chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 13-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6 degree Fahrenheit for 32 hours 30 minutes.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 58 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 58 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 20-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 90 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 21-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.8 degree Fahrenheit for 115 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 22-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 6.8 degree Fahrenheit for 127 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: MMR, MMR
Symptoms: Cardiac pacemaker insertion
Clinical narrative: pacemaker; This spontaneous report was received from a physician regarding to a 94-year-old male patient. 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, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not reported), as prophylaxis; in combination with sterile diluent (BAXTER STERILE DILUENT) (strength, dose, frequency, lot number, expiration date and indication were not reported).  Inbound call was received from physician who had a medical information question on administering a 3rd booster dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) to a 94 year old male who had a pacemaker. After caller disconnected, precautionary AE was identified to due the patient having a pacemaker. Unknown date of when patient received pacemaker and unknown date when patient initially received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) doses. Because a correlation could not be ruled out, precautionary AE filed. Since HCP had already disconnected, most information was unknown. Permission to contact for follow up is unknown. No additional information available. No additional AE/PQC.  At the reporting time, the outcome of pacemaker was unknown.   The causal relationship between the event of pacemaker and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and sterile diluent was not provided.   Upon an internal review, the event of pacemaker was determined to be medically significant.   Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: MMR
Symptoms: Antibody test positive, Developmental regression, Gait disturbance, Hypersensitivity, Pyrexia
Clinical narrative: fever; his Mump titers were elevated; hypersensitivity reaction to a previous dose of MMR-2; "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation; Patient had trouble walking; was regressing in speech which he had to receive early intervention services; This spontaneous report was received from a consumer or other non health professional and refers to a male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions included autoimmune disease, and immunosuppression. Concomitant therapies were not reported.   On 25-Jun-2020, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported).  On 01-Jul-2020, the patient experienced hypersensitivity reaction to a previous dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II); "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation (drug hypersensitivity), fever, trouble walking, was regressing in speech which he had to receive early intervention services, his Mump titers were elevated. At the reporting time, the outcome of the events was not reported. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not applicable.   The reporter considered the event of hypersensitivity reaction to a previous dose of MMR-2; "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. The casual relationship between drug hypersensitivity and the suspect vaccine was possibly related. The casual relationship between fever, trouble walking, was regressing in speech which he had to receive early intervention services, his Mump titers were elevated and the suspect vaccine was not reported.
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: fever; his Mump titers were elevated; hypersensitivity reaction to a previous dose of MMR-2; "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation; Patient had trouble walking; was regressing in speech which he had to receive early intervention services; This spontaneous report was received from a consumer or other non health professional and refers to a male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions included autoimmune disease, and immunosuppression. Concomitant therapies were not reported.   On 25-Jun-2020, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported).  On 01-Jul-2020, the patient experienced hypersensitivity reaction to a previous dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II); "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation (drug hypersensitivity), fever, trouble walking, was regressing in speech which he had to receive early intervention services, his Mump titers were elevated. At the reporting time, the outcome of the events was not reported. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not applicable.   The reporter considered the event of hypersensitivity reaction to a previous dose of MMR-2; "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. The casual relationship between drug hypersensitivity and the suspect vaccine was possibly related. The casual relationship between fever, trouble walking, was regressing in speech which he had to receive early intervention services, his Mump titers were elevated and the suspect vaccine was not reported.
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects or symptoms reported. No Additional AE; HCP called to report a patient received MMR II (03/01/2025) and then received VARIVAX 7 days later  (03/07/2025) instead of the recommended 4-week interval. No side effects or symptoms reported. No Additional information provided. No Additional AE/ N; This spontaneous report was received from a pharmacist 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 01-MAR-2025, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) and on 07-MAR-2025, with varicella virus vaccine live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot# Y015100, expiration date: 06-SEP-2026 (dose number, route of administration and anatomical location were not provided), both reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot# and expiration date were not provided), for prophylaxis. The vaccines were administered in 7-day interval instead of recommended 4-week interval (Inappropriate schedule of product administration). No side effects, symptoms or additional adverse event were reported.  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: My daughter was given Gardasil and developed pain at the site of the injection 1 day later. Please let me know if there's other information needed; This spontaneous report was received from a company representative and refers to a female patient of unknown age.  The patient's medical history, current conditions, and concomitant therapies was not reported.   On an unknown date, the patient was vaccinated Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, anatomical route of administration, lot # and expiration date were not reported) as prophylaxis.  The reporter stated that the patient developed pain at the site of the injection 1 day later (exact dates not provided) (vaccination site pain).   The outcome of the event vaccination site pain was not reported.   The causal relationship between vaccination site pain with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not reported.   Lot number is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillain Barre syndrome; This serious case was reported by a non-health professional via sales rep and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain Barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolving.   The reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-APR-2025 The patient received in office administration of Shingrix (unknown if this was first or second dose). The reporter stated that, three weeks after administration the patient developed Guillain Barre syndrome.  The patient continued to try to recover and is receiving infusion therapy.  The causality was believed by the physician office to be related as they could not identify any other precipitating event.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; got 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 (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: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine several years ago and currently had shingles. They said patient did not get them that bad. Patient would not wish this pain on worst enemy. They knew about shingles and how excruciating the pain associated with the rash could be. She likes to stay on top of her health, so she did some research. She learned that while not everyone at risk will develop shingles, 99 percent of adults over 50 already have the virus that causes shingles inside their body. Take the first step learn more about the risk of shingles and talk to a pharmacist or doctor. Trademarks were owned by or licensed to the GlaxoSmithKline group of companies. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
Sex: M
Vaccine: VARZOS
Symptoms: Testicular swelling
Clinical narrative: Swelling of testicles; This non-serious case was reported by a consumer and described the occurrence of testicular swelling in a 65-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-APR-2025, the patient received the 1st dose of Shingles vaccine. On 06-APR-2025, 2 days after receiving Shingles vaccine, the patient experienced testicular swelling (Verbatim: Swelling of testicles). The outcome of the testicular swelling was not resolved.   It was unknown if the reporter considered the testicular swelling to be related to Shingles vaccine.     It was unknown if the company considered the testicular swelling to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-APR-2025 Patient reported that had swelling of testicles after the first dose of Shingles vaccine. Physician told to patient that the swelling may be a rare side effect of vaccine.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: Patient developed rash on one side of face area; Patient developed rash inside mouth; This serious case was reported by a physician via sales rep and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included varicella zoster (left varicella zoster). Concurrent medical conditions included gout (gout), hepatitis b (hep b), fatty liver (fatty liver), hyperlipidemia (hyperlipidemia) and gallstones (gall stones). Concomitant products included allopurinol.   On 27-MAR-2025, the patient received the 1st dose of Shingrix (left deltoid). On 31-MAR-2025, 4 days after receiving Shingrix, the patient experienced rash (Verbatim: Patient developed rash on one side of face area) (serious criteria other: Serious as per reporter) and rash mouth (Verbatim: Patient developed rash inside mouth) (serious criteria other: Serious as per reporter). The patient was treated with valaciclovir, gabapentin and triamcinolone. On 04-APR-2025, the outcome of the rash and rash mouth were resolved (duration 4 days).   It was unknown if the reporter considered the rash and rash mouth to be related to Shingrix.     The company considered the rash and rash mouth to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-APR-2025 Patient developed rash on one side of face area and inside mouth 2-3 days after first dose of Shingrix. Patient was started on valacyclovir, gabapentin, triamcinolone, vision check and sent to consult with ophthalmologist .; Sender's Comments: Rash is a listed event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK vaccine Oral mucosal eruption Shingrix.  Oral mucosal eruption is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 3rd dose a week early and a day; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G, expiry date 11-APR-2027) for prophylaxis.   Previously administered products included Pediarix (received 1st dose of vaccine on an unknown date). Concomitant products included Pediarix.   On 20-FEB-2025, the patient received the 3rd dose of Pediarix (left thigh). On 20-FEB-2025, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: patient received 3rd dose a week early and a day). The outcome of the drug dose administration interval too short 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: 09-APR-2025 The nurse had given it too soon, the second dose was given on 23rd January and the third dose was administered on 20th February 2025, a week and a day early, which led to Drug dose administration interval too short.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Herpes-Zoster like rash; This non-serious case was reported by a physician via sales rep and described the occurrence of vesicular rash in a 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, 12 months after receiving Shingrix and Shingrix, the patient experienced vesicular rash (Verbatim: Herpes-Zoster like rash). The outcome of the vesicular rash was resolved.   The reporter considered the vesicular rash to be related to Shingrix and Shingrix.     The company considered the vesicular rash to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-APR-2025 The Healthcare professional shared his wife developed a minor Herpes-Zoster like rash that appeared even after having gotten both doses of Shingrix, approximately 12-18 months ago.
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Paraesthesia, Sleep disorder
Clinical narrative: Suspected Vaccination failure; got shingles; have not slept much; 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), shingles (Verbatim: got shingles) and difficulty sleeping (Verbatim: have not slept much). The outcome of the vaccination failure and difficulty sleeping were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine.     The company considered the vaccination failure, shingles and difficulty sleeping to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vaccine but also got shingles going on for 4 weeks now.  The patient reported he/she never really got the blisters, just a small red patch, but dealing with the burning tingly pain just the same. The patient stated it hurts more at night and she/he have not slept much.  Further, patient stated that it probably would have been a lot worse if did not have the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Insomnia are unlisted events which are considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected Vaccination failure; got shingles; have not slept much; 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), shingles (Verbatim: got shingles) and difficulty sleeping (Verbatim: have not slept much). The outcome of the vaccination failure and difficulty sleeping were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine.     The company considered the vaccination failure, shingles and difficulty sleeping to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vaccine but also got shingles going on for 4 weeks now.  The patient reported he/she never really got the blisters, just a small red patch, but dealing with the burning tingly pain just the same. The patient stated it hurts more at night and she/he have not slept much.  Further, patient stated that it probably would have been a lot worse if did not have the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Insomnia are unlisted events which are considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles twice since the vaccine; 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.   The patient's past medical history included shingles (had shingles once prior to vaccine).   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: shingles twice since the vaccine). 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: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient wished the vaccine worked for him/her. The patient got shingles once prior to vaccine and shingles twice since the vaccine.  The patient stated that their immune system had failed them. 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
Symptoms: Burning sensation, Neuralgia
Clinical narrative: get nerve pain; back was burning; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles). Previously administered products included Shingles vaccine (had first dose 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 nerve pain (Verbatim: get nerve pain) and burning sensation (Verbatim: back was burning). The outcome of the nerve pain was not reported and the outcome of the burning sensation was not resolved.   It was unknown if the reporter considered the nerve pain and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that she/he had Shingles and it was bad then got both shots (Shingles vaccine). The patient reported that now she/he got nerve pain and it feels like back is burning that was where they had it (shingles). The patient asked for help to stop the burning.
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccinaion failure; 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 vaccinaion failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with lidocaine. 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: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient had received the shingles vaccine but still got shingles.  He/she used lidocaine cream for the pain, which helped a little, but it did not provide relief for the chills. 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 Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; grandpa got singles; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: grandpa got singles). The outcome of the vaccination failure and shingles were not reported.   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. The company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her grandpa got shingles from the vaccine and it was so painful.  They were fine before it. 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. This case is linked with US2025AMR045180, reported by 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-US2025AMR045180:Same reporter/ different  patient
Vaccine: VARZOS
Symptoms: Blister, Nerve injury
Clinical narrative: nerve damage; occasional blister; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: nerve damage) and blister (Verbatim: occasional blister). The outcome of the nerve damage and blister were not reported.   It was unknown if the reporter considered the nerve damage and blister to be related to Shingles vaccine.     It was unknown if the company considered the nerve damage and blister to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-APR-2025 This case was reported by a patient via interactive digital media. The patient got shingles last year and said that it sucks. The symptoms didn't just went away. They lingered on for months. The doctor told that if he/she took the vaccination, he/she would have 98 percent chance of it not coming back. The patient did take the vaccination and still had nerve damage and occasional blister that breaks out. The patient reported that he/she has fingers crossed that eventually it won't come back.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; a year later I had the 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.   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, 1 year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: a year later I had the shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   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: 10-APR-2025 The case was received from the patient via interactive digital media. The patient had the shingles shot and the booster shot and a year later he/she had the shingles, that was 6 weeks ago. The patient starting to recover. It has been painful, so having the shot doesn't keep you from getting the shingles. 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 Shingles vaccine (dose 1 and 2).
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Herpes zoster, Muscle disorder, Vaccination failure, Wheelchair user
Clinical narrative: Suspected vaccination failure; kept getting shingles; he could no longer walk; 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: kept getting shingles) and unable to walk (Verbatim: he could no longer walk). The outcome of the vaccination failure, shingles and unable to walk were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and unable to walk 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 and unable to walk to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 11-APR-2025 This case was reported by a consumer via interactive digital media. Reporter refused this dad got the shot for shingles and kept getting shingles and he got to where he needed wheel chair he could no longer walk and they called it something in muscles.  So he/she will be refused. 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. This was 1 out of 3 linked cases, reported by same reporter different patient.; 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 Shingles vaccine. US-GSK-US2025AMR045181:same reporter /different patient US-GSK-US2025AMR045186:same reporter /different patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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: 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. Patient had the vaccine and have 2 cases since the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine"
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got them; 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: still got them). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2025 The case was received from the patient via interactive digital media. The patient got the two shots and still got them. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine" US-GSK-US2025AMR045315:Same reporter