chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Has pneumonia; Has pneumonia; This is a spontaneous report received from a Pharmacist from medical information team.  An 88-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), in 2016 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "Has pneumonia".  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: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of efficacy (Pneumonia) with PREVNAR 13 can not be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: stroke; Clot; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "stroke"; THROMBOSIS (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "Clot". It was unknown if therapeutic measures were taken as a result of cerebrovascular accident, thrombosis. Clinical course: an infection preventionist in a nursing home said that one her residents received Comminarty and 10 days later she had a clot and a stroke. The events were reported as non-serious.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Reaction to excipient
Clinical narrative: reaction to the vaccine/was likely due to the polyethylene glycol; This is a spontaneous report received from a Physician.  A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "reaction to the vaccine/was likely due to the polyethylene glycol". It was unknown if therapeutic measures were taken as a result of reaction to excipient.  Additional information: The patient was described as having a reaction to the vaccine, however,  the reaction and its severity were not described. The physician believed reaction was likely due to the polyethylene glycol.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Olfactory issue. Breathing in odor/having a smelling issue. When patient breathe in with nose, patient smell something different and there is no outside influences. Right it is olfactory issues; This is a spontaneous report and received from Consumer or other non HCPs.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Feb2025 at 15:00 as dose 1, single (Lot number: LP1780) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypersensitivity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 28Feb2025 at 16:00, outcome "not recovered", described as "Olfactory issue. Breathing in odor/having a smelling issue. When patient breathe in with nose, patient smell something different and there is no outside influences. Right it is olfactory issues". Therapeutic measures were not taken as a result of parosmia.  Additional information: Facility vaccine was administered from pharmacy or drug store. Patient was not receive any other vaccines within 4 weeks PRIOR to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. Reported Event Olfactory issue. Breathing in I notice an odor. Patient stated, having a smelling issue. When patient breathe in with nose, patient smell something different and there is no outside influences. Right, it is olfactory issues, smelling.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID; had COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunization. The anatomical location of the vaccine was reported as "left". patient's relevant medical history included: "Covid" (unspecified if ongoing); "flu" (unspecified if ongoing). The patient reported that he was very healthy actually, very healthy. There were no concomitant medications. The patient was not taking any medications. The patient did not receive any other vaccines on the same date as BNT162B2 as he did not take flu vaccines, because he did not get the flu, that is just what he was, very healthy like that. If he did get the flu, it did not bother his immune system, it did not "touch" the patient. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID". The event "had covid" required physician office visit and emergency room visit. The patient received the vaccine to protect him and save the world, he will not be putting other people at risk and he was doing a real good thing. The patient stated, "I do not know, they gave me one dose and then they said you gotta take two shots. We cannot do it in one. So that second shot made me definitely ill. They made me extremely. I had to go to the emergency room. I though I broke my back. I was vomiting everywhere. I had a fever, headache and very, very serious situation and that was from your 2nd shot. They said I had COVID. I already had COVID and that was not like any different COVID and if I already had COVID, it did not bother me. The first time I had it, did not need the vaccine. The vaccine did this, it was the vaccine's interaction with the COVID. I really do not know and I really do not care because I got a vaccine so I would not get covered in the first place. So I do not know how I got the vaccine and then 2 weeks later I had COVID and I am in the emergency room for it. That just does not make any sense. I think it was a centered around the vaccine itself." The patient did not underwent any investigations.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500047620 same patient/vaccine, different dose /event;
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Confusional state, Headache, Illness, Memory impairment
Clinical narrative: had COVID; had COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunization. The anatomical location of the vaccine was reported as "left". patient's relevant medical history included: "Covid" (unspecified if ongoing); "flu" (unspecified if ongoing). The patient reported that he was very healthy actually, very healthy. There were no concomitant medications. The patient was not taking any medications. The patient did not receive any other vaccines on the same date as BNT162B2 as he did not take flu vaccines, because he did not get the flu, that is just what he was, very healthy like that. If he did get the flu, it did not bother his immune system, it did not "touch" the patient. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID". The event "had covid" required physician office visit and emergency room visit. The patient received the vaccine to protect him and save the world, he will not be putting other people at risk and he was doing a real good thing. The patient stated, "I do not know, they gave me one dose and then they said you gotta take two shots. We cannot do it in one. So that second shot made me definitely ill. They made me extremely. I had to go to the emergency room. I though I broke my back. I was vomiting everywhere. I had a fever, headache and very, very serious situation and that was from your 2nd shot. They said I had COVID. I already had COVID and that was not like any different COVID and if I already had COVID, it did not bother me. The first time I had it, did not need the vaccine. The vaccine did this, it was the vaccine's interaction with the COVID. I really do not know and I really do not care because I got a vaccine so I would not get covered in the first place. So I do not know how I got the vaccine and then 2 weeks later I had COVID and I am in the emergency room for it. That just does not make any sense. I think it was a centered around the vaccine itself." The patient did not underwent any investigations.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500047620 same patient/vaccine, different dose /event;
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation
Clinical narrative: almost lose my breast due to inflammation; 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. The following information was reported: BREAST INFLAMMATION (medically significant), outcome "unknown", described as "almost lose my breast due to inflammation". The patient stated that the vaccination caused her to almost lose breast due to inflammation.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Kinrix 1-28-25 (Dtap dose #5, IPV dose #4) as due. Returned for another vaccine 2-19-2025 and  received MMR and another dose of KINRIX . No signs or symptoms- NO issues. Vaccine error where 6 year old got an extra dose of Dtap and IPV. It does not effect the schedule and child is  up to date on vaccines.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Patient states she has problems with Shoulder  rotation. Soreness around injection site. Numbness on left thigh . When hands are in water or wet the is numbness of fingertips .
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: REDNESS TO INJECTION AREA WITH PAIN RADIATING TO SHOULDER AND NECK, THAT BEEN ON GOING SINCE INJECTION DATE. AND ITS BEEN 5 DAYS.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has completed  Heplisav B series of 2 in 2023, however, RPH didn't notice and has given #1 Twinrix.  This was discovered when pt came back for #2 dose.   No issue occurred.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received a 3rd dose of shingrix when only 2 needed - no adverse effects reported by pt
Age: 82.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received dose of Prevnar 20 on 04/29/2024 and also on 02/27/2025
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Extra dose administered, Pain in extremity
Clinical narrative: PCV20 was given twice to patient. Once on 2/11/24 and again on 2/28/25. Patient experience no abnormal adverse reaction, besides a sore arm and some redness. Patient did also receive a COVID booster in the same arm at the same time.
Age: 50.0
Sex: M
Vaccine: HEPAB, MMR
Symptoms: Extra dose administered
Clinical narrative: Patient came in to pharmacy and showed a couple of immunization forms that patient told our technicians, that the Health  Clinic did not have the HepA/B vaccine and told to come to our pharmacy.  After the patient received his immunization he pulled out a yellow immunization record card stating he just received the Twinrix.   The pharmacy then contacted the health clinic and there was miscommunication between them and the patient and did not receive the MMR.  So the patient received 2 doses of Twinrix the same day.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. but patient got the first flu shot in august last year. he is not supposed to receive the second dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: long covid; long covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Lot number: EW0185) and on 06Jun2021 as dose 2, single (Lot number: EW0191) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "long covid". Additional information: Patient took the first two Pfizer covid vaccines, the series. After she took the second one, she ran a fever and got covid, or so she believes. Her doctor told her on 26Feb2025, she had the flu for two weeks, he said to take a covid test, patient told him it's not Covid, it's nothing like that. He said patient might have long covid, and said It is very common with the shot she took now, they were the first two in the series. Patient's sister had long covid but she didn't take the shots, and her doctor a podiatrist was also in critical condition, and can only work a few days, he didn't get the shots either. It's in her blood, she doesn't know when it will kill her. She had pneumoa vaccine and then got pneumonia twice after the vaccine. Also had shingles shot and so far, so good. The first shot was nothing. The 2nd hurt a couple of minutes and then she got so sick, doesn't know if it was Covid, she had a fever, she was just sick she rested and whatnot and has the symptoms that her sister has who never took the vaccine that is called long Covid she is sick all the time.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101264274 same patient. different dose and AE;US-PFIZER INC-202101264149 same patient. different dose and AE;
Vaccine: FLUX, RSV
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: patient got Guillain Barre syndrome, hospitalized for 6 weeks and ended up passing away; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (death, hospitalization), outcome "fatal", described as "patient got Guillain Barre syndrome, hospitalized for 6 weeks and ended up passing away". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 42 day(s)). The patient date of death was unknown. Reported cause of death: "Guillain Barre syndrome". It was not reported if an autopsy was performed. Additional information: Calling in regards to the RSV vaccine. Pharmacist did not know if it was GSK or Pfizer product. Caller did confirm that is a GSK designated stocked store for RSV.  Doesn't mean that it is not Abrysvo. A patient got Guillain Barre syndrome, hospitalized for 6 weeks and ended up passing away. The patient was co-administered with the flu vaccine as well. That was the extent of it. They are now concerned with co-administering with RSV in general. Reporter only mentioned that the hospital thought it was possibly co-administration but no true cause of death stated. RSV vaccine: Abrysvo or Arexvy. Stores do not dual stock. Stores either stock GSK or Pfizer. Looked at the reports, store is a GSK vaccine store. There are circumstances, can order Abrysvo for maternal administration on occasion. No patient details. Do not know if by chance Pfizer's was in the fridge for whatever reason. No lot, NDC, expiry to provide. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Current information is very limited for meaningful causal assessment, especially lack of patient demographics, medical history and concomitant medications and event details including latency between the event and the vaccine use.  Extensive investigations and workups are needed to probe etiologies for Guillain Barre syndrome.   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; Reported Cause(s) of Death: Guillain Barre syndrome
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia oral, Paraesthesia
Clinical narrative: The patient reports 10 minutes after receipt of vaccine he experienced onset of tongue tingling, similar to numbing associated with dental procedures. The duration was hours and resolved by morning. He denies any other symptoms to suggest IgE mediated reaction, such as pruritis, urticaria, oral/fac/throat/tongue swelling, flushing, warmth, red, watery eyes, SOB, wheezing, dyspnea, cough , CP, n/v/d. He denies any symptoms to suggest pre-syncope such as dizziness, pallor or cool, clammy skin. Two days later he experienced onset of dry itchy left eye. On inspection he noted left facial droop and loss of forehead wrinkles. He sought care in ER and was diagnosed with Bells palsy. He was treated with steroids (prednisone), in addition to valcyclovir and ocular lubricant. Symptoms fully resolved in 1-2 weeks. He was not referred to neurology. He denies any other prodromal or associated symptoms such as oral ulcers, ear pain, pressure, or other illness symptoms such as fever, chills, malaise, arthralgias, myalgias, cough, SOB, CP, n/c/d, rashes lesions or ulcers. He denies any household illnesses. He denies any prior history or Bell?s palsy. He denies symptoms recurrence.                                                                                                              predniSONE (Sterapred 5 mg oral tablet)take five tablets by mouth every day for 3 days, then take four tablets every day for 3 days, then take three tablets every day for 3 days, then take two tablets every day for 3 days, then take one tablet every day for 3 days. take with food.; Oral (given by mouth). Refills: 0. valACYclovir (Valtrex 1 g oral tablet)1 tabs Oral (given by mouth) 2 times a day for 7 Days. Refills: 0.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Bell's palsy, Dry eye, Eye pruritus, Facial paralysis, Paraesthesia oral
Clinical narrative: The patient reports 10 minutes after receipt of vaccine he experienced onset of tongue tingling, similar to numbing associated with dental procedures. The duration was hours and resolved by morning. He denies any other symptoms to suggest IgE mediated reaction, such as pruritis, urticaria, oral/fac/throat/tongue swelling, flushing, warmth, red, watery eyes, SOB, wheezing, dyspnea, cough , CP, n/v/d. He denies any symptoms to suggest pre-syncope such as dizziness, pallor or cool, clammy skin. Two days later he experienced onset of dry itchy left eye. On inspection he noted left facial droop and loss of forehead wrinkles. He sought care in ER and was diagnosed with Bells palsy. He was treated with steroids (prednisone), in addition to valcyclovir and ocular lubricant. Symptoms fully resolved in 1-2 weeks. He was not referred to neurology. He denies any other prodromal or associated symptoms such as oral ulcers, ear pain, pressure, or other illness symptoms such as fever, chills, malaise, arthralgias, myalgias, cough, SOB, CP, n/c/d, rashes lesions or ulcers. He denies any household illnesses. He denies any prior history or Bell?s palsy. He denies symptoms recurrence.                                                                                                              predniSONE (Sterapred 5 mg oral tablet)take five tablets by mouth every day for 3 days, then take four tablets every day for 3 days, then take three tablets every day for 3 days, then take two tablets every day for 3 days, then take one tablet every day for 3 days. take with food.; Oral (given by mouth). Refills: 0. valACYclovir (Valtrex 1 g oral tablet)1 tabs Oral (given by mouth) 2 times a day for 7 Days. Refills: 0.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, Ventricular fibrillation
Clinical narrative: Vfib heart attack; Vfib heart attack; Safety information originally reported under manufacturer case 202500045586 has been nullified and re-entered under this new manufacturer report number 202500048007.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), 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, SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: VENTRICULAR FIBRILLATION (death, medically significant), MYOCARDIAL INFARCTION (death, medically significant) all with onset Jan2022, outcome "fatal" and all described as "Vfib heart attack". The patient date of death was Jan2022. Reported cause of death: "Vfib heart attack", "heart attack". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Clinical course: The patient passed away in Jan2022 after getting the Pfizer covid 19 shot. In the second one, he was diagnosed with covid and a Vfib heart attack.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500048023 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Vfib heart attack; heart attack
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vfib heart attack; Vfib heart attack; Safety information originally reported under manufacturer case 202500045586 has been nullified and re-entered under this new manufacturer report number 202500048007.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), 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, SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: VENTRICULAR FIBRILLATION (death, medically significant), MYOCARDIAL INFARCTION (death, medically significant) all with onset Jan2022, outcome "fatal" and all described as "Vfib heart attack". The patient date of death was Jan2022. Reported cause of death: "Vfib heart attack", "heart attack". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Clinical course: The patient passed away in Jan2022 after getting the Pfizer covid 19 shot. In the second one, he was diagnosed with covid and a Vfib heart attack.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500048023 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Vfib heart attack; heart attack
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, Ventricular fibrillation
Clinical narrative: Covid; Covid; Safety information originally reported under manufacturer case PV202500024499  has been nullified and re-entered under this new manufacturer report number 202500048023.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "Covid". The patient date of death was Jan2022. The reported cause of death was unknown.  Clinical course: The patient passed away in Jan2022 after getting the Pfizer covid 19 shot the second one he was diagnosed with covid and a Vfib heart attack.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500048007 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; Safety information originally reported under manufacturer case PV202500024499  has been nullified and re-entered under this new manufacturer report number 202500048023.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "Covid". The patient date of death was Jan2022. The reported cause of death was unknown.  Clinical course: The patient passed away in Jan2022 after getting the Pfizer covid 19 shot the second one he was diagnosed with covid and a Vfib heart attack.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500048007 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Syncope; Seizures; This spontaneous report was received from Consumer and refers to her daughter a female patient of unknown age.   The patient's medical history, concurrent conditions and Concomitant therapies were not reported.   On 26-FEB-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Solution for injection, (lot # and expiration date were not reported) as Prophylaxis.  On the same date, short afterward, the patient suffered an episode of syncope followed by two seizures. The reporter said that her daughter was in good health prior to receiving the vaccine. And the timing of the syncope and seizure immediately following the vaccination.  At the reporting time, the outcome of Seizures and Syncope was unknown.    The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) was unknown/not reported/not provided.    Upon internal review, the events of Seizures and Syncope were determined to be medically significant.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunodeficiency, Red blood cell count decreased, Road traffic accident, White blood cell count increased
Clinical narrative: Car accident; immunocompromised; This serious case was reported by a nurse via sales rep and described the occurrence of automobile accident in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-JUN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JUN-2024, less than a day after receiving Shingrix, the patient experienced automobile accident (Verbatim: Car accident) (serious criteria hospitalization and other: Serious as per reporter). On an unknown date, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant). The outcome of the automobile accident was resolved with sequelae and the outcome of the immunocompromised was not reported.   The reporter considered the automobile accident and immunocompromised to be related to Shingrix.     The company considered the automobile accident and immunocompromised to be unrelated to Shingrix.   Additional Information: GSK receipt date: 25-FEB-2025 The patient had car accident. Patient was subsequently hospitalized and was referred to every specialist. It was determined that by doctors that the 2nd dose of Shingrix caused the patient to become immunocompromised. Patient was on Thyroid medicine at the time of reporting for unknown indication.; Sender's Comments: Road traffic accident and Immunodeficiency are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: I lost hearing in my right ear from vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral 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 hearing loss unilateral (Verbatim: I lost hearing in my right ear from vaccine) (serious criteria GSK medically significant). The outcome of the hearing loss unilateral was not reported.   It was unknown if the reporter considered the hearing loss unilateral to be related to Shingles vaccine.     The company considered the hearing loss unilateral to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-FEB-2025  This case was reported by a patient via interactive digital media. The patient stated that he/she lost hearing in his/her right ear from vaccine. Patient never had measles mumps or chickenpox.; Sender's Comments: Deafness unilateral is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off; This is a spontaneous report received from an Other HCP from product quality group,.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: HM9865, Expiration Date: 30Apr2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), outcome "unknown", described as "Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off".  Additional information: Reporter had a box from previous, the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off. They had 2 in a box where this happened. Reporter clarified that it just broke off - on top, it had a metal part inside, so the top of the metal part, like where the actual vial was put to put the diluent in the little syringe part. It was on top of the vial, it was metal, and on top, there was a plasticky glass where the syringe went in and pulled back out. It was the plasticky part that went on. The syringe was okay; it was the syringe that it went into the end that sticks out. It came with a syringe and vial.  Causality for "abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  No follow-up attempts are possible.
Age: 73.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: injection may have been intramuscular instead of subcutaneous; 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 73-year-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   On 25-FEB-2025, the patient received Priorix (intramuscular). On 25-FEB-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: injection may have been intramuscular instead of subcutaneous). 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: 26-FEB-2025 Registered Pharmacist reported that she used 1in needle versus 5 by 8 in needle when administering Priorix on 25 FEB 2025 in a patient. Registered Pharmacist was concerned that injection may have been intramuscular instead of subcutaneous which led to Subcutaneous injection formulation administered by other route.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Neck mass
Clinical narrative: large lump under neck in lymph node area lasted for 6 weeks after tdap/dtap/td vaccination.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she had vaccine and  still got it.  The patient got it in November and it was still lingering with him/her.  The patient was taking that gabapentin to ease that burning pain. This case was considered as suspected vaccination failure as details regarding completion of primary 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Aphasia, Arthralgia, Dizziness, Fall, Feeling abnormal
Clinical narrative: Vaccines were given and patient sat on the exam table for 10 minutes. She was being sent back to her classroom and asked to use the restroom first.  She went into the restroom.  When she came out of the rest room she fell to the floor. This was not witnessed and when she stated "I don't feel right" she was lying on her right side.   She said she felt dizzy in the bathroom and wasn't sure if she passed out or not in there. She stated she was dizzy in there and felt funny and couldn't get words out.  When she was on the floor, she was not sure if she lost consciousness but felt dizzy in her head and was warm to touch and diaphoretic.  She states she hurt her left knee but does not know what she hit her knee on. Ice was applied to the left knee.  A cold cloth was applied to her head and back of neck for comfort.  She was ambulatory and able to walk back to her classroom assisted by the provider.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Hyperhidrosis, Skin warm
Clinical narrative: Vaccines were given and patient sat on the exam table for 10 minutes. She was being sent back to her classroom and asked to use the restroom first.  She went into the restroom.  When she came out of the rest room she fell to the floor. This was not witnessed and when she stated "I don't feel right" she was lying on her right side.   She said she felt dizzy in the bathroom and wasn't sure if she passed out or not in there. She stated she was dizzy in there and felt funny and couldn't get words out.  When she was on the floor, she was not sure if she lost consciousness but felt dizzy in her head and was warm to touch and diaphoretic.  She states she hurt her left knee but does not know what she hit her knee on. Ice was applied to the left knee.  A cold cloth was applied to her head and back of neck for comfort.  She was ambulatory and able to walk back to her classroom assisted by the provider.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives, seen in ER and given steroid and antihistamine and resolved, no other systemic symptoms
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea, Injection site swelling
Clinical narrative: The day after receiving vaccine patient experienced wheezing, chest tightness, and shortness of breath. The area became raised, hot itchy, spread to entire upper arm. Patient did not seek medical attention because she assumed it was a flare up of her asthma. Patient used inhaler during reaction which helped symptoms of wheezing. Patient stated symptoms resolved by the end of the week. Patient did apply topical Benadryl cream to affected area which did not help.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Wheezing
Clinical narrative: The day after receiving vaccine patient experienced wheezing, chest tightness, and shortness of breath. The area became raised, hot itchy, spread to entire upper arm. Patient did not seek medical attention because she assumed it was a flare up of her asthma. Patient used inhaler during reaction which helped symptoms of wheezing. Patient stated symptoms resolved by the end of the week. Patient did apply topical Benadryl cream to affected area which did not help.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Blood glucose normal, Body temperature decreased, Cold sweat, Fatigue, Infant irritability
Clinical narrative: Parents called after-hours triage nurse and reported vaccines given around 1430, parents woke patient up from nap at approx 2130 and found him pale, clammy and rectal temp of 95.8 F, and some fussiness.  Advised to go to ED,  ED triage RN note at 3/3/25 2249 states arrived "pink and at baseline". ED physician note at 3/4/25 at 0025 states "Patient had vaccines at around 2 PM.  Patient was acting normally throughout the rest the day feeding and making wet diapers appropriately.  And slept until around 930 when parents had woken him up.  His parents state that he was cyanotic around the lips face and bottoms of his feet.  At that time he was also "limp ".  Father describes him and pale and clammy. They tried to get him to feed and he fed for approximately 10 minutes but not as vigorous as normal.  They had taken a rectal temperature which was 95 at the time.  They had called their sister who is a pediatrician and spoke to their on-call pediatrician who advised him to come to the emergency department.  By the time they got packed up to come here patient had looked back to normal with cyanosis resolved.  Parents state that now patient is back to baseline but appears slightly sleepier than normal.."  On 3/5/25 mom reported to PCP office RN that since discharge from ED at approx 0300 3/4/25 patient is "doing really good",  he is very tired, a litte fussy, eating well between naps, "seems to be getting back to his normal self.', with temp 98.9F on 3/4/25.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Pallor
Clinical narrative: Parents called after-hours triage nurse and reported vaccines given around 1430, parents woke patient up from nap at approx 2130 and found him pale, clammy and rectal temp of 95.8 F, and some fussiness.  Advised to go to ED,  ED triage RN note at 3/3/25 2249 states arrived "pink and at baseline". ED physician note at 3/4/25 at 0025 states "Patient had vaccines at around 2 PM.  Patient was acting normally throughout the rest the day feeding and making wet diapers appropriately.  And slept until around 930 when parents had woken him up.  His parents state that he was cyanotic around the lips face and bottoms of his feet.  At that time he was also "limp ".  Father describes him and pale and clammy. They tried to get him to feed and he fed for approximately 10 minutes but not as vigorous as normal.  They had taken a rectal temperature which was 95 at the time.  They had called their sister who is a pediatrician and spoke to their on-call pediatrician who advised him to come to the emergency department.  By the time they got packed up to come here patient had looked back to normal with cyanosis resolved.  Parents state that now patient is back to baseline but appears slightly sleepier than normal.."  On 3/5/25 mom reported to PCP office RN that since discharge from ED at approx 0300 3/4/25 patient is "doing really good",  he is very tired, a litte fussy, eating well between naps, "seems to be getting back to his normal self.', with temp 98.9F on 3/4/25.
Age: 0.17
Sex: F
Vaccine: HEPA, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Hep A rather than Vaxelis.  Patient is ok per mom.  No symptoms of a reaction per mom.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: high dose flu inadvertently given.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Vitiligo presented within 2 months
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given a 3rd dose of HPV at age 19, she did not need it due to receiving both her first doses prior to age 14.  She did not have any adverse reactions to the immunization. I contacted my dental director and the health department to ask about next steps.  I will contact the patient and I have added the event into VAERS.
Age: 74.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized redness, swelling, pain. Treated with OTC analgesic. Informed patient to try cold therapy applications to the site, and OTC antihistamine.
Age: 0.17
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DTaP was ordered to be given and the Influenza vaccine was given by mistake.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 2/26/2025 employee noticed redness and some swelling. The next several days it worsen and was itching. On 3/2/2025-3/3/2025 she noticed symptoms improving. Today (3/5/2025) she again states area is improving. Some redness and swelling still present but she denies any issues with moving of arm or shoulder. I informed her to let Employee Health know if symptoms worsen or stop improving.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The patient received Prevanr 20 and the pharmacy on 2/24/25 and 10/22/2022
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Spikevax (12y+), vaccine was received on 10/8/2024 and stored in the refrigerator so the 60 day expiration was 12/7/2024 & patient received vaccine on 12/10/2024. No side effects or adverse events noted.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Spikevax (12y+), vaccine was received on 10/8/2024 and stored in the refrigerator so the 60 day expiration was 12/7/2024 & patient received vaccine on 12/12/2024. No side effects or adverse reactions noted.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: redness, itching, and lump to LT deltoid region
Age: 16.0
Sex: M
Vaccine: COVID19, MNQ
Symptoms: Underdose
Clinical narrative: Pt was administered the Moderna COVID vaccine for 6months-11year instead of 12+. Provider informed by staff. Parent informed.
Age: 31.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Dizziness, Headache, Malaise, Nausea
Clinical narrative: Client calling today to report that Friday (5 days ago)  she received Hep A and Yellow Fever. She woke up Saturday morning with dizziness. No other symptoms. As week has progressed, symptoms of dizziness are worsening, she has a headache and is nauseated. She denies fever, no local reaction at site of admin. She is up and about and working but does not feel well. She has been taking ibuprofen and has been  hydrating with fluids. Advised her to be seen by her provider since symptoms are worsening.  Today is Wednesday.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Acute myocardial infarction, Asthenia, Asthma, Band neutrophil count
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Band neutrophil percentage, Basophil count decreased, Basophil percentage decreased, Bilirubin urine, Blood calcium normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.