chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Feeling abnormal, Headache, Herpes zoster, Incomplete course of vaccination
Clinical narrative: passed out; Shingles; She had declined to take the second dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety, macular degeneration, gastroesophageal reflux disease, allergy and cholesterol. Concomitant products included paroxetine, pantoprazole, montelukast, atorvastatin, ascorbic acid;betacarotene;cupric oxide;tocopheryl acetate;zinc oxide (Preservision), colecalciferol (Vitamin D 3), vitamins nos (Multivitamin) and paraffin (Mineral).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced passed out (Verbatim: passed out) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: She had declined to take the second dose of Shingrix). The outcome of the passed out and shingles were unknown and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the passed out and shingles to be related to Shingrix.     The company considered the passed out to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date : 21-APR-2025 She reported that she received one dose of SHINGRIX about 5 or 6 years ago.  Two weeks later she noted a severe headache.  The following morning she had a swollen right eye.  The rash on her face and side of head, into her hair line followed soon after.  She stated that she was sick for 2 months.  She stated the pain during this time was the worst she had ever experienced.  The itching and weird feeling lasted a few months more.  She reported that she had a visit with her Ophthalmologist during this time and passed out in the chair due to the close quarters and too many people in the room.  She had declined to take the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Malaise, Pain, Pruritus, Rash
Clinical narrative: passed out; Shingles; She had declined to take the second dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety, macular degeneration, gastroesophageal reflux disease, allergy and cholesterol. Concomitant products included paroxetine, pantoprazole, montelukast, atorvastatin, ascorbic acid;betacarotene;cupric oxide;tocopheryl acetate;zinc oxide (Preservision), colecalciferol (Vitamin D 3), vitamins nos (Multivitamin) and paraffin (Mineral).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced passed out (Verbatim: passed out) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: She had declined to take the second dose of Shingrix). The outcome of the passed out and shingles were unknown and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the passed out and shingles to be related to Shingrix.     The company considered the passed out to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date : 21-APR-2025 She reported that she received one dose of SHINGRIX about 5 or 6 years ago.  Two weeks later she noted a severe headache.  The following morning she had a swollen right eye.  The rash on her face and side of head, into her hair line followed soon after.  She stated that she was sick for 2 months.  She stated the pain during this time was the worst she had ever experienced.  The itching and weird feeling lasted a few months more.  She reported that she had a visit with her Ophthalmologist during this time and passed out in the chair due to the close quarters and too many people in the room.  She had declined to take the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Aneurysm, Autoimmune disorder, Death
Clinical narrative: Autoimmune disorder; he had an aneurysm and died; This serious case was reported by a consumer via sales rep and described the occurrence of autoimmune disorder in a elderly male patient 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 autoimmune disorder (Verbatim: Autoimmune disorder) (serious criteria death, GSK medically significant and other: Serious as per reporter) and aneurysm (Verbatim: he had an aneurysm and died) (serious criteria death). The patient died in APR-2025. The reported cause of death was autoimmune disorder and aneurysm.   It was unknown if the reporter considered the autoimmune disorder and aneurysm to be related to Shingrix.     The company considered the autoimmune disorder and aneurysm to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2025 The reporter was a neighbor of the patient who died. Reporter reported that after taken Shingrix, patient developed an autoimmune disorder in which he was prescribed continued use of steroids.  An unknown amount of time later he had an aneurysm and died. The reporter stated death was sometime in last week (from the date of reporting) he/she thought and believed due to an aneurysm.; Sender's Comments: Autoimmune disorder and Aneurysm are unlisted events which are considered unrelated to GSK vaccine Shingrix.; Reported Cause(s) of Death: Autoimmune disorder; Aneurysm
Vaccine: VARZOS
Symptoms: Aphasia, Cardiac arrest, Guillain-Barre syndrome, Intensive care, Loss of control of legs
Clinical narrative: cardiac arrest; GBS/could not talk/lost control of legs; This serious case was reported by a consumer via interactive digital media and described the occurrence of cardiac arrest in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced cardiac arrest (Verbatim: cardiac arrest) (serious criteria hospitalization, GSK medically significant and life threatening) and guillain barre syndrome (Verbatim: GBS/could not talk/lost control of legs) (serious criteria hospitalization and GSK medically significant). The outcome of the cardiac arrest and guillain barre syndrome were not reported.   The reporter considered the cardiac arrest and guillain barre syndrome to be related to Shingles vaccine.     The company considered the cardiac arrest and guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. Patient took the first shot in June of 2022 and 10 days later lost control of legs and went to emergency room.  Patient came down with the worst side effects of shot Guillain Barre syndrome and spent 6 weeks in the hospital, one week in ICU.  Patient went into cardiac arrest and almost died and was completely paralyzed and could not talk. Patient stated that it was from the shot and was done with all shots.; Sender's Comments: Cardiac arrest and Guillain-Barre syndrome  are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Paralysis
Clinical narrative: cardiac arrest; GBS/could not talk/lost control of legs; This serious case was reported by a consumer via interactive digital media and described the occurrence of cardiac arrest in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced cardiac arrest (Verbatim: cardiac arrest) (serious criteria hospitalization, GSK medically significant and life threatening) and guillain barre syndrome (Verbatim: GBS/could not talk/lost control of legs) (serious criteria hospitalization and GSK medically significant). The outcome of the cardiac arrest and guillain barre syndrome were not reported.   The reporter considered the cardiac arrest and guillain barre syndrome to be related to Shingles vaccine.     The company considered the cardiac arrest and guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. Patient took the first shot in June of 2022 and 10 days later lost control of legs and went to emergency room.  Patient came down with the worst side effects of shot Guillain Barre syndrome and spent 6 weeks in the hospital, one week in ICU.  Patient went into cardiac arrest and almost died and was completely paralyzed and could not talk. Patient stated that it was from the shot and was done with all shots.; Sender's Comments: Cardiac arrest and Guillain-Barre syndrome  are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Inflammation, Surgery
Clinical narrative: inflammatory tailspin; This serious case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles 4 years before vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced inflammation (Verbatim: inflammatory tailspin) (serious criteria clinically significant/intervention required). The outcome of the inflammation was not reported.   It was unknown if the reporter considered the inflammation to be related to Shingles vaccine.     The company considered the inflammation to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles then got the Shingles vaccine 4 years later. The patient stated he/she even spaced the two doses out a little further in hopes of not having any side effects.  The vaccine was horrible. The patient stated, sent his/her body into an inflammatory tailspin resulting in surgery to correct.  The patient stated that shingles was worse than childbirth, but the reaction to the vaccine was much easier.; Sender's Comments: Inflammation is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful thing I've ever experienced/agony; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful thing I've ever experienced/agony). The outcome of the pain was resolved (duration 29 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that the most painful thing he/she had ever experienced.  Twenty nine days of pure agony because he/she forgot to get the second vaccine..
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with lysine. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient had shingles, patient was vaccinated and still had after-effects.  Patient stated that lysine or zosterex that contains lysine in its composition, it makes the virus sleep, helped them a lot. Also reported that when immunity drops, it starts to disturb, that's why they use this medication. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was resolved (duration 1 month).   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that the patient got the shingles shot and within two weeks had the shingles for almost a month.
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; ended up with shingles in my eye; 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, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: ended up with shingles in my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date : 26-APR-2025 This case was reported by a patient via interactive digital media. The patient received the shingles shot and a month later ended up with shingles in his/her eye.  The patient stated that never again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: I was sick; arm felt like it was broken it hurt so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I was sick) and pain in arm (Verbatim: arm felt like it was broken it hurt so bad). The outcome of the sickness was resolved and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the sickness and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2025 The case was received from the patient via interactive digital media. The reporter got the vaccine on the second dose he/she was sick for over a week and his/her arm felt like it was broken it hurt so bad.  But the reporter was still glad he/she got it because of all the bad stories of the shingles.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. The patient took this shot and still got it. It was not as bad as others but wished had not taken it. Patient mom had and it was reason to get the shot. The patient remembered her painful time. They did not know what it was till she went to doctor. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; gotten shingles was after they got the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: gotten shingles was after they got the vaccine). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:27-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that ironically the only people he/she know that had gotten shingles was after they got the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; everyone that comes to him with shingles has had the shot; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: everyone that comes to him with shingles has had the shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a reporter via interactive digital media.  Reporter's physician told him/her that everyone that comes to him with shingles has had the shot, and it does nothing but made big pharma richer. He also told reporter not to waste time and put that in his/her body, it was no good. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; took 3 visits to get diagnosed; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: took 3 visits to get diagnosed). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. The patient had the shots too and it took 3 visits to get diagnosed, emergency room, urgent care and family physician 10 out of 10 on the pain chart. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; Shingels; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingels). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that you could get shingles even with the vaccine.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got the first shot over a year, ago but never got the second; This non-serious 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Received the first shot over a year).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: got the first shot over a year, ago but never got the second). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient got the first shot over a year ago but never got the second, so do the patient need to start all over? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I got sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I got sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got sick with the second dose.  Th patient stated it was first time they ever had a reaction to a vaccine.  But they figured way better than getting shingles.
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; rsv three weeks later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 3 weeks after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: rsv three weeks later). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK receipt date: 26-APR-2025 This case was reported by a patient via interactive digital media.  Patient stated that took the rsv shot and came down with rsv (respiratory syncytial virus infection) three weeks later. This case was considered as suspected vaccination failure as laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular administration of Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 19-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 28-APR-2025, the patient received Priorix (intramuscular). On 28-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-APR-2025 The nurse practitioner gave patient the MMR vaccine, the Priorix, the only thing was it was given intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administration by other route. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional mentioned that the birth gender of the patient was male, but the legal gender was female.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after temp. excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number PJ3RP) for prophylaxis.   On 22-APR-2025, the patient received Menveo and Boostrix. On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temp. excursion). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-APR-2025 The reporter called to report a temperature excursion then healthcare professional asked that between the time that the excursion happened until one day before the reporting date, there was 8 vaccines administered, and that's completely fine, correct. The vaccine administration facility was the same as primary reporter. The reporter mentioned that after the temperature excursion, they administered 8 vaccines. This patient received Boostrix and Menveo (1 vial) after temperature excursion, which led to incorrect storage of drug.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: A 63 years old male patient received Priorix IM instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 63-year-old male patient who received MMR (Priorix) (batch number 82B72, expiry date 13-SEP-2026) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 63 years old male patient received Priorix IM instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-APR-2025 On 29th April 2025, a pharmacist had called to report that a 63 year old male patient had received Priorix intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route. The pharmacist had stated that it had probably not reached the muscle completely because she had used a 5/8 inch needle.
Age: 17.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered, Interchange of vaccine products
Clinical narrative: EXPIRED DOSE ADMINISTERED; INTERCHANGE OF VACCINES.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired drug administered in a 17-year-old female patient who received HBV (Engerix B) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 21-APR-2025, the patient received the 1st dose of Engerix B. In MAR-2025, the patient received Heplisav b. On 21-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired drug administered (Verbatim: EXPIRED DOSE ADMINISTERED) and interchange of vaccine products (Verbatim: INTERCHANGE OF VACCINES.). The outcome of the expired drug administered and interchange of vaccine products were not applicable.   Additional Information: GSK Receipt Date: 30-APR-2025 The physician reported that a patient received Engerix on April 21st and unfortunately we found out later that the vaccine had expired on April 11th, which led to expired vaccine used. The reporter was ask what are the adverse effects on that also ask unfortunately received as well heplisav a month prior and we found out after that the Heplisav is not approved for her age range, which led to interchange of vaccine products. The reporter was ask  if they should expect any adverse effects for administering an expired Engerix and if there is like additional adverse effects to be expected for her receiving Heplisav a month before that.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: .  A 77-year-old male patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), on 17Apr2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2025, outcome "unknown" and all described as "Diagnosed with covid". The event "diagnosed with covid" required emergency room visit.  Clinical course: Caller stated that he was diagnosed with covid on Saturday (26Apr2025) at the ER and was taken to the hospital by an ambulance. He didn't know when the symptoms started. He had a vaccine for covid on 17Apr2025. He didn't have any symptoms for a few days. He was told Paxlovid works if you take the medicine within so many days of your first symptoms. First symptom could have been maybe within 5 or 6 days afterwards when it was the 17th and today (28Apr2025) the 11th day after he had the vaccine. And maybe 6 or 7 days after he first noticed the symptoms. He doesn't know if Paxlovid would still be of benefit for him or not because there are some guidelines you need to take it within so many days of first having symptoms of Covid. He added that ha hasn't taken Paxlovid. If it's over 5 days it's not beneficial reporter asked. He was prescribed last Saturday and the pharmacy was closed on Sunday and they called him this Morning. He have not started taking the medicine yet.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: breathes heavy ever since; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "breathes heavy ever since".  Additional information: The reporter stated, "I had blood clots right away years ago but my mom also took the shot she breathes heavy ever since".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 0.92
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Malaise, Oral disorder, Peripheral swelling, Poor feeding infant, Purpura
Clinical narrative: severe purpuric rash of the face and extremities, swelling of the hands, feet and oral lesions associated with malaise, cough, rhinorrhea and poor oral intakewhich began within 24 hours of the vaccines and progressed over the course of a week and the remnants of which are still present 2 1/2 mo later. Was admitted to the hospital and given supportive care and IV antibiotics for an infectious complication of the rash.
Age: 0.92
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Rash, Rhinorrhoea, Skin lesion
Clinical narrative: severe purpuric rash of the face and extremities, swelling of the hands, feet and oral lesions associated with malaise, cough, rhinorrhea and poor oral intakewhich began within 24 hours of the vaccines and progressed over the course of a week and the remnants of which are still present 2 1/2 mo later. Was admitted to the hospital and given supportive care and IV antibiotics for an infectious complication of the rash.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Bone pain, Product administered at inappropriate site
Clinical narrative: My daughter had her vaccine yesterday and complained that her bone hurt a few hours later in her left arm. As a medical assistant myself, I looked at where the injection site was, and it was too close to the shoulder. The placement was too high and too close to shoulder. Patient woke up this morning with the pain being worse than the day before.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 101F
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: Severe L deltoid pain around the injection site with limited ROM w/ abduction, trx includes NSAIDS, activit mod and ice
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Nausea
Clinical narrative: about 3 hours after injection was received, pt complained of significant flu-like symptoms (fever of 101, chills, nausea and lightheadedness. Also complained of headache.  Pt was referred to PCP for evaluation for flu and COVID testing
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: about 3 hours after injection was received, pt complained of significant flu-like symptoms (fever of 101, chills, nausea and lightheadedness. Also complained of headache.  Pt was referred to PCP for evaluation for flu and COVID testing
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: c/o arm pain the day after injection. Day three developed cough requiring treatment.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Influenza virus test negative, SARS-CoV-2 test negative, Wheezing
Clinical narrative: developed wheezing 4/27 with subsequent onset of cough requiring treatment with steroids and antibiotics.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Patients reaction was light headed and dizzy.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Hypervolaemia, Influenza virus test negative, Oxygen saturation decreased
Clinical narrative: onset of cough and congestion 4/28 with decreased oxygen levels and vomiting
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative, Vomiting
Clinical narrative: onset of cough and congestion 4/28 with decreased oxygen levels and vomiting
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT HAPPENED TO THE PATIENT
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site reaction, Paraesthesia, Skin exfoliation
Clinical narrative: Tingling to right hand, upper back pain that started "pretty quickly after the shot." Flaking of skin at injection site and redness at injection site in addition to tingling of right hand and arm and back pain on right upper back.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm soreness and swelling
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Patient came in today for a well child appointment at 4:20pm.  He was also due for two vaccines, menveo and bexsero.  He had previously gotten the first dose and was scheduled to receive the second dose today.  No noted reaction to any vaccine in our office previously.  Grandma accompanied him to his appointment today, called mom and got verbal consent for patient to get his vaccines.  He was talkative while the MA went in to give him the shots.  Afterwards, they went to checkout, patient was talking to the receptionist scheduling his next appointment.  Suddenly he said 'I think I have to' then fell down.  He hit his bottom first then fell back and hit the back of his head on the floor, grandma was unable to catch him.  Our phlebotomist came running thinking the patient had labs done.  Dr. and MAs were close and came running.  Patient was out for a few minutes then woke up.  Dr. did an exam, no bump or bleeding, she didn't find anything abnormal.  He was given ice for his head and water to drink.  He sat on the floor for another 5 minutes drinking water and talking to staff.  Patient said that he felt fine, he was able to get up unassisted, and walked to their vehicle.  Patient was advised that the next time he gets vaccines or a blood draw to make sure he stays seated for 10 minutes afterward so that it doesn't happen again.  I don't think that it was preventable because it had never happened to him before per his report, but after the fact grandma mentioned that it did happen to patient's father once or twice.
Age: 0.67
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event
Clinical narrative: No adverse reaction. Administration error. Vaccines for client's sibling inadvertently administered to this client with appointments at the same time and in the same room. Parent informed of error and provided instructions for follow-up care if needed.
Age: 27.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Patient fainted after vaccine administration. Patient was pale, and requested water prior to event. Patient was non-responsive for 15 seconds. Patient left facility fully recovered within 20 minutes.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Oropharyngeal pain, Pain, Pruritus, Rash
Clinical narrative: body aches, itchy skin, sore throat, fatigue, rash. Was given diphenhydramine 50mg injectable, patient was feeling better when leaving clinic.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Vaccine was not reconstituted, RN administered only the diluent. Patient was contacted, no concerns at the inj sight. Patient aware of need to readminister vaccine after 1 month then follow continued guidelines for done #2 to finish the series 2-6 months after.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Viral test positive
Clinical narrative: tested r/t complaints of not feeling well