chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the 2 shots and broke out again/suspected vaccination failure; got the 2 shots and broke out again/when they broke out, it was worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the 2 shots and broke out again/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the 2 shots and broke out again/when they broke out, it was worse). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient v                                                                                                                                                                                                                                                                                                                                                                                                              interactive digital media. The patient received two shots of shingles vaccine and it only lasted for 8 months before he/she broke out again with shingles. The patient reported that it was supposed to be lasted at least 3 to 5 years and when they broke out, it was worse than without the shots. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Herpes zoster, Illness, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; sick; very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), sickness (Verbatim: sick) and pain (Verbatim: very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles, sickness and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, sickness and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, sickness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that he/she was so sick and bedbound with shingles a few years ago even though he/she had previously had the shingles vaccine. The patient reported that very painful more than anyone who had not had them could not imagine. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: has it now and got his last shot a month ago/suspected vaccination failure; has it now and got his last shot a month ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cancer (unfortunately had cancer 2 years ago). Previously administered products included Chemotherapy (chemotherapy was one of the top 4 things that could bring shingles out).   In FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: has it now and got his last shot a month ago/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has it now and got his last shot a month ago). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient's wife via interactive digital media. The reporter reported that the patient had shingles now and got his last shingles shot a month ago. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: had the shots and had shingles/suspected vaccination failure; had the shots and had shingles; itching really get to me; pain really get to me; fatigue really get to me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots and had shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the shots and had shingles), pruritus (Verbatim: itching really get to me), pain (Verbatim: pain really get to me) and fatigue (Verbatim: fatigue really get to me). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, pain and fatigue were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, pain and fatigue to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pruritus, pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that he/she was on 3rd round of shingles, last had them on December 2022 and already one were ago started again and stated that Shingles shot did nothing for him/her. The patient reported that the itching, pain and fatigue really got to him/her. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got both shots and still got it/suspected vaccination failure; I got both shots and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got both shots and still got it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both shots and still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient via interactive digital media. The patient got both shots and still got them. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, but still had shingles; still had shingles/Worse than poison ivy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot, but still had shingles) (serious criteria GSK medically significant) and shingles (Verbatim: still had shingles/Worse than poison ivy). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient via  interactive digital media. The patient got the shot, but still had shingles. The patient stated worse than poison. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Had 3 shingles vaccine and had shingles/ suspected vaccination failure; Had Shingles 4 times; Had 3 Shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 3 shingles vaccine and had shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had Shingles 4 times) and extra dose administered (Verbatim: Had 3 Shingles vaccine). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a son or daughter of patient via interactive digital media. The reporter reported that the Shingles vaccine does not work. The reporter stated that his or her mother received three doses of Shingles vaccine and experienced Shingles for four times. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingles vaccine in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 shingles vaccines and had shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 shingles vaccines and had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and experienced mild case of shingles. The patient stated that he or she received first dose of Shingles vaccine 2 months before the receiving second dose of Shingles vaccine. The patient reported that all those over 50 years old should receive the Shingles vaccine as soon as possible you will be glad that you did. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the vaccine, got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took the vaccine, got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient wife via interactive digital media. The reporter reported that her husband received Shingles vaccine and experienced shingles. The reporter stated that every time he receive preventive pills and experience shingles. It was unknown if the reporter considered the vaccination failure and shingles to be related to Preventive pills.  This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Pain, Vaccination failure
Clinical narrative: He got the new 2 doseversion vaccine and came down with shingles/ suspected vaccination failure; Shingles; Covid; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 9 years ago prior to the reporting). Previously administered products included Zostavax. Concurrent medical conditions included post herpetic neuralgia (nerve pain).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), covid-19 (Verbatim: Covid) and pain (Verbatim: Pain). On an unknown date, the patient experienced vaccination failure (Verbatim: He got the new 2 doseversion vaccine and came down with shingles/ suspected vaccination failure) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the shingles, covid-19 and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19 and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, covid-19 and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient wife via  interactive digital media. The reporter reported that patient received the two doses of the shingles vaccine.  The reporter stated that two weeks ago patient experienced Covid, then came down with shingles again.  The reporter stated that the vaccine made the pain manageable. The reporter reported that do not be surprised if you break out with shingles. She recently saw a commercial saying vaccine was 90 percentage effective, leave it to her husband to be in the 10 percentage that could still get shingles. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Hurt; Got shingles vaccine had shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In OCT-2022, the patient received Shingles vaccine. In FEB-2023, between 3 and 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles vaccine had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported he or she received Shingles vaccine and experienced shingles while he or she is on vacation. The patient stated that it was not fun and it really hurts. The physician stated that it would have been worse without vaccine. It was bad enough. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot and still got them/suspected vaccination failure; still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via  interactive digital media. The patient got the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles now, had 2 shots/suspected vaccination failure; Shingles; Worse pain ever; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles now, had 2 shots/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Worse pain ever). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the two shingles shots. The patient was suffering with shingles now. The patient had a lot of other painful problems but this was the worse pain ever and he/she was not young.  The patient had for two months.  The reporter stated that wonder if the Covid shots caused this. The reporter considered the adverse event to be related to Covid vaccine. The reporter further stated that an evil. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Had 3 shots and still got them/suspected vaccination failure; Still got them; Had 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 3 shots and still got them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got them) and extra dose administered (Verbatim: Had 3 shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had three shingles shots and still got shingles. The reporter stated that probably not as bad but still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient had three shingles shots, which led to extra dose administered. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the Shingles booster/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after the Shingles booster/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that almost all he/she knew got shingles after the shingles booster. The reporter further stated that what's that told you. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Get Shingles, even though had the vaccine/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get Shingles, even though had the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient still got shingles, even though he/she had the shingles vaccine.  The reporter stated that he/she was glad that he/she was not in a risk group or had any side effects to the vaccine.  The reporter further stated that it was very annoying to still got shingles every now (at the time of reporting) and then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR051223, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR051223:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: it's not effective for everyone/Suspected vaccination failure; it's not effective for everyone; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: it's not effective for everyone/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: it's not effective for everyone). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter found out that shingles vaccine was not effective for everyone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR051216, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR051216:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles had the shot/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles had the shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that every person he/she knew who had shingles and had the shingles shot. The reporter further stated that people needed to stop trusting shingles shots poison. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling hot, Headache, Sensory disturbance
Clinical narrative: Heat felt in brain and spinal cord; Severe heat felt in spinal cord; Debilitating; Lingering headache; This non-serious case was reported by a consumer and described the occurrence of weakness in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling hot (1st dose received on an unknown date, refer linked case US2023AMR047279). Concurrent medical conditions included rosacea and dust allergy. Concomitant products included fexofenadine hydrochloride (Allegra) and ivermectin (Soolantra).   On 25-MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, 4 days after receiving Shingles vaccine, the patient experienced weakness (Verbatim: Debilitating) and headache (Verbatim: Lingering headache). On 26-MAR-2023, the patient experienced abnormal physical sensation (Verbatim: Heat felt in brain and spinal cord) and feeling hot (Verbatim: Severe heat felt in spinal cord). On 27-MAR-2023, the outcome of the abnormal physical sensation and feeling hot were resolved (duration 1 day). The outcome of the weakness and headache were not reported.   It was unknown if the reporter considered the weakness, headache, abnormal physical sensation and feeling hot to be related to Shingles vaccine.     It was unknown if the company considered the weakness, headache, abnormal physical sensation and feeling hot to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR047279   Additional Information: GSK Receipt Date: 29-MAR-2023 The reporter reported that the patient received Shingles vaccine which was so unbearable but she did not go to the emergency room as hoping it would resolve. On 26th March 2023, 1 day after received Shingles vaccine the patient experienced severe heat felt in brain and spinal cord. The patient received treatment for the events. The reporter requested to consent the follow up.; Sender's Comments:  US-GSK-US2023AMR047279:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Tiredness; Injection site pain; Injection site redness; Injection site swelling; Body ache; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included asthma, hyperlipidemia, blood pressure high and sleep apnea. Concomitant products included fluticasone propionate + salmeterol xinafoate (Advair), salbutamol (Albuterol), rosuvastatin, carvedilol and furosemide.  On 28-MAR-2023, the patient received the 2nd dose of Shingrix. On 28-MAR-2023, less than a day after receiving Shingrix and an unknown time after starting Advair, Albuterol and furosemide, the patient experienced injection site pain (Verbatim: Injection site pain), injection site erythema (Verbatim: Injection site redness), injection site swelling (Verbatim: Injection site swelling) and general body pain (Verbatim: Body ache). On 29-MAR-2023, the patient experienced tiredness (Verbatim: Tiredness). The patient was treated with ibuprofen, paracetamol (Tylenol) and benadryl (nos) (Benadryl). The outcome of the injection site pain, injection site erythema, injection site swelling, general body pain and tiredness were not resolved.  It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, general body pain and tiredness to be related to Shingrix.  It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, general body pain and tiredness to be related to Shingrix.  Additional Information: GSK Receipt Date: 31-MAR-2023 The reporter was the patient himself. 1 day after receiving Shingrix the patient experienced tiredness. The patient had treated symptoms with Over the counter (OTC) product such as Tylenol, ibuprofen, and Benadryl. The symptoms were treated. The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Redness on injection site; Swelling on injection site; Chills; Fever of 101; Body Aches; Swelling in the arm pit; Rash in the thigh area.; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness on injection site), injection site swelling (Verbatim: Swelling on injection site), chills (Verbatim: Chills), fever (Verbatim: Fever of 101), general body pain (Verbatim: Body Aches), local swelling (Verbatim: Swelling in the arm pit) and rash (Verbatim: Rash in the thigh area.). The outcome of the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash were not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The patient (nurse) was the reporter. The patient received the1st dose of Shingrix recently. After the vaccination the patient experienced chills, fever of 101, body aches, redness and swelling on injecting site, swelling in the arm pit, then a rash in the thigh area. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: Redness on injection site; Swelling on injection site; Chills; Fever of 101; Body Aches; Swelling in the arm pit; Rash in the thigh area.; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness on injection site), injection site swelling (Verbatim: Swelling on injection site), chills (Verbatim: Chills), fever (Verbatim: Fever of 101), general body pain (Verbatim: Body Aches), local swelling (Verbatim: Swelling in the arm pit) and rash (Verbatim: Rash in the thigh area.). The outcome of the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash were not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The patient (nurse) was the reporter. The patient received the1st dose of Shingrix recently. After the vaccination the patient experienced chills, fever of 101, body aches, redness and swelling on injecting site, swelling in the arm pit, then a rash in the thigh area. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, General symptom
Clinical narrative: Heat in head and typical symptoms; This non-serious case was reported by a consumer and described the occurrence of feeling hot in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rosacea and dust allergy. Concomitant products included fexofenadine hydrochloride (Allegra) and ivermectin (Soolantra).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 26-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling hot (Verbatim: Heat in head and typical symptoms). On 27-MAR-2023, the outcome of the feeling hot was resolved (duration 1 day).   It was unknown if the reporter considered the feeling hot to be related to Shingles vaccine.     It was unknown if the company considered the feeling hot to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023046750   Additional Information: GSK Receipt date: 29-MAR-2023 This report was submitted via the online direct entry reporting system. The patient had difficulty first vaccine with heat in head and typical symptoms and symptoms was treated. Severe heat felt in brain and spinal cord. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023046750:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product use in unapproved indication
Clinical narrative: Varicella immunization requested, HCP advised Shingles vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Shingrix. On 29-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: Varicella immunization requested, HCP advised Shingles vaccine). The outcome of the drug use for unapproved indication was unknown.   Additional Information: GSK receipt date: 29-Mar-2023 The patient received a dose of Shingrix on the day of reporting, but the company said this did not meet the requirement for varicella. The patient asked that was this correct. The patient was trying to understand if Shingrix vaccination was equivalent to Varicella vaccination. The patient stated that his/her physician led him/her down the wrong path. The patient did not mind to had the shingles vaccine, as he/she was not far from 60 years old. This just did not meet the requirement of the company vendor requirements. The patient did not want to went down that path until he/she communicate with his/her physician.  The patient stated that he/she will should had consulted with his/her daughter (who was a pharmacist). If the patient was not satisfied with the physician's response, he/she would then reach out to contact the safety department. The follow-up could not be possible as no contact details were available. The patient had to have the Varicella immunization, but the patient's physician said he/she should just do the shingles vaccination and received a dose of Shingrix on the day of reporting, but the company said this did not meet the requirement for varicella, which led to drug use for unapproved indication.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Mild symptoms, slight fever; Tired the following day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Received first dose on an unknown date, refer case US2023AMR050200).   On 28-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 29-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced fever (Verbatim: Mild symptoms, slight fever) and tiredness (Verbatim: Tired the following day). Rechallenge with Shingles vaccine was positive. The outcome of the fever and tiredness were not reported.   It was unknown if the reporter considered the fever and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the fever and tiredness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050200   Additional Information: GSK receipt date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got his/her second dose on Tuesday. Same mild symptoms as the first, slight fever and tired following day. The follow up would not be possible as no contact details were provided.; Sender's Comments:  US-GSK-US2023AMR050200:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Mild symptoms, slight fever; Tired the following day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced fever (Verbatim: Mild symptoms, slight fever) and tiredness (Verbatim: Tired the following day). The outcome of the fever and tiredness were resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the fever and tiredness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050198   Additional Information: GSK receipt date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got his/her first dose experienced mild symptoms as the first, slight fever and tired following day. The follow up would not be possible as no contact details were provided.; Sender's Comments:  US-GSK-US2023AMR050198:Same reporter.