chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What if i miss my second dose of shingrix, can i still get it; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: What if i miss my second dose of shingrix, can i still get it). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 19-MAR-2025 The case was received from the patient via (Shingrix GSK) The reporter asked what if he/she miss his/her second dose of Shingrix, could he/she still get it. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: broke out in cold sores; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold sores in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, 24 hrs after receiving Shingles vaccine, the patient experienced cold sores (Verbatim: broke out in cold sores). The outcome of the cold sores was not reported.   It was unknown if the reporter considered the cold sores to be related to Shingles vaccine.     It was unknown if the company considered the cold sores to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the 2nd vaccine 2 days ago in March 2025 and broke out in cold sores within 24 hours. Patient was glad that the patient got the vaccine, but someone was the first person that has mentioned this side effect that patient could find.
Vaccine: FLUX, VARZOS
Symptoms: Bedridden, Chills, Headache, Malaise, Pyrexia
Clinical narrative: feeling the worst; severe chills; Within a few hours I had a horrible headache; Fever; bedridden; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine. In MAR-2025, less than a week after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced chills (Verbatim: severe chills), headache (Verbatim: Within a few hours I had a horrible headache) and fever (Verbatim: Fever). On an unknown date, the patient experienced bedridden (Verbatim: bedridden) and feeling abnormal (Verbatim: feeling the worst). The outcome of the chills, headache, fever and feeling abnormal were not reported and the outcome of the bedridden was resolved (duration 3 days).   It was unknown if the reporter considered the chills, headache, fever, bedridden and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the chills, headache, fever, bedridden and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter reported that two dose Shingrix vaccine was in short supply here when it was first introduced. The reporter knew he/she wanted to get protected b/c he/she had heard so many stories about how painful shingles was. The reporter was in and happened to notice a sign at the pharmacy announcing they had the Shingrix vaccine in stock. The patient spoke with the pharmacist and told him the reporter was planning to get the flu shot the next day. The reporter asked him if he/she take the first Shingrix vaccine today and the flu shot tomorrow would that cause problems for the reporter. He said it would be fine, so reporter took the shot. The next day at the reporter told the nurse he/she had just had the first Shingrix shot the previous day and asked if the reporter should wait to get a flu shot. She told me it would be fine to take the flu shot now, so the reporter did. The reporter should have listened to his/her gut instead of the two professionals. Within a few hours the reporter had a horrible headache then severe chills. The reporter spent the next three days in bed, feeling the worst the reporter had ever felt. The reporter had fever reached 103°. So a word to the wise, did not make the same mistake reporter did.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; 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.   The patient's past medical history included pain (Pain was excruciating). Previously administered products included Covid-19 vaccine with an associated reaction of herpes zoster.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain). The outcome of the pain was not reported.   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: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient got 1 month after second shot of first Covid vaccine. Got 3 in a row. Out of work more than a month. Pain was excruciating. Right after patient healed got the vaccine. Knock on wood nothing since, sounds like had the same pain but different reasons for getting it.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shingrix shot in 2021 but didn't get the second one until 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first shingrix shot in 2021 but didn't get the second one until 2024). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 24-MAR-2025 The patient had a chat with that GlaxoSmithKline chat bot. The patient had a questioned regarding Shingrix vaccine. The chatbot replay to visitor the GlaxoSmithKline makes medicines and vaccines that need a prescription they cannot give medical advice it was important to talk with doctor or other healthcare provider for guidance based on your medical history. The patient talked chat specialist pharmacist.  The patient stated that he/she had received first Shingrix shot in 2021 but did not get the second one until 2024. The chat specialist replay to the visitor that the GlaxoSmithKline was very interested in learning more about this potential adverse event and comments will be forwarded to our safety department, who may contact you for additional information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: The new vaccine caused me some aches and fever; The new vaccine caused me some aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever (Verbatim: The new vaccine caused me some aches and fever) and pain (Verbatim: The new vaccine caused me some aches). The outcome of the fever and pain were resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was up to you, since Shingles was not contagious, without direct contact to the fluids. If you have not had chicken pox, you were probably good, but 1 in 3 people get shingles and your chances increase as you get older. The new vaccine caused the reporter some aches and fever for a few hours but he/she would do it again anytime. Even a mild case of shingles was horrid.
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: I am still red; I amd still red and hurting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   In MAR-2025, the patient received Shingles vaccine. On an unknown date, the patient received Pneumococcal vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced erythema (Verbatim: I am still red) and pain (Verbatim: I amd still red and hurting). The outcome of the erythema and pain were not resolved.   It was unknown if the reporter considered the erythema and pain to be related to Shingles vaccine.     It was unknown if the company considered the erythema and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she got shot last Tuesday along with the pneumonia shot in the same arm and I am still red and hurting. Better than getting the sicknesses but patient was not expecting such reaction. It was reported that the patient suffered from pneumonia after receiving pneumonia vaccine.  It was unknown if the reporter considered the adverse events to be related to pneumonia vaccine.
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the shingles/had them on my eye 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: still got the shingles/had them on my eye my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was not resolved.   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: 22-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shot for the shingles and still got the shingles and they did hurt, had them on the eye and eye still bothers. 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, 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.   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: 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. Reporter stated that it was not that bad and said thank god that they had two vaccines. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). US-GSK-US2025AMR036210:Different Patient US-GSK-US2025AMR036152:Different Patient
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm was achy from the shot; 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: my arm was achy from the shot). The outcome of the pain was not reported.   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-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that his/her arm was achy from the shot, get the shot.  They could cause blindness and hearing loss and as you age your immune system wanes.  He/she knew many who did not get the shot, had shingles and wished they had gotten the shot.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is really sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My arm is really sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2025 The patient got the 1st of the series of the Shingles vaccine. Patient's arm was really sore but after reading these comments, the patient would rather have the sore arm.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still get 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.   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she still got shingles even after both shingles shots. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got the first shot and I am 3 months late for my 2nd shot; 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 1st dose on an unknown date).   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: I got the first shot and I am 3 months late for my 2nd shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the first shot and he/she 3 months late for his/her 2nd shot. The patient pray to god it will still protect him/her. The patient reported he/she literally forgot. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to    incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles in his ears; he now has shingles on his neck and a couple of spots on his head; 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: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles in his ears) (serious criteria GSK medically significant) and shingles (Verbatim: he now has shingles on his neck and a couple of spots on his head). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster otitis externa 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-MAR-2025 This case was reported by a patient's relative via interactive digital media. The patient had the shingle shot and he now had shingles on his neck, in his ears and a couple of spots on his head.  The reporter stated that it must be the same shot they use for covid. 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: M
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 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: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   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-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient got the shots, and he now had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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, VARZOS
Symptoms: Incomplete course of vaccination, Pyrexia, Tremor
Clinical narrative: fever and trembling late the day I had it; trembling late the day I had it; So I skipped second shot. Dr has discouraged me starting the two part again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever (Verbatim: fever and trembling late the day I had it), tremor (Verbatim: trembling late the day I had it) and incomplete course of vaccination (Verbatim: So I skipped second shot. Dr has discouraged me starting the two part again). The outcome of the fever and tremor were not reported and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the fever and tremor to be related to Shingrix.     It was unknown if the company considered the fever and tremor to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient had a bad reaction from Shingrix 1st shot and had fever and trembling late the day he/she had it.  The patient said nobody warned him/her, so the patient skipped second shot and doctor had discouraged him/her starting the two part again Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm was a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for himself/herself. patient never had a problem arm was a little sore.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: outbreak of herpes; This non-serious case was reported by a physician via sales rep and described the occurrence of herpes virus infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   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 herpes virus infection (Verbatim: outbreak of herpes). The outcome of the herpes virus infection was not reported.   The reporter considered the herpes virus infection to be related to Shingrix.     The company considered the herpes virus infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2025 Patient reported that vaccine caused outbreak of herpes.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got a nasty case of Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got a nasty case of Shingles). The outcome of the shingles was not reported.   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-MAR-2025 This case was reported by the wife of the patient via interactive digital media. The reporter reported that her husband (patient) got a nasty case of Shingles about 3 weeks after he got the vaccine. The reporter wanted to know was it a coincidence, further she stated, she did not know.
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; very sick; 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.   The patient's past medical history included shingles.   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), shingles (Verbatim: shingles) and sickness (Verbatim: very sick). The outcome of the vaccination failure, shingles and sickness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and sickness 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 and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2025 This case was reported by a patient via interactive digital media. Reporter stated that many people he knew said that vaccine made them very sick or they got shingles  shingles again, and much worse than before. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, 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; still 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got 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: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got shingles 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.; 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, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Hypoaesthesia, Pain in extremity, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; shingles was in my lower back with numbness in my upper leg/pain in leg; My shingles was in my lower back with numbness in my upper leg with; The pain brought me to my knees; The pain got better but I didn't feel myself for about a month; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles was in my lower back with numbness in my upper leg/pain in leg), numbness in leg (Verbatim: My shingles was in my lower back with numbness in my upper leg with), knee pain (Verbatim: The pain brought me to my knees) and feeling abnormal (Verbatim: The pain got better but I didn't feel myself for about a month). The outcome of the vaccination failure, shingles and numbness in leg were not reported and the outcome of the knee pain was resolving and the outcome of the feeling abnormal was resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure, shingles, numbness in leg, knee pain and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, numbness in leg, knee pain and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had both doses of the shingles vaccination and developed shingles in his/her lower back with numbness in his/her upper leg with nothing on his/her skin. The pain brought him/her to his/her knees, and it was awful. The pain got better but he/she did not feel his/herself for about a month. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccine and later developed 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: I had the vaccine and later developed 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: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and later developed shingles. 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: Malaise
Clinical narrative: am feeling a little crappy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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 feeling abnormal (Verbatim: am feeling a little crappy). The outcome of the feeling abnormal was not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2025 This case was reported by a patient via interactive digital media.  Patient vaccinated the other day and was feeling a little crappy but after reading comments reporter will deal with it. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Pain
Clinical narrative: my body has been sore; no appetite; headache; no energy at all; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAR-2025, the patient received the 1st dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: my body has been sore), appetite absent (Verbatim: no appetite), headache (Verbatim: headache) and loss of energy (Verbatim: no energy at all). The outcome of the general body pain, appetite absent, headache and loss of energy were not reported.   It was unknown if the reporter considered the general body pain, appetite absent, headache and loss of energy to be related to Shingles vaccine.     It was unknown if the company considered the general body pain, appetite absent, headache and loss of energy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. Reporter just received his/her first vaccination on this past Friday (from the date of reporting). The patient was glad that he/she got it, but his/her body had been sore, no appetite, headache and no energy at all.
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: that area stills burns at least once a week or more; that area stills itch at least once a week or more; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site burning 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 injection site burning (Verbatim: that area stills burns at least once a week or more) and injection site itching (Verbatim: that area stills itch at least once a week or more). The outcome of the injection site burning and injection site itching were not resolved.   It was unknown if the reporter considered the injection site burning and injection site itching to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the injection site burning and injection site itching to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shot and a booster and that area stills burns and itch at least once a week or more.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vacccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female 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: Suspected vacccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. The company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2025 This case was reported by a patient via interactive digital media. The patient received both doses of Shingles vaccine and experienced shingles. The patient did not however get a rash, just the pain on her right side front back and side.  This was the second time she was getting it in 4 years after the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Pain, Ulcer
Clinical narrative: week later I started breaking up with sores around my hairline; 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 Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced pain (Verbatim: week later I started breaking up with sores around my hairline). The outcome of the pain was not reported.   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: 27-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she never had a problem till the doctor said that he/she should get the shot. The patient mentioned week later he/she started breaking up with sores around his/her hairline.
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I just got over the shingles/got it on my left side of my face; I'm still tired; 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), facial herpes zoster (Verbatim: I just got over the shingles/got it on my left side of my face) and tiredness (Verbatim: I'm still tired). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolved and the outcome of the tiredness was not resolved.   It was unknown if the reporter considered the vaccination failure, facial herpes zoster and tiredness 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 facial herpes zoster and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2025 This case was reported by a patient via interactive digital media. The patient just got over the shingles, he/she got them on left side of face and caught them early and had gotten the shingles shot a year ago. The patient was still tired, no scares on face and it could close to eyes, but was lucky. Physician said to the patient it would have been worse if he/she had not gotten the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 , details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: Had redness; swelling reaction; This non-serious case was reported by a nurse via sales rep and described the occurrence of erythema in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero and an unknown time after receiving Menveo, the patient experienced erythema (Verbatim: Had redness) and swelling (Verbatim: swelling reaction). The outcome of the erythema and swelling were not reported.   It was unknown if the reporter considered the erythema and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the erythema and swelling to be related to Bexsero and Bexsero 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.   Additional Information: GSK Receipt Date: 27-MAR-2025 The patient was given a dose of Bexsero less than one week after Menveo was given. The reporter thought in the same arm. The patient had redness and swelling reaction. The parent thought that the patient had gotten a second dose of the same Meningitis vaccine.