chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: had rsv 2 months after vaccination; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 2 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: had rsv 2 months after vaccination) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she had respiratory syncytial virus infection 2 months after vaccination.  The patient was in hospital for days. The patient stated hate to think if she/he had not been vaccinated. This case was considered as suspected vaccination failure as details regarding the laboratory confirmation regarding respiratory syncytial virus infection 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: F
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got RSV and it was ruff; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 94-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: still got RSV and it was ruff). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by the reporter via interactive digital media. The patient was reporter's mother. The reporter reported that his/her mom (patient) got the vaccine. She still got RSV, and it was ruff. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus infection 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 and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received old vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient said that in too had both the old and new 2 dose of new Shingles vaccine and got shingles.  Not a bad case at all but it happened. His/her pharmacist was amazed. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1& 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have had it a total of 6 times; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have had it a total of 6 times). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 The case was received from the patient via interactive digital media. The reporter had been vaccinated twice, have had it a total of 6 times.  The reporter reported that the vaccine just prevents you from possibly not getting it as bad.  It was not a guarantee you would never get it again. This case was considered as suspected vaccination failure as details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I also had shingles for the first time at about age 22 and have had shingles about 10 times and I'm now 72. Had first vaccine, and later had the newer two vaccine and still have gotten break thru shingles; later had the newer two vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 72-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles first time at about age 22 and had shingles about 10 times).   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I also had shingles for the first time at about age 22 and have had shingles about 10 times and I'm now 72. Had first vaccine, and later had the newer two vaccine and still have gotten break thru shingles) and extra dose administered (Verbatim: later had the newer two vaccines). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she also had shingles for the first time at about age 22 and had shingles about 10 times and he/she was now 72.  Had first vaccine, and later had the newer two vaccines and still had got breakthrough shingles, his/her doctor now had given a daily low dose of Valtrex. This case was considered as suspected vaccination failure as details regarding completion 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, 2 & 3).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got shingles about a month after the shot. .; 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, less than a month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles about a month after the shot. .). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that his/her physician said that the shot doesn't work and that is why they advertise it all the time.  Reporter said he/she got shingles about a month after the shot and also mentioned that never again will take these fake shots filled with poison. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the shot and still got it; Extremely uncomfortable; 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), shingles (Verbatim: Had the shot and still got it) and discomfort (Verbatim: Extremely uncomfortable). The outcome of the vaccination failure was not reported and the outcome of the shingles and discomfort were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort 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 and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the shot and still got them.  Extremely uncomfortable and painful.  Ran its course and so far had not returned. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; this time a lot worse.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had got a mild case).   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: this time a lot worse.). 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: 04-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that her husband had got a mild case then a year or so later got the vaccine and this time a lot worse. He said he did not wish that on his worst enemy. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 36-year-old female patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intravenous). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly). The outcome of the subcutaneous injection 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: 29-APR-2025 Pharmacist called to report that a nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly, which led to subcutaneous injection formulation administered by other route. The reporter wanted to know was there any advice or safety concern on this situation No further information was obtained in this call.  The vaccine administration facility was the same as primary reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after temp. excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number PJ3RP) for prophylaxis.   On 28-APR-2025, the patient received Menveo and Boostrix. On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temp. 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: On 29 April 2025, a Primary coordinator/AMAS called to report a temperature excursion. Healthcare professional mentioned that after the temperature excursion, they administered 8 vaccines. This patient received Boostrix and Menveo (1 vial) which led to incorrect storage of drug. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GSK-US2025051844:same reporter/different patient US-GSK-US2025051843:same reporter/different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in June 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 29-APR-2025  Nurse practitioner wanted to obtain recommendations on a late second dose of Shingrix (the patient got the first dose in June 2024). Only the month in which the patient got vaccinated, her age and gender was provided. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Brain fog, Chills, Hyperhidrosis
Clinical narrative: profuse sweats; chills; brain fog; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles). Previously administered products included Acyclovir (received 5 times a day).   In APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2025, an unknown time after receiving Shingrix, the patient experienced sweating (Verbatim: profuse sweats), chills (Verbatim: chills) and brain fog (Verbatim: brain fog). The outcome of the sweating, chills and brain fog were resolved.   It was unknown if the reporter considered the sweating, chills and brain fog to be related to Shingrix.     It was unknown if the company considered the sweating, chills and brain fog to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist stating that he was procrastinated in getting the vaccine.  He got shingles early on and thought he had immunity to exposure.  He was treated with Acyclovir 5 times a day.  He got hist first dose of Shingrix 3 weeks ago.  He experienced profuse sweats, chills and brain fog that week up to 2 weeks after.  Symptoms were now resolved.  He states he had been told that the 2nd dose of Shingrix was worse but he felt the first dose was worse.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second has not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-APR-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second has not received the second dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist reported that a patient received the first dose of Shingrix on April 11, 2023 and has not received the second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Accidental administration of Infanrix instead of Boostrix.; 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 46-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16-APR-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 16-APR-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Accidental administration of Infanrix instead of Boostrix.). 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-MAY-2025 The nurse practitioner called to inform that, a patient accidentally received a dose of Infanrix.  According to reporter, the initial intention was to administer a booster dose of Boostrix, which led to wrong vaccine administered.
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced 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) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  The reporter inquired about the necessary steps to be taken following the 7 to 10 days incubation period, and how to know that it was cured, and requested guidance on how to prevent the transmission of the virus and was it necessary to take Tameflu medication for TTT. The patient had been in other country for 35 years.  Treatment information was not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea like food poisoning; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea like food poisoning) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-Apr-2025, the patient experienced DIARRHOEA (Diarrhea like food poisoning) and VOMITING (Vomiting). On 26-Apr-2025, DIARRHOEA (Diarrhea like food poisoning) and VOMITING (Vomiting) had resolved.            No concomitant medication was reported.  During the night after vaccine began with vomiting, then diarrhea. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Sex: F
Vaccine: RSV
Symptoms: Allergy to vaccine, Exposure during pregnancy, Rash, Rash erythematous
Clinical narrative: got a red rash all over body; got a red rash all over body; most likely an allergy to something in the vaccine; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "got a red rash all over body"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "most likely an allergy to something in the vaccine". It was unknown if therapeutic measures were taken as a result of rash, rash erythematous, allergy to vaccine. Additional information: the patient received rsv vaccine prot.subunit pref 2v and within a few days the patient developed a red rash all over the body. The provider determined that the event was most likely an allergy to something in the vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Headache, Swelling
Clinical narrative: headache; diarrhea committing; swelling; This is a spontaneous report received from an Other HCP from a sales representative.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 01May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01May2025, outcome "recovered"; DIARRHOEA (non-serious) with onset May2025, outcome "recovered", described as "diarrhea committing"; SWELLING (non-serious) with onset May2025, outcome "recovered". It was unknown if therapeutic measures were taken as a result of headache, diarrhoea, swelling.  Additional information: patient reported headache one hour after administration followed by 3 days of diarrhea committing and swelling. Eventually recovered.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC20
Symptoms: Drug ineffective
Clinical narrative: Doesn't work; constantly seeing ineffectiveness; This is a spontaneous report received from a Physician.  A 3-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Doesn't work; constantly seeing ineffectiveness".; Sender's Comments: Despite no PREVNAR  20 preventable infection currently provided, the case is conservatively handled as LOE with the suspect vaccine in terms of "Doesn't work; constantly seeing ineffectiveness".  More critical information on any infectious condition including pathogen/serotype as a result of 'PREVNAR  20/vaccine ineffectiveness' and vaccination regimen are needed for meaningful causality assessment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the caller mentioned that she had all four Pfizer shots, but she still has COVID; the caller mentioned that she had all four Pfizer shots, but she still has COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the caller mentioned that she had all four Pfizer shots, but she still has COVID".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Immunoglobulin therapy, Myasthenia gravis, Product administered to patient of inappropriate age
Clinical narrative: adacel was administered to a patient above 65 years old; Myasthenia gravis localized in the right eye; Initial information received on 06-May-2025 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 70 years old male patient who had myasthenia gravis localized in the right eye and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was administered to a patient above 65 years old.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: no other vaccines  On 06-Feb-2025, the patient received a dose of 0.5 ml once of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection with strength- standard, (lot U8366A, expiry date- 31-Jan-2027) via intramuscular route in the left arm for Immunization, above 65 years old (off label use) (latency- same day).  On an unknown date in 2025 the patient developed myasthenia gravis localized in the right eye (Ocular myasthenia) (latency- few days approximately) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.   Action taken was not applicable.  The patient was given Prednisone and Ig (immunoglobulins) infusions and eye symptoms improved .  At time of reporting, the outcome was Recovering / Resolving for the event Ocular myasthenia.  Seriousness criteria: The event Ocular myasthenia was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 09-MAY-2025: This case involves a 70 years old male patient who had myasthenia gravis localized in the right eye and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was administered to a patient above 65 years old. Further information regarding allergic history, laboratory investigations, medical history and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.17
Vaccine: DTAPIPVHIB
Symptoms: Seizure
Clinical narrative: patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seizure; Initial information received on 06-May-2025 regarding an unsolicited valid serious case received from an other healthcare professional.  This case involves a 2 months old and unknown gender patient where patient had initial dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday and ended up in the er (emergency room) overnight with a possible seizure.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-May-2025, the patient received a dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UK307AA and expiry date- 31-AUG-2026) via unknown route in unknown administration site (strength: not provided) for Immunization.  On 05-MAY-2025 the patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seizure (seizure) (latency- same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. This event was assessed as medically significant.  Reportedly, No other vaccines were administered at the time. Product used : Used, First time product used : Yes.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovering / Resolving for the event.; Sender's Comments: Sanofi Company Comment dated 07-May-2025: This case involves a 2 months old and unknown gender patient where patient had initial dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday and ended up in the er (emergency room) overnight with a possible seizure. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine can be denied.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt reported to clinic several hours post-vaccine administration c/o Hives and itchiness that started on inner aspect of L arm that traveled to his L axilla. Pt. "brushed it off" and continued with his workday until he noticed hives to be getting worse and  spreading to his trunk, abdomen and R arm/axilla. S/sx of anaphylaxis  assessed but where found to be unremarkable and patient to be in stable condition. Pt. denies SOB, difficulty breathing, Tachypnea or cool clammy skin, feelings of impending doom. RN and MD called in to assess patient per protocol and ordered 50mg of Benadryl, PO to be administered.  Orders carried out with patient endorsing improvement 30 minutes after Rx administration, skin still showing hives. MD educated patient on ER precautions and encouraged OTC allergy meds to be sought out for symptom management. Pt verbalized agreement to care plan and all education provided by medical staff. Pt left clinic; ambulatory and in stable condition.
Age: 63.0
Sex: M
Vaccine: YF, MMR, YF
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The yellow fever vaccine was administered two weeks after the patient had received the MMR vaccine; as such, these two live vaccines were not separated by the recommended 4 weeks. When this error was brought to this RN's attention, she reached out to Sanofi, the manufacturer of the Yellow Fever who provided the following guideline: "ACIP guidelines are that live vaccinations should be administered at least 4 weeks apart. In the case that two live vaccines are given less than four weeks apart, the second vaccination should not be counted, and that dose should be repeated at least 4 weeks later." This RN called and spoke with the patient, he denied experiencing any adverse effects from the vaccines. He had a scheduled appointment to return to the health department to receive other vaccines and was amenable to recieve a second Yellow Fever vaccination.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Soft tissue foreign body, Syringe issue
Clinical narrative: As MMR was being administered it splashed out. Needle stayed in the patient as I pulled out the syringe. Needle pulled out of patient intact right away. Patient did not appear to be in any further distress than just the usual reaction to receiving a shot. Provider informed immediately and provider decided the following steps to patient care in accordance with procedure.
Age: 0.5
Sex: M
Vaccine: PNC20
Symptoms: Crying, Needle issue, Soft tissue foreign body
Clinical narrative: I administered the vaccine, as I was pulling out, the needle portion stayed in the patient's thigh. Right away I pulled out the needle from the patient intact. The patient was crying from receiving the shot but did not appear to be in distress.   Manager and provider made aware of the situation.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/ swelling at injection site , warm to the touch.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin reaction
Clinical narrative: Patient developed skin reaction in her whole body. Rash/redness to the skin.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Phantosmia
Clinical narrative: Phantosmia  smelling cigarette smoke. Sometimes constant (several hours) sometimes only a few times a day- (6-
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous
Clinical narrative: PATIENT REPORTED DARK PINK/RED NON-PURULENT, NON-PRURITC RASH ON LEGS ONLY, NOT AT INJECTION SITE. DURATION OF RASH IS UNKNOWN (POSSIBLY 1-2 DAYS)
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Cough, Dyspnoea, Dysstasia, Headache
Clinical narrative: Light sensitivity, headache, body ache, chills, difficulty standing, difficulty breathing, and cough
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Photophobia
Clinical narrative: Light sensitivity, headache, body ache, chills, difficulty standing, difficulty breathing, and cough
Vaccine: MMR, MMR, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Inbound call from HCP stating that a 2nd dose of MMR-II and VARIVAX were inadvertently administered before the recommended age. These vaccines were administered at 2 years old. The first dose of both of these vaccines were administered on May 3rd, 20; This spontaneous report was received from a consumer or other non health professional and refers to a) 2-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 03-MAY-2024, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL administered by unknown route (anatomical location, lot # and expiration date were not reported) and with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL administered by unknown route as prophylaxis (anatomical location, lot # and expiration date were not reported). The suspect vaccine were reconstituted with sterile diluent (lot # and expiration date were not reported). Then on 17-APR-2025 at 2 year of age, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (as described above) and with the second of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (as described above), inadvertently administered before the recommended age (inappropriate age at vaccine administration).  Patient had not experienced any reactions (no adverse event).  Lot # is being requested and will be submitted if received
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Injection site reaction, Skin exfoliation, Swelling
Clinical narrative: Cellulitis, treated with antibiotics at ER.  Presented with redness and swelling the night she received the vaccine.  Now resolved with residual peeling at injection site.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting x 3 days, fever and headache
Age: 58.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Death, Vomiting
Clinical narrative: Within an hour of getting the Covid booster and shingles vaccine my mom was throwing up every 20 minutes. The vomitting was so bad she had to get an I.V. For fluids. She was found dead in her bed the next day. I am searching for the doctors info. This was a new doctor that was supposed to do bloodwork but pushed vaccines on a new patient.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient is experiencing right arm pain.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rash, Rash erythematous, Rash pruritic, Stress
Clinical narrative: Five min after shot had itchy red rash on face and neck, lasted 2 weeks. Every time she gets"sick" gets rash on torso, and if stressed gets rash on face and neck.
Age: 1.75
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rhonchi, Swelling face, Tracheostomy, Urticaria, Vomiting
Clinical narrative: approximately 2 hours after injections, patient developed full body hives, facial swelling, and vomiting x1. patient has a tracheostomy/stable airway, but did develop course rhonchi but no wheezing. was given 0.1 mg of IM epinephrine and Benadryl x1 with improvement of symptoms. Was hemodynamically stable throughout episode.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm has an injection site reaction. The lower part of her upper arm is very red (about a baseball's width in a circle) and is raised up. Patient has been using Tylenol and ice.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Renal pain
Clinical narrative: Patient was administered moderna spikevax vaccine (2024-2025) that was later identified as possible past suggested BUD but not past the expiration date on the box (06/14/2025). Called patient to explain situation and assess for side effects. Patient said they had minor headache and sore arm. Patient also reported minor kidney area soreness but said it was likely due to her working in her garden during the call. Patient reported they are feeling fine, and patient seemed to be feeling fine, alert, and fully responsive during the call.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented today (3 days post injection) with affected area under injection site, red, swollen, and warm to the touch. Patient explains she did have chills the day after vaccine, but did not check to see if she was running a fever, also complained of body aches, and tiredness. Stated that affected area has gotten larger, advised her to be seen by Dr.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient presented today (3 days post injection) with affected area under injection site, red, swollen, and warm to the touch. Patient explains she did have chills the day after vaccine, but did not check to see if she was running a fever, also complained of body aches, and tiredness. Stated that affected area has gotten larger, advised her to be seen by Dr.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid rash, Rash, Rash erythematous
Clinical narrative: Red bumps on eye and face
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Brain fog, Cardiac flutter, Cardiac function test, Computerised tomogram thorax
Clinical narrative: difficulity sleeping difficulty speaking brain fog demenshia resportaty problem unable to breath bloating muscel spassums heart rate up and fluttering weakness in legs and general al over  problems come on at 4 pm. everyday and get worse dry mouth and hard to swolloe  etc
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Dry mouth, Dysarthria, Dysphagia, Dyspnoea
Clinical narrative: difficulity sleeping difficulty speaking brain fog demenshia resportaty problem unable to breath bloating muscel spassums heart rate up and fluttering weakness in legs and general al over  problems come on at 4 pm. everyday and get worse dry mouth and hard to swolloe  etc
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Laboratory test, Muscle spasms, Muscular weakness
Clinical narrative: difficulity sleeping difficulty speaking brain fog demenshia resportaty problem unable to breath bloating muscel spassums heart rate up and fluttering weakness in legs and general al over  problems come on at 4 pm. everyday and get worse dry mouth and hard to swolloe  etc
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: difficulity sleeping difficulty speaking brain fog demenshia resportaty problem unable to breath bloating muscel spassums heart rate up and fluttering weakness in legs and general al over  problems come on at 4 pm. everyday and get worse dry mouth and hard to swolloe  etc
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Dysgeusia, Hallucination, Headache
Clinical narrative: On 5/10/2025, the patient let the pharmacist know that patient had hallucination, irritation, sweating, headache, dizziness and nausea on the first night after the vaccination on 5/5/2025.   From 5/05/2025 to 5/10/2025, the patient lost some weight due to lack of sleep and bitter taste in the mouth, in addition to other side effects (irritation, headache and dizziness).  On 5/10/2025, patient decided to go to ER because she was afraid that she might have stroke.  ER doctors gave her medications to treat nausea, dizziness and anxiety.