chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.; HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.; Information has been received from Business Partner/CRO on 19-Feb-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) 12-month-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 19-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), Solution for injection (lot #Y015101, expiration date: 06-Sep-2026), dose number 1, (1st dose),. On 19-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), Solution for injection (1st dose), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), for the treatment of prophylaxis.  On 19-Feb-2025, the patient experienced HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.. On 19-Feb-2025, the patient experienced HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC..   At the reporting time, the outcome of HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC. and HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC. was unknown.   The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
Sex: F
Vaccine: PNC21
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness.  Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; HCP reports patient received CAPVAXIVE in her Left Deltoid on 3/7/2025 and on 3/8/2025 developed a large area of redness and warmth around the injection site. HCP states minimal swelling and mild tenderness. Patient also complained of flu like sympt; Patient also complained of flu like symptoms; This spontaneous report has been received from a pharmacist regarding a 78-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 07-MAR-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), as a single dose, administered intramuscularly in the left deltoid as immunization (lot number reported as Y013009, which has been verified as valid, expiration date reported and validated as 17-NOV-2025) (strength, dose, and vaccination scheme were not reported).  On 08-MAR-2025, the patient developed a large area of redness and warmth around the injection site (Vaccination site erythema, Vaccination site warmth). The reporter stated there was minimal swelling and mild tenderness (Vaccination site swelling, Vaccination site pain). On an unknown date in March 2025, patient also complained of flu like symptoms (Influenza-like illness). The outcome of all events was not reported.   The causal relationship between the aforementioned events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP called to report that a 74-year-old patient was administered a dose of GARDASIL 9; This spontaneous report was received from a Pharmacist regarding a 74-year-old patient of unknown gender.   The reporter refused to provide information about the patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (formulation, dose, vaccination scheme frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported) (Product administered to patient of inappropriate age). No additional adverse event reported for the patient (it was also reported it was unknown if side effects or symptoms were reported, conflicting information). No additional information provided.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; HCP calling reporting that a patient has received an improperly stored VARIVAX.  Reference TE case #02773596. HCP reported that the VARIVAX underwent a TE on 03/13/2025. HCP reported that the date of the administration was 03/17/2025. No symptoms or; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-MAR-2025, the patient received improperly stored varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), Injection, lot #Y013350 and expiration date 02-AUG-2026, 0.5 mL for prophylaxis (dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown). The excursion lasted for 45 minutes in temperature of 16.1 Fahrenheit degrees. There was previous excursion that lasted 1 hour in temperature of  13.6 Fahrenheit degrees (product storage error). No additional adverse event/ Product Quality Complaints reported (no adverse event).
Age: 1.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 13-month-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 11-JUL-2023 at 10:04, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # W001598, expiration date: 14-JAN-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).  Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.
Age: 8.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to an 8-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 06-NOV-2023 at 11:48, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # W001598, expiration date: 14-JAN-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).  Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.
Age: 1.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: MMR II was administered after a temperature excursion; No additional AE reported; This spontaneous report was received from a nurse and refers to a 20-months-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 15-JUL-2024, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).  Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.; Reporter's Comments:
Sex: M
Vaccine: TDAP
Symptoms: Autism spectrum disorder
Clinical narrative: now he has autism; This serious case was reported by a consumer via call center representative and described the occurrence of autism in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced autism (Verbatim: now he has autism) (serious criteria GSK medically significant). The outcome of the autism was not resolved.   It was unknown if the reporter considered the autism to be related to Tdap Vaccine.     The company considered the autism to be unrelated to Tdap Vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 The patient's mother reported this case. The patient (son) received Tdap vaccine many years ago and now he had autism.; Sender's Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK Tdap Vaccine.
Vaccine: RVX
Symptoms: Death
Clinical narrative: I would never take a vax again after losing a couple friends within a shot time of receiving  the jab; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: I would never take a vax again after losing a couple friends within a shot time of receiving  the jab) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to RSV vaccine.     The company considered the unknown cause of death to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date : 19-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that she looked into what was in them, she would never took a vaccine again after losing a couple friends within a shot time of received the jab.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not recived 2nd dose/possible missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in Apr 2018), Zostavax (received Zostavax in February of 2013) and Zostavax (Zostavax received on 20 JUN 2018).   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: Patient did not recived 2nd dose/possible missed dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 12-MAR-2025 The patient self-reported this case. Consumer stated that she was vaccinated with Zostavax in February of 2013. She received her first dose of Shingrix in April 2018.  She was vaccinated 20 JUN 2018 with what she believed to be her second dose of Shingrix. Consumer stated she recently received documentation that the dose of medication she received on 20 JUN 2018 was Zostavax. Consumer was in the process of determining if the wrong vaccine was administered or if the information was documented in correctly (possible missed dose.)  Consumer stated she was 71 years old now and she would have been 64 years old at the time of receiving what she thought was the second dose of Shingrix. Consumer declined to provide any demographics or additional information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further information was obtained/provided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: swollen injection site; injection site lump; injection site edema; arm began hurting/ forearm was painful; injection site tenderness/injection site became painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2025, the patient received the 1st dose of Shingrix (left deltoid). In JAN-2025, immediately after receiving Shingrix, the patient experienced injection site tenderness (Verbatim: injection site tenderness/injection site became painful), injection site swelling (Verbatim: swollen injection site), injection site lump (Verbatim: injection site lump), injection site edema (Verbatim: injection site edema) and pain in arm (Verbatim: arm began hurting/ forearm was painful). In JAN-2025, the outcome of the injection site swelling was resolved.  In FEB-2025, the outcome of the injection site lump and injection site edema were resolved. The outcome of the injection site tenderness and pain in arm were not resolved.   It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site lump, injection site edema and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site tenderness, injection site swelling, injection site lump, injection site edema and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2025 The patient reported that she received her first Shingrix vaccine in January of 2025.  The injection was painful, and her arm began hurting immediately, not to resolve for a few weeks.  She reported that in the days immediately following the injection the injection site (Left Deltoid) became swollen and painful, with a hard lump.  These symptoms persisted for a few weeks and the injection site was still painful to the touch.  She also reported that her forearm was painful at the same time, and it was still painful.  She stated that she wears a brace at times due to the pain.  She denied any medications or conditions that could have contributed to the issue.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Shingrix ineffective; Patient got two doses of HZV and developed shingles later; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Shingrix ineffective) (serious criteria GSK medically significant) and shingles (Verbatim: Patient got two doses of HZV and developed shingles later). The outcome of the vaccination failure was not resolved and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date : 14-MAR-2025 Patient got two doses of HZV (herpes zoster vaccine) and developed shingles later. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received the second 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 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (A patient received the first dose of Shingrix 09-JAN-2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 14-MAR-2025 The reporter is a pharmacist. A patient received the first dose of Shingrix 9 -JAN -2020, and has not yet received the second dose, which led to incomplete course of vaccination. The pharmacist was unable to provide the lot number and expiration of the first dose as it was not given at their pharmacy.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: we missed the booster; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 5-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received first dose of Bexsero at 19 months ) and Bexsero (received second dose of Bexsero at 21 months old).   On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: we missed the booster). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-MAR-2025 The patient was the son of the reporter. The reporter reported that the patient had the bexero vaccine when he was 19 months and 21 months old.  At the time reporting he was 5 and they missed the booster.  The reporter asked could he have it at the time of reporting  The reporter reported that it was recommened 12 to 23 months after the second dose. Till the time of reporting the patient did not receive the third dose of Bexsero which led to incomplete course of vaccination.
Sex: F
Vaccine: RVX
Symptoms: Influenza, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: catching the flu after taking the vaccine; Suspected vaccination failiure; Had my shot in September got RSV in January; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2024, the patient received RSV vaccine. In JAN-2025, between 3 and 5 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failiure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had my shot in September got RSV in January). On an unknown date, the patient experienced influenza (Verbatim: catching the flu after taking the vaccine). The outcome of the vaccination failure and influenza were not reported and the outcome of the respiratory syncytial virus infection was unknown.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection and influenza to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by the patient via interactive digital media. The patient reported that she had shot in September got RSV in January. The patient did not mention a specific product name. However, they mentioned having taken an RSV vaccine and still contracting the flu.  Based on this information, it seems the product in question could be the RSV vaccine. The patient did not explicitly mention any other specific side effects, other than still catching the flu after taking the vaccine, which might imply that the vaccine did not provide the expected protection. This case was considered as suspected vaccination failure as details regarding laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.  Respiratory syncytial virus infection and Influenza are unlisted event which are considered unrelated to GSK RSV vaccine.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Reporter was 34 weeks pregnant during time of Arexvy vaccination; Reporter was 34 weeks pregnant during time of Arexvy vaccination; This non-serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included gestational diabetes. Concomitant products included glipizide.   On 24-JAN-2024, the patient received Arexvy. On 24-JAN-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Reporter was 34 weeks pregnant during time of Arexvy vaccination). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Reporter was 34 weeks pregnant during time of Arexvy vaccination). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Actual Delivery Date: XX-FEB-2024 Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Delivery Notes: gender of the baby was female   See case US2025AMR031576 for details regarding the baby case.   Additional Information: GSK Receipt Date: 12-MAR-2025  The patient self-reported this case for herself. Reporter received Arexvy vaccine from pharmacy. She was 34 weeks pregnant during time of vaccination, which led to product use in unapproved population. Reporter was also taken a prenatal vitamin started on 24th June 2023 and ended on 26th February 2024 and was also taken Glipizide 2.5milligrams for gestational diabetes started on 18th December 2023 and ended on 26th February 2024. This case was linked with US2025AMR031576, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR031576:baby case
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first Shingles shot, it had been a few years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had the first Shingles shot, it had been a few years ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 14-MAR-2025 The patient had the first Shingles shot, but it had been a few years ago. The reporter asked if patient should have the second Shingles shot, or should start over with the first. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Don't. I took it n got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Don't. I took it n got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAR-2025 The reporter reported that took it n got 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; had 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that everyone he/she knows who had shingles, his/herself included, took the Shingles shot except one who came down with shingles, in her 40s, shortly after the covid shot. The patient took the Shingles vaccine, and he/she had shingles last year in 2024. The patient mentioned that GlaxoSmithKline was telling him/her it was highly unlikely, that he/she had shingles or that he/she took the Shingles vaccine or that everyone he/she knows that got shingles had the vaccine. Further patient asked what was so highly unlikely. The patient said that what was highly unlikely, apparently, was GSK understanding the and vaccine makers had been lying and had been believing and now could not see truth even when it walks up and shakes their hands. The patient further said that it was much harder to see truth when they had believed a lie for so long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been linked with US2025AMR032397 and US2025AMR032406 reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR032397:same reporter/ created for multiple patient US-GSK-US2025AMR032406:same reporter/ created for dad
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Everyone I know who has had shingles, myself included, took the shingles shot except 1; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Everyone I know who has had shingles, myself included, took the shingles shot except 1). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter reported that everyone he/she knows who had shingles, his/herself included, took the Shingles shot except one who came down with shingles, in her 40s, shortly after the covid shot. The reporter mentioned that GlaxoSmithKline was telling him/her it was highly unlikely, that he/she had shingles or that he/she took the Shingles vaccine or that everyone he/she knows that got shingles had the vaccine. Further reporter asked what was so highly unlikely. The reporter also said his/her two friends also got shingles neither would lie about it and said that what was highly unlikely, apparently, was GSK understanding the and vaccine makers had been lying and had been believing and now could not see truth even when it walks up and shakes their hands. The reporter further said that it was much harder to see truth when they had believed a lie for so long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been linked with US2025AMR032387 and US2025AMR032406 reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR032387:same reporter different patient US-GSK-US2025AMR032406:same reporter different patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the vaccine and 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine and also got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she got the vaccine and also got shingles.  15 months later still battled the pain with lidocaine patches. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got them twice within a matter of months; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them twice within a matter of months). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 The reporter reported that he/she had both vaccines, the first one that was not very effective and the second series of two, and he/she developed shingles after getting the shots.  He/she got shingles every year on his/her arm for at least the last 6 years, but last year got them twice within a matter of months.  He/she sometimes wonder if the shots did not give him/her shingles, because he/she never had an outbreak before getting the shots. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; she got the Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she got the Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 The reporter reported that her sister had the vaccine about a year before she got the Shingles.  Reporter could not believe that she would ever get the shingles but she did.  Not such a bad case of it but she did have it for about a month.  Reporter said that she took the shingle shot about 12 years ago, and it was the older shot so she did not know if it was as good as the newer one that she took since she had the 2 shots with months in between.  The reporter sated that never know when could get the Shingles it was immune system if it was really low.  So be careful out there. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shingles on my upper half of my back up to my neck and mostly on my left side of back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles on my upper half of my back up to my neck and mostly on my left side of back). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-MAR-2025, 16-MAR-2025 and 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingrix shingles vaccine and low and behold got the shingles. The patient stated the same thing happened to a coworker. The patient further said that he/she got shingles after the second dose of Shingrix vaccine, and he/she got it on his/her upper half of his/her back up to his/her neck and mostly on his/her left side of back. The patient thought it was too much viral load.  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. This case was linked with case US2025AMR034444 from the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). US-GSK-US2025AMR034444:different patient/same reporter
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling hot, Migraine
Clinical narrative: Migraine headache; cold; hot; chills; achy; Tired; Feeling so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of migraine headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles on leg a few years ago) and pain (pain was horrible.). Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced migraine headache (Verbatim: Migraine headache), cold (Verbatim: cold), feeling hot (Verbatim: hot), chills (Verbatim: chills), pain (Verbatim: achy), tiredness (Verbatim: Tired) and feeling bad (Verbatim: Feeling so bad). The outcome of the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad were not reported.   It was unknown if the reporter considered the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on leg a few years ago did not know what it was until went to the doctor and was 11 days in, the pain was horrible. The patient just got second shingles shot and it has made feel so bad. Headache (migraine), cold, hot, chills, achy and Tired. But pray it was worth it in the end.
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Migraine headache; cold; hot; chills; achy; Tired; Feeling so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of migraine headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles on leg a few years ago) and pain (pain was horrible.). Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced migraine headache (Verbatim: Migraine headache), cold (Verbatim: cold), feeling hot (Verbatim: hot), chills (Verbatim: chills), pain (Verbatim: achy), tiredness (Verbatim: Tired) and feeling bad (Verbatim: Feeling so bad). The outcome of the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad were not reported.   It was unknown if the reporter considered the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on leg a few years ago did not know what it was until went to the doctor and was 11 days in, the pain was horrible. The patient just got second shingles shot and it has made feel so bad. Headache (migraine), cold, hot, chills, achy and Tired. But pray it was worth it in the end.