chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure immeasurable, Enanthema, Pallor, Rash, Respiratory arrest
Clinical narrative: patient fainted and according to the doctor was "unresponsive for about 10 seconds"/patient was pale; not breathing; "some kind of mucosal rash" on the mouth and lips; Caller stated HCP reported patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30; glucocagon for possible low blood sugar; patient had a rash on her chest; This spontaneous report was received from a physician and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by unknown route (lot # and expiration date were not reported) as prophylaxis.  On an unknown date, after receiving first dose, the patient fainted and according to the doctor was "unresponsive for about 10 seconds". 9-1-1 was called. She was pale and not breathing. The patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30". HCP gave patient glucagon for possible low blood sugar. HCP stated ambulance finally came, however mother refused her daughter to go to the emergency room, because the patient "seemed to be coming around". The patient's mother called the office and stated patient had a rash on her chest and "some kind of mucosal rash" on the mouth and lips. HCP sent the patient to emergency room where she was given steroids and Benadryl and was sent home. HCP stated both "eventually resolved" and stated that the patient was referred to a cardiologist. Dates of all events were unknown. No additional information provided. At the reporting time, the outcome of blood pressure decreased and sugar blood decreased was unknown. The action taken with the suspect vaccine was not applicable.   The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   The reporter considered the all of the events to be life-threatening.
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: patient fainted and according to the doctor was "unresponsive for about 10 seconds"/patient was pale; not breathing; "some kind of mucosal rash" on the mouth and lips; Caller stated HCP reported patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30; glucocagon for possible low blood sugar; patient had a rash on her chest; This spontaneous report was received from a physician and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by unknown route (lot # and expiration date were not reported) as prophylaxis.  On an unknown date, after receiving first dose, the patient fainted and according to the doctor was "unresponsive for about 10 seconds". 9-1-1 was called. She was pale and not breathing. The patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30". HCP gave patient glucagon for possible low blood sugar. HCP stated ambulance finally came, however mother refused her daughter to go to the emergency room, because the patient "seemed to be coming around". The patient's mother called the office and stated patient had a rash on her chest and "some kind of mucosal rash" on the mouth and lips. HCP sent the patient to emergency room where she was given steroids and Benadryl and was sent home. HCP stated both "eventually resolved" and stated that the patient was referred to a cardiologist. Dates of all events were unknown. No additional information provided. At the reporting time, the outcome of blood pressure decreased and sugar blood decreased was unknown. The action taken with the suspect vaccine was not applicable.   The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   The reporter considered the all of the events to be life-threatening.
Sex: F
Vaccine: HPV9
Symptoms: Cervicectomy
Clinical narrative: GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis.  The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) caused a removal of cervix (Hysterectomy) for 2 daughters (This report refers to one of them and the other female patient was captured in case # 2320738) and one daughter developed a "knot" on her breast (Captured in case # 2320739). At the reporting time, the outcome of hysterectomy was not provided.  The reporter considered the event of hysterectomy to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9).  Upon internal review, the event of hysterectomy was considered medically significant.   This is one of three reports from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Cervicectomy
Clinical narrative: GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis.  The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) caused a removal of cervix (Hysterectomy) for 2 daughters (This report refers to one of them and the other female patient was captured in case # 2320735) and one daughter developed a "knot" on her breast (Captured in case # 2320739). At the reporting time, the outcome of hysterectomy was not provided.  The reporter considered the event of hysterectomy to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9).  Upon internal review, the event of hysterectomy was considered medically significant.   This is one of three reports from the same reporter.
Vaccine: VARZOS
Symptoms: Adrenal insufficiency, Central vision loss, Raynaud's phenomenon, Retinal operation, Retinal tear
Clinical narrative: retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Raynauds; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal tear in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced retinal tear (Verbatim: retina tear) (serious criteria GSK medically significant and clinically significant/intervention required), central vision loss (Verbatim: loss my center vision) (serious criteria GSK medically significant), rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), sjogren's (Verbatim: sjogrens) (serious criteria GSK medically significant), systemic lupus erythematosus (Verbatim: lupus) (serious criteria GSK medically significant), adrenal insufficiency (Verbatim: adrenal deficiency) (serious criteria GSK medically significant) and raynauds (Verbatim: Raynauds). The patient was treated with Steroids. The outcome of the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds were not reported and the outcome of the adrenal insufficiency was not resolved.   It was unknown if the reporter considered the retinal tear, central vision loss and adrenal insufficiency to be related to Shingrix. The reporter considered the rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds to be related to Shingrix.     The company considered the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and adrenal insufficiency to be unrelated to Shingrix. The company considered the raynauds to be related to Shingrix.   Linked case(s) involving the same patient:  US2021AMR198955   Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient received shingrix vaccine a few years ago (from reporting date) that triggered rheumatoid arthritis, sjogrens, raynauds, lupus and at the time of reporting also had adrenal deficiency that he/she steroid dependent on to live.  The patient also developed a retina tear that had three surgeries on and loss his/her center vision.  The patient would never tell anyone not to get a vaccine but dang sure would say to do some deep research beforehand.; Sender's Comments: A case of Retinal tear, Central vision loss, Rheumatoid arthritis, Sjogren's syndrome, Systemic Lupus erythematosus and Adrenal insufficiency, unknown time after receiving Shingrix in a patient.  Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GLAXOSMITHKLINE-US2021AMR198955:same patient
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Raynauds; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal tear in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced retinal tear (Verbatim: retina tear) (serious criteria GSK medically significant and clinically significant/intervention required), central vision loss (Verbatim: loss my center vision) (serious criteria GSK medically significant), rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), sjogren's (Verbatim: sjogrens) (serious criteria GSK medically significant), systemic lupus erythematosus (Verbatim: lupus) (serious criteria GSK medically significant), adrenal insufficiency (Verbatim: adrenal deficiency) (serious criteria GSK medically significant) and raynauds (Verbatim: Raynauds). The patient was treated with Steroids. The outcome of the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds were not reported and the outcome of the adrenal insufficiency was not resolved.   It was unknown if the reporter considered the retinal tear, central vision loss and adrenal insufficiency to be related to Shingrix. The reporter considered the rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds to be related to Shingrix.     The company considered the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and adrenal insufficiency to be unrelated to Shingrix. The company considered the raynauds to be related to Shingrix.   Linked case(s) involving the same patient:  US2021AMR198955   Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient received shingrix vaccine a few years ago (from reporting date) that triggered rheumatoid arthritis, sjogrens, raynauds, lupus and at the time of reporting also had adrenal deficiency that he/she steroid dependent on to live.  The patient also developed a retina tear that had three surgeries on and loss his/her center vision.  The patient would never tell anyone not to get a vaccine but dang sure would say to do some deep research beforehand.; Sender's Comments: A case of Retinal tear, Central vision loss, Rheumatoid arthritis, Sjogren's syndrome, Systemic Lupus erythematosus and Adrenal insufficiency, unknown time after receiving Shingrix in a patient.  Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GLAXOSMITHKLINE-US2021AMR198955:same patient
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Pneumonia
Clinical narrative: atrial fibrillation; pneumonia; This 76-year-old female subject was enrolled in an open label study titled A phase 3b, randomized, open label, multi-country,multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV withheld protocol #) study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 µg on 14-AUG-2025, for prophylaxis.   On 30-DEC-2024, before receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 pneumonia (Verbatim: pneumonia). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation (Verbatim: atrial fibrillation) on 31-DEC-2024 with serious criteria of hospitalization. The outcome of pneumonia was resolved on 12-JAN-2025. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 02-JAN-2025).   The investigator considered that there was no reasonable possibility that the pneumonia and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E.    Linked case(s) involving the same subject:  US2025105120   GSK Receipt date: 14-Aug-2025, 15-Aug-2025 and 18-Aug-2025  Hospital admission date of pneumonia and atrial fibrillation was 30-Dec-2024. Hospital discharge date of pneumonia and atrial fibrillation was 12-Jan-2025. Date of event (pneumonia) became serious was 30-Dec-2024. Date of event (atrial fibrillation) became serious was 31-Dec-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI).; Sender's Comments: The company has assessed that it is unlikely that Pneumonia and Atrial fibrillation were caused by the study vaccine. The events occurred prior to vaccine administration. US-GSK-US2025105120:
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Mammogram
Clinical narrative: Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Other HCP.  A female patient received BNT162b2 (BNT162B2 NOS), in 2023 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: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for covid-19 immunization, reaction(s): "Generic flu like symptoms", "Lymph node enlargement"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2022, for covid-19 immunization, reaction(s): "Generic flu like symptoms", "Lymph node enlargement". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node enlargement"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Generic flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter had some side effects, to the extent where, she was no longer going to take the mrna vaccine. Clarified, there were 2 different side effects. There were 2 side effects, that would usually occur every time she got Covid vaccine, back in 2021, 2022, 2023. That is what reporter was guessing. This occurred when getting 2 dose primary series, occurring both with first and second doses, with third booster dose, got a little bit of it but, was not as much as first and second primary doses. Guessing about the 2021, 2022 and 2023. They were back to back. reporter were thinking it started with first Covid pandemic, which was back in 2020, did not remember if 2020 or 2021 but put 2021, 2022 and 2023, to the best of their knowledge. The lymph node enlargement required her to get a mammogram, and lasted about 6 months. Believes reporter recovered from it. Clarified second side effect as, just generic  flu like symptoms, lasted about 4 days.  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-202500165794 same patient, different dose;US-PFIZER INC-202500165859 same patient, different dose;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bad fever; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: EW0170) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: ER8733; anatomical location:Upper arm, pretty sure right arm.), administration date: 30Mar2021, when the patient was 59-year-old, for COVID-19 Immunization, reaction(s): "heart palpitations". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "bad fever".  Additional information: Patient takes vitamins but stopped for a while. Caller stated well now, but nothing back in 2021 doesn't believe. Did the patient receive any other vaccines on the same date as the Pfizer vaccine reported as No. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as No.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: second time testing positive for Covid; second time testing positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19, reaction(s): "Dysgeusia (metal taste)"; Paxlovid for COVID-19, reaction(s): "diarrhea"; Paxlovid for COVID-19, reaction(s): "Felt nauseated but didn't vomit"; Paxlovid for COVID-19, reaction(s): "lost his appetite". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Flu vaccine (flu vaccine decades ago, got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "AMPPE"; Flu vaccine (After treatment with high dose steroids, I was able to regain my vision, got a shot in the arm, Name of steroids unknown.), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost my central vision"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "second time testing positive for Covid". The patient underwent the following laboratory tests and procedures: Body temperature: maybe .1 or .2 increase; SARS-CoV-2 test: Positive, notes: The second time. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient had original 2 doses and believed he had had 3 boosters. He had contracted Covid twice after the Covid vaccine and boosters. The second time testing positive for Covid, the patient called his doctor on a Friday and he called in script for child dosage of Paxlovid, but he was unable to obtain it. On Monday he called his doctor back and said no one had Paxlovid and can't get it. The doctor asked him how he felt and his temperature was maybe .1 or .2 increase. His doctor said if you are not running a high fever and feel ok don't bother taking it and caller didn't take it the second time. Then he was fine after and his symptoms improved. He didn't need any other treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166339 same patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: body became very cold; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number 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: FEELING COLD (non-serious) with onset 2021, outcome "recovered" (2021), described as "body became very cold". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Additional information: The consumer told company representative about her experience with Pfizer Covid vaccine from 2021. Felt like he would just call it in, to be safe. When asked to provide experience reporter had reported to caller, he states, she relayed that, pretty immediately after she received her vaccination, her body became very cold for about 2 minutes, then subsided. That was really the only detail that was provided. Caller had asked her if she felt like it was chills, said it was not really chills, whole body felt cold. Caller did not know how to describe that. Reporter was mentally having to recall when this occurred. Was with her first Covid vaccine, which became available in 2021, caller believed. Clarified, as previously stated, was from 4 years ago, was not a recent event.
Sex: F
Vaccine: COVID19
Symptoms: Fasciitis
Clinical narrative: fasciitis in her lower leg; This is a spontaneous report received from a Nurse from medical information team.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot unknown), administration date: 07Mar2021, for covid-19 immunisation; Bnt162b2 (dose 2, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 3, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 4, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 5, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 6, lot unknown), for covid-19 immunisation. Her first Pfizer COVID-19 vaccine was on 07Mar2021 and stated that she already had at least seven Pfizer COVID-19 vaccines. The following information was reported: FASCIITIS (non-serious) with onset Oct2024, 1 week after the suspect product(s) administration, outcome "unknown", described as "fasciitis in her lower leg". The event "fasciitis in her lower leg" required physician office visit. Therapeutic measures were taken as a result of fasciitis. She also stated that she had Physical therapy and anti-inflammatory medications.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Weight
Clinical narrative: had actual Covid - bad case but not hospitalized; had actual Covid - bad case but not hospitalized; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0164), in arm, on 07May2021 as dose 2, single (Lot number: EW0165), in arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 59 years, in arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2023 as dose number unknown (booster), single intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Strong Menopause symptoms" (unspecified if ongoing). There were no concomitant medications (the patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine, and did not receive any other vaccines on the same date as the Pfizer vaccine). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "had actual Covid - bad case but not hospitalized". The patient underwent the following laboratory tests and procedures: Weight: 160. Clinical course: had actual Covid-bad case but not hospitalized in early 2023.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Barrel chest, Cough, Rash, Rash erythematous, Rash macular
Clinical narrative: The patient presented to Clinic on 08/18/2025 at approximately 0800 for routine immunizations. ProQuad was administered in the left thigh and Kinrix in the right thigh. The patient tolerated the injections without complication and departed the clinic at approximately 0910.  At 0915, the patient?s father called reporting a new onset rash and cough. He was advised to return to the clinic for further evaluation. Upon arrival, the patient was noted to be in respiratory distress. Dr. and FNP-BC evaluated the patient. Oxygen saturation was 92% on room air. Examination revealed barrel chest, retracted breathing, and a splotchy erythematous rash across the torso. The patient also demonstrated tachypnea and vomiting.  At 0950, Dr. administered Epinephrine 0.15 mg IM to the left thigh, followed by Decadron 4 mg/mL and Diphenhydramine 50 mg/mL. The patient showed an adequate response to treatment with improvement in oxygen saturation to 98% on room air and a pulse of 132 bpm.  An ambulance was dispatched for transfer to Emergency Department for continued monitoring. The patient arrived at approximately 1043. He remained stable throughout observation and was prescribed Prednisolone 15 mg/5 mL for home use. The patient was discharged in stable condition at 1252.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Respiratory distress, Tachypnoea, Use of accessory respiratory muscles, Vomiting
Clinical narrative: The patient presented to Clinic on 08/18/2025 at approximately 0800 for routine immunizations. ProQuad was administered in the left thigh and Kinrix in the right thigh. The patient tolerated the injections without complication and departed the clinic at approximately 0910.  At 0915, the patient?s father called reporting a new onset rash and cough. He was advised to return to the clinic for further evaluation. Upon arrival, the patient was noted to be in respiratory distress. Dr. and FNP-BC evaluated the patient. Oxygen saturation was 92% on room air. Examination revealed barrel chest, retracted breathing, and a splotchy erythematous rash across the torso. The patient also demonstrated tachypnea and vomiting.  At 0950, Dr. administered Epinephrine 0.15 mg IM to the left thigh, followed by Decadron 4 mg/mL and Diphenhydramine 50 mg/mL. The patient showed an adequate response to treatment with improvement in oxygen saturation to 98% on room air and a pulse of 132 bpm.  An ambulance was dispatched for transfer to Emergency Department for continued monitoring. The patient arrived at approximately 1043. He remained stable throughout observation and was prescribed Prednisolone 15 mg/5 mL for home use. The patient was discharged in stable condition at 1252.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Since 2 months post vax, my hair fell out in copious amounts. The first year, I lost at least 1/3 of my hair. Now, still, in 2025, I lose hair in cycles. So does my 18 year old daughter who was 14 at time of "vaccination" thus making it unlikely to be a hormonal thing related to menopause. There are many of us out there- who lost a lot of hair. Please research.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Patient given Arexvy instead of Abrysvo. Pt reports EGA 35+2. Patient at risk of adverse event due to side effects of pregnant patient receiving Arexvy. Patient remained at clinic for one hour after event. Patient did not report any s/s of preterm labor. Patient's OB provider made aware of incident. Pt reports that her OB provider would call her to discuss what happened, possible side effects, precautions, and next steps. Incident also reported to (withheld) Clinical Consult Team (phone# withheld opt.1).
Age: 37.0
Sex: F
Vaccine: COVID19, HEP, HPV9
Symptoms: Lip swelling, Urticaria
Clinical narrative: Many hours after the shot, I developed hives, which eventually covered about 80% of my body. My top lip swelled but I did not have any breathing trouble. My doctor sent a steroid and now they are starting to go away, 2 days later.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine give after 10 week expiration date. No reactions or illness symptoms took place.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Chest pain heart beats fast fatigue shortness of breath.
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, RV1, UNK
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: My son passed away on May 11th 2024 his cause of death has been ruled SUID undetermined
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient had pain, redness, and heat coming from injection site, as well as the presence of a hard lump. Patient was treated with ibuprofen and Benadryl and was told that if symptoms do improve over the course of 24 hours, to go to the doctor.
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "mild fibromyalgia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 17Sep2021, for COVID-19 immunization, reaction(s): "Ankylosing Spondylitis". The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "spondyloarthropathy with ankylosing attributes or conditions". Therapeutic measures were taken as a result of ankylosing spondylitis.  Clinical course: She has lots of things that happened after the vaccination that has now caused her lots of health problems and is on lots of medications. She wants to tell Pfizer what the vaccine did to her and her health for the last two, three or four years, clarifies as since 2021 since she got the second vaccination. She has very mild fibromyalgia intermittently that only affected her arm joint that was she confirms was diagnosed prior to the covid vaccine.  She did not have immediate issues after first dose then states she cannot delineate since the doses were weeks apart but immediately after the second dose, her entire body was on fire on the inside and every joint in her body awakened with pain, joints that she had never felt before. Her primary doctor had never heard of this. She went to the fibromyalgia website and there were hundreds of reports of fibromyalgia patients experiencing the same thing. No further details provided. Treatment: did not know what treatment to get. When querying outcome states she was taking biologic medication now since the covid vaccine caused spondyloarthropathy with ankylosing attributes or conditions, states she does not know what it was called.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: UNK
Symptoms: Syringe issue
Clinical narrative: No AE; Finger Flange Broken - During or After Injection; following administration while applying needle safety cover , the glass PFS broke; This spontaneous report was received from a Nurse on 15-AUG-2025.  The complaint description was reported as follow: Health care professional (HCP) called to report a product quality complaint (PQC) for Hepatitis B Vaccine (Recombinant) (RECOMBIVAX H) Suspension for injection (lot #Z004729, has been verified to be valid lot #, expiration date was provided and confirmed as: 04-Sep-2027). Caller reported that on 15-AUG-2025, following administration while applying needle safety cover, the glass pre-filled syringe (PFS) broke (Syringe issue). Caller stated that "it broke in half and shards were everyone". Finger flange broken, it broken into 2 pieces with multiple shards. No patient involved. No injury to patient or HCP. Product available for retrieval. No adverse event (AE) was reported. No additional PQC. Date PQC observed: 15-AUG-2025.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Allergy test, Food allergy
Clinical narrative: Patient became allergic to peanuts. He first had peanuts when he was just over a year old in September of 2014.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Myocarditis
Clinical narrative: myocarditis
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Fatigue, Intussusception, Lethargy, Ultrasound abdomen abnormal
Clinical narrative: Patient with sudden onset of fatigue and lethargy on 07/17/25, with multiple episodes of bilious vomiting. Patient seen in ED where workup was completed; ultrasound remarkable for large colonic to colonic intussusception. Patient received barium enema which reduced the majority of the intussusception; admitted for observation and received additional enemas to reduce intussusception.; no surgery. Seen in office 07/20/25 and was noted to be doing well and is followed by pediatric surgery.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Patient with sudden onset of fatigue and lethargy on 07/17/25, with multiple episodes of bilious vomiting. Patient seen in ED where workup was completed; ultrasound remarkable for large colonic to colonic intussusception. Patient received barium enema which reduced the majority of the intussusception; admitted for observation and received additional enemas to reduce intussusception.; no surgery. Seen in office 07/20/25 and was noted to be doing well and is followed by pediatric surgery.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
Age: 78.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Patient had injection site reaction. Injection site was inflamed and itchy - about 2 inches x 4 inches patch on 8/22/25. Started roughly 5 days after vaccine administration (on 8/21/25).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Altered state of consciousness, Diarrhoea, Irritability, Pyrexia
Clinical narrative: getting his vaccines along with dupixent; fever and diarrhea after getting his vaccines; fever ans diarrhea after getting his vaccines; more fussy and "not like self after getting the vaccine"; more fussy and "not like self after getting the vaccine"/ cranky; fussiness and crankiness to patient teething; This spontaneous report was received from a consumer via other company and refers to a 1-year-old male patient. His medical history was not reported. The patient's concurrent conditions included ongoing multiple food allergies. Concomitant therapies were not reported.   On 31-Dec-2024, the patient started therapy with Dupixent (Dupilumab) solution for injection 200 mg (strength 200mg), administered by subcutaneous route for the treatment of eczema (lot # and expiration date were not reported). On 08-Jun-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Hepatitis A Vaccine, Inactivated (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); and with Typhoid Conjugate Vaccine (reported as TCV vaccine) administered by unknown route (lot # and expiration date were not reported). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown) were reconstituted with sterile diluent (no details provided).  On 08 -JUN-2025, per mom, the patient had a fever and diarrhea after getting his vaccines. They did not know about avoiding live vaccines regarding Dupixent injection (contraindicated product administered). She stated patient did seem more fussy and "not like self" after getting the vaccines (altered state of consciousness) (onset: 2025), fever and diarrhea had resolved the next day, on 09-JUN-2025 (reported also as 7/9/2025, discrepancy). The patient was administered Tylenol (date unknown). He was still a little fussy and cranky (irritability) (onset: 2025) but better, the fussiness and crankiness were attributed to the patient's teething (irritability) (onset: 2025). The action taken was not applicable for all of the vaccines. Dupilumab was continued for all events. The patient recovered from the event of fever and diarrhea after getting his vaccines on 09-Jun-2025. At the reporting time, the patient was recovering from irritability. The outcome of the patient's teething and altered state of consciousness was unknown.   The causal relationship between the events and the suspect vaccines was not provided.  Upon internal review, all of the events were determined to be medically significant.
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bells palsy;  This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy 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 bell's palsy (Verbatim: Bells palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     The company considered the bell's palsy to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. Bell's palsy had been his/her reward for getting the shingles vaccine.; Sender's Comments: A case of Bell's palsy, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
Clinical narrative: passed away 2 years ago; Suspected vaccination failure; worst case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male 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 unknown cause of death (Verbatim: passed away 2 years ago) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: worst case of shingles). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the unknown cause of death and vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-AUG-2025 This case was reported by son-in-law or daughter-in-law of the patient via interactive digital media. The reporter reported his/her father-in-law (patient) got the jab and came down with the worst case of shingles he/she had ever seen. In reporter's opinion the jab caused. Further reporter said, sadly the patient passed away 2 years ago (from the date of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Death, unknown time after receiving Shingles vaccine in a male patient.  Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death