chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 15-Dec-2022 (Safety received 14-Mar-2023)   A patient reported to the Registry that she (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization within 28 days of her last menstrual period (LMP). The patient asked if she could register.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) within 28 days The route and site was not provided.   A copy was emailed to the patient. She requested time to read and a return call. Several attempts were made by the pregnancy registry on 15-Dec, 22-Dec and 29-Dec-2022 to follow-up with the patient to confirm if she reviewed the consent and to discuss participation. Voice messages were left requesting a return call with registry hotline number and hours provided. On 05-Jan-2023, a final email was sent. Permission was not provided for Dynavax to follow-up with the patient.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 18-Nov-2022 (Safety received 14-Mar-2023)   A patient reported to the Registry that her sister (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site was not provided.   The reporter was provided with the Dynavax medical information number and declined to provide their contact information. The reporter was requested to provide the Registry number to her sister so she may contact the registry for potential enrollment.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 09-Dec-2022 (Safety received 14-Mar-2023)   A nurse reported to the Registry that a patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when 25 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    08-Dec-2022, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site was not provided. The patient was 25 weeks pregnant.  The nurse was calling about enrollment, but the patient only speaks another language, so the nurse was asking for options. The registry staff asked the reporter if they could call her back with options after speaking with a manager. The patient may not be able to be consented if she does not understand as is not translated.   The Pregnancy Registry attempted to several follow-ups on 12-Dec, 19-Dec and 29-Dec-2022 with the reporter on whether the reporter would enroll the patient de-identified and left several messages to return the call. Follow-up with the patient was not obtained.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received an Expired Dose; Initial Report Received on 18-Jan-2023   A registered nurse reported that a 51-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 15-Dec-2022, the patient received the first dose of HEPLISAV-B (Lot # 935849, expiration date 13-Jan-2023, and NDC # 43528-003-01) intramuscularly in the left deltoid.  On 17-Jan-2023, 34 days after having received the first dose, the patient received a second dose of HEPLISAV-B that had expired (Lot # 935849, expiration date 13-Jan-2023, and NDC # 43528-003-01) intramuscularly in the right deltoid by another nurse at the clinic. The patient did not experience any adverse effects.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received Out of Date HEPLISAV-B; Initial Report Received on 30-Jan-2023   A licensed practical nurse reported that a 34-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired and was administered HEPLISAV-B as a third dose.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 12-Nov-2019 and 12-Dec-2019, the patient received 2 doses of the Engerix-B vaccine.   On 30-Jan-2023, the patient received the HEPLISAV-B vaccine (Lot # 935844, expiration date 04-Nov-2022, NDC # 43528-003-01) as the third dose of a hepatitis B vaccine intramuscularly in the right deltoid. The HEPLISAV-B vaccine that was given to the patient was expired (88 days). Per the reporter, the patient did not experience any adverse effects.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shot, got a mild case/Suspected vaccination failure; got a mild case; 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 shot, got a mild case/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got a mild case). 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: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient had shot and got a mild case. 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and still got it on my face/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: Got the vaccine and still got it on my face/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: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and still got shingles on his/her face, fortunately there was no pain.  The reporter stated that it was nasty looking though. 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, VARZOS
Symptoms: Herpes zoster, Urticaria, Vaccination failure
Clinical narrative: had both vaccinations now have shingles/suspected vaccination failure; shingles on face; raised welts; 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 (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, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had both vaccinations now have shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on face) and welts (Verbatim: raised welts). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the welts was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was not necessarily.  The patient had both Shingrix vaccinations and now he/she had shingles on the left side of his/her face.  The reporter stated that it appeared that it was going to be a mild case, probably because of Shingrix. So far, he/she did not have blisters but rather, raised welts. 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles vaccine and still got a mild case/Suspected Vaccination Failure; got a mild case; 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 shingles vaccine and still got a mild case/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got a mild case). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 3 weeks).   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: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient had his/her shingles vaccine and still got a mild case of shingles for three weeks. The doctor said that it would have worse if he/she did not get the shingles vaccine. 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: had shingles 3 times/Suspected vaccination failure; had shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 82-year-old 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 shingles 3 times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times). 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: 24-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient had shingles 3 times since getting the shingles vaccine. 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: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shingles recently; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the shingles recently). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Apr-2023 This case was reported by a patient via interactive digital media. The consumer's sister received the Shingles vaccine and experienced the shingles recently. The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter think that the event might have been related to the product or device.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: both Shingrix shots and have had two very light cases/ Suspected vaccination failure; had two very light cases since; 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 (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  The patient's past medical history included shingles.  On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: both Shingrix shots and have had two very light cases/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two very light cases since). 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 Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported by the patient via interactive digital media. The reporter stated that he/she had Shingles then had both Shingrix shots and have had two very light cases (Shingles) since. 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: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Got the two vaccines but it does not give any improvement/Suspected Vaccination Failure; 3 years ago he/she had shingles; Burning; Itching; Pain; 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: Got the two vaccines but it does not give any improvement/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: 3 years ago he/she had shingles), burning sensation (Verbatim: Burning), pruritus (Verbatim: Itching) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the burning sensation, pruritus and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that almost 3 years ago he/she had shingles and still feel the burning and itching.  His/her physician prescribed pills and the patient already got the two vaccines shot of Shingles vaccine but it did not gave him/her any improvement.  The patient still had burning and itching day and night and he/she had both shot of Shingles vaccine, but it was an insupportable pain.  This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not reported.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Vaccination failure
Clinical narrative: Got vaccinated, now I have it; Now I have it; I don't sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had strongly about 15 years before).   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 vaccinated, now I have it) (serious criteria GSK medically significant), shingles (Verbatim: Now I have it) and insomnia (Verbatim: I don't sleep). The outcome of the vaccination failure was unknown and the outcome of the shingles and insomnia were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and insomnia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Apr-2023. the patient vaccinated every certain time they had to get vaccinated. The patient got it very strongly about 15 years ago and now he/she had it again. The patient did not sleep, and already took the medications. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diaphragmatic disorder, Feeding disorder, Herpes zoster, Oesophageal disorder, Vaccination failure
Clinical narrative: had both doses of the Shingrex vaccine... 6 Months later he got the worst kind of Shingles/Suspected vaccination failure; Shingles was the most dangerous type/internal shingles affected his esophagus and diaphragm; lost 11 pounds in less than a week; couldn't eat; 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 (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, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had both doses of the Shingrex vaccine... 6 Months later he got the worst kind of Shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles was the most dangerous type/internal shingles affected his esophagus and diaphragm), weight loss (Verbatim: lost 11 pounds in less than a week) and unable to eat (Verbatim: couldn't eat). The outcome of the vaccination failure was unknown and the outcome of the shingles, weight loss and unable to eat were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, weight loss and unable to eat to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, weight loss and unable to eat to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 25-MAR-2023 The case  was received from the patient's wife via interactive digital media. The patient never had shingles prior to that. The reporter stated that just so you all know that the vaccine did not mean you would not get shingles. The patient got the Shingles vaccine and 6 months later he got shingles. The reporter stated that his type of shingles was the most dangerous because they were internal and they affected his esophagus and diaphragm.  The patient lost 11 pounds in less than a week because he could not eat.  The reporter stated that could had been worse because the shingles could have gone to his liver, kidneys, heart, and brain and in that event he most likely would had died, so did not ever say you could not get singles after taking the vaccine. The reporter stated that vaccine was absolutely not fool proof, so do the research before thinking the vaccine was an absolute solution.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: had both doses of the Shingrex vaccine... 6 Months later he got the worst kind of Shingles/Suspected vaccination failure; Shingles was the most dangerous type/internal shingles affected his esophagus and diaphragm; lost 11 pounds in less than a week; couldn't eat; 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 (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, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had both doses of the Shingrex vaccine... 6 Months later he got the worst kind of Shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles was the most dangerous type/internal shingles affected his esophagus and diaphragm), weight loss (Verbatim: lost 11 pounds in less than a week) and unable to eat (Verbatim: couldn't eat). The outcome of the vaccination failure was unknown and the outcome of the shingles, weight loss and unable to eat were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, weight loss and unable to eat to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, weight loss and unable to eat to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 25-MAR-2023 The case  was received from the patient's wife via interactive digital media. The patient never had shingles prior to that. The reporter stated that just so you all know that the vaccine did not mean you would not get shingles. The patient got the Shingles vaccine and 6 months later he got shingles. The reporter stated that his type of shingles was the most dangerous because they were internal and they affected his esophagus and diaphragm.  The patient lost 11 pounds in less than a week because he could not eat.  The reporter stated that could had been worse because the shingles could have gone to his liver, kidneys, heart, and brain and in that event he most likely would had died, so did not ever say you could not get singles after taking the vaccine. The reporter stated that vaccine was absolutely not fool proof, so do the research before thinking the vaccine was an absolute solution.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and still got shingles/Suspected Vaccination Failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (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 vaccine and still got shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got 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: 25-MAR-2023 The case was received from the patient's siblings via interactive digital media. The reporter stated that his/her sister had the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: can still get shingles if you got the shot/Suspected Vaccination Failure; get 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: can still get shingles if you got the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: get 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: 25-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that you could still get shingles if you got the shingle shot and he/she knew people who had. 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: got the shots and still got shingles; got shingles on back and around the right side; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots and still got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles on back and around the right side). 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: 23-Apr-2023 The patient reported this case via interactive digital media. The patient got the shots and still got shingles on his/her back and around the right side. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles shot and got the shingles for 5 plus years/suspected vaccination failure; got the shingles shot and got the shingles for 5 plus years; 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: got the shingles shot and got the shingles for 5 plus years/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles shot and got the shingles for 5 plus years). 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: 24-APR-2023 This case was reported by the patient's wife via interactive digital media. The reporter had stated that, her husband got the shingles shot and got the shingles for 5 plus years. 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. Follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included CellCept (received CellCept on 6th October 2008) and Tacrolimus (received Tacrolimus on 6th October 2008).   On 13-APR-2023, the patient received the 1st dose of Shingrix. On 15-APR-2023, 2 days after receiving Shingrix, the patient experienced hives (Verbatim: Hives). On 18-APR-2023, the outcome of the hives was resolved (duration 3 days).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date: 18-APR-2023 The case was self reported by the patient. This case was submitted by public reporting reference via the online direct entry reporting system. The patient received first dose of Shingrix and had hives. The patient asked should she got the second shot of Shingrix. The patient reported that symptoms were treated. The reporter did not consent to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: Fatigue; High fever for 9 hrs, low grade fever for 24 hrs; Vomiting; Diarrhea; Mild pain around abdomen; This non-serious case was reported by a consumer and described the occurrence of abdominal pain in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 577BF, expiry date SEP-2023) for prophylaxis.   On 17-APR-2023, the patient received Shingrix .5 ml. In APR-2023, an unknown time after receiving Shingrix, the patient experienced abdominal pain (Verbatim: Mild pain around abdomen). On 17-APR-2023, the patient experienced fatigue (Verbatim: Fatigue), fever (Verbatim: High fever for 9 hrs, low grade fever for 24 hrs), vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). On 19-APR-2023, the outcome of the fatigue, fever, vomiting and diarrhea were resolved (duration 2 days). The outcome of the abdominal pain was not reported.   It was unknown if the reporter considered the abdominal pain, fatigue, fever, vomiting and diarrhea to be related to Shingrix.     It was unknown if the company considered the abdominal pain, fatigue, fever, vomiting and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-APR-2023 The patient had an additional side effect was mild pain around the abdomen. Also experienced fatigue, high fever for 9 hours, low grade fever for 24 hours, vomiting, and diarrhea. The symptoms were not treated.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Rash
Clinical narrative: Rash in arm; Arm stay hot, arm be warm to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingles vaccine. In APR-2023, less than a week after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash in arm) and extremities hot feeling of (Verbatim: Arm stay hot, arm be warm to touch). The outcome of the rash and extremities hot feeling of were not resolved.   It was unknown if the reporter considered the rash and extremities hot feeling of to be related to Shingles vaccine.     It was unknown if the company considered the rash and extremities hot feeling of to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2023 The patient wanted to know that how many days his or her arm would stay hot with rash or warm to touch with a rash, as it had been 4 days since first shingles vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site reaction
Clinical narrative: Injection site reaction; Led to a rash; Shingles outbreak; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site reaction 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 reaction (Verbatim: Injection site reaction), injection site rash (Verbatim: Led to a rash) and shingles (Verbatim: Shingles outbreak). The outcome of the injection site reaction, injection site rash and shingles were not reported.   It was unknown if the reporter considered the injection site reaction, injection site rash and shingles to be related to Shingrix.     It was unknown if the company considered the injection site reaction, injection site rash and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter was a physician assistant. The patient had injection site reaction which led to a rash that presented as a shingles outbreak. The follow-up permission denied.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Arm was sore; Felt like had a bad flu; Headache; Achy body, flu like pain; Nauseous; Felt bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was sore), influenza-like symptoms (Verbatim: Felt like had a bad flu), headache (Verbatim: Headache), general body pain (Verbatim: Achy body, flu like pain), nausea (Verbatim: Nauseous) and feeling bad (Verbatim: Felt bad). The outcome of the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad were not reported.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient went to pharmacy this past monday and got first shingles vaccine. The patient arm was pretty sore the next morning, and he/she felt like he/she had a bad flu. achy body and a headache, nauseous.  Even though patient felt pretty bad. The patient sure from what he/she have read and seen on people. The patient know who have had shingles her/his flu like pain does not compare. The patient will get his/her next vaccine in 6 months.  the patient stated that everyone should get the vaccine like he/she did. even if he/she would get shingles, hopefully it won't be a bad case. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; Felt like had a bad flu; Headache; Achy body, flu like pain; Nauseous; Felt bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was sore), influenza-like symptoms (Verbatim: Felt like had a bad flu), headache (Verbatim: Headache), general body pain (Verbatim: Achy body, flu like pain), nausea (Verbatim: Nauseous) and feeling bad (Verbatim: Felt bad). The outcome of the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad were not reported.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient went to pharmacy this past monday and got first shingles vaccine. The patient arm was pretty sore the next morning, and he/she felt like he/she had a bad flu. achy body and a headache, nauseous.  Even though patient felt pretty bad. The patient sure from what he/she have read and seen on people. The patient know who have had shingles her/his flu like pain does not compare. The patient will get his/her next vaccine in 6 months.  the patient stated that everyone should get the vaccine like he/she did. even if he/she would get shingles, hopefully it won't be a bad case. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Illness, Malaise, Pain, Pyrexia
Clinical narrative: Really sick; Feverish; Ached all over; In bed for a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden 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, an unknown time after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: In bed for a week), sickness (Verbatim: Really sick), fever (Verbatim: Feverish) and general body pain (Verbatim: Ached all over). The outcome of the bedridden was resolved (duration 1 week) and the outcome of the sickness, fever and general body pain were not reported.   It was unknown if the reporter considered the bedridden, sickness, fever and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the bedridden, sickness, fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a terrible reaction to the first of the two new shots. The patient in bed for a week really sick, ached all over, feverish, etc. The patient won't be having any more shots. The patient reported it to appropriate medical authorities. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles three times; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles three times). The outcome of the shingles was resolved (duration 2 months).   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles three times plus the shot. later on she/he had the booster, so praying he/she won't ever have it again.  The first time it lasted for a year.  The next two times was about 2 to 3 months. much lighter also. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information. Note: shingrix vaccine contain 2 doses scheduled as per narrative patient had shingles three times plus the shot and now received booster dose hence for the suspect product dose number capture as one.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm  is sore; Arm  swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Pfizer vaccine with an associated reaction of herpes zoster and Shingles vaccine (1st dose received more than 10 years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm  is sore) and swelling arm (Verbatim: Arm  swollen). The outcome of the pain in arm and swelling arm were not reported.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and swelling arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient got shingles 5 days after he/she had the first Pfizer vaccine shot.  More than 10 years ago the patient had the first shingles vaccine, but have been advised he/she need the new one so, patient just gotten the first shot a few days ago.  The second shot will be in two months.  The patient arm was sore and a bit swollen but no major side effects so far. The patient stated that no one wants to get this disease. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.