chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: Reviewed with patient how he would like to receive the vaccine; and confirmed he has personal epi pen with him; reviewed allergy list and completed screening questionnaire;    Patient lying down, using breathing techniques and administered vaccine in left deltoid; had immediate feeling of pain and burning at the site of the injection, more than he expected; the patient remained alert throughout course of administration; remained supine for approximately 15-20 minutes after injection; pulse remained strong and steady 75-80 bpm; moved to sitting position on his own; given cold pack for injection site; states he has sharp jabbing pain in ribs under left arm    About 45 minutes post injection stated he was tired; denies any s/s of allergic reaction; injection site unremarkable; sipping on a sports drink   @ 1116 c/o slight dizziness, nausea and abdominal cramping; improved with ambulation   @1145 c/o tight feeling around his chest similar to jabbing pain he had earlier in ribs under left arm; comes in waves; no SOB, no diaphoresis; in no apparent distress   @ 1215 states nausea and abd cramping has resolved; rechecked BP; 132/85 P 64; reviewed follow up care with his friend who accompanied him to the appt;    Discharged to home with appt scheduled in 2 months for booster.    12/16/21;  But immediate thing for me is how awful I feel right now - esp pain in legs.  I'm doing/trying everything I know to do - long Epson baths on days I can; taking more RED MM for pain than I ever have ... at least once a day where if I took 1 or 2 a month that was rare & putting RED MM pain balm on my legs during day & at night to try help get to sleep, heating pad & ice packs on me constant.  See you next Tues.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal chest pain, Nausea, Pain in extremity, Sleep disorder
Clinical narrative: Reviewed with patient how he would like to receive the vaccine; and confirmed he has personal epi pen with him; reviewed allergy list and completed screening questionnaire;    Patient lying down, using breathing techniques and administered vaccine in left deltoid; had immediate feeling of pain and burning at the site of the injection, more than he expected; the patient remained alert throughout course of administration; remained supine for approximately 15-20 minutes after injection; pulse remained strong and steady 75-80 bpm; moved to sitting position on his own; given cold pack for injection site; states he has sharp jabbing pain in ribs under left arm    About 45 minutes post injection stated he was tired; denies any s/s of allergic reaction; injection site unremarkable; sipping on a sports drink   @ 1116 c/o slight dizziness, nausea and abdominal cramping; improved with ambulation   @1145 c/o tight feeling around his chest similar to jabbing pain he had earlier in ribs under left arm; comes in waves; no SOB, no diaphoresis; in no apparent distress   @ 1215 states nausea and abd cramping has resolved; rechecked BP; 132/85 P 64; reviewed follow up care with his friend who accompanied him to the appt;    Discharged to home with appt scheduled in 2 months for booster.    12/16/21;  But immediate thing for me is how awful I feel right now - esp pain in legs.  I'm doing/trying everything I know to do - long Epson baths on days I can; taking more RED MM for pain than I ever have ... at least once a day where if I took 1 or 2 a month that was rare & putting RED MM pain balm on my legs during day & at night to try help get to sleep, heating pad & ice packs on me constant.  See you next Tues.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: Reviewed with patient how he would like to receive the vaccine; and confirmed he has personal epi pen with him; reviewed allergy list and completed screening questionnaire;    Patient lying down, using breathing techniques and administered vaccine in left deltoid; had immediate feeling of pain and burning at the site of the injection, more than he expected; the patient remained alert throughout course of administration; remained supine for approximately 15-20 minutes after injection; pulse remained strong and steady 75-80 bpm; moved to sitting position on his own; given cold pack for injection site; states he has sharp jabbing pain in ribs under left arm    About 45 minutes post injection stated he was tired; denies any s/s of allergic reaction; injection site unremarkable; sipping on a sports drink   @ 1116 c/o slight dizziness, nausea and abdominal cramping; improved with ambulation   @1145 c/o tight feeling around his chest similar to jabbing pain he had earlier in ribs under left arm; comes in waves; no SOB, no diaphoresis; in no apparent distress   @ 1215 states nausea and abd cramping has resolved; rechecked BP; 132/85 P 64; reviewed follow up care with his friend who accompanied him to the appt;    Discharged to home with appt scheduled in 2 months for booster.    12/16/21;  But immediate thing for me is how awful I feel right now - esp pain in legs.  I'm doing/trying everything I know to do - long Epson baths on days I can; taking more RED MM for pain than I ever have ... at least once a day where if I took 1 or 2 a month that was rare & putting RED MM pain balm on my legs during day & at night to try help get to sleep, heating pad & ice packs on me constant.  See you next Tues.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: pt started experiencing  a rash on his chest a back the next day.  it became worse.  he states that it does not hurt  and it is not itchy.  i suggested he take benadryl and let us know if the rash became worse
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: Urinary Tract infection
Age: 94.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient recieved 2 doses of COVID vaccine, on 2/26/21 & 3/26/21, she lost her card and insisted she needed 8/20/21 dose which was given, no adverse reaction was noted. Upon looking in state immunization database the error was found.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Cardiac flutter, Cardiac stress test, Cardiovascular symptom
Clinical narrative: Experienced my heart fluttering in May. doctor appt on July 7 did EKG and heart rate was 113 dx with Atrial Fibrillation. Doctor sent me to ER and they dx me with atrial fibrillation with rapid ventricular response. ER again on 7/14/21 with adverse reaction to medication Diltiazem and was given new medication Metoprolol Succinate. ER on 7/24/21 by ambulance due to heart attack symptoms released after heart rate and blood pressure reduced. ER on 8/3/21 per Dr. request because heart rate after EKG was 132/139. In ER was given a cardioversion which did not work ordered Amiodarone IV drip and converted my heart to sinus rhythm. ER 8/7/21 High blood pressure. taking meds to hopefullkeep heart in sinus rhythm. 8/9/21 - Visit with Dr to discuss possible Atrial Flutter Catheter Ablation. 8/13/21 - Visit with Dr to discuss my current medications and follow up visit to ER. Dr suggested getting off of the Amiodarone long term to discuss with my cardiologist 8/17/21 - Visit with Dr to discuss changing to a new Arrhythmia medication. Dr prescribed Propafenone 8-18-21 - ER visit with high blood pressure due to new Propafenone Adverse Reaction and suggested not taking subsequent doses & to see my cardiologist. 8-19-21 - Visit with Dr to discuss my high blood pressure with Arrhythmia medications and she took me off that med. She discussed Atrial Fibrillation Catheter ablation also. My heat was in sinus Rhythm. Dr wanted to keep me on Lisinopril for blood pressure and Metroprolol for my heart rate. I will see her again in November unless I have more high blood pressure or high heart rate issues. This has been a nightmare for me. In and out of ER & hospitals and numerous Dr visits. My heart has not liked these various medications and I have been through lots of stress. In January, February & March of this year I had a perfect heart rate & blood pressure until after the second dose of the covid vaccine. Heart Rate was 72 BPM, BP was 117/77
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Echocardiogram, Electrocardiogram abnormal, Heart rate increased, Hypertension
Clinical narrative: Experienced my heart fluttering in May. doctor appt on July 7 did EKG and heart rate was 113 dx with Atrial Fibrillation. Doctor sent me to ER and they dx me with atrial fibrillation with rapid ventricular response. ER again on 7/14/21 with adverse reaction to medication Diltiazem and was given new medication Metoprolol Succinate. ER on 7/24/21 by ambulance due to heart attack symptoms released after heart rate and blood pressure reduced. ER on 8/3/21 per Dr. request because heart rate after EKG was 132/139. In ER was given a cardioversion which did not work ordered Amiodarone IV drip and converted my heart to sinus rhythm. ER 8/7/21 High blood pressure. taking meds to hopefullkeep heart in sinus rhythm. 8/9/21 - Visit with Dr to discuss possible Atrial Flutter Catheter Ablation. 8/13/21 - Visit with Dr to discuss my current medications and follow up visit to ER. Dr suggested getting off of the Amiodarone long term to discuss with my cardiologist 8/17/21 - Visit with Dr to discuss changing to a new Arrhythmia medication. Dr prescribed Propafenone 8-18-21 - ER visit with high blood pressure due to new Propafenone Adverse Reaction and suggested not taking subsequent doses & to see my cardiologist. 8-19-21 - Visit with Dr to discuss my high blood pressure with Arrhythmia medications and she took me off that med. She discussed Atrial Fibrillation Catheter ablation also. My heat was in sinus Rhythm. Dr wanted to keep me on Lisinopril for blood pressure and Metroprolol for my heart rate. I will see her again in November unless I have more high blood pressure or high heart rate issues. This has been a nightmare for me. In and out of ER & hospitals and numerous Dr visits. My heart has not liked these various medications and I have been through lots of stress. In January, February & March of this year I had a perfect heart rate & blood pressure until after the second dose of the covid vaccine. Heart Rate was 72 BPM, BP was 117/77
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stress
Clinical narrative: Experienced my heart fluttering in May. doctor appt on July 7 did EKG and heart rate was 113 dx with Atrial Fibrillation. Doctor sent me to ER and they dx me with atrial fibrillation with rapid ventricular response. ER again on 7/14/21 with adverse reaction to medication Diltiazem and was given new medication Metoprolol Succinate. ER on 7/24/21 by ambulance due to heart attack symptoms released after heart rate and blood pressure reduced. ER on 8/3/21 per Dr. request because heart rate after EKG was 132/139. In ER was given a cardioversion which did not work ordered Amiodarone IV drip and converted my heart to sinus rhythm. ER 8/7/21 High blood pressure. taking meds to hopefullkeep heart in sinus rhythm. 8/9/21 - Visit with Dr to discuss possible Atrial Flutter Catheter Ablation. 8/13/21 - Visit with Dr to discuss my current medications and follow up visit to ER. Dr suggested getting off of the Amiodarone long term to discuss with my cardiologist 8/17/21 - Visit with Dr to discuss changing to a new Arrhythmia medication. Dr prescribed Propafenone 8-18-21 - ER visit with high blood pressure due to new Propafenone Adverse Reaction and suggested not taking subsequent doses & to see my cardiologist. 8-19-21 - Visit with Dr to discuss my high blood pressure with Arrhythmia medications and she took me off that med. She discussed Atrial Fibrillation Catheter ablation also. My heat was in sinus Rhythm. Dr wanted to keep me on Lisinopril for blood pressure and Metroprolol for my heart rate. I will see her again in November unless I have more high blood pressure or high heart rate issues. This has been a nightmare for me. In and out of ER & hospitals and numerous Dr visits. My heart has not liked these various medications and I have been through lots of stress. In January, February & March of this year I had a perfect heart rate & blood pressure until after the second dose of the covid vaccine. Heart Rate was 72 BPM, BP was 117/77
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Inadvertently givenmonovalent IM covid primary instead of bivalent booster.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 84.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: After shot 5, I had COVID; After shot 5, I had COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 84-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 84 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3249) intramuscular, in left arm, on 30Jan2021 as dose 2, single (Lot number: EN5318), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After shot 5, I had COVID".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024573 same patient, different vaccine dose/event;
Age: 84.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: After shot 5, I had COVID; After shot 5, I had COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 84-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 84 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3249) intramuscular, in left arm, on 30Jan2021 as dose 2, single (Lot number: EN5318), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After shot 5, I had COVID".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024573 same patient, different vaccine dose/event;
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: missed the second dose; no additional adverse events; This spontaneous report was received from a pharmacist referring to a 32-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, at around age 30 or 31, the patient was vaccinated with the dose 1 of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, one dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Th patient only received one dose and did not get the second dose within the 6-18 month recommended period. The patient missed the second dose. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP calling to report administration of expired MMR-II vaccine and requesting information regarding stability after expiration.; No additional AE; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter/once, lot #U006486, expiration date: 26-FEB-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (expired product administered). The reporter requested information regarding stability after expiration. It was reported that there were no temperature excursions to product.  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; expired dose of GARDASIL 9 was administered to a patient on 09Mar2023; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 09-MAR-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot #T028583, expiration date: 04-MAR-2023 (administration site, and route of administration were not provided) administered for prophylaxis (expired product administered). The reporter confirmed  that the dose was stored properly up through the time of administration. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date, the patient experienced shingles (herpes zoster).      The outcome of herpes zoster and its causal relationship with the vaccine was not reported.
Sex: U
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthosthatic tachycardia syndrome; This spontaneous report was received from a consumer regarding a case in litigation, referring to a patient of unknown age and gender. Information about the patient medical history, concomitant medications, drug allergies or reactions was not provided.  On an unknown date,  the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), for prophylaxis (2 doses, scheme , dose, administration route, lot number and expiry date were not provided).  On an unknown date, after the two shots the patient experienced postural orthostatic tachycardia syndrome (POTS).    The outcome of postural orthostatic tachycardia syndrome was unknown.   The reporter considered postural orthostatic tachycardia syndrome to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  This is one o 2 cases from the same reporter.; Sender's Comments:  US-009507513-2303USA007760: US-009507513-2303USA007746:
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; one year old son was accidently administered an adult dose of hepatitis A vaccine, instead of pediatric dose; This spontaneous report was received from a consumer (patient's father) and refers to an 1-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dosage, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The patient was accidently administered an adult dose instead of pediatric dose (incorrect dose administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs.; TE for VARIVAX. Product administered after TE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 22-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W022605, expiration date 17-JUL-2024 (dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of -4.5 degrees Celsius for 1 hour. No previous excursions were detected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional clarifying statements or AE details were provided.; a patient was administered a dose of VARIVAX that was involved in temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 20-FEB-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), lot# W021740, expiry date 10-JUL-2024 (dose, route of administration and anatomical location were not provided) for prophylaxis.  The used vaccine was involved in a temperature excursion (temperature: 14.7 F at a time frame of 1 hour and 3 minutes) (product storage error). The vaccine had no previous temperature excursions. No additional adverse event (AE) details were provided (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported.; patient who received GARDASIL 9 outside of the recommended dosing schedule. Patient first dose was 11/22/2023, second dose 1/23/2023 and third dose 3/23/2023; This spontaneous report has been received from a medical assistant referring a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 22-NOV-2022 (conflicting information, also reported as 22-NOV-2023), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, the second dose on 23-JAN-2023 and the third dose on 23-MAR-2023 (strengths, specific dosages, routes of administration, anatomical sites of application, lot numbers and expiration dates were not provided) (inappropriate schedule of product administration). No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, Tilt table test, Unevaluable event
Clinical narrative: adult patient who had a titer performed, and the patient needs a dose of MMRII; This spontaneous report was received by customer who refers to an adult patient (exact age was not provided).   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date, the patient experienced antibody test negative. The outcome of antibody test negative was unknown.  The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; 2 weeks old patient received VAQTA; This spontaneous report as received from a physician and refers to a 2-week-old patient of unknown gender. No information on medical history, current conditions or concomitant medication was provided.  On 24-MAR-2023 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter for prophylaxis (route of administration, lot# and expiration date were not provided) (product administered to patient of inappropriate age and no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Pharmacist reports expired PNEUMOVAX 23 was administered to 2 patients. Product expired 1/8/2023 and was administered to 2 patients today 3/28/2023. Product had not experienced any temperature excursions through the date of administration. See additi; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On 28-MAR-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (lot number U018309 has been verified to be valid; expiration date reported an established as 08-JAN-2023) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse events were reported.   This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA010066:
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Formication, Herpes zoster, Neuralgia, Pruritus
Clinical narrative: I've had shingles shots/Suspected Vaccination failure; shingles started/ bugs crawling feeling biting; bad itching; nerve wracking; burning; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've had shingles shots/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles started/ bugs crawling feeling biting), pruritus (Verbatim: bad itching), nerve pain (Verbatim: nerve wracking) and burning sensation (Verbatim: burning). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, nerve pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, nerve pain and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, nerve pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots year ago and going 3 months ago shingles started and still had them right side, bad itching burning bugs crawling feeling biting , nerve wracking. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Sensory disturbance, Vaccination failure
Clinical narrative: I've had shingles shots/Suspected Vaccination failure; shingles started/ bugs crawling feeling biting; bad itching; nerve wracking; burning; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've had shingles shots/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles started/ bugs crawling feeling biting), pruritus (Verbatim: bad itching), nerve pain (Verbatim: nerve wracking) and burning sensation (Verbatim: burning). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, nerve pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, nerve pain and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, nerve pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots year ago and going 3 months ago shingles started and still had them right side, bad itching burning bugs crawling feeling biting , nerve wracking. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have the shot didn't work./Suspected Vaccination Failure; I have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have the shot didn't work./Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:11-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots and it did not work.  The patient had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had both shots but still got shingles/Suspected vaccination failure; Shingles; Painful shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots but still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful shots). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient had both painful Shingles shots but still got shingles.  The patient asked, how common is that? This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Ended up in the hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization 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 hospitalization (Verbatim: Ended up in the hospital) (serious criteria hospitalization). The outcome of the hospitalization was recovered/resolved (duration 3 months).   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2023 The case was received from the patient interactive digital media. The patient got a Shingles shot from them and ended up in the hospital for three months. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Neuropathy peripheral, Pain, Vaccination failure
Clinical narrative: Got the 2nd and 3rd shots/Suspected Vaccination; Neuropathy; Shingles; painful; Got the 2nd and 3rd shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the 2nd and 3rd shots/Suspected Vaccination) (serious criteria GSK medically significant), neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: painful) and extra dose administered (Verbatim: Got the 2nd and 3rd shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the neuropathy, shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, neuropathy, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient got the first Shingles shot and got Shingles.  The patient got the 2nd and 3rd shots and horrible reactions.  The patient still had painful neuropathy from the Shingles.  The could not say the shot was the answer. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot/ Suspected Vaccination Failure; also got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shot/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: also got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient via interactive digital media. The patient had the shot and also got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Even if I had the vaccine shot I still got it/ Suspected vaccination failure; had it, around neck, lasted a month (shingles); This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Even if I had the vaccine shot I still got it/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it, around neck, lasted a month (shingles)). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient via interactive digital media. The patient stated that it was terrible as he or she had it. The patient had the vaccine shot and still got it around the neck and it lasted about a month. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots, get this virus over and over/ Suspected vaccination failure; Get this horrible virus over and over; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots, get this virus over and over/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Get this horrible virus over and over). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient via interactive digital media. The patient stated that he or she had the shots too and guessed that he or she was the only one who was going to get this horrible virus over and over. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got shot, still got Shingles/ suspected vaccination failure; still got Shingles; Still hurt; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, still got Shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got Shingles) and pain (Verbatim: Still hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient's wife via interactive digital media. The reporter and patient got the shot, but the patient still got shingles, not as bad but it still hurt. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available. This case was linked to case US2023AMR047342, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR047342:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Taken vaccine, ended up with shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Taken vaccine, ended up with shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she know that most of the people had received the Shingles vaccine and experienced shingles. The patient stated that it seems to his or her it was just as effective as the Covid vaccine which mean it was not good at its job. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2020, 2nd dose not yet received /Shingrix late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2020, 2nd dose not yet received /Shingrix late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAR-2023 A reporter reported that a patient did not receive another dose (2nd dose) of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia, Formication, Skin ulcer
Clinical narrative: Hair fail out; Sores all over my head; Felt like thing's were crawling over my scalp; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hair loss 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 hair loss (Verbatim: Hair fail out), skin ulcer (Verbatim: Sores all over my head) and crawling sensation of skin (Verbatim: Felt like thing's were crawling over my scalp). The outcome of the hair loss, skin ulcer and crawling sensation of skin were not reported.   It was unknown if the reporter considered the hair loss, skin ulcer and crawling sensation of skin to be related to Shingles vaccine.     It was unknown if the company considered the hair loss, skin ulcer and crawling sensation of skin to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced bad reaction his or her hair fail out and got sores all over his or her head and it felt like things were crawling over his or her scalp. Follow-up would not possible as no contact details were available.