY - NO ITCHING
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 40.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered
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Patient received a double dose of Boostrix. First dose on 2/21/2025 and second dose on 8/5/2025.
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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: F
Vaccine: FLU3, MMR, MNQ
Symptoms: Syncope
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Patient syncope
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure
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It affected my right eye; singles beginning 9/19/24 on my forehead on the right side; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On 19-SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: singles beginning 9/19/24 on my forehead on the right side). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It affected my right eye) (serious criteria GSK medically significant). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 08-AUG-2025 This case was reported by a patient via interactive digital media. Patient had singles beginning 19th September 2024 on his/her forehead on the right side. It affected his/her right eye. It was nearly one year and he/she still had a red mark over his/her eyebrow and itching. If patient had not been vaccinated it would have been much worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
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Patient passed out; This serious case was reported by a nurse via call center representative and described the occurrence of passed out in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7DC, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number 5XA2U, expiry date 31-MAY-2028) for prophylaxis. On 31-JUL-2025, the patient received Menveo and Bexsero. On 31-JUL-2025, less than a day after receiving Menveo and Bexsero, the patient experienced passed out (Verbatim: Patient passed out) (serious criteria GSK medically significant). The outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the passed out to be unrelated to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JUL-2025 The nurse reported that a patient received Menveo (1-vial) along with Bexsero on the day of reporting and she had a reaction, she passed out.; Sender's Comments: A case of Loss of consciousness, less than a day after receiving Menveo, Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in a 17-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.
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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: F
Vaccine: COVID19
Symptoms: COVID-19
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called moderna every time come down with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (called moderna every time come down with covid) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received tenth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (called moderna every time come down with covid). At the time of the report, COVID-19 (called moderna every time come down with covid) outcome was unknown. Concomitant medication was not reported. Patient wanted to know when the newest formulation will be released. Patient had moderna Covid Vaccine 10 times. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to MOD-2022-660956, MOD-2025-782652 (Patient Link).
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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: COVID-19
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contracted COVID-19 despite being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19 despite being vaccinated) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Cancer and Immunocompromised. 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 (contracted COVID-19 despite being vaccinated). At the time of the report, COVID-19 (contracted COVID-19 despite being vaccinated) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient didn't experienced symptoms following vaccination and mentioned that his immune system was somewhat compromised due to a past cancer diagnosis. Furthermore, he contracted COVID-19 despite being vaccinated but recovered without complications. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Diarrhoea, Neoplasm malignant, Systemic lupus erythematosus
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lupus; cancer; diarrhea; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on (03Feb2025), this case now contains all required information to be considered valid. 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". 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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Vaccine: COVID19
Symptoms: Alopecia
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lose a ton of hair within a few days of getting it; This is a spontaneous report received from a Consumer or other non HCP from medical information team. 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: ALOPECIA (non-serious), outcome "unknown", described as "lose a ton of hair within a few days of getting it". Additional information: Chat question Verbatim: If your covid 19 vaccine caused me to lose a ton of hair within a few days of getting it, what disorder do I have and what are the remedies? 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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Vaccine: COVID19
Symptoms: Autoimmune disorder
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I am suffering with an auto immune disease after my second covid vaccine, what should I do?; 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I am suffering with an auto immune disease after my second covid vaccine, what should I do?". Clinical course: AE description: Unique Identification number: NA, UTC Time stamp: 08Aug2025 7:20:30AM, Chat question Verbatim: I am suffering with an auto immune disease after my second covid vaccine, what should I do? 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: Myelodysplastic syndrome
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MDS; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient (not pregnant) 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: MYELODYSPLASTIC SYNDROME (disability, medically significant), outcome "not recovered", described as "MDS". It was unknown if therapeutic measures were taken as a result of myelodysplastic syndrome. Clinical course: Patient self reports that, FMD that she has MDS as a result of the Covid vaccination. It was unknown that other vaccine was received on same date, other vaccine in four weeks and other medications in two weeks. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Dyspnoea, Echocardiogram, Malaise, Muscle atrophy
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3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary arterial hypertension
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3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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Pulmonary Arterial Hypertension in the right chamber of my hear; I am only 41 and my body feels like it is shutting down most days; I continued to have problems with my breathing; I now use a walker since my muscles are also starting to shutdown; This is a spontaneous report received from a Consumer or other non HCP. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Lot number: FF2587) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3180, in arm at Pharmacy or Drug Store), administration date: 20Aug2021, when the patient was 37-year-old, for Covid-19 Immunization. The following information was reported: MALAISE (disability) with onset 06Mar2023, outcome "not recovered", described as "I am only 41 and my body feels like it is shutting down most days"; DYSPNOEA (disability) with onset 06Mar2023, outcome "not recovered", described as "I continued to have problems with my breathing"; MUSCLE ATROPHY (disability) with onset 06Mar2023, outcome "not recovered", described as "I now use a walker since my muscles are also starting to shutdown"; PULMONARY ARTERIAL HYPERTENSION (disability, medically significant) with onset 06Mar2023, outcome "not recovered", described as "Pulmonary Arterial Hypertension in the right chamber of my hear". The event "pulmonary arterial hypertension in the right chamber of my hear" required physician office visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Pulmonary Arterial Hypertension; Echocardiogram: Pulmonary Arterial Hypertension. Therapeutic measures were taken as a result of pulmonary arterial hypertension, malaise, dyspnoea, muscle atrophy. Clinical course: Patient reported that her body feels like it is shutting down most days. Had 1st and 2nd dose of the Pfizer vaccines in Aug2021 and Sep2021. 3 weeks later, she got covid really bad. She continued to have problems with breathing, so in Feb2023, she saw her doctor and they referred her to a cardiologist that did the right catheterization in neck and TEE test and diagnosed with Pulmonary Arterial Hypertension in the right chamber of heart. Patient is taking 4 medications that she will now be on the rest of her life. Patient now use a walker since her muscles are also starting to shut down. Worst decision ever getting the vaccine. Patient had no issues prior to the Pfizer vaccines.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Dyspnoea, Echocardiogram, Malaise, Muscle atrophy
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Pulmonary Arterial Hypertension in the right chamber of my hear; I am only 41 and my body feels like it is shutting down most days; I continued to have problems with my breathing; I now use a walker since my muscles are also starting to shutdown; This is a spontaneous report received from a Consumer or other non HCP. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Lot number: FF2587) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3180, in arm at Pharmacy or Drug Store), administration date: 20Aug2021, when the patient was 37-year-old, for Covid-19 Immunization. The following information was reported: MALAISE (disability) with onset 06Mar2023, outcome "not recovered", described as "I am only 41 and my body feels like it is shutting down most days"; DYSPNOEA (disability) with onset 06Mar2023, outcome "not recovered", described as "I continued to have problems with my breathing"; MUSCLE ATROPHY (disability) with onset 06Mar2023, outcome "not recovered", described as "I now use a walker since my muscles are also starting to shutdown"; PULMONARY ARTERIAL HYPERTENSION (disability, medically significant) with onset 06Mar2023, outcome "not recovered", described as "Pulmonary Arterial Hypertension in the right chamber of my hear". The event "pulmonary arterial hypertension in the right chamber of my hear" required physician office visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Pulmonary Arterial Hypertension; Echocardiogram: Pulmonary Arterial Hypertension. Therapeutic measures were taken as a result of pulmonary arterial hypertension, malaise, dyspnoea, muscle atrophy. Clinical course: Patient reported that her body feels like it is shutting down most days. Had 1st and 2nd dose of the Pfizer vaccines in Aug2021 and Sep2021. 3 weeks later, she got covid really bad. She continued to have problems with breathing, so in Feb2023, she saw her doctor and they referred her to a cardiologist that did the right catheterization in neck and TEE test and diagnosed with Pulmonary Arterial Hypertension in the right chamber of heart. Patient is taking 4 medications that she will now be on the rest of her life. Patient now use a walker since her muscles are also starting to shut down. Worst decision ever getting the vaccine. Patient had no issues prior to the Pfizer vaccines.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary arterial hypertension
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Pulmonary Arterial Hypertension in the right chamber of my hear; I am only 41 and my body feels like it is shutting down most days; I continued to have problems with my breathing; I now use a walker since my muscles are also starting to shutdown; This is a spontaneous report received from a Consumer or other non HCP. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Lot number: FF2587) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3180, in arm at Pharmacy or Drug Store), administration date: 20Aug2021, when the patient was 37-year-old, for Covid-19 Immunization. The following information was reported: MALAISE (disability) with onset 06Mar2023, outcome "not recovered", described as "I am only 41 and my body feels like it is shutting down most days"; DYSPNOEA (disability) with onset 06Mar2023, outcome "not recovered", described as "I continued to have problems with my breathing"; MUSCLE ATROPHY (disability) with onset 06Mar2023, outcome "not recovered", described as "I now use a walker since my muscles are also starting to shutdown"; PULMONARY ARTERIAL HYPERTENSION (disability, medically significant) with onset 06Mar2023, outcome "not recovered", described as "Pulmonary Arterial Hypertension in the right chamber of my hear". The event "pulmonary arterial hypertension in the right chamber of my hear" required physician office visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Pulmonary Arterial Hypertension; Echocardiogram: Pulmonary Arterial Hypertension. Therapeutic measures were taken as a result of pulmonary arterial hypertension, malaise, dyspnoea, muscle atrophy. Clinical course: Patient reported that her body feels like it is shutting down most days. Had 1st and 2nd dose of the Pfizer vaccines in Aug2021 and Sep2021. 3 weeks later, she got covid really bad. She continued to have problems with breathing, so in Feb2023, she saw her doctor and they referred her to a cardiologist that did the right catheterization in neck and TEE test and diagnosed with Pulmonary Arterial Hypertension in the right chamber of heart. Patient is taking 4 medications that she will now be on the rest of her life. Patient now use a walker since her muscles are also starting to shut down. Worst decision ever getting the vaccine. Patient had no issues prior to the Pfizer vaccines.
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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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diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient have been taking the Pfizer vaccine for COVID every six months and today it was reported that patient was still diagnosed with COVID-19 on an unspecified date. She was prescribed with unspecified medication and was very expensive. Outcome of the events was unknown. 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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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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got covid vaccine from Pfizer but still ended up with covid; got covid vaccine from Pfizer but still ended up with 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 "got covid vaccine from Pfizer but still ended up with 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
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it didn't work for her because she got covid now; it didn't work for her because she got covid now; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "it didn't work for her because she got covid now". 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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Vaccine: COVID19
Symptoms: Vision blurred
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after getting 3 shots with booster my eyes started to get blurry; 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. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "after getting 3 shots with booster my eyes started to get blurry". Additional information: Patient read in the news that Pfizer covid vaccine causes eye damages and reported "after getting 3 shots with booster my eyes started to get blurry".
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Alopecia, Anxiety, Blood test, Brain fog
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Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chills, Cholecystectomy, Colonoscopy, Computerised tomogram abdomen
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Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Decreased appetite, Depression, Electrocardiogram, Endoscopy upper gastrointestinal tract
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Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Hepatobiliary scan, Hyperacusis, Inflammation
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Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Laboratory test, Nausea, Palpitations, Parosmia
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Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rash
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Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Neoplasm malignant, Thrombosis
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Two cancers, a stroke, blood clots
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Death
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resident passed away
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
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No adverse symptoms documented. Patient received 3rd dose MMR on 7/30/2025. Previous doses were given 9/27/22, 4/9/2025. A follow call was made by an RN, and patient reported to be well. Parent denied any symptoms.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Product preparation issue
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Patient unintentionally received 2 doses of Menveo in the right deltoid at the same time. Doses were of different lot numbers. One dose's lot number was AMVB056A, the other lot number is unknown. The pre-mixed single dose of Menveo was unintentionally used to reconstitute the powder of another Menveo lot. Patient has no adverse reactions.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 34.0
Sex: F
Vaccine: PNC21
Symptoms: Myalgia
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Patient describes painless and event free vaccination for rabies in early May with a 2 vaccine series. Patient describes ongoing arthralgia 1 week following vaccination, exacerbated by strenuous physical exercise. Patient was not experiencing the left deltoid pain until 1 week following vaccination, to be clear. The pain was brought on initially when driving, exacerbated while rowing a raft. She was encouraged to follow up with a physical therapist and primary care, as I believe the cause is most likely not associated with vaccination, though could have been exacerbated by introduction of IM injection. Patient is very clear that vaccination itself was painless, uneventful, and without symptoms for days following.
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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: COVID19
Symptoms: Acoustic stimulation tests, Aphasia, Brain fog, Cognitive disorder, Computerised tomogram ear
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After taking the vaccine, I noticed changes going on in my body. I felt like my body was vibration internally. Another time I ended up in the hospital with bad chest palpitations. A month or so after the vaccine, I started to notice a hissing or buzzing sound in my ears, that wasn?t bothersome at first. Fast forward to 2024, I started having hearing loss and extreme hissing or buzzing sound in my ears that has gotten progressively worst. It has affected my cognitive function, memory or brain fog. I am having trouble remembering words, names or even spelling some of them. I lived a relative healthy life before I took this Johnson and Johnson vaccine. The most I complained out up until then was some back pain.
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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: COVID19
Symptoms: Deafness, Memory impairment, Palpitations, Sensory disturbance, Tinnitus
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After taking the vaccine, I noticed changes going on in my body. I felt like my body was vibration internally. Another time I ended up in the hospital with bad chest palpitations. A month or so after the vaccine, I started to notice a hissing or buzzing sound in my ears, that wasn?t bothersome at first. Fast forward to 2024, I started having hearing loss and extreme hissing or buzzing sound in my ears that has gotten progressively worst. It has affected my cognitive function, memory or brain fog. I am having trouble remembering words, names or even spelling some of them. I lived a relative healthy life before I took this Johnson and Johnson vaccine. The most I complained out up until then was some back pain.
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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: FLU3
Symptoms: Extra dose administered, No adverse event
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Patient received vaccine on 8/1/25 and again on 8/7/25 - no side effects reported
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dry eye, Dyspnoea, Erythema, Eye irritation
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I went back to work and my arm was swelling up and it turned red and i got really weak. The lady i was taking care of at the time thought i had COVID so she sent me home. And i went to the hospital and they gave me a shot for the swelling of my arm and they took pictures. And i have been messed up ever since with sinus infections, eyes burning, dry eyes, and headaches, I'm also always out of breath.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Peripheral swelling, Sinusitis
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I went back to work and my arm was swelling up and it turned red and i got really weak. The lady i was taking care of at the time thought i had COVID so she sent me home. And i went to the hospital and they gave me a shot for the swelling of my arm and they took pictures. And i have been messed up ever since with sinus infections, eyes burning, dry eyes, and headaches, I'm also always out of breath.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Product preparation issue
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Patient was given all 3 doses in the Pfizer Covid yellow cap vial for 6month to 4 year olds without the dilution added to the vial.
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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: M
Vaccine: COVID19, MMR
Symptoms: Anxiety, Condition aggravated, Dizziness, Dyspnoea, Hypertension
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The day after receiving both the COVID-19 ( Moderna ) and the MMR II vaccines patient started feeling very anxious, nausea, dizziness and shortness of breath. Patient called his primary care doctor but because it was Saturday he was directed to the Emergency Room. They did a full workup, EKG and blood work. His blood pressure was high. He was told by the doctor it wasn't necessary for him to receive the MMR II since he got this as an child.
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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: M
Vaccine: COVID19, MMR
Symptoms: Nausea
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The day after receiving both the COVID-19 ( Moderna ) and the MMR II vaccines patient started feeling very anxious, nausea, dizziness and shortness of breath. Patient called his primary care doctor but because it was Saturday he was directed to the Emergency Room. They did a full workup, EKG and blood work. His blood pressure was high. He was told by the doctor it wasn't necessary for him to receive the MMR II since he got this as an child.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Breakthrough COVID-19
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SARS-CoV-2 infection post vaccine; This serious initial Spontaneous (Literature) safety report was received by Novavax on 04-Aug-2025 from a Consumer or other non-health professional. An individual of an unspecified age (65 year or older) and unspecified gender was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report), on an unspecified date. No medical history was reported. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced "SARS-CoV-2 infection post vaccine" (Breakthrough COVID-19) (Serious: Caused/Prolonged Hospitalization). At the time of reporting, the event outcome of Breakthrough COVID-19 was Unknown.; Sender's Comments: This individual of an unspecified age (65 year or older) and unspecified gender experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Breakthrough COVID-19 was reported as serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Breakthrough COVID-19 is considered Possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autonomic nervous system imbalance, Brain fog, Exercise tolerance decreased, Fatigue
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Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypotension, Impaired work ability, Loss of personal independence in daily activities, Muscular weakness
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Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Orthostatic intolerance, Postural orthostatic tachycardia syndrome, Pyrexia, Wheelchair user
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Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 79.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of product administration
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Rph administered a dose of Boostrix while patient had it recently (09/07/2024). There was no justification for a dose so close to prior (i.e. cut/injury, Newborn baby etc) checked with patient.
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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: Alcohol intolerance, Allergy test negative, Anaphylaxis treatment, Dyspnoea, Erythema
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The vaccine was given at Super Store in (withheld). The groceries I purchased, I thought had been poisoned as I was extremely sick for a week. My fav Xmas gift from my husband each year is perfume. That Xmas, I reacted to by becoming bright red and had a hard time breathing. From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot. I had to stop drinking wine or beer. I have been to the ER twice for the worse cases of hives because of air borne flowering bushes. Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed.
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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: Feeling hot, Lip swelling, Malaise, Perfume sensitivity, Swelling face
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The vaccine was given at Super Store in (withheld). The groceries I purchased, I thought had been poisoned as I was extremely sick for a week. My fav Xmas gift from my husband each year is perfume. That Xmas, I reacted to by becoming bright red and had a hard time breathing. From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot. I had to stop drinking wine or beer. I have been to the ER twice for the worse cases of hives because of air borne flowering bushes. Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed.
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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: Urticaria
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The vaccine was given at Super Store in (withheld). The groceries I purchased, I thought had been poisoned as I was extremely sick for a week. My fav Xmas gift from my husband each year is perfume. That Xmas, I reacted to by becoming bright red and had a hard time breathing. From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot. I had to stop drinking wine or beer. I have been to the ER twice for the worse cases of hives because of air borne flowering bushes. Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
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Neuropathy in all four extremities. More stronger on left side/arm as left arm was where injections where given. I received initial shot and two boosters. All Moderna. Second booster is what gave me reaction.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
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skin lesions in face and back; This serious case was reported by a pharmacist via sales rep and described the occurrence of skin lesion in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included recurrent urinary tract infection. On 26-MAY-2025, the patient received the 1st dose of Shingrix. On 30-JUN-2025, 35 days after receiving Shingrix, the patient experienced skin lesion (Verbatim: skin lesions in face and back) (serious criteria other: Other medically imp. condition). The outcome of the skin lesion was not resolved. The reporter considered the skin lesion to be related to Shingrix. The company considered the skin lesion to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-AUG-2025 Patient reported skin lesions in face and back was reported as worsened. Patient with skin lesions (similar to shingles lesion) need to consult specialist dermatologist. The patient was taking antibiotics for Recurrent urinary tract infections.; Sender's Comments: A case of Skin lesion, 35 days after receiving Shingrix, in a 66-year-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: UNK, VARCEL
Symptoms: Antibody test negative, Autoimmune disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Varicella virus test negative
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Consumer calling reports VARIVAX AE. Consumer reports she recently had blood work done and it showed no immunity to chicken pox. Consumer reports she received the VARIVAX vaccine as a child (unknown age of administration) and now at 21 years old she; lupus; autoimmune disorder; have rheumatoid arthritis; Information has been received from Business Partner/CRO on 08-Aug-2025. This spontaneous report was received from an Consumer or other non health professional and refers to a 21-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot # and expiration date were not reported). On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prevention. On an unknown date, the patient experienced autoimmune disorder, lupus syndrome, rheumatoid arthritis and varicella virus test negative. The patient recently had blood work done and it showed no immunity to chicken pox. She is not sure if her current prescription could be causing the lack of immunity. She currently seeing a rheumatologist and taking a prescription Hydroxychloroquine to mitigate symptoms of a possible autoimmune disorder. The patient has symptoms of an autoimmune disorder and she may have rheumatoid arthritis or lupus but has not had an official diagnosis. At the reporting time, the patient had not recovered from the events The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable. The causal relationship between the events and sterile diluent was not provided. The causal relationship between the events and Varicella Virus Vaccine Live (Oka-Merck) was not provided. Upon internal review, the events of lupus autoimmune disorder and have rheumatoid arthritis were determined to be medically significant.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Paraplegia
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believed it was called GBS; paralyzed from the waist down; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: believed it was called GBS) (serious criteria GSK medically significant) and acute paraplegia (Verbatim: paralyzed from the waist down) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and acute paraplegia were not reported. It was unknown if the reporter considered the guillain barre syndrome and acute paraplegia to be related to Shingles vaccine. The company considered the guillain barre syndrome and acute paraplegia to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by the friend of the patient via interactive digital media. The reporters buddy (patient) received the vaccine for this and was almost instantly paralyzed from the waist down. The reporter believed that it was called Guillain-Barre Syndrome (GBS), it was rare, but it happened.; Sender's Comments: A case of Guillain-Barre syndrome and Paraplegia, immediately after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RVX
Symptoms: Death
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passed way yesterday do to the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On 06-AUG-2025, an unknown time after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: passed way yesterday do to the vaccine) (serious criteria death and GSK medically significant). The patient died on 06-AUG-2025. The reported cause of death was unknown. The reporter considered the unknown cause of death to be related to RSV vaccine. The company considered the unknown cause of death to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 07-AUG-2025 This case was reported by a patient's sibling via interactive digital media. The patient passed away yesterday due to the RSV vaccine .; Sender's Comments: The company considers that there was no reasonable possibility that the event death may have been caused by RSV vaccine. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.; Reported Cause(s) of Death: Unknown cause of death
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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: COVID19, FLUX, PPV
Symptoms: Asthma, Pneumonia, Respiratory syncytial virus infection
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It triggered my asthma; pneumonia and put me into the hospital; caught RSV a year and a half ago; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (It triggered my asthma), PNEUMONIA (pneumonia and put me into the hospital) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Pneumococcal vaccine for an unknown indication and Influenza vaccine for an unknown indication. The patient's past medical history included Respiratory syncytial virus infection. Concurrent medical conditions included Asthma (acute asthma) and Immune system disorder (compromised immune system). On 03-Apr-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 03-Aug-2025, received dose of Influenza vaccine (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine (unknown route) 1 dosage form. In February 2024, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHMA (It triggered my asthma) (seriousness criterion hospitalization) and PNEUMONIA (pneumonia and put me into the hospital) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHMA (It triggered my asthma) and PNEUMONIA (pneumonia and put me into the hospital) outcome was unknown and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) was resolving. No concomitant medication was reported. Patient was interested in receiving the RSV vaccine as she had RSV a year and a half ago. She was recovering from it. It triggered her asthma, had pneumonia and went to the hospital. Patient was up to date with every single COVID booster that the patient got. Patient was up to date with pneumonia and flu vaccines. Patient got influenza vaccine on 03-Apr-2025 and got another one 03-Aug-2025. Patient got every vaccine she needed to get only with the exception of the two that were shingles and the RSV. No additional details provided. It is unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact; Reporter's Comments: Co-suspect products Pneumococcal and Influenza vaccine; past medical history of Respiratory syncytial virus infection, asthma and Immune system disorder are contributors for the events. Due to lack of biological plausibility, the causality of the events Pneumonia and Respiratory syncytial virus infection 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: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
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had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) in a 94-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Family history included Cancer (The reporter states that cancer runs in her family) since an unknown date. Concurrent medical conditions included Systemic lupus erythematosus (auto immune disorders (lupus)) and Autoimmune disorder (Patient has a bunch of autoimmune diseases and she is a wreck. The reporter confirmed that her autoimmune illnesses were present before receiving the COVID vaccine). On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2025, the patient experienced NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) outcome was unknown. No concomitant medication was reported. The reporter stated that she had 5 Moderna COVID vaccines and was diagnosed with cancer a day before reporting, even though she had known it for 8 months. The reporter stated that she really needed the COVID vaccine because there were many things wrong with her and she had a house full of people who won't go by the rules. The reporter stated that she did not believe there to be a connection to the vaccine. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: Concurrent medical condition Systemic lupus erythematosus is a contributor for the event. Due to lack of biological plausibility, the causality of the event 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: Guillain-Barre syndrome
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GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) in a 61-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2023, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) had resolved with sequelae. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. The patient did not know the details of medication and reason for taking the medicine. No treatment medications were 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
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None stated.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mass, Neoplasm malignant
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Enlarged lymph node on left side of the neck. Started 1 year after vaccination. Saw a physician regarding lump 2 years after vaccination. Diagnosed with cancer 4 years after vaccination
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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: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
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Patient was administered the pediatric dose of Covid Vaccine. There were no adverse reactions. Patient did not have any symptoms related to administered dose.
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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: F
Vaccine: COVID19
Symptoms: Expired product administered
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Patient was given Covid vaccine after the past use date.
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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: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Nail operation, Nail ridging, Onychoclasis, Onychomadesis
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About one week after he notices ridges in his nails on the fingers of both hands. This progressively became worse and his nails are "decaying" and flaking and falling off. They are splintering and chipping off his fingers.
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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: M
Vaccine: COVID19, COVID19
Symptoms: Onychomycosis
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About one week after he notices ridges in his nails on the fingers of both hands. This progressively became worse and his nails are "decaying" and flaking and falling off. They are splintering and chipping off his fingers.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
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Patient came to pharmacy today (8/13/25) to discuss vaccinations. While we were talking, she informed me that she experienced severe vertigo for about 4 months that started 10 days after she was vaccinated with the covid vaccine. She also mentioned that she was hospitalized for the vertigo for a period of time (did not get dates for this). She said this reaction never happened with any of the other covid shots she got (all Pfizer)
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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redness, swelling, soreness, and heat around the injection site which is currently ongoing at time of reporting. patient states that after the initial pain from the shot, the other symptoms followed a day or two later.
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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, Hypoacusis, SARS-CoV-2 test
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Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday and it tested positive; Tested positive; speak louder cause I can't really hear; This is a spontaneous report received from a Consumer or other non HCP. A 71-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: HYPOACUSIS (non-serious) with onset 2025, outcome "unknown", described as "speak louder cause I can't really hear"; DRUG INEFFECTIVE (medically significant) with onset 05Aug2025, outcome "unknown", described as "Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday and it tested positive"; COVID-19 (medically significant) with onset 05Aug2025, outcome "unknown", described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2025) positive; (05Aug2025) positive. Clinical course: The patient mentioned taking the vaccines (clarified as Pfizer Covid-19 Vaccine) in the past. Took antigen test yesterday and it tested positive and just was prescribed the medication (Clarified as Paxlovid) today and some cough syrup. Patient have covid and head feels like it's underwater and can't hear really well. Patient have not taken Paxlovid yet and have to go pick it up. Patient was not feeling well. 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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Vaccine: COVID19, COVID19
Symptoms: Heat illness, Hypoaesthesia, Paraesthesia
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due to heat, effects from the heat; numbness; tingling sensation; 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: HEAT ILLNESS (death), outcome "fatal", described as "due to heat, effects from the heat"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation". The patient date of death was unknown. Reported cause of death: "due to heat, effects from the heat". It was not reported if an autopsy was performed. Additional information: reporter stated two "kids" have died and they claimed it was due to heat, effects from the heat. They were in running/in sports. They were having numbness/tingling sensation. The reporter added that this vaccine affects the nerves, heart, and lungs. 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-202500161086 same reporter/products/events, different patient;; Reported Cause(s) of Death: due to heat, effects from the heat
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19, COVID19
Symptoms: Heat illness, Hypoaesthesia, Paraesthesia
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due to heat, effects from the heat; numbness; tingling sensation; 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: HEAT ILLNESS (death), outcome "fatal", described as "due to heat, effects from the heat"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation". The patient date of death was unknown. Reported cause of death: "due to heat, effects from the heat". It was not reported if an autopsy was performed. Additional information: reporter stated two "kids" have died and they claimed it was due to heat, effects from the heat. They were in running/in sports. They were having numbness/tingling sensation. The reporter added that this vaccine affects the nerves, heart, and lungs. 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-202500161086 same reporter/products/events, different patient;; Reported Cause(s) of Death: due to heat, effects from the heat
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19, COVID19
Symptoms: Heat illness, Hypoaesthesia, Paraesthesia
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have died and they claimed it was due to heat, effects from the heat.; numbness; tingling sensation; 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: HEAT ILLNESS (death), outcome "fatal", described as "have died and they claimed it was due to heat, effects from the heat."; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation". The patient date of death was unknown. Reported cause of death: "have died and they claimed it was due to heat, effects from the heat.". It was not reported if an autopsy was performed. 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-202500161085 same reporter/events, different patient;; Reported Cause(s) of Death: have died and they claimed it was due to heat, effects from the heat.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19, COVID19
Symptoms: Heat illness, Hypoaesthesia, Paraesthesia
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have died and they claimed it was due to heat, effects from the heat.; numbness; tingling sensation; 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: HEAT ILLNESS (death), outcome "fatal", described as "have died and they claimed it was due to heat, effects from the heat."; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation". The patient date of death was unknown. Reported cause of death: "have died and they claimed it was due to heat, effects from the heat.". It was not reported if an autopsy was performed. 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-202500161085 same reporter/events, different patient;; Reported Cause(s) of Death: have died and they claimed it was due to heat, effects from the heat.
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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: Asthma, COVID-19, Chronic obstructive pulmonary disease, Drug ineffective
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COVID after Pfizer COVID shots; COVID after Pfizer COVID shots; Asthma; COPD; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old 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. Vaccination history included: Bnt162b2 (Primary immunization series completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID shots"; ASTHMA (non-serious), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". The events "covid after pfizer covid shots", "asthma" and "copd" required physician office visit. Additional information: patient went to the pharmacy, diagnosed with COVID, for Paxlovid. The doctors prescribed this medication from Urgent Care. Patient had asthma with COPD. All his shots were with Pfizer and added he "got all of them except the last one" and his primary doctor told him to wait a while to get it cause he had done all the rest of them. Patient added "the last one got bout the same thing that the one before that had in it". Primary doctor will let him know when to come get it (COVID shot). 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, Diabetes mellitus, Drug ineffective, Lung neoplasm malignant, Pulmonary sarcoidosis
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diabetes; lung cancer; sarcoid of the lung; 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)), in 2025 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 2025, outcome "unknown" and all described as "COVID"; LUNG NEOPLASM MALIGNANT (medically significant) with onset 2025, outcome "unknown", described as "lung cancer"; PULMONARY SARCOIDOSIS (medically significant) with onset 2025, outcome "unknown", described as "sarcoid of the lung"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". Clinical course: Patient recently fell Ill to COVID, and was informed he was able to get Paxlovid. Much to his surprise of the cost of this medicine (stated as ridiculous). Patient and his wife did get the Pfizer shot at the start of year (2025). Patient is also dealing with diabetes, sarcoid of the lung (an autoimmune disease) and recently found out to have lung cancer. 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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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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did not work; did not work; 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 work". 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: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Electrocardiogram abnormal, Electromyogram abnormal, Fatigue
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PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING
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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: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypertensive crisis, Injection site pain, Injection site reaction, Injection site swelling
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PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING
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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: M
Vaccine: FLU3
Symptoms: Lower limb fracture, Mobility decreased, Muscle atrophy, Syncope
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PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING
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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: FLU3, FLU3
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Pain, Product administered at inappropriate site
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Pain in the arm was addressed with our pharmacy the next day in February 2025. August 2025 addressed it was numbness in the arm
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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: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain in extremity
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Pain in the arm was addressed with our pharmacy the next day in February 2025. August 2025 addressed it was numbness in the arm
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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: Biopsy, COVID-19, Drug ineffective, Investigation, Lichen planus
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infected with COVID-19 the next month; infected with COVID-19 the next month; vaccine-associated vulvovaginal lichen planus; This is a literature report. This case report presents a 66-year-old female exhibiting symptoms of vulvovaginal burning, pain, inflammation, and bleeding which were ultimately attributed to lichen planus possibly correlating with the administration of COVID-19 vaccination. Methods: A 66-year-old female with a remote medical history of stage 1 endometrial cancer treated with total hysterectomy and bilateral salpingo-oophorectomy, vulvar herpetic lesions, and psoriasis presented to her dermatologist with a new complaint of "unbearable pain", dyspareunia, vaginal bleeding, irritation, and burning with urination and showering. She used nystatin cream per dermatologist recommendation with minimal relief. After persistence of symptoms for 12 months, in Apr2023, the patient presented to her sexual medicine gynecologist who started her on clobetasol 0.05% ointment for erosive VLP. This was based on a clinical exam and a punch biopsy. Of note, the patient had received multiple doses of the Pfizer COVID-19 vaccine (two vaccines in Feb2021,a booster in Nov2021, and an additional booster in 2022) and symptoms began soon after. Results: Repeat punch biopsies were consistent with a diagnosis of erosive VLP. The patient was subsequently started on six weeks of systemic corticosteroids and pelvic floor therapy and local estrogen therapy. Patient responded well to therapy and no longer reported dyspareunia. She then received her fifth vaccine (Moderna) in Sept2023, was infected with COVID-19 the next month, and experienced a recurrence of VLP shortly after. Patient returned to the gynecologist in Jan2024 and received hydrocortisone vaginal suppositories to help manage the recurrence. By Jun2024, the patient was using tacrolimus and receiving intralesional steroid injections. She is currently feeling better, is sexually active with no issues, and reports minimal pain. Conclusions: This case report highlights the importance of including mucocutaneous complications like VLP on the differential diagnoses if a patient presents similarly after vaccine administration. While there is no current evidence establishing a causal link between COVID-19 vaccination and LP, the timeline of this patient's disease progression and previous case reports of similar instances indicate that the vaccines may potentially serve as a significant triggering factor for the onset or recurrence of this condition. However, the benefits of COVID-19 vaccination greatly outweigh this potential risk, making it a crucial tool for the health and safety of a population.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Covid-19, Drug ineffective, Lichen planus and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500160983 Same article/patient/drug and different event;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Seizure like phenomena, Syncope
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Syncopal episode, dizziness, seizure like activity,
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
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patient experiencing injection site reaction below the injection area. redness and warmth with some soreness
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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: COVID-19, SARS-CoV-2 test positive
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Hospitalization related to COVID 19 following completion of primary vaccine series
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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: FLU3
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain, Chronic kidney disease
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1 hour after shot, patient grabbed her chest and gasped for a moment. Then at about 30 hours after the vaccine, she started having severe chest pain as if she was having a heart attack. We went to ER and they found nothing significant. We went home, she tried to nap but felt the same severe pain so we went to another ER. She then was in and out of ERs about 10-15 times over the next month, with severe Afib issues, needing to have her heart stopped/restarted to control the Afib. On Dec 1-10 she was put in Hospitol for 10 days for pneumonia and to control the Afib. Had 2 stints put in and by the end of that Hospitol stay, she was labeled as having congestive heart failure and significant kidney damage (within 4 months she was labeled as having Stage 3 kidney failure). She repeatedly was in and out of the hospitol until May 25, 2025 when she passed away.
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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: FLU3
Symptoms: Coronary arterial stent insertion, Death, Electrocardiogram, Pneumonia
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1 hour after shot, patient grabbed her chest and gasped for a moment. Then at about 30 hours after the vaccine, she started having severe chest pain as if she was having a heart attack. We went to ER and they found nothing significant. We went home, she tried to nap but felt the same severe pain so we went to another ER. She then was in and out of ERs about 10-15 times over the next month, with severe Afib issues, needing to have her heart stopped/restarted to control the Afib. On Dec 1-10 she was put in Hospitol for 10 days for pneumonia and to control the Afib. Had 2 stints put in and by the end of that Hospitol stay, she was labeled as having congestive heart failure and significant kidney damage (within 4 months she was labeled as having Stage 3 kidney failure). She repeatedly was in and out of the hospitol until May 25, 2025 when she passed away.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Electric shock sensation, Headache, Immediate post-injection reaction
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Patient experienced shortness of breath, became clammy and had a headache immediately after vaccine. About 5 minutes later, she started to feel better, however, her blood pressure was 207/98. It appeared to be a panic attack. She states that it felt like an electric shock when the vaccine was given. Her son then took her to the ER to be evaluated.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
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Patient experienced shortness of breath, became clammy and had a headache immediately after vaccine. About 5 minutes later, she started to feel better, however, her blood pressure was 207/98. It appeared to be a panic attack. She states that it felt like an electric shock when the vaccine was given. Her son then took her to the ER to be evaluated.
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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: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Eye pruritus, Generalised tonic-clonic seizure, Headache
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Patient's guardian reported grand mal seizures the morning after vaccination. Patient was sent EMS to hospital. Guardian reports no side effects the evening after vaccination. Patient participated in a cross-country team run through a corn field that evening. A headache was reported to Guardian, who recommended on Tylenol. Guardian reported early in the morning the patient was acting unusual and patient reported to the guardian that they had taken 5 benadryl for itchy eyes the night before. The patient had grand mal seizure early that morning, witness by Guardian, who is a school nurse. EMS responded and patient was sent to Hospital before being transferred to another hospital. Guardian reports that the hospital MD and PCP agreed that the benadryl was most likely the cause of the seizures. Of note, the biological sister reportedly was hospialized for a seizure two weeks prior to this event. No history of personal or family history of seizure disorders were known of previously. Guardian was present for all DTAP and TDAP given in 2018 and no adverse effects were noticed after those vaccinations. Guardian reports that the patient has recovered back to baseline.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Memory impairment
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Memory started to go bad. I had a hard time remember things. I because fuzzy minded. My short term memory was affected as I couldn't recall thing as sharply as I used to.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Death
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Unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown. The reporter considered the unknown cause of death to be possibly related to Shingles vaccine. The company considered the unknown cause of death to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter's cousin got the shot, died three days later. It was reported as there seems to be a connection. Keep your shot.; Sender's Comments: A case of Death, 3 days after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR104452:Original Case Number : US2025AMR104452_Same reporter; Reported Cause(s) of Death: Unknown cause of death
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: HPV4
Symptoms: Exposure during pregnancy, Foetal death, Foetal malformation, Investigation normal, Ultrasound antenatal screen abnormal
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Drug exposure during pregnancy; Death; Absent limb; Congenital limb malformation NOS; Exomphalos; This spontaneous report was received from a/an Other health professional and refers to a(n) Foetus patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-May-2011, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Injection administered by Unknown route (lot # and expiration date were not reported). On 27-Jul-2011, the patient started therapy with Injection (lot #668229/1569Z) administered by Transplacental route (expiration date was not reported). The patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), for the treatment of ??. The patient started therapy with GARDASIL Aqueous Suspension for Intramuscular Injection Syringe for the treatment of ??. On Sep-2011, the patient experienced Death. On 2011, the patient experienced Absent limb. On 2011, the patient experienced Congenital limb malformation NOS. On 2011, the patient experienced Exomphalos. On an unknown date, the patient experienced Drug exposure during pregnancy. On Sep-2011, Investigation showed Test Result: normal. On 14-Sep-2011, Ultrasound scan showed Test Result: Fetus was no longer viable/ alive.. At the reporting time, the patient had not recovered from Absent limb, Congenital limb malformation NOS and Exomphalos. At the reporting time, the outcome of Drug exposure during pregnancy was unknown. On 01-Sep-2011, the patient died because of the event(s) of Death. It was unknown whether an autopsy was performed. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was reported as not applicable. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Suspension for injection was reported as not applicable. The reporter considered the event of Drug exposure during pregnancy to be not related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine. The causal relationship between the event of Death and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Absent limb and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Congenital limb malformation NOS and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Exomphalos and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The reporter considered the event(s) of Absent limb Congenital limb malformation NOS and Exomphalos to be congenital anomaly/birth defect.; Reported Cause(s) of Death: death
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Angina pectoris, Back pain, Dyspnoea, Headache
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couldn't think through her process; Heart pain; felt like she couldn't breathe; was hyperventilating; she wasn't feeling good; waking with abdominal pain; woke with her heart racing and heart pain; Sick back pain; weird pain in her spine; she woke with numbness in her arm; A weird electrical feeling in her hand; Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think through her process) and ANGINA PECTORIS (Heart pain) in a 39-year-old female patient 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 MENTAL IMPAIRMENT (couldn't think through her process) (seriousness criterion medically significant), ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm), PARAESTHESIA (A weird electrical feeling in her hand), MYALGIA (Body aches) and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain). At the time of the report, MENTAL IMPAIRMENT (couldn't think through her process), ANGINA PECTORIS (Heart pain), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm) and PARAESTHESIA (A weird electrical feeling in her hand) outcome was unknown, MYALGIA (Body aches) had resolved and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. Patient experienced a bad reaction to the Moderna Covid Vaccine and wanted information in regards to the Pfizer Covid pill. Patient reported adverse effects after receiving Paxlovid. Patient experienced headache and body aches and weird episodes once per week for four weeks. Patient woke up with numbness in her arm, and felt like she couldn't breathe and was hyperventilating. Patient had a weird electrical feeling in her hand. On the next morning, she wasn't feeling good, so, she went to the hospital. The hospital staff did not believe that she was having an adverse reaction to the vaccine but she was given IV fluids and then began to feel better. The headaches began again and patient had this weird brain pain and couldn't think through her process. Patient reported going to bed and having a dream and then waking with abdominal pain. On the next night, when she slept, she had another dream but during this time, she woke with her heart racing and heart pain, so then she went back to the emergency room visit. Patient did not state outcome of this emergency room visit. Patient continued to have episodes of crazy headaches. Patient purchased something with which she could check blood pressure and oxygen level. Patient was also having sick back pain, weird pain in her spine and felt like crap from January to March. Reporter did not allow further contact; 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
|
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Hypoaesthesia, Malaise, Mental impairment, Myalgia
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couldn't think through her process; Heart pain; felt like she couldn't breathe; was hyperventilating; she wasn't feeling good; waking with abdominal pain; woke with her heart racing and heart pain; Sick back pain; weird pain in her spine; she woke with numbness in her arm; A weird electrical feeling in her hand; Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think through her process) and ANGINA PECTORIS (Heart pain) in a 39-year-old female patient 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 MENTAL IMPAIRMENT (couldn't think through her process) (seriousness criterion medically significant), ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm), PARAESTHESIA (A weird electrical feeling in her hand), MYALGIA (Body aches) and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain). At the time of the report, MENTAL IMPAIRMENT (couldn't think through her process), ANGINA PECTORIS (Heart pain), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm) and PARAESTHESIA (A weird electrical feeling in her hand) outcome was unknown, MYALGIA (Body aches) had resolved and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. Patient experienced a bad reaction to the Moderna Covid Vaccine and wanted information in regards to the Pfizer Covid pill. Patient reported adverse effects after receiving Paxlovid. Patient experienced headache and body aches and weird episodes once per week for four weeks. Patient woke up with numbness in her arm, and felt like she couldn't breathe and was hyperventilating. Patient had a weird electrical feeling in her hand. On the next morning, she wasn't feeling good, so, she went to the hospital. The hospital staff did not believe that she was having an adverse reaction to the vaccine but she was given IV fluids and then began to feel better. The headaches began again and patient had this weird brain pain and couldn't think through her process. Patient reported going to bed and having a dream and then waking with abdominal pain. On the next night, when she slept, she had another dream but during this time, she woke with her heart racing and heart pain, so then she went back to the emergency room visit. Patient did not state outcome of this emergency room visit. Patient continued to have episodes of crazy headaches. Patient purchased something with which she could check blood pressure and oxygen level. Patient was also having sick back pain, weird pain in her spine and felt like crap from January to March. Reporter did not allow further contact; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Spinal pain
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couldn't think through her process; Heart pain; felt like she couldn't breathe; was hyperventilating; she wasn't feeling good; waking with abdominal pain; woke with her heart racing and heart pain; Sick back pain; weird pain in her spine; she woke with numbness in her arm; A weird electrical feeling in her hand; Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think through her process) and ANGINA PECTORIS (Heart pain) in a 39-year-old female patient 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 MENTAL IMPAIRMENT (couldn't think through her process) (seriousness criterion medically significant), ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm), PARAESTHESIA (A weird electrical feeling in her hand), MYALGIA (Body aches) and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain). At the time of the report, MENTAL IMPAIRMENT (couldn't think through her process), ANGINA PECTORIS (Heart pain), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm) and PARAESTHESIA (A weird electrical feeling in her hand) outcome was unknown, MYALGIA (Body aches) had resolved and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. Patient experienced a bad reaction to the Moderna Covid Vaccine and wanted information in regards to the Pfizer Covid pill. Patient reported adverse effects after receiving Paxlovid. Patient experienced headache and body aches and weird episodes once per week for four weeks. Patient woke up with numbness in her arm, and felt like she couldn't breathe and was hyperventilating. Patient had a weird electrical feeling in her hand. On the next morning, she wasn't feeling good, so, she went to the hospital. The hospital staff did not believe that she was having an adverse reaction to the vaccine but she was given IV fluids and then began to feel better. The headaches began again and patient had this weird brain pain and couldn't think through her process. Patient reported going to bed and having a dream and then waking with abdominal pain. On the next night, when she slept, she had another dream but during this time, she woke with her heart racing and heart pain, so then she went back to the emergency room visit. Patient did not state outcome of this emergency room visit. Patient continued to have episodes of crazy headaches. Patient purchased something with which she could check blood pressure and oxygen level. Patient was also having sick back pain, weird pain in her spine and felt like crap from January to March. Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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