chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Varicella
Clinical narrative: broke out with chicken pox; 2. Vaccines in two days.They gave him vaccine again; off label use; This case was reported by a consumer and described the occurrence of chickenpox in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced chickenpox, drug dose administration interval too short and off label use. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the chickenpox was not recovered/not resolved and the outcome of the drug dose administration interval too short and off label use were unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced chicken pox. For tolerance of 1st dose of Shingles vaccine, refer case US2021AMR178362. The physician gave two vaccines to the patient in two days and broke out with chicken pox. He got the Shingles vaccine, then he broke out.  The reporter took him back to physician, who gave him Shinles vaccine again, he broke out still. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178362:Same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Rash pruritic
Clinical narrative: Approx 15 outbreaks since first and second dose; Rash is itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced approximately 15 outbreaks of Shingles since receiving first).  In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were recovered/resolved.  It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received shingrix vaccine and experienced approximately 15 outbreaks of Shingles. The patient reported that outbreak always occurs on the left side, on the upper buttocks, lower back where the waistband of the underwear lies. The patient stated that rash was itchy and had the appearance on mosquito or spider bites. The reporter consented to follow up. For second dose refer this case US2021177371,reported by the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177371:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took the shingles on thursday and stated was not suffered much but it did hurt a lot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got them really bad after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother in law. The age at vaccination was not reported. The patient got shingles really bad after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (had twice).   In August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and overnight got shingles all over the area of shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, still got Shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 chickenpox (patient had very bad chickenpox when he/she was young which left scars).   In December 2020, the patient received the 2nd dose of Shingles vaccine. In October 2020, the patient received the 1st dose of Shingles vaccine. In February 2021, between 1 and 3 months after receiving Shingles vaccine and between 3 and 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received two doses of Shingles vaccine and still got shingles. The patient was glad that he/she got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; pain; I have been miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles nonstop for almost 2 years since the patient got the shot. The patient was miserable and in pain since received the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles shot for shingles and 3 months later patient experienced shingles. 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 not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Small intestinal perforation
Clinical narrative: perforation in my small intestine; shingles; pain; nerve damage; This case was reported by a consumer via media  and described the occurrence of intestinal perforation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced intestinal perforation (serious criteria GSK medically significant), shingles, pain and nerve damage. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the intestinal perforation, shingles, pain and nerve damage were unknown.   It was unknown if the reporter considered the intestinal perforation, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had Shingles this summer from the date of reporting.  The steroids used to treat them caused a perforation in small intestine. Unspecified Steroids used for treatment were also considered as suspect for intestinal perforation. The pain was unbearable and at the time of reporting the patient had nerve damage.  The patient could get the vaccine in 6 month but the patient had one shot before and was not told to get a 2nd shot of vaccine. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; another attack; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (in 40's).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had vaccine then better one was available then the patient had another attack.  The patient said that the patient did not want them again, it was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; so did I. Ive had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles and had a mild case. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR104430, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104430:comment response
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt awful; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingle shot and said that if you did not feel bad on the 1st one did not let it fool, because he/she felt awful on the 2nd one, but still the patient was glad he/she did it. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles five times; they hurt bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles five times in one year. The patient reported that, it was not fun to get shingles, they hurt bad. The patient finally stayed clear enough to get the shot. The patient suggested that, if you had not got the shot, it was a lot better to get it than to get the shingles. The patient again stated that, shingles hurt like crazy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated, it was not an absolute and wished it were and also stated, they were not fun as you too know. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated, shingles was brutal. The patient also reported that, the vaccine had side effects, especially if you did not rest. All the same, the patient had two different vaccinations and would get a third to avoid shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: shot 1, shot 2 in oct, recently in mouth& troat/ suspect vaccination failure; recently in mouth & troat; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that shingles were terrible. The patient stated every time he or she went for shot, got it. The patient had shingles 5 times. The patient finally was able to get shot 1, shot 2 in October. The patient stated that worst for the patient that had recently in mouth  and throat, and lost a tooth because of it and others questionable.  The patient hope this would stop now. The patient had 3 inside of body and 2 outside. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: is suffering with it right now and she was vaccinated/suspected vaccination failure; shingles; painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's child. The age at vaccination was not reported. The patient was vaccinated with Shingles and was suffered with the Shingles at the time of reporting. As per the reporter, shingles were very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR183382, reproted by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183382:IDM response comment
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shots still got it/suspected vaccination failure; got it; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shots and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccination and still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I took mine and still had a slight case of them/suspected vaccination failure; had a slight case of them.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine and still had a slight case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: it was on my face and eye; shingles on eye; it was on my face and eye. Got 2 Vaccines/suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization) and ophthalmic herpes zoster (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure, shingles and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had Shingles and was admitted into the hospital because it was on face and eye. The patient further specified that the patient got 2 vaccines so far. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: i had shingles. I had a shingle shot / suspected vaccination failure; shingles; pain was unreal; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had Shingles, the pain was unreal. The patient said that he or she never would like to want to go through that again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: 3 shots but still had shingles / Suspected vaccination failure; Had shingles, lite case; Have had 3 shots; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had 3 shots of vaccine which led to extra dose administered. But still the patient had shingles, little case. The patient stated that if he or she did not get the shots he or she would hate to think how bad they would have been. The patient suggested to get the shots. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Vaccine positive rechallenge
Clinical narrative: super tired.; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of fatigue (received 1st dose on an unknown date, refer case US2021AMR183085).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and that left him/her super tired. The patient advised to take vaccine when you could take a couple days off. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183085:same patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: super tired.; This case was reported by a consumer via  interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and that left him/her super tired. The patient advised to take vaccine when you could take a couple days off. The follow-up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2021AMR183058.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183058:same patient same reporter US-GLAXOSMITHKLINE-US2021AMR183058:same patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Inappropriate schedule of product administration, Muscle spasms, Peripheral swelling, Pyrexia
Clinical narrative: The second one about killed me; I had spasms all over my body.; arm swelled up; fevered; arm redness; I got my second a month later; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   In August 2021, the patient received the 2nd dose of Shingles vaccine. In August 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), spasms (serious criteria life threatening), swelling arm (serious criteria life threatening), fever (serious criteria life threatening), erythema of extremities (serious criteria life threatening) and drug dose administration interval too short. On an unknown date, the outcome of the near death experience, spasms, swelling arm, fever, erythema of extremities and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the near death experience, spasms, swelling arm, fever and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient itself. The age at vaccination was not reported. On 17th July 2021, the patient got the 1st Shingles shot and got 2nd a month later, which led to drug dose administration interval too short. The 2nd dose of Shingles about to killed the patient. The patient had spasms all over body.  The patient's arm swelled up, fevered and red. The patient did not think reaction to the Shingles shot was as bad. The follow-up would not possible as no contact details were available. This case has been linked with the case US2021AMR183210, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain
Clinical narrative: had them three times.; excruciating pain; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (has had three times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient's wife. The patient received a dose of Shingrix on 17th July and experienced shingles 3 times and excruciating pain and could not get his 2nd shot. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: pain; had the vaccination and still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. In June 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient had a Shingles vaccine and still got shingles about 2 months ago from reporting date. The patient stated that still not over the pain completely. The doctor said they would had been much worse without the shot. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles all over; This case was reported by a physician via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th May 2021).   On 12th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case reported by the patient's spouse, who was also a physician. Retired physician reported that patient had received Shingrix and was now experiencing clear Shingles all over the body on face, neck, trunk, arms and legs.  Outbound call placed to spouse who was also a physician to gather more details.  Physician confirmed that he experienced shingles all over the body on face, neck, trunk, arms and leg after the second dose of Shingrix.  The reporter did not consent to follow-up. This case was linked with US2021177363 and US2021177365, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177363:same reporter US-GLAXOSMITHKLINE-US2021177365:reporter´s case
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin discolouration, Skin reaction, Skin weeping
Clinical narrative: shingles all over; This case was reported by a physician via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th May 2021).   On 12th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case reported by the patient's spouse, who was also a physician. Retired physician reported that patient had received Shingrix and was now experiencing clear Shingles all over the body on face, neck, trunk, arms and legs.  Outbound call placed to spouse who was also a physician to gather more details.  Physician confirmed that he experienced shingles all over the body on face, neck, trunk, arms and leg after the second dose of Shingrix.  The reporter did not consent to follow-up. This case was linked with US2021177363 and US2021177365, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177363:same reporter US-GLAXOSMITHKLINE-US2021177365:reporter´s case
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received Adjuvant  (Without the Lyophilized Antigen Component); received Adjuvant  (Without the Lyophilized Antigen Component); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis.   In August 2021, the patient received Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The clinical coordinator reported that, the patient received the AS01B Adjuvant of Shingrix without lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, 1 patient received only adjuvant of shingrix vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: did not get his second dose within 2-6 months due to the Covid outbreak; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year and a half ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not get his second dose within 2-6 months due to the Covid outbreak, which led to social problem. The reporter was asking for guidance on getting the second dose. Spoke per Shingrix FAQ content containing clinical disease center guidelines to get the second dose as soon as possible. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second shot 7 months after the first vaccine; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th April 2019).   On 30th November 2019, the patient received the 2nd dose of Shingrix. On 30th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received second Shingrix shot approximately 7 months after she received the first vaccine, which led to lengthening of vaccination schedule. The patient did not know the lot number or expiration date of the vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: received full schedule but has no detectable titer; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included dialysis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and the 4th dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that, no other details of patient and vaccine was available. The pharmacist reported that, the patient on dialysis received full schedule, all 4 doses of Engerix-B but had no detectable titer.  The reporter would like to know if there was a booster shot for Engerix-B. The pharmacist did not consent to follow-up.