chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: patient was given the pediatric dose; patient was given the pediatric dose; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number M2RH3, expiry date 21-FEB-2026) for prophylaxis.   On 24-FEB-2025, the patient received Engerix B pediatric. On 24-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: patient was given the pediatric dose) and adult use of a child product (Verbatim: patient was given the pediatric dose). The outcome of the underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-FEB-2025 The other health professional reported that 45 year old patient was given the pediatric dose which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-FEB-2025, the patient received Shingrix. On 26-FEB-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm) and headache (Verbatim: headache). The outcome of the pain in arm and headache were not resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     It was unknown if the company considered the pain in arm and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2025 The patient received a subsequent dose of Shingrix and experienced sore arm and headache.
Vaccine: FLUX, RVX
Symptoms: Bone pain, Decreased appetite, Influenza, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: Suspected vaccination failure; Got RSV; Flu; 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.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and Influenza 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), respiratory syncytial virus infection (Verbatim: Got RSV) and influenza (Verbatim: Flu). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection and influenza were resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection and influenza to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the Flu and RSV vaccine and still got RSV (respiratory syncytial virus infection), very congested, fevers, no appetite, ache bones was lasting a week. The patient did not know if it was RSV or the flu. It was unknown if the reporter considered the adverse events to be related to Flu (Influenza) vaccine. 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.  Respiratory syncytial virus infection and Influenza are unlisted events which are considered unrelated to GSK vaccine RSV vaccine.
Vaccine: FLUX, RVX
Symptoms: Respiratory tract congestion, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got RSV; Flu; 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.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and Influenza 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), respiratory syncytial virus infection (Verbatim: Got RSV) and influenza (Verbatim: Flu). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection and influenza were resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection and influenza to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the Flu and RSV vaccine and still got RSV (respiratory syncytial virus infection), very congested, fevers, no appetite, ache bones was lasting a week. The patient did not know if it was RSV or the flu. It was unknown if the reporter considered the adverse events to be related to Flu (Influenza) vaccine. 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.  Respiratory syncytial virus infection and Influenza are unlisted events which are considered unrelated to GSK vaccine RSV vaccine.
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Got my shot and still got it; 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, 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: Got my shot and still got it). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved.   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: 23-FEB-2025 This case was reported by a patient via interactive digital media. The patient had got RSV shot and still got it and it was terrible and shut you down for days at a time. This case was considered as suspected vaccination failure as details regarding 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 RSV vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I've had shingles 5 times received both Shingrix vaccines get milder each time; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times). Concurrent medical conditions included leukemia.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had shingles 5 times received both Shingrix vaccines get milder each time). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles 5 times and yes then patient received both Shingrix vaccines and they get milder each time.  The patient's hematology oncologist attributed this to his/her leukemia. This case was considered as suspected vaccination failure since the details regarding the 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 the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-FEB-2025 This case was reported by a patient via interactive digital media. Patient had the shots two years ago and still got shingles.  It was the worst pain he/she had ever experienced. 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. The follow-up could not be possible as no contact details were available.; 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 vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: had severe fever blisters on his/her lips; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever blister (Verbatim: had severe fever blisters on his/her lips). The outcome of the fever blister was not reported.   It was unknown if the reporter considered the fever blister to be related to Shingrix.     It was unknown if the company considered the fever blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2025 The patient self reported this case for himself/herself. This case was reported by a patient via (shingrix GSK chatbot) interactive digital media. After his/her first shingles shot 2-3 days later he/she had severe fever blisters on his/her lips and was asking was that normal.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-FEB-2025 The case was received from the patient via interactive digital media. The reporter had the shingle shot and am having the side effects so the reporter was wondering if he/she could take gabapentin for pain.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: instead of pneumococcal vaccine they administered a Pediarix dose; instead of pneumococcal vaccine they administered a Pediarix dose; patient received 2 prior Pediarix doses on November 18th 2024 and February 12th 2025; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and Pneumococcal vaccine for prophylaxis.   Previously administered products included Hepatitis B (Received on 18-SEP-2024). Concomitant products included PEDIARIX.   On 18-FEB-2025, the patient received the 3rd dose of Pediarix. On 12-FEB-2025, the patient received the 2nd dose of Pediarix. On an unknown date, the patient received Pneumococcal vaccine. On 12-FEB-2025, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: patient received 2 prior Pediarix doses on November 18th 2024 and February 12th 2025). On 18-FEB-2025, the patient experienced wrong vaccine administered (Verbatim: instead of pneumococcal vaccine they administered a Pediarix dose) and drug dose administration interval too short (Verbatim: instead of pneumococcal vaccine they administered a Pediarix dose). The outcome of the drug dose administration interval too long, wrong vaccine administered and drug dose administration interval too short were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-FEB-2025 The physician reported that a patient came for a pneumococcal vaccine but instead of that one they administered a Pediarix dose (as 3rd dose) which led to wrong vaccine administered  and shortening of vaccine schedule. The patient received 2nd dose of Pediarix later than the recommended interval, which led to lengthening of vaccine schedule. The reporter did not have lot numbers or expiration dates for any of the vaccines.
Age: 76.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the first 2 doses 6 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received HAB (Twinrix) (batch number m4b34) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 01-JUN-2024).   On 02-DEC-2024, the patient received the 2nd dose of Twinrix. On 02-DEC-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received the first 2 doses 6 months apart). The outcome of the drug dose administration interval too long 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: 25-FEB-2025 The pharmacist contacted GlaxoSmithKline to report that a patient received the first 2 doses 6 months apart, which led to lengthening of vaccination schedule.  The patient still has not received the third dose of Twinrix. They asked to know how to proceed. The vaccine administration facility was the same as primary reporter.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Boostrix; 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 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GH32J, expiry date 29-NOV-2024) for prophylaxis.   On 26-FEB-2025, the patient received Boostrix. On 26-FEB-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Boostrix). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-FEB-2025 The other health professional reported that they administered an expired dose of Boostrix to a female patient on the day of reporting.  The other health professional asked does the patient needs to be revaccinated.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B administration after expiration date; 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 20-month-old female patient who received HBV (Engerix B) (batch number Y3NE2, expiry date 23-FEB-2025) for prophylaxis.   On 26-FEB-2025, the patient received Engerix B. On 26-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B administration after expiration date). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-FEB-2025 The medical assistant asked if a patient should be revaccinated with Engerix-B after receiving an expired dose which led to expired vaccine used.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered with a third dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number PC5Y3, expiry date 30-JAN-2027) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd December 2023 of batch number N425G and expiry date of 7 December 2025) and Shingrix (received 2nd dose on 27 February 2024 of batch number 49EB3 and expiry date of 18 April 2026).   On 27-FEB-2025, the patient received the 3rd dose of Shingrix. On 27-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: inadvertently administered with a third dose). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 27-FEB-2025 The patient inadvertently administered with a third dose of Shingrix, which led to extra dose administered.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose of Havrix was administered to a patient; 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 13-year-old female patient who received HAV (Havrix) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis.   On 25-FEB-2025, the patient received Havrix. On 25-FEB-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Havrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2025 The operations supervisor reported that an expired dose of Havrix was administered to a patient, which led to expired vaccine used The Vaccine Administration Facility is the same as Primary Reporter.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patients were administered with expired doses of Havrix; 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 14-year-old male patient who received HAV (Havrix pediatric) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 27-FEB-2025, the patient received the 1st dose of Havrix pediatric. On 27-FEB-2025, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: patients were administered with expired doses of Havrix). The outcome of the expired vaccine used 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: 28-FEB-2025 The patient was administered with expired dose which led expired vaccine used. This was the first Hepatitis A vaccine for the patient.  The reporter consented to follow up. This case was linked with case US2025025537 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025025537:Same reporter/Different patient
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired dose administration; 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 patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 28-FEB-2025, the patient received Havrix. On 28-FEB-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix expired dose administration). 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: 28-FEB-2025 The nurse practitioner reported that there was an expired dose administration of Havrix vaccine to patient, which led to expired vaccine used. The reporter wanted to knew if there was any kind of half-life extension and if it will lose its property and if it was any medical concern that they need to know. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: came back to request the second one; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 years ago).   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: came back to request the second one). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 28-FEB-2025 The physician reported that a patient received their first dose of Shingrix over 6 years ago and came back to request the second one and wanted to know if a third one was necessary after the long lapse between doses. not information was given about the previous dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Myocarditis
Clinical narrative: myocarditis; she gets light headed; rapid heart beat; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; DIZZINESS (non-serious), outcome "not recovered", described as "she gets light headed"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat".  Clinical course: Caller was looking for the side effects related to the Pfizer covid 19 vaccine from 2022, he states, she couldn't get anything, only information found was for 2024/2025 vaccine. He was calling on behalf of his wife who had two covid vaccine. Caller states, Reporter not sure if patient took Moderna or Pfizer covid 19 vaccine. She was been having this side effect, rapid heart beat, started right after she had gotten it, after the 2nd shot, after she had the booster. Caller clarified and states, she went for the first shot and went back for the second shot some time after about 2 months.  What she was having it was intermittent, not happening all the time, intermittently sometimes every two or three months, she gets light headed. Reporter thought she might have myocarditis. They didn't think anything, at first it went away and then it came back and went a way for a little while and came back again and was happening now more and more. She started having them with in a month from the taking shot. Caller declined to report and would like to verify first if was the Pfizer covid vaccine, he was not sure at this time. We got a card, we need to find it. He doesn't want to false report. She had an appointment with her regular physician and will possibly be referred to Cardiologist to see. Patient suspects it was the vaccine because it started happening after the second shot. Reporter just wanted to see the side effects because it did show myocarditis but it was for the 2024/2025 vaccine.  The information on the batch/lot number for [bnt162b2] will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Myocarditis
Clinical narrative: Myocarditis; rapid heart beat; she gets light headed; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine - manufacturer unknown (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "she gets light headed", "rapid heart beat", "Myocarditis". The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat"; DIZZINESS (non-serious), outcome "unknown", described as "she gets light headed".  Additional information: Caller stated, he was not sure if his wife took Moderna or Pfizer covid 19 vaccine. She had been having this side effect, rapid heart beat, started right after she had gotten it, after the 2nd shot, after she had the booster. Caller clarified and stated, she went for the first shot and went back for the second shot some time after about 2 months. What she was having it was intermittent, not happening all the time, intermittently sometimes every two or three months, she got light headed. He thought she might have myocarditis. They didn't think anything, at first it went away and then it came back and went a way for a little while and came back again and was happening now more and more. She started having them with in a month from the taking shot. Caller declined to report and would like to verify first if was the Pfizer covid vaccine, he was not sure at this time. We got a card, we need to find it. He did not want to false report. She had an appointment with her regular physician and will possibly be referred to Cardiologist to see. His wife suspects it was the vaccine because it started happening after the second shot.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500045590 same patient, different dose number and events;
Vaccine: PNC13
Symptoms: Death, Meningitis pneumococcal
Clinical narrative: Pneumococcal meningitis; This is a spontaneous report received from a Physician.  A 2-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: MENINGITIS PNEUMOCOCCAL (death), outcome "fatal", described as "Pneumococcal meningitis". The patient date of death was unknown. Reported cause of death: "Pneumococcal meningitis". It was not reported if an autopsy was performed. Clinical course: The patient passed away several months ago from pneumococcal meningitis. This is relevant because the parent reported back to the withheld that it was Sero-Type 15B that caused the fatal case of pneumococcal meningitis. ST-15B is not contained in PCV13 or PCV15 but it is contained in PCV20. According to doctor the medical clinics across (redacted) continued to use PCV13 for childhood vaccinations after PCV20 was approved and available in order to deplete PCV13 stock before ordering the newer PCV20 vaccine. The parents believe the child may not have died if the withheld had begun using PCV20 as soon as it was available instead of continuing to use PCV13. This is all reported second hand from doctor during the vaccines field medical interaction.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Pneumococcal meningitis with non PREVNAR 13 covered serotype (15B ) represents an intercurrent bacterial infection; no lack of efficacy with the suspect vaccine was evidenced.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumococcal meningitis
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: terrible COVID/now the baby has it/they give half a covid shot so two weeks ago; terrible COVID/now the baby has it/they give half a covid shot so two weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 6-month-old female patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), in Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2025, latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "terrible COVID/now the baby has it/they give half a covid shot so two weeks ago". The patient underwent the following laboratory tests and procedures: Body temperature: 102. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: reporter's son and daughter-in-law both have terrible COVID. They got a prescription from their doctor's office. Now they have a baby, a little baby that's 6 months old, and now the baby has it, and they have a 102 fever, and they're coughing. They're locked up in they're house in a little apart, they live with the mom, they're coughing they've got a high 102 fever their eyes are all, they can't even...one got it Wednesday, and one got it today (28Feb2025), and now the baby's got it. The baby can not have any medication she's just going to turn 7 months the baby can not have any medication her paediatrician said except Tylenol and she's had the fever of a 102 the baby, but they gave her, "I guess now they give half a covid shot so two weeks ago (Feb2025), so I'm hoping that's going to help her".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myopericarditis
Clinical narrative: perimyocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, 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), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (medically significant), outcome "unknown", described as "perimyocarditis". The event "perimyocarditis" required physician office visit. The patient (reporter's son) was diagnosed with perimyocarditis after receiving his second Pfizer covid vaccine in Jun2021. He was in [Withheld] and has to follow up yearly with a cardiologist. He is entering college this fall.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV9, HPV9, HPV9
Symptoms: Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise
Clinical narrative: is experiencing light headedness; breathing  issues; sharp pains in her stomach; She also feels anxious; her throat has been bothering her; she feels generally unwell; Consumer called to report that they received extra doses of HPV vaccine.  Consumer stated that her HCP told her she had not been previously vaccinated for HPV and recommended GARDASIL 9.  After receiving all 3 doses of GARDASIL 9, with the first dose; This spontaneous report was received from a 34-year-old non pregnant female patient reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 04-MAY-2007, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), then on unspecified dates in 2007, the patient received the other doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis. On 25-JUN-2024, the patient received the first dose (Extra dose administered) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 27-AUG-2024, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 17-DEC-2024, the patient received the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided). All doses for prophylaxis. It was mentioned that the patient's health care professional stated that she had not been previously vaccinated for any HPV vaccine and recommended Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), then she discovered she had previously received the full series of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (first dose administered on 04-MAY-2007); the prior administration of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was discovered while she was reviewing her immunization records. Her HCP stated that he did not see that in her history. After vaccination of 3 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) in December 2024, she experienced generally unwell, light headedness, breathing issues, sharp pain in her stomach, anxiety and her throat had been bothering her.  On unspecified date the patient's flu and COVID tests were negative. The outcome of all adverse events was considered as not recovered as it was mentioned that they happened on and off.  The causal relationship between all adverse events and both suspect therapies was not reported.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV9, HPV9, HPV9
Symptoms: Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative
Clinical narrative: is experiencing light headedness; breathing  issues; sharp pains in her stomach; She also feels anxious; her throat has been bothering her; she feels generally unwell; Consumer called to report that they received extra doses of HPV vaccine.  Consumer stated that her HCP told her she had not been previously vaccinated for HPV and recommended GARDASIL 9.  After receiving all 3 doses of GARDASIL 9, with the first dose; This spontaneous report was received from a 34-year-old non pregnant female patient reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 04-MAY-2007, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), then on unspecified dates in 2007, the patient received the other doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis. On 25-JUN-2024, the patient received the first dose (Extra dose administered) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 27-AUG-2024, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 17-DEC-2024, the patient received the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided). All doses for prophylaxis. It was mentioned that the patient's health care professional stated that she had not been previously vaccinated for any HPV vaccine and recommended Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), then she discovered she had previously received the full series of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (first dose administered on 04-MAY-2007); the prior administration of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was discovered while she was reviewing her immunization records. Her HCP stated that he did not see that in her history. After vaccination of 3 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) in December 2024, she experienced generally unwell, light headedness, breathing issues, sharp pain in her stomach, anxiety and her throat had been bothering her.  On unspecified date the patient's flu and COVID tests were negative. The outcome of all adverse events was considered as not recovered as it was mentioned that they happened on and off.  The causal relationship between all adverse events and both suspect therapies was not reported.
Vaccine: HIBV, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-FEB-2025, a the vaccines Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), and Pneumococcal 15-valent Conjugate Vaccine (Vaxneuvance); suffered a temperature excursion (TE) of 2 hours and 12 minutes at 32.0 F.   On 25-Feb-2025, the patient was vaccinated with the vaccines involved in the TE: first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y009341 has been verified to be valid for this vaccine, expiration date reported and confirmed as 24-Nov-2025), administered orally; with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #X028614 has been verified to be valid for this vaccine, expiration date reported as 24-Nov-2025 and confirmed as 05-Jul-2026) (dose and route of administration not provided); and with the first dose of pneumococcal 15-valent Conjugate Vaccine (Vaxneuvance) (lot #Y005465 has been verified to be valid for this vaccine, expiration date reported and confirmed as 08-Jan-2027) (dose and route of administration not provided). All of them administered as prophylaxis. (Product storage error). No additional adverse events were reported (No adverse event).
Vaccine: HIBV, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; VFC immunization coordinator calling to report T/E for  PEDVAX HIB , ROTATEQ,  VAXNEUVANCE that was administered.   T/E date was on 2/18/2025 and PEDVAX HIB , ROTATEQ,  VAXNEUVANCE were administered on 2/25/2025.  Permission was given to contact HCP; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 18-Feb-2025 a temperature excursion of above 32.0 Fahrenheit (F) for a time frame of 2 hours, 12 minutes and 0 seconds occurred.   On 25-Feb-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), lot #Y005878, expiration date: 28-Oct-2025 (strength and dose were not provided); with the first dose of Pneumococcal 15-valent Conjugate Vaccine lot #Y005465, expiration date: 08-Jan-2027 (strength, dose, route of administration and anatomical site of injection were not provided); and with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), lot #X028614, expiration date: 05-Jul-2026 (strength, dose, route of administration and anatomical site of injection were not provided). All vaccines were administered for prophylaxis (Product storage error).    No additional adverse event was reported (no adverse event). No previews temperature excursions were reported.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Two Dose Series Completed, and Received A Third Dose; 1st Dose Given in Nov-2024, 2nd Dose given in Jan-2025; Initial report received on 12-Feb-2025.  A pharmacist reported that a 25-year-old male received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two months after the first and received a third dose of HEPLISAV-B.    No medical history or concomitant medications were reported.  On 20-Nov-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945656, expiration date 24-Jan-2027, NDC# 43528-003-01) intramuscularly in the left arm.    On 23-Jan-2025, 64 days after receiving dose 1 of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945659, expiration date 31-Jan-2027, NDC# 43528-003-01) intramuscularly in the left arm.    On 11-Feb-2025, 19 days after receiving dose 2 of HEPLISAV-B, the patient received dose 3 of a hepatitis B vaccine [HEPLISAV-B (lot # 945659, expiration date 31-Jan-2027, NDC# 43528-003-01) intramuscularly in the right arm.  This was the third dose of HEPLISAV-B.  No adverse effects were reported to any of the 3 doses the patient received.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and Received Heplisav-B; Initial report received on 12-Feb-2025.  A pharmacist reported that a female (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No medical history or concomitant medications were reported.    On an unknown date, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route and site not available)].  The patient was pregnant.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.