chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got 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 provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, it was not too bad though. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had an extreme case; 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, 6 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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 both doses of Shingles vaccine, 6 months later, the patient had an extreme case of shingles. At the time of reporting, the patient was in week 8 of shingles and still healing. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Migraine, Photopsia, Vertigo, Vision blurred
Clinical narrative: Inability to regulate temperature (hot to cold in a matter of seconds), vertigo, flashes of light, blurred vision, severe migraine headaches.  Sporadic vertigo and headaches persist 8 days later.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Shot at 2:30 pm, headaches and fever  at 11 pm
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash erythematous, Vaccination failure
Clinical narrative: suspected vaccination failure; diagnosed as shingles on my left arm (underside); blisters that  are very small; bright red patch/spread in a rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and red rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blister and red rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and red rash to be related to Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient's doctor diagnosed with shingles on his/her left arm underside.  The patient reported that, he/she did not have blisters, or if he/she did, they were very small. The patient asked, had a bright red patch on his/her upper under that had spread in a rash. This case was considered as suspected vaccination failure since the details regarding the completion of the primary immunization, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Vaccination failure
Clinical narrative: Supsected vaccination failure; Bells Palsy; internal 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), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, bell's palsy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, bell's palsy 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 still got internal shingles along with Bell's palsy. This case was considered as suspected vaccination failure since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Body ache; Headache; Shivering; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2021, the patient received Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced general body pain, headache and shivering. On an unknown date, the outcome of the general body pain, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache and shivering to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was experiencing body ache, headache, shivering and no fever at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first / vaccine two years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked could get 2nd shot or did have to restart again.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got my first / in Dec; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting,the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the Shingrix over a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a  year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked did have to restart the series.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine / two years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if needed to restart the series or just get the 2nd shot.
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.  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 still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had a severe case; 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 severe shingles. The patient stated that, they did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; ended up getting the 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 ended up getting the shingles. The follow-up would not possible as no contact details were available. 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 of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had it twice; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   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 twice. The follow-up would not possible as no contact details were available. 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 of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got Shingles; Still have nerve pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she had the Shingles shot and still got shingles and still experienced nerve pain, it's been 2 years. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination 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: Had the shot /dealing with internal singles/suspected vaccination failure; internal singles head and face right hand side to back of head; 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and was dealing with internal singles on head, face and right hand side to back of head. The patient stated that he/she was on medication. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: get vaccinated / got it after the vaccine/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.  The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient started getting shingles in late 20s and finally was able to get vaccinated last fall. The patient still got shingles after the vaccine but not as bad as before. The patient stated that nothing is 100 percent. 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. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot / got a mild case/Suspected vaccination failure; Got a mild case of them; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   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 reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and got a mild case of shingles. 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. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after the vaccine / suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient friend. The age at vaccination was not reported. The reporter stated that the patient suffered with shingles after taking the Shingles vaccine, why there were class action lawsuits, but we did not want to talk about that part. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case had been linked with US2021AMR174908, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174908:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: Got my vaccine. / about kilt me; 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.   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 near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated that he/she got Shingles vaccine and the second one about kilt him/her. The patient stated that still glad he/she got it. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/got the shot / got the shingles; 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received Shingles vaccine and still experienced shingles and they were bad. Follow-up would not be possible as no contact details provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles / after this vaccine,/Suspected vaccination failure; Got shingles near their eyes; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient got shingles near her eyes after Shingles vaccine. The follow-up would not possible as no contact details were available. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported. This case had been linked with US2021AMR174985, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174985:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccination / 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had shingles after getting vaccinated. The follow-up would not possible as no contact details were available. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Herpes zoster, Vaccination failure
Clinical narrative: got shingles / after this vaccine/suspected vaccination failure; Got shingles near their eyes; 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 age at vaccination was not reported. The patient got shingles near his/her eyes after Shingles vaccine. The follow-up would not possible as no contact details were available. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported. This case had been linked with US2021AMR174963, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174963:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: First shot / came down with / Shingles; This case was reported by a consumer 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, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: Age at vaccination was not provided. The case was reported by patient himself/herself. The patient got 1st shot and than came down with the shingles. Doctor told the patient not to take the 2nd shot. The follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (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: This case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles. The patient told the doctor that he wanted his money back, as the doctor claimed that he would have had a worse case if he not had the vaccine. The reporter stated that the vaccine did not prevent shingles, as the patient had it pretty bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got vaccinated / got internal shingles 3 weeks later; This case was reported by a consumer via (Facebook) 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 Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and 3 weeks later got shingles which lasted for 3 months. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; get shingles; had three (3) of the injections; 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 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, Shingles vaccine and 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, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had 3 injections and still got shingles. The patient got 3rd dose of Shingles vaccine, which led to extra dose administered. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia eye, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles a while ago and am still numb in my left eye; numb in my left eye; 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and eye numbness. On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown and the outcome of the eye numbness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and eye numbness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccination and still got shingles a while ago and was still numb in the left eye. 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: got vaccinated for shingles / shingles/ suspected vaccination failure; awful case of 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got vaccinated for shingles and a couple of years later, got an awful case of shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose / expiration date: 08/08/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X2XJ7, expiry date 8th August 2021) for prophylaxis.   On 9th August 2021, the patient received Boostrix. On 9th August 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The Medical assistant called to report that, the patient received an expired dose of Boostrix, which led to expired vaccine used. The reporter wanted to know if she had to revaccinate the patient or if the dose given was considered valid. The reporter did not consent to follow up. No further details were reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Disorientation, Irritability, Nightmare
Clinical narrative: Confusion; irritability; nightmares; disorientation; This case was reported by a consumer via call center representative and described the occurrence of confusion in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included duloxetine hydrochloride (Cymbalta) for drug use for unknown indication.   On 5th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient started Cymbalta 60 mg twice daily (120 mg daily). On 7th August 2021, 2 days after receiving Shingrix, the patient experienced confusion, irritability, nightmare and disorientation. The action taken with Cymbalta was unknown. On an unknown date, the outcome of the confusion, irritability, nightmare and disorientation were not recovered/not resolved.   It was unknown if the reporter considered the confusion, irritability, nightmare and disorientation to be related to Shingrix.  Additional details were provided as follows: The case reported by the patient's brother. The patient received the 1st dose of Shingrix and in her left arm for the past 4 nights before reporting date the patient had confusion, irritability, nightmares, and disorientation. The patient was also taking Cymbalta 60mg morning and evening at 5pm which was not a new medication for the patient and she recently had a dose increase from 30mg to 60mg. It was unknown if reporter considered confusion, irritability, nightmares, and disorientation to be related to the Cymbalta use. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: achy; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid vaccine (Covid vaccine received in winters). Concomitant products included acetylsalicylic acid (Aspirin).   On 10th June 2021, the patient received the 1st dose of Shingrix. On 11th June 2021, 1 days after receiving Shingrix, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient received the Covid vaccine in winters. The patient received the 1st dose of Shingrix and next day after the vaccination the patient felt achy and had a sore arm. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR170252.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170252:Same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Chills, Pain in extremity
Clinical narrative: Stomach swollen; Stomach pain; Sore arm; Chills / still present; She had vomited all night; Upset stomach / still present; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th August 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, chills and vomiting. On 8th August 2021, the patient experienced swollen abdomen and stomach pain. In August 2021, the patient experienced upset stomach. The patient was treated with simeticone (Gas X) and ibuprofen (Motrin). On an unknown date, the outcome of the pain in arm and vomiting were recovered/resolved and the outcome of the chills, swollen abdomen, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, vomiting, swollen abdomen, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and within 2 hour, she experienced sore arm, chills, and then she had vomited all night. One day after vaccination, the patient experienced stomach swollen and stomach pain. The patient had taken GasX and Motrin to treat the symptoms, but nothing was alleviating the symptoms. The symptoms of sore arm and vomiting have gotten better, however, chills and upset stomach was still present. The reporter did not have lot number or expiry date of the vaccine. The reporter gave a consent to follow-up with health care professional. However, she did not have the first name of health care professional, a complete address to health care professional, as well as fax number and an email address to health care professional. The reporter provided her email address.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Stomach swollen; Stomach pain; Sore arm; Chills / still present; She had vomited all night; Upset stomach / still present; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th August 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, chills and vomiting. On 8th August 2021, the patient experienced swollen abdomen and stomach pain. In August 2021, the patient experienced upset stomach. The patient was treated with simeticone (Gas X) and ibuprofen (Motrin). On an unknown date, the outcome of the pain in arm and vomiting were recovered/resolved and the outcome of the chills, swollen abdomen, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, vomiting, swollen abdomen, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and within 2 hour, she experienced sore arm, chills, and then she had vomited all night. One day after vaccination, the patient experienced stomach swollen and stomach pain. The patient had taken GasX and Motrin to treat the symptoms, but nothing was alleviating the symptoms. The symptoms of sore arm and vomiting have gotten better, however, chills and upset stomach was still present. The reporter did not have lot number or expiry date of the vaccine. The reporter gave a consent to follow-up with health care professional. However, she did not have the first name of health care professional, a complete address to health care professional, as well as fax number and an email address to health care professional. The reporter provided her email address.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Syringe issue, Underdose
Clinical narrative: partial dose was received; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were provided as follows: The case was reported by the patient for herself. The reporter was a registered nurse (RN), she received a dose of Shingrix to be administered independently from her hospital pharmacy.  The reporter stated a coworker attempted to administer the dose to her but only a partial dose was received after the needle separated from the Tip-Lok syringe which led to incomplete course of vaccination.  The reporter stated that, the syringe used was not a Glaxosmithkline product.  The reporter did not wish to identify the coworker.  The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong Vaccine Administered; Administered to an elven year old child; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th December 2020, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 18th December 2020, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician called to report wrong vaccine administered to a 11 years old patient with Infanrix vaccine, which led to inappropriate age at vaccine administered and wrong vaccine administered. The reporter consented to follow up.