chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 10-SEP-2021, temperature excursion occurred for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457 has been verified to be valid, expiration date 23-FEB-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026961 has been verified to be valid, expiration date 02-APR-2023). On 22-SEP-2021, the patient was vaccinated with both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral; dose details were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (route and dose details were not provided) for prophylaxis (incorrect product storage).   The storage temperature of both vaccines was 48.7 degrees Fahrenheit for a time frame of 10 minutes. There was no previous temperature excursion. No product quality complaint was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 10-SEP-2021, temperature excursion occurred for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707460 has been verified to be valid, expiration date 14-MAR-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026961 has been verified to be valid, expiration date 02-APR-2023). On 13-SEP-2021, the patient was vaccinated with both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral; dose details were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (route and dose details were not provided) for prophylaxis (incorrect product storage).   The storage temperature of both vaccines was 48.7 degrees Fahrenheit for a time frame of 10 minutes. There was no previous temperature excursion. No product quality complaint was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.    On 10-SEP-2021, the improperly stored vaccines rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported; lot # 1707460 and expiration date was 14-MAR-2022; orally) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported; lot # T026961 and expiration date was 02-APR-2023) were administrated for prophylaxis after temperature excursion (product storage error). These vaccines experienced temperature excursion of 48.7 fahrenheit (F) for 10 minutes. There were no previous temperature excursions.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 2016, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at the pharmacy. Subsequently, on an unknown date, the pt was treated by a healthcare provider at the hospital, for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): shingles and other zoster-related conditions. The outcome of shingles and other zoster-related conditions was not reported. The reporter considered both events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Anogenital warts
Clinical narrative: genital warts; This spontaneous report was received from a physician via company representative and refers to a female patient who was 16-year-old at the time of reporting. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, she was diagnosed with genital warts. The reporter did not know the type of genital warts of if the patient had a history of sexually transmitted diseases (STD's). Outcome of the event was unknown.  Causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: swelling of the arm; This spontaneous report was received from a physician and refers to a 67-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (dose, anatomical location, lot # and expiration date were not provided) as pneumococcal vaccine. On an unknown date (reported as approximately 48 hours after vaccination), she experienced swelling of the arm. It was unknown whether the patient received any treatment for the event. Outcome of the event was reported as recovered.  Causality assessment was not provided
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea
Clinical narrative: NAUSEATED; This spontaneous report received from a health care professional concerned an adult female. The patient's weight was 90 kilograms, and height was not reported. The patient's concurrent conditions included: pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, and dose, start therapy date were not reported for drug used for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: bosentan (tablet, oral, batch number: 0W037A0106, expiry: UNKNOWN) dose was not reported, 2 times every 1 day, therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nauseated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Fatigue, Pain in extremity, Rheumatoid arthritis
Clinical narrative: flare up of rheumatoid arthritis (RA); dry mouth; dry eyes; bilateral hand pain; extreme fatigue; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021147334).  This serious solicited report was reported to Amgen on 21/SEP/2021 by a consumer from a commercial program and involves a 61 years old female patient who had a bilateral hand pain/ her symptoms are a flare up of RA/ dry mouth, dry eyes/ extreme fatigue [PT: rheumatoid arthritis] while receiving Enbrel with Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included covid-19 vaccine. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. On an unknown date in 2021 three weeks ago, the patient received the COVID19 vaccine and developed a dry mouth, dry eyes, bilateral hand pain and extreme fatigue which continue. She believed that her symptoms were a flare up of rheumatoid arthritis (RA). No treatment information was received. The outcome of the events rheumatoid arthritis was reported as not recovered/not resolved. Action taken with Enbrel and Single Dose Prefilled Syringe was continued for the events rheumatoid arthritis. The causal relationship between the events rheumatoid arthritis and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. Follow up has been requested for lot number only.  Amgen comment: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events with the suspect product etanercept and BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  Amgen's Causality Assessment: The events of Rheumatoid arthritis flare up was considered as unrelated to etanercept.; Sender's Comments: Based on the reported information and based on the temporal association, there is a reasonable possibility that the events are causally related to BNT162B2. Events  are assessed as unrelated to etanercept .
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: cannot afford second dose; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient's relative reported the case. The age at vaccination was not applicable for this report. The reporter stated that, the patient got the 1st dose of Shingrix without any charge.  When the patient went to get her second shot, she could not afford the vaccine charge as she had no script coverage. Till the time of reporting, the patient might have not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAREs details pertains to 1st dose of Shingrix. GSK note- From the reported information, it is not clear if patient had exceeded time interval to receive the 2nd dose of Shingrix or not and also contact to reporter was also not possible. Therefore, by considering worst case approach, the case is considered for incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Burning sensation, Pruritus, Rash, Sleep disorder
Clinical narrative: i have a allergy to the vaccine.; hot burning rash.; hot burning rash.; itching; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (was born with chickenpox).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced allergy to vaccine, rash, burning sensation and pruritus. On an unknown date, the outcome of the allergy to vaccine, rash, burning sensation and pruritus were not recovered/not resolved.   The reporter considered the allergy to vaccine to be possibly related to Shingles vaccine. It was unknown if the reporter considered the rash, burning sensation and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The reporter stated that, he/she got the first dose of Shingles vaccine and woke up in the middle of the night with a hot burning rash, it's  been 3 months and the patient still itching.  The patient thought he/she have a allergy to the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Influenza like illness
Clinical narrative: I got sick; Flu-like symptoms; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, influenza-like symptoms and headache. On an unknown date, the outcome of the sickness, influenza-like symptoms and headache were unknown.   The reporter considered the sickness to be related to Shingles vaccine. It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingles vaccine.  Additional details were provided as follows:  The reporter was the patient.  The age at vaccination was not reported.  The patient got sick from the vaccine, but he/she stated that it was far better than having shingles.  The patient had flu-like symptoms and a headache. The follow-up would not possible as no contact details were available. For tolerance of the 2nd dose, refer US2021AMR205341 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205341:Same reporter,same patient, same suspect, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: I got sick; Flu-like symptoms; Headache; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (patient received 1st dose on an unknown date and also experienced influenza-like symptoms and headache, refer case US2021AMR205337).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, influenza-like symptoms and headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness, influenza-like symptoms and headache were unknown.   The reporter considered the sickness to be related to Shingles vaccine. It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingles vaccine.  Additional details were provided as follows:  The reporter was the patient.  The age at vaccination was not reported.  The patient got sick from the vaccine, but he/she stated that it was far better than having shingles.  The patient had flu-like symptoms and a headache. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205337:Same reporter,same patient, same suspect, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: uncomfortable; This case was reported by a consumer via (Shingrix chat boot) interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2021, the patient received Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said he/she just had the vaccine yesterday from the day of reporting and felt uncomfortable all day and night. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR205346 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205346:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: uncomfortable; This case was reported by a consumer via (GSK Chatbot) interactive digital media and described the occurrence of discomfort in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2021, the patient received Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter said they just had the vaccine yesterday from the day of reporting and they felt uncomfortable all day and night. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR205344 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205344:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Incomplete course of vaccination
Clinical narrative: shingles/ went right up to the side of face, in my mouth; ill; will not be getting the 2nd vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got a huge outbreak of shingles immediately after vaccination, that went right up to the side of his/her face, in my mouth and then cleared up, refer case US2021AMR205389 ).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (serious criteria hospitalization), sickness (serious criteria hospitalization) and incomplete course of vaccination. On an unknown date, the outcome of the shingles, sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that he/she had another shingles outbreak right after when the 1st outbreak was cleared up and was so ill and was hospitalized for it. The patient would not receive 2nd dose of Shingles, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available. This case was linked with case US2021AMR205389, reported by same reporter for same patient. Note: As it was not cleared if the 2nd dose schedule was over or not, hence conservatively captured 2nd dose as suspect and incomplete course of vaccine as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205389:same report
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shot and still got them / Suspected vaccination failure; got shot and still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient had the shot and still got them. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Extremely sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she took flu vaccine and always got extremely sick after taking it. The patient was no longer taking Flu vaccine. The follow up would not possible as contact information was not available. For tolerance of Shingles vaccine refer case US2021AMR205442.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205851:tag at post US-GLAXOSMITHKLINE-US2021AMR205442:same reporter
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after my last shot / suspected vaccination failure; shingles; had 3 shingle shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles 4 times).   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had shingles 4 times. The patient had 3 shingle shots and got shingles twice after last shot. The patient received 3rd dose of vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster, Illness, Influenza, Vaccination failure
Clinical narrative: get a flu shot, got the flu / suspected vaccination failure; flu; sick; This case was reported by a consumer (facebook) via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient did not get flu shots or pneumonia shots either, because every time patient used to get a flu shot  and get super sick with the flu, so the patient afraid to get the vaccine for shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. THis case has been linked with US2021AMR205452 and US2021AMR205442, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205452:tag at post / same reporter US-GLAXOSMITHKLINE-US2021AMR205442:tag at post / same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot in 2020 and had Shingles / suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shot in 2020 and had Shingles for the first time summer of 2021. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the shot and then got shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and got shingles / Suspected vaccination failure; got shingles; This case was reported by a consumer  via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shot and still got Shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shots and I got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 82-year-old 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shots and got shingles for the very first time. The reporter stated that it does not prevent shingles. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: bad case of shingles and he was vaccinated / Suspected vaccination failure; bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's family member. The patient was reporter's brother in law. The age at vaccination was not reported. The patient got a really bad case of the shingles and he was vaccinated. Plus a booster (unspecified time, before event or after event). The reporter asked how safe and effective they were. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required..
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingle shot, got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received shingle shot and got shingles a month later, for his/her second time. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Really painful arm; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th September 2021, the patient received the 1st dose of Shingles vaccine. On 29th September 2021, less than a day after receiving Shingles vaccine, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received shingles vaccine on the day of reporting and had fever and really painful arm. The follow up would not possible as contacts information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Incomplete course of vaccination, Injected limb mobility decreased, Pain
Clinical narrative: straight line shingles; hurt my shoulder for; couldn´t lift my arm; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (Old shingles vaccine).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the shingles and injected limb mobility decreased were unknown and the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shingles, shoulder pain and injected limb mobility decreased to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The new shingles vaccine actually hurt the patient's shoulder for months due to the way the patient was injected. The patient couldn't lift the arm without a lot of pain. Weeks later, the patient got a mild case of straight line shingles across face.  The patient further stated that shingles could blind you if it gets in your eyes. The patient's doctor recommended the new shingles vaccine to the patient.  The patient never went back for the second shot of the new vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pruritus, Rash, Vaccination failure
Clinical narrative: had the vaccine and got shingles/ suspected vaccination failure; got shingles; rash; little itching; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, tingling and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, rash and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pruritus to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that the vaccine does not totally prevent shingles. The patient had the Shingles vaccine and got shingles, a rash and little itching. The patient stated that the vaccine does lesson the effects of shingles. No tingling or pain like the patient usually had with shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: mild form of Bell's Palsy; This case was reported by a consumer via media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovered/resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had a mild form of bells palsy after the shingles vaccine. The follow up would not possible as contact information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died ather shot; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient just died after Shingles shot.  The reporter asked was this coincidence and there were immediate and profound symptoms. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got shot, got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had shingles, then the patient received the two Shingles shots that was supposed to be better and got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had Shingrix vaccine and have Shingles/ suspected vaccination failure; have Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had Shingrix vaccine and had Shingles at the time of reporting. The patient asked how often this happens. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Very tired; Fever of 99.8; Occasional chills; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received the 1st dose of Shingrix. On 1st October 2021, 1 days after receiving Shingrix, the patient experienced fatigue, fever and chills. On an unknown date, the outcome of the fatigue, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever and chills to be related to Shingrix.  Additional details provided were as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received a dose of Shingrix and on the next day, the patient was very tired, had a fever of 99.8 degree F and occasional chills. The patient asked how long did the side effects last. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red area where you received your shot; raised area where you received you shot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.  Additional details provided were as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and had a very large raised red area where he/she received the shot. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and now I get the breakouts/ suspected vaccination failure; breakouts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with eucalyptus. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both shingles shots and now get the shingles breakouts more often. The patient had started using eucalyptus on shingles and stated that they sell eucalyptus at walmart. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: took the shot and I also got them/ suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the Shingles shot and got shingles again. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.