chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired Engerix B to 5 different consumers; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of expired vaccine used in a specified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered expired Engerix B to 5 different consumers). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 Nurse practitioner reported that she inadvertently administered an expired Engerix B to 5 different consumers (patients), which led to an expired vaccine used. No additional detail or information were provided. No additional AE (adverse event) reported.  No PQC (product quality complaint) reported.
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: What to do shingrix causes weakness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weakness 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 weakness (Verbatim: What to do shingrix causes weakness). The outcome of the weakness was not reported.   The reporter considered the weakness to be related to Shingrix.     The company considered the weakness to be related to Shingrix.   Additional Information: GSK Receipt Date : 04-APR-2025  This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The reporter asked that what to do shingrix caused weakness.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; came down with it; 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 patients 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: came down with it). 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: 07-APR-2025 This case was reported by a patient via interactive digital media. The reporter know people who got the shot and came down with it. One was his/her doctors wife, he was angry and gave her the Antivirus medicine. 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 vaccine Shingles vaccine.
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Post herpetic neuralgia; both kinds the one shot and the two shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2024, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia) and extra dose administered (Verbatim: both kinds the one shot and the two shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, shingles and post herpetic neuralgia to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 06-APR-2025  This case was reported by a patient via interactive digital media. The patient had both kinds, the one shot and the two shots of Shingles.  The patient had shingles and still have the resulting post herpetic neuralgia, it was April 2025 when he/she writes this. The pain was horrible. The patient received 3 doses of Shingles vaccine, which led to an extra dose administered. 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,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Post herpetic neuralgia are unlisted events which are considered unrelated to GSK Shingles vaccine. "
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have 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: have 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: 07-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she just got back from doctors.  The patient reported to have shingles.  The patient got the (Shingles vaccine) shots. 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: Abdominal pain, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; Tummy ache; Very sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a 71-year-old 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 fever (Verbatim: Fever), headache (Verbatim: Headache), abdominal pain (Verbatim: Tummy ache) and pain in arm (Verbatim: Very sore arm). The outcome of the fever, headache, abdominal pain and pain in arm were resolved (duration 3 days).   It was unknown if the reporter considered the fever, headache, abdominal pain and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the fever, headache, abdominal pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-APR-2025 The patient was sick for three days. The patient had fever, headache, tummy ache and very sore arm. The patient will be getting second in May. The patient was almost 71 years old and had one of the worst cases, six had seen.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; did get both rounds of shinglex but it didn't help at all; 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.   The patient's past medical history included shingles (flareups).   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) and shingles (Verbatim: did get both rounds of shinglex but it didn't help at all). 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: 06-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she did get both rounds of Shinglex (Shingles vaccine), but it did not help at all. The patient mentioned that probably because he/she had already been having flareups long before there was a shot. 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 (h/o shingles, insufficient information regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Influenza, Rash
Clinical narrative: severe flu symptoms; rash all over my stomach and chest; allergic to that vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms 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 flu symptoms (Verbatim: severe flu symptoms), rash (Verbatim: rash all over my stomach and chest) and allergy to vaccine (Verbatim: allergic to that vaccine). The outcome of the flu symptoms was resolving and the outcome of the rash was not resolved and the outcome of the allergy to vaccine was not reported.   It was unknown if the reporter considered the flu symptoms, rash and allergy to vaccine to be related to Shingles vaccine.     It was unknown if the company considered the flu symptoms, rash and allergy to vaccine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-APR-2025 The patient got first Shingle shot last week. The patient really planned to get both shots because he/she knew shingles could be really painful. But after having first shot, the patient would not have the next. The patient had severe flu symptoms and never felt that bad in my life. And just when the patient started to feel a little better, now he/she has a rash all over stomach and chest. The patient guessed that he/she was allergic to that vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm for a week.; put me to bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness 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 muscle soreness (Verbatim: sore arm for a week.) and bedridden (Verbatim: put me to bed). The outcome of the muscle soreness was resolved (duration 1 week) and the outcome of the bedridden was resolved (duration 1 day).   It was unknown if the reporter considered the muscle soreness and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the muscle soreness and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The shot put reporter to bed for a day and sore arm for a week. The reporter said get the damn shot. This case has been linked to the US2025AMR043507 case reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR043507:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort
Clinical narrative: right shoulders hurts me; little discomfort for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain 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 shoulder pain (Verbatim: right shoulders hurts me) and discomfort (Verbatim: little discomfort for a few days). The outcome of the shoulder pain was not reported and the outcome of the discomfort was resolved.   It was unknown if the reporter considered the shoulder pain and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the shoulder pain and discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 06-APR-2025 This case was reported by a patient via interactive digital media. Patient was not happy that he got the shot. Patient got shot 3 years ago when right shoulders hurt him all the time. Patient did not know why or what they got in that shot as they call it patient's wife had shingles and it was not no big deal. Patient stated that a guy used to drive a truck with had shingles. No big deal again. Just a little discomfort for a few days. Patient indicated that do not let him fear over you and kill you with snake venom and animal DNA parts from little children. Patient indicated that let them fear do some research. Patient stated that they had to really press them hard to get the fact sheets of the side effects of their debilitating drugs.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; 9 months later got a horrible case of 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, 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 9 months later got a horrible case of 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: 06-APR-2025 This case was reported by a patient's child via interactive digital media. The patient (dad) got the Shingles vaccine and 9 months later got a horrible case of shingles. The reporter stated that shingles vaccine didn't work and that was a propaganda. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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 completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Migraine, Mobility decreased
Clinical narrative: Shingles on forehead close to eyes/ suspected vaccination failure; Shingles on forehead close to eyes; spent a day in bed; Migraines were worse; 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: Shingles on forehead close to eyes/ suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles on forehead close to eyes), bedridden (Verbatim: spent a day in bed) and migraine (Verbatim: Migraines were worse). The outcome of the vaccination failure, facial herpes zoster and migraine were not reported and the outcome of the bedridden was resolved.   It was unknown if the reporter considered the vaccination failure, facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The reporter considered the bedridden to be related to 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 facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The company considered the bedridden to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on forehead close to the eyes. The patient suffered from severe migraines and it felt a lot like that. However, when the blisters showed up the patient realized what it was. The patient was so used to migraines and vomiting, that the patient mistook the pain. By the time the patient made it to the doctor it was too late to treat it but the doctor sent the patient to an ophthalmologist. Fortunately, the patient's eye was ok. The patient had both shingles vaccinations 3 years ago. The second shot made the patient sick and had spent a day in bed. The shingles pain was sharp and intense but the migraines were even worse because they were so frequent. 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, VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: Shingles on forehead close to eyes/ suspected vaccination failure; Shingles on forehead close to eyes; spent a day in bed; Migraines were worse; 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: Shingles on forehead close to eyes/ suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles on forehead close to eyes), bedridden (Verbatim: spent a day in bed) and migraine (Verbatim: Migraines were worse). The outcome of the vaccination failure, facial herpes zoster and migraine were not reported and the outcome of the bedridden was resolved.   It was unknown if the reporter considered the vaccination failure, facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The reporter considered the bedridden to be related to 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 facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The company considered the bedridden to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on forehead close to the eyes. The patient suffered from severe migraines and it felt a lot like that. However, when the blisters showed up the patient realized what it was. The patient was so used to migraines and vomiting, that the patient mistook the pain. By the time the patient made it to the doctor it was too late to treat it but the doctor sent the patient to an ophthalmologist. Fortunately, the patient's eye was ok. The patient had both shingles vaccinations 3 years ago. The second shot made the patient sick and had spent a day in bed. The shingles pain was sharp and intense but the migraines were even worse because they were so frequent. 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: Malaise
Clinical narrative: sick 3 days.; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: sick 3 days.). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was sick 3 days.  Did not get the 2nd shot.
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: fever blister; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included fever blister. Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced fever blister (Verbatim: fever blister). The outcome of the fever blister was not reported.   It was unknown if the reporter considered the fever blister to be related to Shingles vaccine.     It was unknown if the company considered the fever blister to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient had both shots and it was easy. The patient had a fever blister last week and it was different from past ones.
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: agitated nerves are just calming down now; Suspected vaccination failure; Shingles last 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.   On an unknown date, the patient received Shingles vaccine. In MAR-2025, 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 last month). On an unknown date, the patient experienced agitation (Verbatim: agitated nerves are just calming down now). The outcome of the vaccination failure and shingles were not reported and the outcome of the agitation was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and agitation 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 agitation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported he/she got Shingles vaccine and got shingles last month (from the date of reporting) but thankfully a milder case and patient thanked to the vaccine.  The patient was put on an antiviral medication which shortened the rash time, but the agitated nerves were just calming down now (at the time of reporting) 6 weeks later. 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: The first one made me 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.   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 sickness (Verbatim: The first one made me 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: 08-APR-2025 The patient reported that the first (Shingles vaccine) made him/her sick.  The patient was further informed that the second one would make him/her even more sick.  The patient stated that they would have to get it when they had time to be sick
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had a shot and still got shingles/still have flare ups after 10 years; 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: Had a shot and still got shingles/still have flare ups after 10 years). 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: 08-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had a shot and still got shingles which never go away for good, still had flare ups after 10 years. 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, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I got shingles after I took my second shot,hurt something horribly,it has been 2 months and the pain is still unbearable,I have them on the inside; 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: I got shingles after I took my second shot,hurt something horribly,it has been 2 months and the pain is still unbearable,I have them on the inside). 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 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: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient got shingles after he/she took second Shingles shot and it hurt something horribly and it has been 2 months and the pain was still unbearable and the patient have them on the inside This case was considered as suspected vaccination failure since the details regarding the 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had 2 cases of Shingles since then. One is happening now; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 2 cases of Shingles since then. One is happening now). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media. The consumer reported that he/she need some guidance on if he/she could take a second set of shots.  The patient was vaccinated with Shingrix in 2021. His/her second dose was 6 months after the first one.  This was in 2021.  The patient had 2 cases of shingles since then. One was happening now (at the time of reporting) in 2025. This case was considered as suspected vaccination failure as details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Supposed to last 3, still have a mild case after 2 yrs; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Supposed to last 3, still have a mild case after 2 yrs). 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: 08-APR-2025 This case was reported by a patient via interactive digital media.  Patient developed shingles anyway 2 years after the shot. Patient stated it was supposed to last 3, but patient still had a mild case after 2 years. Patient reacted to the medication, at the time of reporting patient was using Biofreeze to relieve the itch. 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 completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccibation failure/experienced shingles after the two vaccines; experienced shingles and pain after the two vaccines; 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 vaccibation failure/experienced shingles after the two vaccines) (serious criteria GSK medically significant) and shingles (Verbatim: experienced shingles and pain after the two vaccines). 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: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient would not wish shingles on worst enemy. The patient never ever experienced such pain. The patient had two vaccines before all of this. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (dose 1 and 2).
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: nerve pain on my back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of neuralgia 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 neuralgia (Verbatim: nerve pain on my back). The outcome of the neuralgia was not reported.   It was unknown if the reporter considered the neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vaccine and it nearly killed me. The patient reported that now he/she had a nerve pain on his/her back.
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Pain in arm; not feeling well; 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: Pain in arm) and feeling unwell (Verbatim: not feeling well). The outcome of the pain in arm and feeling unwell were not reported.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR040571   Additional Information: GSK receipt date: 02-APR-2025 This case was reported by a patient via interactive digital media.  Patient stated that, got second shot on the day of reporting and patient's arm was hurting and not feeling well just like the first one. For tolerance of second dose, please refer US2025AMR040571.
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: vaccine was not supposed to be frozen and accidentally gave to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old male patient who received MMR (Priorix) (batch number 2JX7Y) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: vaccine was not supposed to be frozen and accidentally gave to patient). 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: 02-APR-2025 Nurse reported that a new vaccine the MMR with a different brand that was not supposed to be frozen and accidentally gave to patient, which led to incorrect storage of drug. The Priorix vaccines were exposed to a temperature of minus 23.5°C. This case is linked with case US2025039712, reported by the same reporter.; Sender's Comments:  US-GSK-US2025039712:SAME REPORTER
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: have not received a second dose so far; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15-JUL-2019 of batch number 5TH3L and expiry date of 19-NOV-2021). Concurrent medical conditions included asthma (has asthma).   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: have not received a second dose so far). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-APR-2025 The Pharmacy Technician had a patient that got first dose of Shingrix vaccine but they have not received a second dose so far. The pharmacist reported that patient had a history of asthma, but she was not sure if patient was considered immunocompromised.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Pharmacy Technician explained they do not have an email address for the facility so they declined consent to follow up with Safety Team.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received only two doses of Twinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose on 1999) and Twinrix (Patient received second dose on 1999).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received only two doses of Twinrix ). The outcome of the incomplete course of vaccination 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: 03-APR-2025 A Nurse Practitioner wanted to know if a patient could receive Heplisav-B instead of Twinrix (because they ran out of it at the facility) to complete the schedule for the immunization of Hepatitis B.  Also wanted to know, if the latter it's possible, if the patient should receive one or two doses of Heplisav-B.  Till the time of reporting the patient did not receive the third dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription for Bexsero for a patient that is older than 25; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 32-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: prescription for Bexsero for a patient that is older than 25). The outcome of the intercepted drug prescribing error 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: 04-APR-2025 Other HCP reported that a prescription for Bexsero for a patient that was older than 25 but the doctor send it specifically, because he was trying to get a transplant so, he was getting lots of vaccines. The one they got was, they noticed that it said that it was up to 25, which led to intercepted drug prescribing error. So they wanted to know if he still get that one, they were requiring him to get a meningococcal vaccine.