chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: Patient advised she took COVID-19 Vaccine and formed blood clots in leg; This is a solicited report from a non-Pfizer sponsored program: -CW2891702, received from a contactable consumer, based on information received by Pfizer from manufacturer (manufacturer control number: BMS-2021-032881), license party for apixaban.  This 86-year-old female patient was involved in a patient support program. The patient (patient ID: (ID)) received APIXABAN. The report describes a case of THROMBOSIS (Patient advised she took COVID-19 Vaccine and formed blood clots in leg). Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN (Unknown) was unknown. At the time of the report, THROMBOSIS outcome was unknown. For APIXABAN (Unknown), the reporter did not provide any causality assessments. This report was received from consumer. The patient received therapy with apixaban and COVID-19 Vaccine for unknown indication. Follow-up is unable to be performed. Medical evaluation comment: This patient had blood clots in the leg after apixaban therapy. Based on the limited information regarding medical history, event details, treatment details, it cannot be ascertained that the suspect drug contributed to the reported event.  The reporter's assessment of the causal relationship of the event Thrombosis leg with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Amgen's assessment: the event, Thrombosis leg, was assessed as unrelated to apixaban.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event of thrombosis and the suspect vaccine BNT162B2 cannot be excluded. Based on known mechanism of action of the drug, the event of thrombosis is assessed as not related to Apixaban.  The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypersensitivity
Clinical narrative: possible Guillain-Barre syndrome; possible allergic reaction to Shingrix; This case was reported by a physician and described the occurrence of guillain barre syndrome in a female 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 guillain barre syndrome (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the guillain barre syndrome and allergic reaction were unknown.   It was unknown if the reporter considered the guillain barre syndrome and allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient had a possible Guillain-Barre syndrome or possible allergic reaction to the flu vaccine years before reporting. The primary reporter would like GSK to contact him for further inquiry and to possibly speak to his colleague.  Minimal information provided.  The reporter consented to follow up. This case had been linked to the case US2021079377 reported by the same reporter and same patient for shingrix vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021079377:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had shingles twice / Once / then several years had vaccine /Then had shingles the second time/suspected vaccination failure; shingles 2nd time; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had prior to the vaccination).   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: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had shingles twice. Once and then several years before the reporting, the pateint had vaccine and had shingels the 2nd time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; I got the shot but still got; No lasting pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chemotherapy.   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 and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter stated that, got shingles shot and still got shingles during chemotherapy but the patient bet it would have been a lot worse if the patient had not received it. The reporter stated that, no lasting pain either. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: My sister had the new shot and still got the shingles/suspected vaccination failure; still got the shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's sibling. The age at vaccination was not reported. The reporter stated that the patient had the new shot (Shingles vaccine) and still got the shingles and did not had as much pain but still got them. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: was sore / around the site; red around the site; This case was reported by a consumer and described the occurrence of injection site pain in a adult 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 pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient self reported the case. The patient was vaccinated with Shingles vaccine and experienced sore and red around the site. The patient said it was better than having shingles. The patient did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had the shingle shot / just moved them to a different location on my body/suspected vaccination failure; had the shingle shot / just moved them to a different location on my body; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions 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 provided as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The reported stated that he or she had the shingle shot and it just moved shingles to a different location on body. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shingles shot and just got shingles/ suspected vaccination failure; shingles / maybe a slighter case; pain is terrible; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient had Shingles shot and just got shingles last month. The reporter mentioned that, this might be a slighter case but the pain was terrible and was getting better. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for shingles and laboratory test confirming shingles were unknown at the time of reporting. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot got the Shingles/ Suspected vaccination failure; Had the shot got the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pruritus, Vaccination failure
Clinical narrative: It has been 3 years I have been struggling with shingles / yes I had both shots because it can come back again / checked with my doctor and the pharmacist/ suspected vaccination failure; struggling with shingles / on my left side of my forehead and head area; itch; nervous pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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), shingles, pruritus and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and nerve pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient had been struggling with shingles for 3 years and also had nervous pain and itch. The reporter stated that, he or she had shingles luckily on the left side of the forehead and head area and luckily did not have the rash and spray areas as some people had but 3 years were just too much. The patient received both the doses because shingle could come back again and had already checked with his or her doctor and the pharmacist. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding Shingles and time to onset for Shingles were unknown at the time of reporting. The case had been linked with the case- US2021AMR081522, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081522:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Took the shot then got the Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the shot. Months later got shingles; Darn.painfull; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. Several months after receiving vaccination, the patient got shingles which was painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Fall, Gait disturbance, Pain, Walking aid user
Clinical narrative: 2nd shot i could not walk the day after / Now / have a cane to get around; Kept falling down.; Pain and have a cane to get around.; This case was reported by a consumer and described the occurrence of walking difficulty in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of no adverse event.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced walking difficulty (serious criteria disability), fall and pain. The patient was treated with gabapentin. On an unknown date, the outcome of the walking difficulty, fall and pain were unknown.   It was unknown if the reporter considered the walking difficulty, fall and pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient could not walk the day after vaccination. Kept falling down. The patient was taking Gabapentin for the pain and have a cane to get around. The physician told to the patient not to even take the flu vaccine anymore.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine and two years later got shingles in my throat/Suspected vaccination failure; I had the vaccine and two years later got shingles in my throat; Never have I felt so bad; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling bad. On an unknown date, the outcome of the vaccination failure, shingles and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The reporter informed that it probably helped most people so got it but had the vaccine and two years later got shingles in throat.  The patient further specified that he or she never have felt so bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and about a year later got shingles\suspected Vaccination failure; I got the shot and about a year later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 information was provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient got shingles vaccine and about a year later got shingles. This case was considered as suspected vaccination failure, as information about Shingrix dose number, laboratory test confirmation for shingles infection were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: had shingles 5 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult 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 details were provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient had Shingles 5 times after 1st shot. The patient would not take 2nd shot.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Herpes zoster
Clinical narrative: 2 scabs; Discoloration too; I had fatigue; I felt very weak; Had a little bit of fever; forehead hurt / when the sun hit my forehead; did not eat much either; I lost weight.; I stayed inside / husband and my son / help me out / I could not do this alone; I had the Shingles last year but / I got the shingles shot 2 years ago/Suspected vaccination failure; I had the Shingles / they were just there / on the right side of my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine 2 years before day of reporting. In 2020 (last year), the patient had the shingles for 5 weeks, but they did not hurt or itch, they were just there, and she had them on the right side of my forehead with 2 scabs and discoloration too. The patient had fatigue in which she felt very weak and had a little bit of fever. The patient stated that the only time her forehead hurt was when the sun hit her forehead, so she stayed inside, and she did not eat much either and she lost weight. She was glad that she had her husband and her son with her to help her out because she could not do this alone. The patient stated that before this she never had shingles and she did not want them again and she had heard if you get them the second time it was worse than the first time, so she just pray that she did not get a second time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR081738, for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081738:Same reporter. Hearsay case.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Photosensitivity reaction, Pyrexia, Scab, Skin discolouration
Clinical narrative: 2 scabs; Discoloration too; I had fatigue; I felt very weak; Had a little bit of fever; forehead hurt / when the sun hit my forehead; did not eat much either; I lost weight.; I stayed inside / husband and my son / help me out / I could not do this alone; I had the Shingles last year but / I got the shingles shot 2 years ago/Suspected vaccination failure; I had the Shingles / they were just there / on the right side of my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine 2 years before day of reporting. In 2020 (last year), the patient had the shingles for 5 weeks, but they did not hurt or itch, they were just there, and she had them on the right side of my forehead with 2 scabs and discoloration too. The patient had fatigue in which she felt very weak and had a little bit of fever. The patient stated that the only time her forehead hurt was when the sun hit her forehead, so she stayed inside, and she did not eat much either and she lost weight. She was glad that she had her husband and her son with her to help her out because she could not do this alone. The patient stated that before this she never had shingles and she did not want them again and she had heard if you get them the second time it was worse than the first time, so she just pray that she did not get a second time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR081738, for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081738:Same reporter. Hearsay case.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure, Weight decreased
Clinical narrative: 2 scabs; Discoloration too; I had fatigue; I felt very weak; Had a little bit of fever; forehead hurt / when the sun hit my forehead; did not eat much either; I lost weight.; I stayed inside / husband and my son / help me out / I could not do this alone; I had the Shingles last year but / I got the shingles shot 2 years ago/Suspected vaccination failure; I had the Shingles / they were just there / on the right side of my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine 2 years before day of reporting. In 2020 (last year), the patient had the shingles for 5 weeks, but they did not hurt or itch, they were just there, and she had them on the right side of my forehead with 2 scabs and discoloration too. The patient had fatigue in which she felt very weak and had a little bit of fever. The patient stated that the only time her forehead hurt was when the sun hit her forehead, so she stayed inside, and she did not eat much either and she lost weight. She was glad that she had her husband and her son with her to help her out because she could not do this alone. The patient stated that before this she never had shingles and she did not want them again and she had heard if you get them the second time it was worse than the first time, so she just pray that she did not get a second time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR081738, for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081738:Same reporter. Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot still get 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 adult 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 details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received shingles vaccine still got 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: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated, I have shingles right now/ 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 adult 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 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 Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received shingles vaccine and was having shingles at present. 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: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; The 2 Shringrix vaccinations / got them in 2019 and he now has / Shingles; Very painful!!; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The reporter was the patient's wife. The age at vaccination was not reported. In 2019, the patient received 2 Shingrix vaccinations 6 month apart and he now had a case of Shingles. The reporter stated shingles were very painful. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 adult 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 details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingles shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles / getting over them now after about three weeks; pain wasn't as intense; itching has been horrible; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, pain and pruritus were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had the vaccination and still got the shingles again. The patient was getting over them after about three weeks. It was reported that the pain was not as intense but the itching had been horrible. The case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation were not provided.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected Vaccination failure; Got a light case of shingles a year later / got shingles after my second COVID shot; Still itchy; This case was reported by a consumer via facebook interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, COVID 19 VACCINE for prophylaxis and COVID 19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine, the 2nd dose of COVID 19 VACCINE and the 1st dose of COVID 19 VACCINE. On an unknown date, 1 year after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got both doses of the vaccine and got a light case of shingles a year later and it was still itchy. The patient got shingles after second COVID shot. The patient asked if this was related. It was unknown if the reporter considered the shingles and pruritus to be related to Covid 19 vaccine. The case was considered, as suspected vaccination failure since the details regarding laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shot and yep got shingles for the first time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months 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 provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient never had shingles before the vaccination. The patient received the shot and got shingles about 6 months later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; After I got the shot about six months later I got the shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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, 6 months 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 provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient had shingles in past and when that cleared up and went away the patient received the Shingles vaccine. About 6 months after the vaccination the patient experienced shingles again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: not so bad pain full but not long; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional information provided were as follows: The case was reported for the mother. Age at vaccination was not reported. The reporter reported that he/she don't like anything injected in body. The reporter reported that her mother friend also had bad pain but not so long. Note: No additional case was created for mother's friend as the vaccine received by her was unspecified.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081910:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Got the shingles shot and had shingles anyway. It was a very mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The case was reported by the patient for himself/herself. The age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. The patient received the shingles shot and had shingles anyway. It was a very mild case and it surprised the patient's physician. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Pain
Clinical narrative: felt like I had the flu cause I acked; ache; One year after my first Shingrix shot I got another; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms, pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. One year after first Shingrix shot the patient got another shot which led to lengthening of vaccination schedule as patient forgot to take vaccination.  The patient had another shot and had bad reactions, felt like had the flu cause he/she ached.