chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero was unintentionally administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis.   On 24-JUN-2025, the patient received the 1st dose of Bexsero. On 24-JUN-2025, immediately after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero was unintentionally administered). The outcome of the wrong vaccine administered was not applicable.   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: 01-JUL-2025 A vaccine coordinator reported the administration of a Bexsero vaccine to a patient by a member of the staff.   She wanted to know how to proceed after this incident. The reporter wanted to report that Bexsero was unintentionally administered, and no other data was provided, which led to wrong vaccine administered. It was explained that it was administered within the recommended range of age. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Breast cancer female, Chemotherapy, Mastectomy, Myelodysplastic syndrome
Clinical narrative: Breast Cancer diagnosed in November 2022. Never had any issues prior to the Moderna vaccine. Mastectomy one breast January 2023. Diagnosed with MDS May 2024. Blood work showed very low platelets and high white blood count. Has tried chemotherapy pill that gave my mother extreme neuropathy. My mother has had 3 different very painful bone marrow biopsys. My mother has had many transfusions and etc. prior to the Moderna Booster my mother was in very good health. My mother has now been given a very poor prognosis.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Transfusion, White blood cell count increased
Clinical narrative: Breast Cancer diagnosed in November 2022. Never had any issues prior to the Moderna vaccine. Mastectomy one breast January 2023. Diagnosed with MDS May 2024. Blood work showed very low platelets and high white blood count. Has tried chemotherapy pill that gave my mother extreme neuropathy. My mother has had 3 different very painful bone marrow biopsys. My mother has had many transfusions and etc. prior to the Moderna Booster my mother was in very good health. My mother has now been given a very poor prognosis.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: reconstituted with sterile water from Merck Sharp  and amp;; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult female patient who received MMR (Priorix) (batch number J942L, expiry date 08-NOV-2026) for prophylaxis.   On 23-JUN-2025, the patient received Priorix. On 23-JUN-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water from Merck Sharp  and amp;). The outcome of the wrong solution used in drug reconstitution was not applicable.   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: 24-JUN-2025 Nurse practitioner explained that on June 23rd 2025, 2 patients were vaccinated with Priorix doses that were accidentally reconstituted with sterile water from Merck Sharp. Dohme vaccines instead of the Priorix corresponding diluent provided by Glaxo Smith Kline which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2025079396, reported by same reporter different patient; Sender's Comments:  US-GSK-US2025079396:same reporter /different patient
Age: 85.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful.; The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful.; The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful./However, pain and redness spread up to her elbow; However, pain and redness spread up to her elbow; This spontaneous report was received from a pharmacist and refers to a 85-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported.   On 12-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) solution for injection, 1 dose, lot #Y019157, expiration date: 23-MAY-2026, administered by intramuscular route as routine vaccination (anatomical site was not reported).  For first 4 days after the vaccination the patient complained that her arm was "sore" and on the 5th day the injection site got red and swollen and her arm was painful. She went to an urgent care and received a prescription for Doxycycline 100mg twice a day for 7 days. However, pain and redness spread up to her elbow, so she went to an unspecified hospital and received unspecified IV antibiotic. Confirmed with pharmacist that the patient was not hospitalized. At the reporting time, the patient had not recovered from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported but established as not applicable.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; expired dose of GARDASIL 9 was administered to a patient.; This spontaneous report was received from a Registered Nurse 30-Jun-2025.and refers to a patient of unknown age and gender.   The patient's medical history concurrent conditions and concomitant therapies were not reported.    On 25-Feb-2025, the patient was vaccinated with an expired vaccine of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) (dose number, lot #W031448, expiration date: 12-Feb-2025), dose:0.5 mL for Prophylaxis (Expired product administered). No symptoms reported
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; Healthcare worker reported that a 2 month old patient received a dose of GARDASIL 9.     No additional AEs were reported, no further information provided. No PQC.; This spontaneous report was received from a healthcare worker and refers to 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 03-Jul-2025, the 2-month-old patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (invalid lot #z014790, expiration date: 22-Apr-2026) for prophylaxis (product administered to patient of inappropriate age).  No additional adverse events (AEs) were reported. no further information provided.
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AEs were reported; Healthcare worker reported that a 2 month old patient received a dose of GARDASIL 9.     No additional AEs were reported, no further information provided. No PQC.; This spontaneous report was received from a healthcare worker and refers to 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 03-Jul-2025, the 2-month-old patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (invalid lot #z014790, expiration date: 22-Apr-2026) for prophylaxis (product administered to patient of inappropriate age).  No additional adverse events (AEs) were reported. no further information provided.
Vaccine: FLUN3
Symptoms: Arthralgia, Ear pruritus, Throat irritation, Urticaria
Clinical narrative: Hives; itchy throat; Itchy ears; acid reflux; joint pain; A spontaneous report has been received from a non-health professional. The report concerns a female adult patient of (withheld) ethnic origin born in 2000 (age 24 years, height 167 cm, weight 56.699 kg).  No medical history was reported.   No concomitant products were reported.  The patient received Flumist (batch number(s) Unknown), via nasal use on 08-OCT-2024. The patient received 1 dose(s).    On 14-OCT-2024, the patient experienced acid reflux (preferred term: Gastrooesophageal reflux disease),hives (preferred term: Urticaria),itchy ears (preferred term: Ear discomfort),itchy throat (preferred term: Throat irritation),joint pain (preferred term: Arthralgia).     It is unknown if any action was taken with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv).  At the time of reporting, the event acid reflux, hives, itchy ears, itchy throat and joint pain was improving.      The events were considered non-serious.   The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): acid reflux, hives, itchy ears, itchy throat and joint pain. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): acid reflux, hives, itchy ears, itchy throat and joint pain.  Device Information:  Product As Reported: Accuspray Single Dose Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use: Yes
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in on his back and on his front; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUN-2025, the patient received Shingrix. In JUN-2025, less than a week after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles in on his back and on his front). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2025  The patient received a dose of the Shingrix vaccine on Friday.  It was not stated if it was the first or second dose.   On Saturday (21-JUN-2025) or Sunday (22-JUN-2025), the patient began to break out in a full case of Shingles.  The Shingles in on his back and on his front.  The patient was taken to an urgent care facility and was prescribed an antiviral.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was suppose to boostrix but was administered with Pediarix in error; patient was supposed to boostrix but was administered with Pediarix in error; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 10-JUN-2025, the patient received Pediarix (left deltoid). On an unknown date, the patient did not receive Boostrix. On 10-JUN-2025, immediately after receiving Pediarix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: patient was suppose to boostrix but was administered with Pediarix in error) and inappropriate age at vaccine administration (Verbatim: patient was supposed to boostrix but was administered with Pediarix in error). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   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:01-JUL-2025 The reporter HCP found out about it when they were doing their audit.  The patient was supposed to Boostrix but was administered with Pediarix in error and no symptoms had been reported by the patient. The patient wanted to get it as a prevention but instead of Boostrix, Pediarix was administered in error, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis.   On 20-FEB-2025, the patient received Shingrix. On 20-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2025061270:same reporter differnt patient
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis.   Concurrent medical conditions included hypertension, blood cholesterol increased and obesity. Concomitant products included lisinopril dihydrate (Lisinopril), atorvastatin calcium (Atorvastatin), pioglitazone hydrochloride (Pioglitazone) and tirzepatide (Mounjaro).   On 07-APR-2025, the patient received Shingrix. On 07-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2025061270:same reporter differnt patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 2 minor flare ups since being vaxxed; 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 an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 2 minor flare ups since being vaxxed). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure 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: 26-JUN-2025 This case was reported by a patient via interactive digital media. Patient had two minor flare-ups since being vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles 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, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; 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 an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure 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: 26-JUN-2025 This case was reported by a patient via interactive digital media. Patient had also had the shots and had shingles now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles 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, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 18-JUN-2025 09:40, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix plus Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 24-JUN-2025 Administration after temperature excursion which led to incorrect storage of drug. Pharmacist called to verify if doses of vaccines that had been exposed to low temperatures should be repeated.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 20-JUN-2025 09:30, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that had been exposed to low temperatures should be repeated.  Boostrix was administered after temperature excursion which led to Incorrect storage of drug.; Sender's Comments:  US-GSK-US2025079387:same reporter /different patient US-GSK-US2025079386:same reporter /different patient US-GSK-US2025079384:same reporter /different patient US-GSK-US2025079385:same reporter /different patient US-GSK-US2025079382:same reporter /different patient US-GSK-US2025079374:same reporter /different patient US-GSK-US2025079376:same reporter /different patient US-GSK-US2025079375:same reporter /different patient US-GSK-US2025079378:same reporter /different patient
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Maladministration in a eleven year old patient (Age administration error/Underdose); was given a Dtap instead of Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9PT28, expiry date 10-MAR-2026) and (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 24-JUN-2025, the patient received Infanrix (intramuscular use) .5 ml. On an unknown date, the patient received Tdap Vaccine. On 24-JUN-2025, an unknown time after receiving Infanrix and not applicable after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration in a eleven year old patient (Age administration error/Underdose)) and wrong vaccine administered (Verbatim: was given a Dtap instead of Tdap). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable.   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: 24-JUN-2025 and 26-JUN-2025 The patient had no adverse effects, was given a Dtap instead of Tdap, whc=ich led wrong vaccine administered. Infanrix vaccine administered to an eleven year old patient, which led inappropriate age at vaccine administered, with the dosage difference, The reporter asked how effective it was.  The reporter reported he/she gave the lower dose he/she guesses. The reporter asked was there any advice for this. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered.; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis.   On 25-JUN-2025, the patient received the 2nd dose of Shingrix. On 25-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 25-JUN-2025 Other HCP reported that earlier on the day of reporting, they had administered only the diluent of Shingrix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Reporter mentioned that after realizing this medication error, they administered on that same visit a valid dose of Shingrix. No further details were obtained.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: received Priorix IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 23-year-old female patient who received MMR (Priorix) (batch number 4n222, expiry date 13-SEP-2026) for prophylaxis.   On 15-APR-2025, the patient received Priorix (intramuscular use). On 15-APR-2025, an unknown time after receiving Priorix, the patient experienced intramuscular formulation administered by other route (Verbatim: received Priorix IM instead of SC). The outcome of the intramuscular formulation administered by other route was not applicable.   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: 26-JUN-2025 The patient received Priorix intramuscularly instead of subcutaneous, which led intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 85-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Paxlovid. Past adverse reactions to the above products included No adverse effect with Paxlovid.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The patient had covid again despite of the vaccination (Unspecified Vaccine) and everything. The patient had mixed vaccines some of Pfizer and Moderna both were unspecified.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787883 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787883:Male patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Paxlovid. Past adverse reactions to the above products included No adverse effect with Paxlovid.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The patient had covid again despite of the vaccination (Unspecified Vaccine) and everything. The patient had mixed vaccines some of Pfizer and Moderna both were unspecified.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787882 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787882:Male patient
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Anxiety, Balance disorder, Brain fog, Chest pain
Clinical narrative: Severe anxiety, numbness over entire body , migraines , sudden mood changes, loss of balances , extreme fatigue and brain fog , tachycardia, tremors, adrenaline issues,  severe chest pain, inability to exercise or engage in daily tasks.  I still experience many of these  symptoms 3 years later
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Hypoaesthesia, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Severe anxiety, numbness over entire body , migraines , sudden mood changes, loss of balances , extreme fatigue and brain fog , tachycardia, tremors, adrenaline issues,  severe chest pain, inability to exercise or engage in daily tasks.  I still experience many of these  symptoms 3 years later
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart abnormal, Migraine, Mood altered, Pulmonary mass, Tachycardia
Clinical narrative: Severe anxiety, numbness over entire body , migraines , sudden mood changes, loss of balances , extreme fatigue and brain fog , tachycardia, tremors, adrenaline issues,  severe chest pain, inability to exercise or engage in daily tasks.  I still experience many of these  symptoms 3 years later
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tilt table test positive, Tremor
Clinical narrative: Severe anxiety, numbness over entire body , migraines , sudden mood changes, loss of balances , extreme fatigue and brain fog , tachycardia, tremors, adrenaline issues,  severe chest pain, inability to exercise or engage in daily tasks.  I still experience many of these  symptoms 3 years later
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Mounjaro 7.5mg causes temporary paralysis in legs and spine which may become permanent.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Chest discomfort, Chest pain, Magnetic resonance imaging heart normal, Troponin increased
Clinical narrative: Myocarditis Event on March 23. Chest pain and tightness, went to the ER, initially thought to be a non-Stemi heart attack, troponin level went over 5.2. Heart Cath done, no major blockages. MRI the next day, ruled Myocarditis
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Arm soreness lasting >1 week, soreness spreading to whole arm outside of the injection site. Warmth at injection site. Vaccine administration technique was appropriate, injection site not too high up on the arm. Patient also complaining of feeling lightheaded the past week or so as well.
Age: 65.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm at the area where 2 injection occured
Age: 60.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Patient had a reaction of redness around the injection site which seems like spreading but slowly, tenderness with warm touch, fever, chills, and itchiness. Patient started to react around 3rd day of injection, and it has not healed after a week. Recommended patient to apply cold compresses and to take ibuprofen, Tylenol to help reach remission of fever and chills. Also, asked them to get medical attention but patient refused.
Age: 60.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient had a reaction of redness around the injection site which seems like spreading but slowly, tenderness with warm touch, fever, chills, and itchiness. Patient started to react around 3rd day of injection, and it has not healed after a week. Recommended patient to apply cold compresses and to take ibuprofen, Tylenol to help reach remission of fever and chills. Also, asked them to get medical attention but patient refused.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ectopic pregnancy, Human chorionic gonadotropin increased, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Ectopic pregnancy
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT WAS 58 YEARS OF AGE AT TIME OF VACCINE AND DID NOT HAVE A PRESCRIPTION FROM PHYSICIAN, FAMILY HAD REQUESTED VACCINES AT NURSING HOME AND I DID NOT REALIZE HE HAD NO PRESCRIPTION REQUEST.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: PATIENT REQUESTED SHINGRIX SHOT AT CLINIC, IT WAS GIVEN BUT UPON BILLING I DISCOVERED THAT HE HAD RECEIVED BOTH DOSES IN 2018
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Derealisation
Clinical narrative: Following this set of vaccinations, child became extremely ill within 3 weeks. He developed a high fever and respiratory distress, which lasted over 2 weeks - far more severe than any prior illness. After recovering from the physical symptoms, he did not return to his prior developmental state. He had previously been meeting and exceeding milestones, but after this illness, we observed the following regressions: lost all previously acquired speech, stopped making eye contact, no longer responded to his name, began repetitive hand-flapping, begin banging head on objects, developed sleep disturbances, appeared disconnected, as if trapped in his own body. Symptoms have persisted long-term. He was formally diagnosed on August 7, 2023, with: level 2 nonverbal autism (F84.0) As well as mixed receptive-expressive language disorder (F82.0), lack of expected normal physiological development in childhood (R62.50), abnormality of gait and mobility (R26.89). He currently presents with significant impairments in language, gross motor, fine motor, sensory processing, and social responsiveness. Currently receiving support therapies.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Developmental delay, Developmental regression, Fine motor delay, Gait disturbance, Gross motor delay
Clinical narrative: Following this set of vaccinations, child became extremely ill within 3 weeks. He developed a high fever and respiratory distress, which lasted over 2 weeks - far more severe than any prior illness. After recovering from the physical symptoms, he did not return to his prior developmental state. He had previously been meeting and exceeding milestones, but after this illness, we observed the following regressions: lost all previously acquired speech, stopped making eye contact, no longer responded to his name, began repetitive hand-flapping, begin banging head on objects, developed sleep disturbances, appeared disconnected, as if trapped in his own body. Symptoms have persisted long-term. He was formally diagnosed on August 7, 2023, with: level 2 nonverbal autism (F84.0) As well as mixed receptive-expressive language disorder (F82.0), lack of expected normal physiological development in childhood (R62.50), abnormality of gait and mobility (R26.89). He currently presents with significant impairments in language, gross motor, fine motor, sensory processing, and social responsiveness. Currently receiving support therapies.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Head banging, Language disorder, Malaise, Pyrexia, Respiratory distress
Clinical narrative: Following this set of vaccinations, child became extremely ill within 3 weeks. He developed a high fever and respiratory distress, which lasted over 2 weeks - far more severe than any prior illness. After recovering from the physical symptoms, he did not return to his prior developmental state. He had previously been meeting and exceeding milestones, but after this illness, we observed the following regressions: lost all previously acquired speech, stopped making eye contact, no longer responded to his name, began repetitive hand-flapping, begin banging head on objects, developed sleep disturbances, appeared disconnected, as if trapped in his own body. Symptoms have persisted long-term. He was formally diagnosed on August 7, 2023, with: level 2 nonverbal autism (F84.0) As well as mixed receptive-expressive language disorder (F82.0), lack of expected normal physiological development in childhood (R62.50), abnormality of gait and mobility (R26.89). He currently presents with significant impairments in language, gross motor, fine motor, sensory processing, and social responsiveness. Currently receiving support therapies.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Sensory processing disorder, Sleep disorder, Stereotypy, Unresponsive to stimuli
Clinical narrative: Following this set of vaccinations, child became extremely ill within 3 weeks. He developed a high fever and respiratory distress, which lasted over 2 weeks - far more severe than any prior illness. After recovering from the physical symptoms, he did not return to his prior developmental state. He had previously been meeting and exceeding milestones, but after this illness, we observed the following regressions: lost all previously acquired speech, stopped making eye contact, no longer responded to his name, began repetitive hand-flapping, begin banging head on objects, developed sleep disturbances, appeared disconnected, as if trapped in his own body. Symptoms have persisted long-term. He was formally diagnosed on August 7, 2023, with: level 2 nonverbal autism (F84.0) As well as mixed receptive-expressive language disorder (F82.0), lack of expected normal physiological development in childhood (R62.50), abnormality of gait and mobility (R26.89). He currently presents with significant impairments in language, gross motor, fine motor, sensory processing, and social responsiveness. Currently receiving support therapies.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Headache, Hemiparaesthesia, Magnetic resonance imaging head
Clinical narrative: Full body left sided paresthesia, worked up for rule out stroke or TIA. Vertigo/dizziness/headache. Referred to ENT after hospitalization.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Scan with contrast, Vertigo
Clinical narrative: Full body left sided paresthesia, worked up for rule out stroke or TIA. Vertigo/dizziness/headache. Referred to ENT after hospitalization.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient had injection site reaction: swelling, redness, itchiness
Age: 72.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Date of immunization:  6/28/2025, date of symptoms: 7/4/2025, symptoms: area of vaccination redness, soreness and swelling, recommendation: apply ice pack wrapped in a dry cloth to avoid direct contact to the area and over the counter medication: ibuprofen
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Chills, extreme fatigue, headache, muscle aches, nausea
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Injection site warmth, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: patient states she woke up 7/2 with hives but they resolved on own, both arms were sore but @ 9pm pain got worse and she felt shooting pain down right arm both arms red, swollen, warm to touch at injection site
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: patient states she woke up 7/2 with hives but they resolved on own, both arms were sore but @ 9pm pain got worse and she felt shooting pain down right arm both arms red, swollen, warm to touch at injection site
Vaccine: PNC20
Symptoms: Death, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Inappropriate dose of vaccine administered; This is a spontaneous report received from a Nurse from a sales representative.  An elderly patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, single (Lot number: GW7964) and as dose number unknown, single (Lot number: LP4947) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Oct2024, outcome "unknown", described as "Inappropriate dose of vaccine administered"; VACCINATION SITE ERYTHEMA (death, hospitalization), VACCINATION SITE SWELLING (death, hospitalization), VACCINATION SITE DISCOMFORT (death, hospitalization), outcome "fatal" and all described as "Redness, swollen, discomfort at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site discomfort. The patient date of death was unknown. Reported cause of death: "Redness, swollen, discomfort at the injection site". It was not reported if an autopsy was performed.  Clinical course: Redness, swollen, discomfort at the injection site. At least two occurrences of this of late, one of which required hospitalization.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination site erythema, vaccination site swelling, and vaccination site discomfort; 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.; Reported Cause(s) of Death: Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Knee arthroplasty, Pain, Pyrexia
Clinical narrative: fever; sick; aches, pains; knee replacement surgery in January; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ER2613) at the age of 62 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Weight loss" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ZEPBOUND taken for weight decreased (ongoing); NEVIBOLOL DCI taken for hypertension (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 21Jan2025, outcome "unknown", described as "knee replacement surgery in January"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown" and all described as "aches, pains". Clinical course: the patient reported that when she got a covid vaccine, she experienced a fever within few hours and got pretty sick. She had aches, pains and a fever. She also had knee replacement surgery in Jan, so she thought perhaps that had something to do with her experience.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132274 Same patient and drug, different dose and event;
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Blood clots formed in superficial veins in right leg.  They dissipated after 5 weeks with no treatment.  Blood clots returned on 7/4/2025 in right leg.  Moderate pain is being observed by the patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, chills, headache, vomiting, nausea
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Fatigue, Herpes zoster, Hypoaesthesia
Clinical narrative: Got shingles 2 weeks after.  Chest pain arm numbness, extreme fatigue and of course the blisters
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Headache, Nausea
Clinical narrative: Patient called clinic to report that after she got home, approximately 1 hours after immunization, she began to have headache, backache and nausea. She took two ibuprofen (200mg each) and currently (about 2 hours after administration) feels like symptoms are subsiding.  Advised her to continue to monitor symptoms, rest, and drink plenty of fluids, and if symptoms worsen in any way, she should go to ER for evaluation. Plan is to follow up with patient tomorrow by phone to check on her condition.
Age: 79.0
Sex: F
Vaccine: HEP
Symptoms: Neuropathy peripheral
Clinical narrative: Patient started getting neuropathy in both feet on or around 06/26/25. The sensation is progressing upward to her legs. As of 07/05/25 she is still experiencing the neuropathy.  She received 2 vaccines on 6/23 and 6/25 so unable to determine which vaccine may have caused the reaction
Age: 60.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Cellulitis
Clinical narrative: PATIENT CAME IN TO THE PHARMACY AND REPORTED THAT THEY HAD STARTED EXPERIENCING MILD CELLULITIS SYMPTOMS AND WANTED US TO REPORT. THE PATIENT IS AN MD. NOT CURRENTLY NEEDING TO RECEIVE ANY TREATMENT FOR HTE CONDITION.
Age: 55.0
Sex: M
Vaccine: HEP, PNC20
Symptoms: Injection site swelling, Pain
Clinical narrative: after 3 days, pain slowly improving , no redness, slightly swollen around injection site
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Laboratory test normal, Mouth ulceration, Pain, Pyrexia
Clinical narrative: Spiked a 103 fever, chills, body aches, and Apthous Ulcer in Vulva and mouth.  Fever broke on July 2, she is still suffering with the ulcers.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal, Vulval ulceration
Clinical narrative: Spiked a 103 fever, chills, body aches, and Apthous Ulcer in Vulva and mouth.  Fever broke on July 2, she is still suffering with the ulcers.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient reports that exactly one week after vaccination, she experienced joint pain and muscle pain all over her body. Now, 3 weeks later, she only has pain in one elbow - she says it feels bruised.