chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy artery, Blood test, Gingivitis, Magnetic resonance imaging, Optic ischaemic neuropathy
Clinical narrative: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure; she lost vision in her right eye (optic ischemic neuropathy); she lost vision in her right eye; gum infection; gum infection on the same side determined to be a shingles infection; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure) (serious criteria GSK medically significant), ischemic optic neuropathy (Verbatim: she lost vision in her right eye (optic ischemic neuropathy)) (serious criteria GSK medically significant), loss of vision (Verbatim: she lost vision in her right eye) (serious criteria GSK medically significant), gingival infection (Verbatim: gum infection) and oral herpes zoster (Verbatim: gum infection on the same side determined to be a shingles infection). The outcome of the vaccination failure and gingival infection were unknown and the outcome of the ischemic optic neuropathy was not resolved and the outcome of the loss of vision was resolving and the outcome of the oral herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2023 The patient self-reported this case.  The patient stated that she lost vision in her right eye (optic ischemic neuropathy).  The patient developed an upper and lower gum infection on the same side, which was determined to be a shingles infection, and caused her loss of sight.  The patient had a loss of vision of 50 percent at first. It had now improved but was at 25 percent now.  This was potential legal case. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Viral infection, Visual field tests, Visual impairment
Clinical narrative: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure; she lost vision in her right eye (optic ischemic neuropathy); she lost vision in her right eye; gum infection; gum infection on the same side determined to be a shingles infection; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure) (serious criteria GSK medically significant), ischemic optic neuropathy (Verbatim: she lost vision in her right eye (optic ischemic neuropathy)) (serious criteria GSK medically significant), loss of vision (Verbatim: she lost vision in her right eye) (serious criteria GSK medically significant), gingival infection (Verbatim: gum infection) and oral herpes zoster (Verbatim: gum infection on the same side determined to be a shingles infection). The outcome of the vaccination failure and gingival infection were unknown and the outcome of the ischemic optic neuropathy was not resolved and the outcome of the loss of vision was resolving and the outcome of the oral herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2023 The patient self-reported this case.  The patient stated that she lost vision in her right eye (optic ischemic neuropathy).  The patient developed an upper and lower gum infection on the same side, which was determined to be a shingles infection, and caused her loss of sight.  The patient had a loss of vision of 50 percent at first. It had now improved but was at 25 percent now.  This was potential legal case. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blindness unilateral, Gingivitis, Herpes zoster, Optic ischaemic neuropathy, Oral herpes zoster
Clinical narrative: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure; she lost vision in her right eye (optic ischemic neuropathy); she lost vision in her right eye; gum infection; gum infection on the same side determined to be a shingles infection; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure) (serious criteria GSK medically significant), ischemic optic neuropathy (Verbatim: she lost vision in her right eye (optic ischemic neuropathy)) (serious criteria GSK medically significant), loss of vision (Verbatim: she lost vision in her right eye) (serious criteria GSK medically significant), gingival infection (Verbatim: gum infection) and oral herpes zoster (Verbatim: gum infection on the same side determined to be a shingles infection). The outcome of the vaccination failure and gingival infection were unknown and the outcome of the ischemic optic neuropathy was not resolved and the outcome of the loss of vision was resolving and the outcome of the oral herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2023 The patient self-reported this case.  The patient stated that she lost vision in her right eye (optic ischemic neuropathy).  The patient developed an upper and lower gum infection on the same side, which was determined to be a shingles infection, and caused her loss of sight.  The patient had a loss of vision of 50 percent at first. It had now improved but was at 25 percent now.  This was potential legal case. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure; she lost vision in her right eye (optic ischemic neuropathy); she lost vision in her right eye; gum infection; gum infection on the same side determined to be a shingles infection; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: gum infection on the same side determined to be a shingles infection / Suspected vaccination failure) (serious criteria GSK medically significant), ischemic optic neuropathy (Verbatim: she lost vision in her right eye (optic ischemic neuropathy)) (serious criteria GSK medically significant), loss of vision (Verbatim: she lost vision in her right eye) (serious criteria GSK medically significant), gingival infection (Verbatim: gum infection) and oral herpes zoster (Verbatim: gum infection on the same side determined to be a shingles infection). The outcome of the vaccination failure and gingival infection were unknown and the outcome of the ischemic optic neuropathy was not resolved and the outcome of the loss of vision was resolving and the outcome of the oral herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ischemic optic neuropathy, loss of vision, gingival infection and oral herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2023 The patient self-reported this case.  The patient stated that she lost vision in her right eye (optic ischemic neuropathy).  The patient developed an upper and lower gum infection on the same side, which was determined to be a shingles infection, and caused her loss of sight.  The patient had a loss of vision of 50 percent at first. It had now improved but was at 25 percent now.  This was potential legal case. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 59.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site reaction
Clinical narrative: 2 DAY AFTER PCV20 VACCINE WAS GIVEN TO THE PATIENT. SHE STARTED WITH THE FOLLOWING SYMPTOMS, RASH , HEADACHE, BODYACHES, DIZZINESS AND FEEL VERY HOT INSIDE OF THE BODY.
Age: 59.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Dizziness, Feeling hot, Headache, Pain, Rash
Clinical narrative: 2 DAY AFTER PCV20 VACCINE WAS GIVEN TO THE PATIENT. SHE STARTED WITH THE FOLLOWING SYMPTOMS, RASH , HEADACHE, BODYACHES, DIZZINESS AND FEEL VERY HOT INSIDE OF THE BODY.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adrenal insufficiency, Blood test, Cardiac stress test, Catheterisation cardiac, Chronic fatigue syndrome
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory response syndrome, Echocardiogram, Electrocardiogram, Gene mutation identification test, General physical health deterioration
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypobarism, Hypovolaemia, Injection site pain, Laboratory test, Magnetic resonance imaging heart
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Plasma cells decreased, Post viral fatigue syndrome, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Red blood cell count decreased
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Renal function test, Stress echocardiogram, Vaccination complication, Volume blood decreased, Wheelchair user
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adrenal insufficiency, Chronic fatigue syndrome, Chronic inflammatory response syndrome, Decreased ventricular preload, Hypovolaemia
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Post viral fatigue syndrome, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Volume blood
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Volume blood decreased
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID test result=Positive; COVID test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EN6207) and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pelvic floor dysfunction" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: DULERA; GAVILYTE C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test result=Positive". The patient underwent the following laboratory tests and procedures: Blood test: Positive; SARS-CoV-2 test: Positive; Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300237581 same patient/product, different dose/event;
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Concussion, Dizziness, Fall, Head injury
Clinical narrative: The patient was given three vaccines in clinic. Immediately after receiving the 3rd vaccine the patient had a syncopal event, falling forward to the floor hitting his head. The patient then had a witnesses generalized tonic clonic seizure lasting about 5 seconds. The patient recovered from the seizure but continued with intermittent clamminess, hot/cold,  and vascilating pulses.  After monitoring in clinic for some time, the provider made the decision to transfer the patient to the Emergency Department for further monitoring.  The patient recovered well after arriving to the ED and was discharged.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Laboratory test abnormal, Loss of consciousness, Pulse abnormal
Clinical narrative: The patient was given three vaccines in clinic. Immediately after receiving the 3rd vaccine the patient had a syncopal event, falling forward to the floor hitting his head. The patient then had a witnesses generalized tonic clonic seizure lasting about 5 seconds. The patient recovered from the seizure but continued with intermittent clamminess, hot/cold,  and vascilating pulses.  After monitoring in clinic for some time, the provider made the decision to transfer the patient to the Emergency Department for further monitoring.  The patient recovered well after arriving to the ED and was discharged.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: The patient was given three vaccines in clinic. Immediately after receiving the 3rd vaccine the patient had a syncopal event, falling forward to the floor hitting his head. The patient then had a witnesses generalized tonic clonic seizure lasting about 5 seconds. The patient recovered from the seizure but continued with intermittent clamminess, hot/cold,  and vascilating pulses.  After monitoring in clinic for some time, the provider made the decision to transfer the patient to the Emergency Department for further monitoring.  The patient recovered well after arriving to the ED and was discharged.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Fall, Feeling of body temperature change, Generalised tonic-clonic seizure, Head injury
Clinical narrative: The patient was given three vaccines in clinic. Immediately after receiving the 3rd vaccine the patient had a syncopal event, falling forward to the floor hitting his head. The patient then had a witnesses generalized tonic clonic seizure lasting about 5 seconds. The patient recovered from the seizure but continued with intermittent clamminess, hot/cold,  and vascilating pulses.  After monitoring in clinic for some time, the provider made the decision to transfer the patient to the Emergency Department for further monitoring.  The patient recovered well after arriving to the ED and was discharged.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Heart rate irregular, Immediate post-injection reaction, Syncope
Clinical narrative: The patient was given three vaccines in clinic. Immediately after receiving the 3rd vaccine the patient had a syncopal event, falling forward to the floor hitting his head. The patient then had a witnesses generalized tonic clonic seizure lasting about 5 seconds. The patient recovered from the seizure but continued with intermittent clamminess, hot/cold,  and vascilating pulses.  After monitoring in clinic for some time, the provider made the decision to transfer the patient to the Emergency Department for further monitoring.  The patient recovered well after arriving to the ED and was discharged.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report that a 7-Month-old was given a dose of VARIVAX. No symptoms reported. Permission to contact given. No further AE details/No PQC.; No symptoms reported. No further AE details/No PQC.; This spontaneous report was received from a healthcare professional regarding a 7-month-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 06-JUN-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5ml, once, as prophylaxis (lot number W024335 and expiration date 01-AUG-2024, both confirmed as valid) (no more vaccination details provided) (product administered to patient of inappropriate). No symptoms reported and no further adverse event (AE) details (no adverse event).
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Temperature: 70F; This spontaneous report was received from a pharmacist and a nurse, referred to a 5-year-old patient of unknown gender. Information about the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 02-MAR-2023, doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W025273, expiration date: 10-AUG-2024) experienced a temperature excursion of 70 Fahrenheit (F) for 9 minutes with no previous temperature excursion. It was not known if digital data logger was involved. On 06-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (lot# W025273, expiration date: 10-AUG-2024; strength, anatomical location, and route of administration were not provided) (Product storage error). No symptoms reported. No further adverse event (AE) details and no product quality complaints (PQCs) were reported.  This case is one of multiple reports from the same reporter.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported. ; Sender Comments: Keywords : US-009507513-2306USA011972:
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Poor quality product administered, Product administration error
Clinical narrative: Anemia; doses 2 and 3 were given after the beyond use date; doses 2 and 3 were given after the beyond use date; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 10-month-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Mar2023 as dose 3 (maroon cap), single (Lot number: GK1667) at the age of 10 months intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history included: "Patent Ductus arteriosus" (unspecified if ongoing); "Atrial septal defect" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE, Anatomical site of injection: Right Thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 22Apr2022, when the patient was 1-day-old, for COVID-19 Immunization, reaction(s): "Overdose", "Inappropriate age at vaccine administration", "GER"; BNT162b2 (DOSE 2 (MAROON CAP), SINGLE, Anatomical site of injection: Right Thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 06Jan2023, when the patient was 8-month-old, for COVID-19 immunization, reaction(s): "1st dose: 22Apr2022; 2nd dose: 06Jan2023", "doses 2 and 3 were given after the beyond use date", "doses 2 and 3 were given after the beyond use date"; fluzone (DOSE 2, SINGLE, Manufacturer: Sanofi, Batch/Lot#: UT7716LA, Route: IM, Anatomical site of injection: Left thigh, No. of previous doses: 1), administration date: 06Jan2023, when the patient was 8-month-old, for Influenza immunisation; Fluzone (DOSE 1, SINGLE), for Influenza immunisation. The following information was reported: ANAEMIA (non-serious) with onset 03Mar2023, outcome "unknown", described as "Anemia"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 03Mar2023, outcome "unknown" and all described as "doses 2 and 3 were given after the beyond use date".  Additional Information: The patient did not experience any adverse event(s) as a consequence of the error.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300150037 same reporter, product, different patients and event;US-PFIZER INC-PV202300113800 same reporter, vaccine, patient, different dose and event;US-PFIZER INC-202300234323 same reporter, vaccine, patient, different dose and event;
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on Paxlovid treatment from 20May2023 to 24May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: now I am having seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: SEIZURE (medically significant), outcome "unknown", described as "now I am having seizures". Clinical course: Patient was a member of the covid vaccination study and now she was having seizures. She would like some additional work ups to ensure there was no connection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vitiligo
Clinical narrative: developing white patches on face where there was depigmentation. developed vitiligo on right side of face. lost most pigmentation on right side of face. diagnosed with segmental vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 2, single (Lot number: ew0270) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 18Jan2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EW0164, Location of injection: Arm Right), administration date: 02Aug2021, for COVID-19 immunisation. The following information was reported: VITILIGO (disability) with onset 01Oct2021, outcome "not recovered", described as "developing white patches on face where there was depigmentation. developed vitiligo on right side of face. lost most pigmentation on right side of face. diagnosed with segmental vitiligo". The event "developing white patches on face where there was depigmentation. developed vitiligo on right side of face. lost most pigmentation on right side of face. diagnosed with segmental vitiligo" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: post vaccination; (18Jan2021) Positive. Therapeutic measures were not taken as a result of vitiligo. Clinical course: Oct2021 started developing white patches on face where there was depigmentation. Around Dec2021 to Jan2022 patient developed vitiligo on the right side of face. Patient had lost most pigmentation on the right side of face. Patient was diagnosed with segmental vitiligo.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Vaccine dose number: 6; Vaccine dose number: 6; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Jun2023 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR and Novadoz, stop date: 17Jun2023. Vaccination history included: Covid-19 vaccine (Dose 5), for COVID-19 immunization; Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset Jun2023, outcome "unknown", described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Jun2023, outcome "unknown" and all described as "Vaccine dose number: 6". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective/Symptoms including running nose and fever; COVID-19/Symptoms including running nose and fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 29Jun2023, outcome "not recovered", described as "COVID-19/Symptoms including running nose and fever"; DRUG INEFFECTIVE (medically significant) with onset 29Jun2023, outcome "not recovered", described as "Drug ineffective/Symptoms including running nose and fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative test after treatment; Positive, notes: positive antigen test five days post negative test after treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies, had no other medication in 2 weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high BP" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Jun2023 to 19Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac operation
Clinical narrative: Got vaccinated now and she has a heart problem; Got vaccinated now and she has a heart problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: CARDIAC OPERATION (medically significant), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "Got vaccinated now and she has a heart problem". Therapeutic measures were taken as a result of cardiac operation, cardiac disorder.  Addition information: She is calling about the Pfizer Covid Vaccine (Clarified as Pfizer COVID-19 Vaccine) because she mention that her mom got vaccinated now and she has a heart problem. I mean her heart surgery and they want to know if what is the risk does she have for getting the vaccine and the Pfizer Medical Information is already closed at this time, I decided to connect the caller since she is calling on h of her mom. She have, because she had a heart surgery. She wants to know what the risk are.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single, on 23Mar2021 as dose 2, single, on 29Nov2021 as dose 3 (booster), single and on 20May2022 as dose 4 (booster), single at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "NAFLD" (unspecified if ongoing); "Mild Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 23Jun2023 to 27Jun2023 for COVID-19 treatment.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 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), administration date: 2021, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Jul2022, outcome "unknown", described as "heart attack". The event "heart attack" required physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300114139 same patient/product, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: legs began to get bigger at a greater rate and itch and hot to the touch; legs began to get bigger at a greater rate and itch and hot to the touch; legs began to get bigger at a greater rate and itch and hot to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "legs began to get bigger at a greater rate and itch and hot to the touch".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.