chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and it came back.more than once; Came back.more than once; 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 (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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but selected as an adult as per vaccine indication. The patient reported that got Shingrix shot and it came back more than once. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer 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.   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 patient stated that they got the shingles from the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Got the new double shot. / I had Shingles / Not a pleasant experience; Got the new double shot. / I had Shingles / Not a pleasant experience; I had my 1st shot and 2 years later got the new double shot.; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, Shingrix and Shingrix, 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 Shingrix, Shingrix and Shingrix.  Additional details were reported as follows: 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 shingle vaccine and had shingles 2 years prior to report. The 2 years later the patient got the new double shot of Shingrix, which led to extradose administered and stated that neither of them worked. The patient had shingles both times and was not pleasant experienced. No other information was available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Muscle spasms, Myalgia, Nerve injury
Clinical narrative: weakness; created cramp-like; shooting pain; muscle twinges; neurological damage; not sure if it was Guillain-barre syndrome; welts on her chest; tingling in her hands and legs / that started in her feet and went up her legs and arms; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2011-12 season) for prophylaxis.   On 28th September 2010, the patient received FluLaval 2011-12 season. On 28th September 2010, 30 min after receiving FluLaval 2011-12 season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), welts, tingling of extremity and nerve damage. On 26th November 2010, the patient experienced weakness, cramp, pain and muscle pain. On an unknown date, the outcome of the guillain barre syndrome, welts, tingling of extremity, weakness, cramp, pain, muscle pain and nerve damage were unknown.   It was unknown if the reporter considered the guillain barre syndrome, welts, tingling of extremity, weakness, cramp, pain, muscle pain and nerve damage to be related to FluLaval 2011-12 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the H1N1 Glaxo's Flulaval vaccine in her right arm on 28th September 2010 and within 30 minutes, she developed welts on her chest and tingling in hands and legs, which required a doctors visit the next day on the 29th September 2010. On 26th November 2010, 59 days later out of nowhere, the patient noticed that she started getting weakness, tingling that started in her feet and went up her legs and arms and spread quickly. It created cramp-like, shooting pains and muscle twinges, especially at night; that went on for months. Because of that, the patient had never gotten the flu, shingles, or pneumonia vaccine since 28th September 2010. The patient was not sure if it was Guillain-barre syndrome. The patient asked if anyone had suffered what she has went through and had anyone suffered neurological damage. The patient stated there was thimerosal in the H1N1 vaccine she received in 2010 that was used as a preservative and was wondering if the COVID vaccine had thimerosal. The patient asked how the H1N1 vaccine she received in 2010 that was inactivated different from the Covid 19 vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Urticaria
Clinical narrative: weakness; created cramp-like; shooting pain; muscle twinges; neurological damage; not sure if it was Guillain-barre syndrome; welts on her chest; tingling in her hands and legs / that started in her feet and went up her legs and arms; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2011-12 season) for prophylaxis.   On 28th September 2010, the patient received FluLaval 2011-12 season. On 28th September 2010, 30 min after receiving FluLaval 2011-12 season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), welts, tingling of extremity and nerve damage. On 26th November 2010, the patient experienced weakness, cramp, pain and muscle pain. On an unknown date, the outcome of the guillain barre syndrome, welts, tingling of extremity, weakness, cramp, pain, muscle pain and nerve damage were unknown.   It was unknown if the reporter considered the guillain barre syndrome, welts, tingling of extremity, weakness, cramp, pain, muscle pain and nerve damage to be related to FluLaval 2011-12 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the H1N1 Glaxo's Flulaval vaccine in her right arm on 28th September 2010 and within 30 minutes, she developed welts on her chest and tingling in hands and legs, which required a doctors visit the next day on the 29th September 2010. On 26th November 2010, 59 days later out of nowhere, the patient noticed that she started getting weakness, tingling that started in her feet and went up her legs and arms and spread quickly. It created cramp-like, shooting pains and muscle twinges, especially at night; that went on for months. Because of that, the patient had never gotten the flu, shingles, or pneumonia vaccine since 28th September 2010. The patient was not sure if it was Guillain-barre syndrome. The patient asked if anyone had suffered what she has went through and had anyone suffered neurological damage. The patient stated there was thimerosal in the H1N1 vaccine she received in 2010 that was used as a preservative and was wondering if the COVID vaccine had thimerosal. The patient asked how the H1N1 vaccine she received in 2010 that was inactivated different from the Covid 19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; year later got shingles on neck and side of head; 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, 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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: Additional details were reported 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 the vaccine and about a year later got shingles on neck and side of head, that was gone in two weeks. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Cataract operation, Herpes zoster, Vaccination failure
Clinical narrative: ot a mild case of them in my head and down my face/suspected vaccination failure; Got a mild case of them in my head and down my face; 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: This case was reported by patient him/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 patient received shingles vaccine and got a mild case of shingles in his/her head and down his/her face on one side. The patient stated that he/she just had cataract surgery also. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Impaired work ability, Vaccination failure
Clinical narrative: Get the shots, had shingles 9 months later/ suspected vaccination failure; Get the shots, had shingles 9 months later; This case was reported 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 9 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 and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had a shots, and experienced shingles 9 months later.  The patient was not able to work. This case was considered as suspected vaccination failure since the details time to onset and laboratory confirmation was not provided
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: suffering from nerve damage from shingles/ suspected vaccination failure; suffering from nerve damage from shingles; suffering from nerve damage from 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 (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, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selcted as an adult as per vaccine indication. The reporter stated that, received double vaccine in 2020 and had nerve damaage from shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure / shingles; shingles; very itchy; rashes; 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 (Shingrix) for prophylaxis.   In October 2020, the patient received Shingrix. In December 2020, between 1 and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and rash. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. In December 2020, the patient became very itchy and had rashes and was diagnosed with shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 46.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Suspected vaccination failure; Getting worst outbreak of shingles; Patient was 46 years old when 2nd dose was received; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 46-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had outbreaks of shingles 2 to 6 times a year for the past 10 years). Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer linked case US2021AMR033939).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure and inappropriate age at vaccine administration were 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 and Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that she was a rare case who had been getting outbreaks of shingles 2 to 6 times a year for the past 10 years or so. The age at vaccination was not reported for 1st dose, it could be 45 or 46 years. The patient had received the 2nd dose at the age of 46, which led to inappropriate age at vaccine administration. Within weeks of getting the 2nd dose, the patient got one of the worst outbreaks they had ever had and presently she was getting her 2nd outbreak. The patient stated that they had received 2nd dose in December and it was presently only February for the outbreak. The patient was not sure if taking the 2nd dose made the vaccine less effective because they were younger than 50. The reporter could not see any studies or comments and was trying to get more information. This case was considered as suspected vaccination failure since the details regarding lab test confirmation and exact time to onset were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR033939:Same reporter, same suspect, same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: Suspected vaccination failure; 4 times / Miserable illness! Ex, more miserable! / Rather have shingles; Miserable illness; 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 illness. On an unknown date, the outcome of the vaccination failure, shingles and illness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and illness 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 it was captured as adult as per vaccine indication. The patient had all the shots. The reporter stated that 4 times. Miserable illness. Ex, more miserable. Rather had Shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles twice after receiving the vaccine; This case was reported 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) 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 patient was reporter's mother. The age at vaccination was not reported. The patient had shingles twice after receiving the vaccine. This case was considered as suspected vaccination failure, as information about Shingles vaccine dose number, laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up would not possible as no contact details were available.
Age: 33.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Blister; continues to contract shingles; continues to contract shingles; administer Shingrix despite patients age being younger than the indicated age of 50 years; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 35-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (cases of shingles since before patient turned 25 years old).   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 29th January 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced off label use in unapproved age group. In November 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced blister. On an unknown date, the outcome of the vaccination failure, blister and off label use in unapproved age group 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 blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix and experienced shingles. The patient received 2 doses of Shingrix, at the age below than recommended, which led to off label use in unapproved age group. The patient was suggested to receive a fluid sample from current blister and to have a medical test to analyze it. The reporter mentioned that, patient had an appointment to dermatology office that week. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. This case has been linked with US2021AMR036064, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR036064:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the shot and still got the Shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in an 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 it was captured as adult as per vaccine indication. The patient had the shot and got the Shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: extra dose administered; Diagnosed with shingles (on Scalp) / receive both the Shingrix Vaccine and the earlier Shingles Vaccine; Diagnosed with shingles (on Scalp) / receive both the Shingrix Vaccine and the earlier Shingles Vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergic reaction to analgesics, allergy to topical drugs, reaction to drug preservatives and perfume sensitivity. Concomitant products included atorvastatin calcium (Lipitor), acetylsalicylic acid (Aspirin) and fexofenadine hydrochloride (Allegra).   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingrix and the 3rd dose of Shingrix. On 3rd February 2021, unknown after receiving Shingles vaccine, Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced 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, Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The patient received extra dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles.; Got shingles.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding 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, Vaccination failure
Clinical narrative: Got ours shots several years ago / got shingles again / have had them three times/spected vaccination failure; Got ours shots several years ago / got shingles again / have had them three times; This case was reported by a consumer and described the occurrence of suspected vaccination failure in an unspecified patients 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. It was reported the patient shots several years ago and still got shingles again, had them three times. 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 herpes zoster were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; Broke out; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Polio shot (received in childhood.).   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), shingles and skin breakout. On an unknown date, the outcome of the vaccination failure, shingles and skin breakout were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and skin breakout to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  After receiving dose of Shingrix, patient experienced shingles (broke out). The caller also mentioned that she already asked her doctor and hospital but does not have definite answer for her. This case was considered as suspected vaccination failure, as information about shingrix dose number, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had that shot & thought that I was safe too, but now I have them/suspected vaccination failure; Had that shot & thought that I was safe too, but now I have them; This case was reported by a consumer 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 selected as adult as per vaccine indication. The patient had that shot and thought that the patient was safe too. But now the patient had shingles. It was a total surprise to patient. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles two years ago. Very light case. I had had the shot/ suspected vaccination failure; Had shingles two years ago. Very light case. I had had the shot.; 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) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   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 group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient self reported the case. It was reported that patient had very light case of shingles two years before the reporting date. The patient had had the shot and paid for the shot.  Gabapentin helped a lot. 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; a friend has had shingles since Nov / get the shingles from the shot; This case was reported by a consumer 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. In November 2020, 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.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.  Additional details were provided as follows: Reporter was patient's friend. The age at vaccination was not reported. The patient received shingles shot and had shingles. Reporter stated that it was 1 in 10000 that get the shingles,from the shot but the patient was one of that. 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 at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had The Two Dose Shingle Vaccine And I Still Get Shingles; This case was reported by a consumer 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 1st dose of Shingles vaccine and the 2nd 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 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 and Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported.  After receiving 2 doses of Shingles vaccine, the patient got shingles. 1st dose of Shingles vaccine made the patient really sick. For the tolerance of 1st dose, refer linked case US2021AMR041526. 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.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041526:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Bed rest, Herpes zoster, Vaccination failure
Clinical narrative: got the two shots doses and still got shingles for a second time after two years/ suspected Vaccination failure; got the two shots doses and still got shingles for a second time after two years; forced me to bed rest; 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 (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 2 years after receiving Shingrix and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and bed rest. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles and bed rest were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the bed rest to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received two shots doses and still got shingles for a second time after two years and experienced shingles and forced to bed rest. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The information regarding consent to follow up was not reported. This case was linked with case US2021AMR041531.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041531:1st-shingles case
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had 2 shingle shots and still got them; This case was reported by a consumer 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. 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 provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had two shingle shots and still got them and it was not fun. This case was considered as suspected vaccination failure since the details regarding time to onset and lab test confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Suspeced vaccination failure; have had two Shingrix shots have since gotten shingles twice; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient experienced 2 times Shingles after 2 Shingrix shots. The patient asking if need another Shingrix shot. This case was considered as suspected vaccination failure as details regarding TTO was  unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles / was vaccinated about 2 years ago with Shingrix/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 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported via Interactive Digital Media. The age at vaccination was not reported. The reporter stated that needed treatments to supplement vaccines. The patient received dose of shingrix about 2 years prior to the report and just got shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rheumatoid arthritis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (severe shingles episode prior to taking the Shingrix shots).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), rheumatoid arthritis (serious criteria GSK medically significant) and shingles. The patient was treated with methotrexate. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the rheumatoid arthritis and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, rheumatoid arthritis and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported but it could be 76 or 77 years old. wanted to ask if it was okay to get the Moderna or Pfizer Covid-19 vaccine if she was taking Methotrexate for rheumatoid arthritis Prior to taking the Shingrix shots, the patient had shingles episodes which were more severe. The patient had received Shingrix shots two or three years ago and did fine. The patient mentioned that the shingles she had presently was only a light case and milder one. The reporter wanted to get off the phone and did not wanted to answer any further questions, hence she could not be asked for MD contact information.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Lack of effect/Suspected vaccination failure; mild case of shingles; This case was reported by a consumer via call center representative 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient had completed the Shingrix vaccination series about 3 years ago, but he got a mild case of shingles. This case was considered as suspected vaccination failure, as information about time to onset and laboratory test confirmation for shingles infection was unknown. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix Trivalent 2012-2013 season) (batch number AFLUA736AA, expiry date 30th June 2013) for prophylaxis.   On an unknown date, the patient received Fluarix Trivalent 2012-2013 season. On an unknown date, unknown after receiving Fluarix Trivalent 2012-2013 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix Trivalent 2012-2013 season.  Additional details were reported as follows: This case was reported by pharmacy student. The age at vaccination was not reported. The patient had a severe anaphylactic reaction to Fluarix 2012-2013 vaccine.  The reporter was unsure if it had already been reported back when it happened and did not have patient initials.