chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-month-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 04-NOV-2024, the patient received the 1st dose of Infanrix. On 04-NOV-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired vaccine). The outcome of the expired vaccine used was unknown.   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: 04-NOV-2024 The Healthcare Professional reported about the administration of an expired dose of Infanrix to a patient.  They mentioned that the patient was a 3 month old female, with this being their first dose.  The dose was administered on 4th November 2024. The patient received an expire dose of Infanrix, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Priorix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received MMR (Priorix) (batch number 53F2A, expiry date 01-NOV-2024) for prophylaxis.   On 04-NOV-2024, the patient received Priorix. On 04-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Priorix expired dose). The outcome of the expired vaccine used was unknown.   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: 05-NOV-2024 The medical assistant reported that an expired dose of Priorix was administered to a patient, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: inadvertently given an expired dose of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received MMR (Priorix) (batch number AA25F, expiry date 01-NOV-2024) for prophylaxis.   On 04-NOV-2024, the patient received Priorix. On 04-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: inadvertently given an expired dose of Priorix). The outcome of the expired vaccine used was unknown.   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: 05-NOV-2024 The clinic manager stated a female patient was inadvertently given an expired dose of Priorix on 04th November 2024 which led to expired vaccine used.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93PD7, expiry date 22-OCT-2024) for prophylaxis.   Concomitant products included diltiazem.   On 22-NOV-2023, the patient received the 1st dose of Arexvy (right arm) .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Soreness at injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Linked case(s) involving the same patient: US2024AMR137727   Additional Information: GSK Receipt Date: 05-NOV-2024 The reporter reported that a patient received Arexvy vaccine and experienced soreness at the injection site that resolved.   Patient could not remember any more details about the first injection due to the lapse of time. This case is linked with US2024AMR137727, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR137727:Same patient/Dose 1
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Drug Exposure During Pregnancy/Administration During Pregnancy; Product use in unapproved population; they have a 4 month old infant that was born to a mother who was administered Arexvy while pregnant instead of Abrysvo.; This non-serious retrospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy and patient did not received Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy/Administration During Pregnancy), product use in unapproved population (Verbatim: Product use in unapproved population) and wrong vaccine administered (Verbatim: they have a 4 month old infant that was born to a mother who was administered Arexvy while pregnant instead of Abrysvo.). The outcome of the vaccine exposure during pregnancy, product use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 19-NOV-2024 The Healthcare Professional from a pediatric office state that they have a 4 month old infant that was born to a mother who was administered Arexvy while pregnant instead of Abrysvo.  The nurse did not know the date the Arexvy was administered, or at how many weeks gestation. The nurse did not know any patient details about the mother, as she was not a patient at their practice.  The patient who was pregnant Arexvy instead of Abrysvo, which led to vaccine exposure during pregnancy, Product use in unapproved population and wrong vaccine administered.
Sex: U
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 50-year-old patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in 2023).   On an unknown date, the patient received the 2nd dose of Engerix B. In SEP-2024, the patient received Heplisav b. On an unknown date, an unknown time after receiving Engerix B, the patient experienced interchange of vaccine products (Verbatim: Interchange of vaccine). The outcome of the interchange of vaccine products was unknown.   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: 19-NOV-2024 The nurse reported that a patient that completed Heplisav both doses but did not convert.  It was wondering how long needed to wait to administered Engerix after completion of Heplisav. They did received 2 doses of Engerix-B prior to the Heplisav, which led to interchange of vaccine products. The reporter did not know if that was necessary to know that, it would be the third dose of Engerix-B. Patient received 2 doses of Engerix B on 2023, a dose of Heplisav B on September 2024 and a second dose of Heplisav B on October 2024.  Now was getting not detected titers.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA305876 (SANOFI ), AE-016690 (LLP-BioNTech).  A 25-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; dupilumab (DUPIXENT) at 300 mg (300 mg, every 2 weeks), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown". The action taken for dupilumab was unknown.  Additional information: On an unknown date, the patient suffered a non-serious event rash (rash) (unknown latency) following the first dose intake of DUPILUMAB and COVID-19 vaccine. It was reported 'Patient stated he has a rash after taking the covid shot'. It was not reported if the patient received a corrective treatment for the event rash.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Flushing
Clinical narrative: flares on her skin and states symptoms started after she got the flu vaccine; flushing; getting random hot/throbbing episodes; Initial information received on 22-Nov-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case is linked to case- US-SA-2023SA394122  This case involves "an approximately" a 42 year old female patient (52.27 kg) who had flares on her skin and states symptoms started after she got the flu vaccine, flushing and getting random hot/throbbing episodes after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Mycophenolate mofetil (Mycophenolate); and Prednisone.  On an unknown date in November 2024, the patient received suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, form, dose, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date in November 2024 the patient had flares on her skin and states symptoms started after she got the flu vaccine (condition aggravated) (unknown latency). On an unknown date in 2024 the patient had flushing, getting random hot/throbbing episodes (feeling hot) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for all the events; Sender's Comments:  US-SA-2023SA394122:
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered FLUZONE HIGH-DOSE for a second time this season, with no reported adverse event; Initial information received on 22-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 77 years old male patient who was inadvertently administered influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] for a second time this season, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Nov-2024, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine of Suspension for injection in pre-filled syringe (expiry date- 30-Jun-2025 and lot U8524CA) via intramuscular route in left deltoid. On 10-Oct-2024 she also received an unknown dose of same vaccine as Immunization with no reported adverse event (extra dose administered) (latency- same day following last dose).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. ; Sender's Comments:  US-SA-2024SA352638:
Age: 16.0
Sex: M
Vaccine: MEN, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive Bexsero and MENQUADFI, but instead, ADACEL and MENQUADFI were administered, and Bexsero was not given with no reported adverse event; Initial information received on 22-Nov-2024 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves a 16 years old male patient where patient was supposed to receive Bexsero and menquadfi, but instead, diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] and Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] were administered, and bexsero was not given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Nov-2024, the patient received 0.5 ml dose 2 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength- standard) (lot- U8015AA and expiry date- 01-MAR-2026) via intramuscular route in the upper left arm for Prophylactic vaccination and received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for Prophylactic vaccination.  On an unknown date, dose of suspect Bexsero not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for Prophylactic vaccination.  On 21-Nov-2024 the patient was supposed to receive bexsero and menquadfi, but instead, adacel and menquadfi were administered, and bexsero was not given with no reported adverse event (wrong product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TTOX
Symptoms: Unevaluable event
Clinical narrative: reaction to tetanus; Initial information received on 25-Nov-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves Elderly female patient who had reaction to Tetanus Toxoid.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Allergy to vaccine.   On an unknown date, the patient received a unknown dose of suspect Tetanus Toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) (strength, formulation, expiry date was unknown). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date the patient developed reaction to tetanus (immunisation reaction) (unknown latency) following the administration of Tetanus Toxoid.  Reportedly "New grandparents (69- and 70-year-old) were told that they need a TDAP vaccine before they could visit the baby. Caller also mentioned the whooping cough Wife is allergic to tetanus and all of our vaccines seem to have a tetanus portion. Caller asked if his wife could still get the TDAP vaccine if she has had a reaction to tetanus in the past?"  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (reaction to tetanus).  At time of reporting, the outcome was Unknown for the event reaction to tetanus.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired PENTACEL to a patient (with no reported adverse event); Initial information received on 26-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 15 months old female patient who received expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] to a patient (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20) for Immunisation.  On 25-Nov-2024, the patient expired received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength once with lot UJ973AA and expiry date 19-Nov-2024 via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (Latency same day).  Reportedly, She said that it should have been the 3rd dose of pentacle.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: medical assistant did not use the manufacturer's diluent, but used sterile water instead with no reported adverse event; Initial information received on 26-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2-month-old and unknown gender patient and medical assistant did not use the manufacturer's diluent but used sterile water instead with no reported adverse event while administering diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Nov-2024, medical assistant did not use the manufacturer's diluent but used sterile water instead while administering suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength, expiry date, dose, lot number not reported) via unknown route in unknown administration site for Prophylactic Vaccination (immunization) with no reported adverse event (product preparation error) (latency: on same day).  Reportedly, They wanted to know if the efficacy is affected, if they need to revaccinate, and what is the duration in between first vaccination and revaccination.   Information regarding batch number corresponding to the one at time of event occurrence is requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: potentially receiving two doses of Fluzone Hd (with no reported adverse event); Initial information received on 27-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 75 years old male patient who potentially receiving two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD](with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2024, the patient received a dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, batch and expiry date unknown).Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date in 2024 patient potentially received a dose 2 of same vaccine (with no reported adverse event) (extra dose administered) (same day latency).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertent administration of QUADRACEL to a patient instead of the prescribed PENTACEL with no reported adverse event; Initial information received on 27-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-month-old female patient whom inadvertent administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (Vero)] instead of the prescribed diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) and Rotavirus Vaccine for Immunisation.  On 27-Nov-2024, the patient had inadvertent administration of unknown dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine Solution for injection strength: standard and frequency; once of lot U7931AB and expiry date: 09-Nov-2025 via intramuscular route in the left thigh for immunization instead of Diphtheria/Tetanus/5 Hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE with no reported adverse event (wrong product administered) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Investigation, Myocardial infarction, Vascular bypass dysfunction
Clinical narrative: microvascular dysfunction/ Vascular bypass dysfunction; refractory angina; feel like having a heart attack; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jun2021 as dose 2, single (Lot number: EW0183) at the age of 27 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, disability) with onset Jun2021, outcome "not recovered", described as "feel like having a heart attack"; VASCULAR BYPASS DYSFUNCTION (hospitalization, disability) with onset Jun2021, outcome "not recovered", described as "microvascular dysfunction/ Vascular bypass dysfunction"; ANGINA PECTORIS (hospitalization, disability) with onset Jun2021, outcome "not recovered", described as "refractory angina". The events "microvascular dysfunction/ vascular bypass dysfunction", "refractory angina" and "feel like having a heart attack" required physician office visit. The patient underwent the following laboratory tests and procedures: multitude of test: Unknown Results. Therapeutic measures were taken as a result of vascular bypass dysfunction, angina pectoris, myocardial infarction. Clinical course: Patient did not receive any other vaccine on same date, no other vaccine in four weeks and it was unknown if patient received other medications in two weeks. Developed microvascular dysfunction & refractory angina. Constantly feel like having a heart attack. Have seen multiple doctors and had a multitude of test to confirm this. Had no symptoms before the second dose of vaccine. Adverse events treatment: medication. Patient's Known allergies was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: breakouts on my legs/ doctor says it looks like a allergic reaction but it's under the skin; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "breakouts on my legs/ doctor says it looks like a allergic reaction but it's under the skin".  Additional information:I got the Pfizer Vaccine for COVID and ever since I got breakouts on my legs. My doctor said it looked like an allergic reaction but it was under the skin. After a friend researched, she saw a photo of my breakout under REDACTED. This was an issue That had caused me to miss several days at work and I was not happy about it.
Sex: U
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest
Clinical narrative: cardiopulmonary arrest; This is a literature report for the following literature source(s).  A patient (age and gender not provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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. The following information was reported: Author described a case of a cardiopulmonary arrest occurring the same day of vaccination with mRNA COVID-19 vaccine.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cardio-respiratory arrest and the suspect drug BNT162B2 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Post-acute COVID-19 syndrome
Clinical narrative: long covid; long covid; Long Covid; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single) and in 2021 as dose 2, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "recovered"; POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2023, outcome "recovered" (2023), described as "Long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (2023) and all described as "long covid". Clinical course: Patient had his primary series with the Moderna vaccine in 2021, had two shots back then. On Dec2021, had a booster from Pfizer. And it was his last Covid vaccine. He had long covid last year, like fatigue and brain fog. In there community, they recommended the Novavax vaccine as a better alternative. That's why he was getting one and wanted to confirm how many shots did he need. Confirmed with consumer: long Covid was resolved last year, and he was younger than 65 years old.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Blood alkaline phosphatase decreased, Blood test, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: TIA
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Scan with contrast, Transient ischaemic attack
Clinical narrative: TIA
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: CMA gave the adult COVID vaccine dose to  pediatric patient
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia
Clinical narrative: Patient  stated that he lost the strength in his arm after getting the covid vaccine.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Sterile diluent was expired on 11/17/2024 , vaccine expiration date is 11/11/2025.  Vaccination will need to be repeated.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea
Clinical narrative: patient received three vaccines, rsv and covid in left arm and flu in the right arm. day 1 patient was fine, by day 3 patient had developed a bruise where rsv shot was given, and began to feel nausea and " out of it". Vomited once, and experienced nausea. over the course of ten days patient's "persona" began to decline. Her husband decided to take her to the hospital after several days of feeling terrible. they have been trying blood tests to try to figure out what has been going on, with no clear diagnosis. patient has been in hospital since Saturday or Sunday at this point. They are suspecting possible carbon monoxide excess per husband as they have patient on a cpap machine. she has been feeling less nauseated, although she is still in hospital under medical care. The bruise has turned to a purple at this point.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Personality change, Positive airway pressure therapy, Vomiting
Clinical narrative: patient received three vaccines, rsv and covid in left arm and flu in the right arm. day 1 patient was fine, by day 3 patient had developed a bruise where rsv shot was given, and began to feel nausea and " out of it". Vomited once, and experienced nausea. over the course of ten days patient's "persona" began to decline. Her husband decided to take her to the hospital after several days of feeling terrible. they have been trying blood tests to try to figure out what has been going on, with no clear diagnosis. patient has been in hospital since Saturday or Sunday at this point. They are suspecting possible carbon monoxide excess per husband as they have patient on a cpap machine. she has been feeling less nauseated, although she is still in hospital under medical care. The bruise has turned to a purple at this point.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Patient uncooperative, Underdose
Clinical narrative: Patient became agitated and began pulling arm away and stood up during needle insertion and injection of Fluad. Immunizer was not able to inject the full dose of Fluad due to this.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder, Electroencephalogram, Electroencephalogram abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Starting 5 days after he received the Moderna Monovalent vaccine, patient had an onset of seizure-like activity consisting of right numbness in his hand/arm, excessive salivation, impaired speech, and trouble walking.  These events last between 5 - 45 minutes, and occur several times weekly.  Patient had no history of seizure-like activity prior to this time.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary hypersecretion, Seizure like phenomena, Speech disorder
Clinical narrative: Starting 5 days after he received the Moderna Monovalent vaccine, patient had an onset of seizure-like activity consisting of right numbness in his hand/arm, excessive salivation, impaired speech, and trouble walking.  These events last between 5 - 45 minutes, and occur several times weekly.  Patient had no history of seizure-like activity prior to this time.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pharyngitis, Rhinorrhoea
Clinical narrative: Significant URI symptoms developed 48-72 hours post inoculation with FluMist and resolved over the course of a week. Symptoms predominated in the nasopharyx and  including pharyngitis, nasal congestion/ rhinorrhea,  minor dry cough . Resolved 75%  over course of 7 days, hopefully fully resolve soon but TBD. One could argue it was coincidental infection with other pathogen or alternatively that inoculation with the hopefully attenuated virus was just temporally associated with URI symptom production. Take note that I ve received at least 3 of the past versions of the same FluMist annually.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Neck pain
Clinical narrative: Constant headache x 9 days unrelieved by any OTC medication, numbness and tingling down right arm into wrist, hand, and fingers, severe neck and shoulder pain unrelieved by OTC medication or professional massage. Symptoms impacted ADLs and ability to pick up and carry toddler daughter.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Constant headache x 9 days unrelieved by any OTC medication, numbness and tingling down right arm into wrist, hand, and fingers, severe neck and shoulder pain unrelieved by OTC medication or professional massage. Symptoms impacted ADLs and ability to pick up and carry toddler daughter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in requesting his second dose of the Shingles vaccine. Upon review of the State Immunization Registry, I discovered the patient had already received 4 doses of Shingrix - three of the doses were given at an outside pharmacy between August 2020 and December 2020. The fourth dose was given at our location on 10/02/2024. Upon speaking with the patient and his wife, the patient did not have any adverse effects to the vaccine he was given back in October. Patient had remembered receiving a Shingles vaccine at the outside pharmacy but could not remember how many he had received. Patient is doing well and has had no adverse effects to my knowledge.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Chest X-ray normal, Eosinophil count increased, Full blood count, Influenza A virus test negative, Influenza B virus test negative
Clinical narrative: developed swelling of left lower arm, followed by urticaria of the left lower arm, then bilat knees and then left shin
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Lymphocyte count increased, Monocyte count increased, Peripheral swelling, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: developed swelling of left lower arm, followed by urticaria of the left lower arm, then bilat knees and then left shin
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Urine analysis normal, Urticaria, White blood cell count increased
Clinical narrative: developed swelling of left lower arm, followed by urticaria of the left lower arm, then bilat knees and then left shin
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria (lasting about 1.5 years)
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Light rash noted at injection site, along with a firm lump.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: Anaphylactic reaction within one minute of administration - nausea, felt weird, sat on chair, experienced chest tightness and difficulty breathing. Face hot and flushed. Pharmacist notified, drank water, symptoms subsided within 5 min without medical intervention. First time receiving Moderna COVID-19 vaccine. Previously got 5 doses of Pfizer COVID-19 vaccine (2021, 2022, 2023) including co administration with flucelvax without major reactions. Patient is HCP.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Flushing, Nausea
Clinical narrative: Anaphylactic reaction within one minute of administration - nausea, felt weird, sat on chair, experienced chest tightness and difficulty breathing. Face hot and flushed. Pharmacist notified, drank water, symptoms subsided within 5 min without medical intervention. First time receiving Moderna COVID-19 vaccine. Previously got 5 doses of Pfizer COVID-19 vaccine (2021, 2022, 2023) including co administration with flucelvax without major reactions. Patient is HCP.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: covid-19; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced covid-19 (Verbatim: covid-19). The outcome of the covid-19 was not reported.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     It was unknown if the company considered the covid-19 to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-NOV-2024 This case was reported by a patient via interactive digital media. The reporter reported that a patient received Shingles vaccine and went to the emergency room twice in four days, thinking had covid or something worse. It was the vaccine and no one warned beforehand.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: the patient had a 2nd dose of Arexvy administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 95-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52R7B, expiry date 15-OCT-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 05-NOV-2024, the patient received the 2nd dose of Arexvy. On 05-NOV-2024, an unknown time after receiving Arexvy and an unknown time after receiving AREXVY, the patient experienced extra dose administered (Verbatim: the patient had a 2nd dose of Arexvy administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-NOV-2024 The reporter called to inform that they had a patient that had requested to get Arexvy a couple weeks ago. Upon discovery he was like 95 years old and he found that same vaccine (Arexvy) back in August already, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Rash and swelling on injection site L deltoid, rash was red and hot, went half way down upper arm. Very sore and swollen, felt like there was a ball in arm. Last 4 days.
Age: 7.0
Sex: M
Vaccine: HEP, IPV, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT AND FATHER WERE ASKED TO CONFIRM PATIENTS NAME AND THEY DID CONFIRM THAT THIS PATIENT IS (REDACTED) WHEN ASKED BY THIS RN. UPON FURTHER INVESTIGATION, WHEN GIVING THIS CHILDS SIBLINGS THEIR VACCINES, THEY MIXED THEIR NAMES UP. THIS PATIENT (REDACTED) GOT THE VACCINES THAT WERE INTENDED FOR HIS OLDER BROTHER (REDACTED). PATIENTS MOTHER CALLED THE HEALTH DEPARTMENT AND SAID THE CHILDREN GOT EACH OTHERS VACCINES. MOTHER WAS INSTRUCTED THAT SHE SHOULD BRING THE OLDER SIBLING BACK TO GET THE CORRECT VACCINES AND TO REPORT ANY ADVERSE EFFECTS OF THE PATIENT TO (REDACTED). THIS PATIENT DID NOT HAVE ANY ADVERSE REACTIONS TO THESE ADDITIONAL VACCINES.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Immunization expired 11/19/2024- was administered 11/25/2024 in error.. Incident report filed, patient's parents notified. No symptoms or adverse reactions noted.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient seen in office 12 days after vaccine administration (11/18/24) for continued/worsening arm and shoulder joint pain, stated she knew immediately that something felt different with this vaccine administration. Physician diagnosed the patient with SIRVA despite noting that this diagnosis relates to more significant effect on the shoulder joint than patient experienced.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Cold sweat, Deafness, Pallor, Posture abnormal
Clinical narrative: Patient became pale, clammy, and unresponsive minutes after recieving the vaccine. He began to posture. This lasted for one minute. When he came back around he stated that he could not hear or see. 911 was called and EMS arrived and transported patient to the ED
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient became pale, clammy, and unresponsive minutes after recieving the vaccine. He began to posture. This lasted for one minute. When he came back around he stated that he could not hear or see. 911 was called and EMS arrived and transported patient to the ED
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Hib was diluted with sterile water instead of saline.   No adverse reactions reported
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Metastases to lung, Metastases to peritoneum, Pancreatic carcinoma metastatic
Clinical narrative: worsening abdominal pain for 4 months, found to have pancreatic cancer with metastasis to the lung and peritoneum
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: fever, sweats, cold chills, stiff and sore neck, severe headache, pain at injection site, painful lymph glands, severe fatigue
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Musculoskeletal stiffness, Neck pain, Pyrexia
Clinical narrative: fever, sweats, cold chills, stiff and sore neck, severe headache, pain at injection site, painful lymph glands, severe fatigue
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Rash, Urticaria
Clinical narrative: Rash/ Hives in multiple areas. Started on both elbows, spread to belly, groin area, and arm pits. There was also bruising in the groin on both legs near the femoral artery. Elbows lasted 2 weeks, belly and groin are ongoing.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Limb discomfort, Pain
Clinical narrative: Persistent, severe pain in left shoulder started 4 hours after vaccine.  Had difficulty raising arm for 1 week after vaccine.  Some improvement after 1 week but has now been stable.  The pain is described as severe, affecting the entire arm and causing significant discomfort, especially at night. The patient reports difficulty in lifting and pushing with the affected arm due to the pain.  Patient is taking NSAIDs and referred to PT for follow up.
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Ecchymosis, Injected limb mobility decreased, Magnetic resonance imaging, Pain in extremity, Tenderness
Clinical narrative: Patient used tylenol and biofreeze gel on arm for soreness/ pain. Limited ROM of right arm, ecchymosis, pain tenderness seen in UC on 12/5/24
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of Beyfortus was given to an adult patient at the same appointment that they received a Zoster vaccine.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Immediate post-injection reaction, Nausea
Clinical narrative: pt received the vaccine 2 days ago, and immediately developed  nausea and pain in multiple joints.  Symptoms lasted for 4-5 hrs.  Felt better  after laying down.  The next day he was fine.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypertension, Limb discomfort, Palpitations, Paraesthesia
Clinical narrative: Patient developed lightheadedness and palpitations while walking a few minutes after vaccine administration.  She was hypertensive with SBP 160s-170s and tachycardic with HR 130s.  No difficulty breathing, shortness of breath.  She developed left arm heaviness and tingling.  She felt improved with rest and HR decreased to 93.  Physician recommended transfer to the Emergency Department for evaluation and pt declined.  Pt escorted to her workplace in the same medical facility.   No recurrence of symptoms with walking.  Pt advised to report to the ED for recurrence of symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tachycardia
Clinical narrative: Patient developed lightheadedness and palpitations while walking a few minutes after vaccine administration.  She was hypertensive with SBP 160s-170s and tachycardic with HR 130s.  No difficulty breathing, shortness of breath.  She developed left arm heaviness and tingling.  She felt improved with rest and HR decreased to 93.  Physician recommended transfer to the Emergency Department for evaluation and pt declined.  Pt escorted to her workplace in the same medical facility.   No recurrence of symptoms with walking.  Pt advised to report to the ED for recurrence of symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Electrocardiogram, Hypertension, Limb discomfort, Palpitations
Clinical narrative: Patient developed lightheadedness and palpitations while walking a few minutes after vaccine administration.  She was hypertensive with SBP 160s-170s and tachycardic with HR 130s.  No difficulty breathing, shortness of breath.  She developed left arm heaviness and tingling.  She felt improved with rest and HR decreased to 93.  Physician recommended transfer to the Emergency Department for evaluation and pt declined.  Pt escorted to her workplace in the same medical facility.   No recurrence of symptoms with walking.  Pt advised to report to the ED for recurrence of symptoms.