chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Limb injury, Poor quality product administered, Syringe issue, Underdose
Clinical narrative: The patient swatted at the syringe and the needle scrapped the patients leg; The nurse then administered the dose to the patient from that same syringe that had some of the dose leak out and that the patient received a less than recommended dose / she is unsure of how much of the dose the patient received.; some of the PROQUAD leaked out of the syringe.; the nurse then administered the dose to the patient from that same syringe that had some of the dose leak out; This spontaneous report has been received from a nurse referring a 4-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-MAR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), subcutaneous injection ,at a dose of 0,5 milliliter, lot number W030849 that has been verified to be a valid lot number with expiration date 26-MAR-2024, administered subcutaneously for prophylaxis (strength, vaccination scheme, anatomical site of application were not provided).  On that same day, the patient swatted at the syringe, the needle scrapped the patients leg (limb injury) and some of the with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant Human albumin (rHA), leaked out of the syringe (syringe issue), then the nurse then administered the dose to the patient from that same syringe that had some of the dose leak out, she was unsure of how much of the dose the patient received or if received a less than recommended dose (underdose) (poor quality product administered).   The outcome and the action taken with suspect therapy was not provided.   The causal relationship between the events and (PROQUAD) was not reported.
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Patient uncooperative, Scratch, Underdose
Clinical narrative: The patient swatted at the syringe and the needle scrapped the patients leg; The nurse then administered the dose to the patient from that same syringe that had some of the dose leak out and that the patient received a less than recommended dose / she is unsure of how much of the dose the patient received.; some of the PROQUAD leaked out of the syringe.; the nurse then administered the dose to the patient from that same syringe that had some of the dose leak out; This spontaneous report has been received from a nurse referring a 4-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-MAR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), subcutaneous injection ,at a dose of 0,5 milliliter, lot number W030849 that has been verified to be a valid lot number with expiration date 26-MAR-2024, administered subcutaneously for prophylaxis (strength, vaccination scheme, anatomical site of application were not provided).  On that same day, the patient swatted at the syringe, the needle scrapped the patients leg (limb injury) and some of the with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant Human albumin (rHA), leaked out of the syringe (syringe issue), then the nurse then administered the dose to the patient from that same syringe that had some of the dose leak out, she was unsure of how much of the dose the patient received or if received a less than recommended dose (underdose) (poor quality product administered).   The outcome and the action taken with suspect therapy was not provided.   The causal relationship between the events and (PROQUAD) was not reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces
Clinical narrative: foamy poops; This spontaneous report was received from a Medical Assistant, via Company Representative, and refers to a 3-month-old male patient (Also reported as "her grandson"). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unspecified date in 2023 (at 2 Months Old), the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral for prophylaxis (Strength, dose, frequency, lot number and expiration date were not reported).   On an unspecified date in 2023, 2 weeks after the patient received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced foamy poops (abnormal faeces). It was reported that the patient did not seek for medical attention and that no treatment was provided for the event. At the reporting time, the outcome of the event was not provided.   The causal relationship between the event and therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE details or PQC.; administration of PROQUAD instead of VARIVAX to a patient; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-MAR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W032152, expiration date: 07-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) with sterile diluent (manufacturer unknown),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided); instead of  varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Wrong vaccine administered). No additional adverse event administered.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Depressed level of consciousness, Wrong product administered
Clinical narrative: Decreased alertness; This serious case was reported by a physician and described the occurrence of alertness decreased in a infant female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   The patient's past medical history included congenital aortic stenosis (on 07-NOV-2022), prematurity (on 07-NOV-2022, 36 weeks gestation), congenital mitral stenosis (on 07-NOV-2022), aortic coarctation (on 07-NOV-2022) and secondary hypertension (on 07-NOV-2022).   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced alertness decreased (Verbatim: Decreased alertness) (serious criteria GSK medically significant). The outcome of the alertness decreased was not reported.   It was unknown if the reporter considered the alertness decreased to be related to Pediarix and Pediarix Pre-Filled Syringe Device.  It was unknown if the company considered the alertness decreased to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient: US2023031103, US2023AMR044927   Additional Information: GSK Receipt Date: 21-MAR-2023 The reporter reported that on 10 February 2023, the patient was scheduled to receive a dose of Pediarix alone as part of her 4 month vaccine series.  She had decreased alertness after her two-month vaccines, so patient's mom had requested to get each of the 4 month vaccines on separate days. She had scheduled for a nurse visit only, to receive the vaccine and then leave the clinic, so no medical provider saw the patient that day. The medical assistant who gave the vaccine mistakenly gave a Flulaval vaccine instead of a Pediarix vaccine.  This case has been linked to the case US2023031103 reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023031103:Same reporter US-GSK-US2023AMR044927:Same reporter / Invalid case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Get shingles after getting vaccinated with Shingrix/ Suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Get shingles after getting vaccinated with Shingrix/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-MAR-2023 The physician reported that he had seen patients got shingles after getting the Shingrix vaccine. He did not provide additional information and said it was due to a specific Shingles vaccine. He stated this after discussion of Shingrix indication, efficacy and safety, made the above comment and had to return to patients and did not get further clarification. The reporter did not agree to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: patients complain of acute hearing loss; This serious case was reported by a nurse via sales rep and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss (Verbatim: patients complain of acute hearing loss) (serious criteria GSK medically significant). The outcome of the hearing loss was not reported.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.     It was unknown if the company considered the hearing loss to be related to Shingrix.   Additional Information: GSK receipt date:22-MAR-2023 The reporter reported that the patient complained of acute hearing loss after administration of Shingrix vaccine. Some resolve but some sent to specialty. The reporter agrees to follow up from GlaxoSmithKline. This case had been linked with US2023AMR044540 reported by the same reporter; Sender's Comments:  US-GSK-US2023AMR044947:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Acute hearing loss; This serious case was reported by a nurse via sales rep and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss (Verbatim: Acute hearing loss) (serious criteria GSK medically significant). The outcome of the hearing loss was recovered/resolved.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.     It was unknown if the company considered the hearing loss to be related to Shingrix.   Additional Information: GSK receipt date:22-MAR-2023 The reporter reported that the patient complained of acute hearing loss after administration of Shingrix vaccine. Some resolve but some sent to specialty. The reporter agrees to follow up from GlaxoSmithKline. This case had been linked with US2023AMR044540 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR044540:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shot and got shingles/suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot and got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient's friend via interactive digital media. The patient took the shot and got shingles. The reporter did not believed in that either. The reporter reported that he/she could and have had both and in hospital for kidney stones removal. But shingles worse, which the reporter had probably went down in history for having so many times. The reporter stated that shingles can get in your eyes also and which it did. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shots, had it twice/suspected vaccination failure; had it twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shots, had it twice/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shots and had them twice and it was terrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was conservatively processed with suspected vaccination and shingles events considering that the patient received the shingles shots and had target disease.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Then shot it been back 2 more times/suspected vaccination failure; It back 2 more times not as bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them once was bad).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Then shot it been back 2 more times/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It back 2 more times not as bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-Mar-2023 The case was received from the patient via interactive digital media. The patient had shot and it had been back 2 more times but not as bad. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shingles shot, but ended with shingles/suspected vaccination failure; shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles shot, but ended with shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shingles shot but he/she had ended up with shingles and there painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have had the shingles vaccine, and still got them/Suspected vaccination failure; Shingles not as severe; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have had the shingles vaccine, and still got them/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles not as severe). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient had the Shingles vaccine and still got them, maybe not as severe, but had been at this now for three months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Mobility decreased, Pain, Vaccination failure
Clinical narrative: Had shots, however have had shingles/Suspected Vaccination Failure; had shingles, are hellish; shots hurt like hell; couldn't move the arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots, however have had shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: had shingles, are hellish), pain (Verbatim: shots hurt like hell) and mobility decreased (Verbatim: couldn't move the arm). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and mobility decreased were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she would be honest the shots hurt like hell.  The reporter could not move my arm for four days.  However, the patient have had shingles and would take the shots anyway.  The patient stated that shingles were hellish. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had my shots but still get them/Suspected Vaccination Failure; still get them/ small spot; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had my shots but still get them/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still get them/ small spot) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient stated that it was painful and had Shingles shots but still got them about once a year.  The patient stated that it was just a small spot now and about the size of a half dollar. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: had 2 shots, have it on face/suspected vaccination failure; have it on face urge to scratch; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 shots, have it on face/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have it on face urge to scratch). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient had the 2 Shingles shots and shingles appeared on his/her right side of face from what he/she had been reading.  The patient would be going to the physician tomorrow.  The patient was fighting the urge to scratch.  The patient's husband got poison oak medicine it helped some what. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the vaccine and still got shingles/suspected vaccination failure; Shingles; Horribly painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, between 2 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Horribly painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine three months ago and still experienced shingles on last week. The patient stated that it was horribly painful sucks. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Herpes zoster, Injury
Clinical narrative: Lifelong autoimmune diseases; shingles; Vaccine injury; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: Lifelong autoimmune diseases) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and injury (Verbatim: Vaccine injury). The outcome of the autoimmune disorder, shingles and injury were not reported.   It was unknown if the reporter considered the autoimmune disorder, shingles and injury to be related to Shingles vaccine.     It was unknown if the company considered the autoimmune disorder, shingles and injury to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The patient had shingles, and nothing compared to the lifelong autoimmune diseases he/she had from a vaccine injury. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated, experience shingles/suspected vaccination failure; shingles symptoms less than severe; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccinated, experience shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles symptoms less than severe). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient's wife interactive digital media. The reporter stated that her husband and she both got vaccinated with Shingles vaccine. The patient did just recently experience shingles, but symptoms were much less than severe than what they had heard. A The reporter stated that apparently the vaccination was 90 percent effective. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shot still have it/suspected vaccination failure; suffering with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot still have it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: suffering with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient was suffering right now with shingles.  The patient had a Shingles shot and still had it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles shot, then had shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles shot, then had shingles) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 The patient got the shingles shot and then had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, got them anyway; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot, got them anyway) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 The reporter reported the case via interactive digital media. The reporter's friend got the shot, got them anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shingrix still have break outs; have shingles break outs; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (recurrent shingles and had them well over a dozen times).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had shingrix still have break outs) (serious criteria GSK medically significant), shingles (Verbatim: have shingles break outs) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-Mar-2023 The reporter reported the case via interactive digital media. The patient had recurrent shingles and had them well over a dozen times.  The patient had the Shingrix vaccine and still had break outs. The reporter said it was painful. The patient was hoping one day that the chicken pox could be eradicated so people do not had to suffer from shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had gotten the shot and it was excruciating/Suspected vaccination failure; It was excruciating; It was excruciating; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had gotten the shot and it was excruciating/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: It was excruciating) and pain (Verbatim: It was excruciating). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient said shingles was excruciating. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles after the shot/suspected vaccination failure; had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before shot).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles after the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got his/her too, had shingles before and after the shot. The patient stated that hopefully that was it for him/her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had Shingles, was vaxxed against it/Suspected Vaccination Failure; Had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had Shingles, was vaxxed against it/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that shingles was something, people who got vaccinated against shingles and got shingles.  The reporter further stated that every person he/she knew who had shingles was vaccinated against it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the 2 shots, then had it 2 years ago/ suspected vaccination failure; Shingles on back thigh; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the 2 shots, then had it 2 years ago/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on back thigh). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received two doses of Shingles vaccine and then experienced shingles two years ago on his/her back thigh. The patient stated that for the last month he/she felt as if shingles wanted to come back in the same spot. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Need walking aids and wheelchair for the rest of life; Need walking aids and wheelchair for the rest of life; This serious case was reported by a consumer via interactive digital media and described the occurrence of wheelchair user in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced wheelchair user (Verbatim: Need walking aids and wheelchair for the rest of life) (serious criteria disability) and walking aid user (Verbatim: Need walking aids and wheelchair for the rest of life) (serious criteria disability). The outcome of the wheelchair user and walking aid user were not reported.   It was unknown if the reporter considered the wheelchair user and walking aid user to be related to Shingles vaccine.     It was unknown if the company considered the wheelchair user and walking aid user to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. GBS or CIDP is a debilitating life sentence if you had an allergic reaction to this shot.  The patient went from being a health active person to needing walking aids and wheelchair for the rest of his/her life.  The patient said if he/she could go back and redo getting the shot he/she would rather suffer with shingles than go through what he/she went through and would always had the reminder of getting the shot. The follow-up would not possible as no contact details were available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Oral herpes
Clinical narrative: Arm sore at site of injection; Cold sore on mouth; Feeling lethargic; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 31-JAN-2023, the patient received the 2nd dose of Shingrix. On 03-FEB-2023, 3 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Arm sore at site of injection), cold sores (Verbatim: Cold sore on mouth) and lethargy (Verbatim: Feeling lethargic). On 10-FEB-2023, the outcome of the injection site pain, cold sores and lethargy were recovered/resolved (duration 7 days).   It was unknown if the reporter considered the injection site pain, cold sores and lethargy to be related to Shingrix.     It was unknown if the company considered the injection site pain, cold sores and lethargy to be related to Shingrix.   Additional Information: GSK Receipt date: 14-MAR-2023 The reporter was the patient. The patient stated that she had the second Shingrix (singles vaccine) and had a cold sore develop on her mouth that lasted about a week.. The patient also stated that she felt lethargic for a couple of days after the shot, also stated that her arm was sore at site of injection.  No other information provided
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine with an associated reaction of pruritus (received 1st dose on an unknown date, refer link case US2023AMR036645).   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 pruritus. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR036645   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had shingles they were bad took. One vaccine fifty dollars Later got second vaccine. The patient had itching every now and then. Note: it was unknown whether itching was after 1st dose or 2nd dose or after both doses. Therefore, conservatively captured for both doses.; Sender's Comments:  US-GSK-US2023AMR036645: