chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: I got GBS from the shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: I got GBS from the shingles shot) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the Guillain-Barre syndrome from the shingles shot. The follow-up could not be possible as no contact details were available. This case has been linked with US2022AMR134320, reported by same reporter; Sender's Comments: Guillain-Barre syndrome is a listed event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK Shingles vaccine. US-GLAXOSMITHKLINE-US2022AMR134320:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of swelling arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-SEP-2024, the patient received the 1st dose of Shingrix (left deltoid). On 17-SEP-2024, 4 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling arm). On 24-SEP-2024, the outcome of the swelling arm was resolved.   The reporter considered the swelling arm to be related to Shingrix.     The company considered the swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025 The patient self reported this case for himself. Patient had swelling greater than 100 mm took 7 to 10 days to resolve.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: she developed a rash on her lower back; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included insomnia, depression, bipolar ii disorder and seasonal allergy. Concomitant products included eszopiclone (Lunesta), venlafaxine hydrochloride (Effexor), olanzapine (Zyprexa) and clarithromycin (Claritin).   On 29-MAR-2025, the patient received the 1st dose of Shingrix. On 29-MAR-2025, less than a day after receiving Shingrix, the patient experienced rash (Verbatim: she developed a rash on her lower back). The outcome of the rash was resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK receipt date: 03-APR-2025 The patient is the reporter. The patient developed a rash on her lower back after receiving the first dose of Shingrix.
Vaccine: VARZOS
Symptoms: Periarthritis
Clinical narrative: Adhesive capsulitis of shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of adhesive capsulitis of shoulder in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adhesive capsulitis of shoulder (Verbatim: Adhesive capsulitis of shoulder). The outcome of the adhesive capsulitis of shoulder was resolved.   The reporter considered the adhesive capsulitis of shoulder to be related to Shingrix.     The company considered the adhesive capsulitis of shoulder to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025  Physician discussed two cases of this adhesive capsulitis occurring in separate patients.  Both occurring after the first dose of Shingrix was administered and both resolved.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: swelling at injection site; red at injection site; hard lump at injection site; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 25-MAR-2025, the patient received the 1st dose of Shingrix (left arm). On 26-MAR-2025, 1 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at injection site), injection site erythema (Verbatim: red at injection site) and injection site lump (Verbatim: hard lump at injection site). The outcome of the injection site swelling, injection site erythema and injection site lump were resolving.   The reporter considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix.     The company considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025  The patient received concomitant product wygovey. The reporter reported injection was further down arm than typically done, roughly midway between shoulder and elbow.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Malaise
Clinical narrative: flu symptoms; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a female 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: flu symptoms) and sickness (Verbatim: Sick). The outcome of the flu symptoms and sickness were not reported.   It was unknown if the reporter considered the flu symptoms and sickness to be related to Shingles vaccine.     It was unknown if the company considered the flu symptoms and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date 01-APR-2025 This case was reported by the parent of the patient via interactive digital media. The reporter reported that he/she and her daughter (patient) got first shot and they would have to booster soon. Further reporter stated his/her daughter had side effects like flu symptoms were sick. No other symptoms. Reporter said it was just dependent on the physical situation.  The reporter guessed that patient don't want to get Booster, but it was her decision.  This case was linked to the US2025AMR039854, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR039854:same reporter
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: swollen arm; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling 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 swelling arm (Verbatim: swollen arm) and pain in arm (Verbatim: sore arm). The outcome of the swelling arm and pain in arm were resolved (duration 3 days).   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient had swollen sore arm 3 days and there were no other symptoms. This case is linked with case US2025AMR039848, reported by the same reporter.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm 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.   The patient's past medical history included shingles. Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: left arm sore). The outcome of the pain in arm was resolved.   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: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient had it just like the picture, miserable.  Just got second Shingrix shot.  The left arm sore for the past week.  The doctor said the patient may still get shingles but it would be less than before.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Still in extreme pain; Suspected vaccination failure; have had the shingles since February 16th; 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 16-FEB-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: have had the shingles since February 16th). On an unknown date, the patient experienced pain (Verbatim: Still in extreme pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and had the shingles since 16th February and had worst pain ever with still in extreme pain. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise
Clinical narrative: Sick; Not feeling well; This non-serious case was reported by a nurse via sales rep and described the occurrence of sickness in a adult female 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 sickness (Verbatim: Sick) and feeling unwell (Verbatim: Not feeling well). The outcome of the sickness and feeling unwell were not reported.   It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingrix.     It was unknown if the company considered the sickness and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-APR-2025 The reporter reported a patient had been vaccinated with Shingrix but unknown if this was the first or second dose of Shingrix and if the patient completed the two dose series. The patient was sick and missed work for a day or 2 due to not feeling well after Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: experienced soreness; did not feel well after the first dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer (now also recovered from her cancer treatment).   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 pain (Verbatim: experienced soreness) and feeling unwell (Verbatim: did not feel well after the first dose). The outcome of the pain and feeling unwell were not reported.   It was unknown if the reporter considered the pain and feeling unwell to be related to Shingrix.     It was unknown if the company considered the pain and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025 The nurse reported that the patient experienced soreness and did not felt well after the first dose of Shingrix vaccine. It was unknow if the symptoms occurred after the second dose. The patient had breast cancer and her physician was treating the cancer suggested she get vaccinated with Shingrix (the cancer was pre-existing before the vaccination). She did completed the 2 dose Shingrix series and the patient was now also recovered from her cancer treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Product prescribing issue, Vaccination failure
Clinical narrative: Suspected vaccination failure; Patient having an active case of shingles; The patient recived Shingrix vaccine 3 to 4 time per year; Prescribed Shingrix now while patient had active with shingles; This serious case was reported by a other health professional via other manufacturer and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Patient having an active case of shingles), extra dose administered (Verbatim: The patient recived Shingrix vaccine 3 to 4 time per year) and drug prescribing error (Verbatim: Prescribed Shingrix now while patient had active with shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the extra dose administered and drug prescribing error were not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025 The patient received Shingrix vaccine 3 to 4 times per year and states that he was being prescribed this now while having an active case of shingles.  The physician was unable to provide any further information and no other adverse events and product quality complaints. The patient received Shingrix vaccine 3 to 4 times per year which led to extra dose administered and prescribed Shingrix now while patient had active with shingles which led to drug prescribing error. 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 vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had one shot, got shingles about a month ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Had one shot, got shingles about a month ago). The outcome of the shingles was resolving.   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: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient had one shot, got shingles about a month ago. The patient expressed that wow, think that he/she was getting through the worst. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; shingles and had It took 2.5 months of agonizing nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: shingles and had It took 2.5 months of agonizing nerve pain). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The reporter wife had both vaccines and two years later caught the Shingles. She had the shingles for 2.5 months before a doctor finally made a diagnosis. It took 2.5 months of agonizing nerve pain before a minor rash appeared. She has had the Shingles for almost 7 months, and it was just starting to get tolerable. She had been on Valtrex for 4.5 months and will probably have to take it for several more months. So, she paid 160.00 out of pocket for snake oil.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Vaccine: RSV
Symptoms: Eye discharge
Clinical narrative: problems with both eyes including a lot of goop in one eye; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of eye discharge in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced eye discharge (Verbatim: problems with both eyes including a lot of goop in one eye). The outcome of the eye discharge was not resolved.   The reporter considered the eye discharge to be related to Arexvy.     The company considered the eye discharge to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that GlaxoSmithKline was about money. The reporter was shocked how much they changed  medicare part, then the reporter problems with both eyes including a lot of goop in one eye. The reporter stated that it turned a mistake getting RSV.
Age: 60.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathic pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; have a very light case of it on a section of my thigh, with only 2 spots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have a very light case of it on a section of my thigh, with only 2 spots). 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: 05-APR-2025 This case was reported by a patient via interactive digital media.  Patient reported about the Shingle shot. Patient stated that it would save a painful case of it down the road if ever got shingles. Patient got it at 60 and was 68 at the time of reporting and just the past 2 weeks from reporting patient had a very light case of it on a section of his/her thigh, with only 2 spots. Patient got on the anti-viral medications and the next day had nerve itching. Reporter stated if caught soon that helps a lot. 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, Vaccination failure
Clinical narrative: got both shots about a year ago and still two days ago I have the virus/ suspected vaccination failure; Got the mild case of shingles virus 3 days ago; 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, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got both shots about a year ago and still two days ago I have the virus/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the mild case of shingles virus 3 days ago). 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: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient got both shots about a year ago and that started three days ago had a mild case(so far) of the virus. The patient was on an antibiotic and so far it was a milder case. Patient did not had any one small patch and hopped that this was a minor case. 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 completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Age: 55.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scab, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/on my back, right side and stomach so much pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chix pox twice as a kid) and shingles (shingles at 25).   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/on my back, right side and stomach so much pain). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 06-APR-2025 This case was reported by a patient via interactive digital media.  Patient had chicken pox twice as a kid, shingles at 25. Patient got the vaccine at 55. Patient was 57 at the time of reporting and got shingles about 2 weeks ago, on back, right side and stomach. Patient stated that so much pain was there. Gabapentin was the only thing that takes the edge of pain off. Reporter stated that Shingles was no joke. The spots were started to scab but still so much pain. Patient was not sure how much the vaccine helped. Maybe it would have been worse without the vaccine, can't even imagine. 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  details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: vaccinated for years and now have shingles/ suspected vaccination failure; Shingles/ big rash but so far not as painful as it could be; 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: vaccinated for years and now have shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ big rash but so far not as painful as it could be). 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: 04-APR-2025 and 05-APR-2025 This case was reported by a patient via interactive digital media. The patient have been vaccinated for years and now the patient had shingles. The patient got the vaccine in 2023 and had shingles and now a big rash but so far not as painful as it could be. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Neuropathy peripheral, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; neuropathy; still got shingles; use a walker; 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), neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and walker user (Verbatim: use a walker). The outcome of the vaccination failure, neuropathy, shingles and walker user were not reported.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and walker user to be related to Shingles vaccine.     The company considered the vaccination failure and neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and walker user 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 the shots a number of years ago.  Thought he/she was covered.  Still got the shingles.  The patient was expecting the rash but did not know neuropathy could also be a problem.  Six months later having to use a walker because there was no feeling on right side from the waist down.  Was told that the vaccine was gotten years ago has been replaced by a better product.  Planning to get it when doctor says it was time. 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. Neuropathy peripheral is an unlisted event which is considered unrelated to GSK vaccine  Shingles vaccine.
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Suspected vaccination failure; neuropathy; still got shingles; use a walker; 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), neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and walker user (Verbatim: use a walker). The outcome of the vaccination failure, neuropathy, shingles and walker user were not reported.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and walker user to be related to Shingles vaccine.     The company considered the vaccination failure and neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and walker user 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 the shots a number of years ago.  Thought he/she was covered.  Still got the shingles.  The patient was expecting the rash but did not know neuropathy could also be a problem.  Six months later having to use a walker because there was no feeling on right side from the waist down.  Was told that the vaccine was gotten years ago has been replaced by a better product.  Planning to get it when doctor says it was time. 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. Neuropathy peripheral is an unlisted event which is considered unrelated to GSK vaccine  Shingles vaccine.
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles 3 times; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times). 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 via interactive digital media. The patient had the Shingles vaccine shot 5 years ago from reporting date. The patient had shingles 3 times in the last 2 years.  The reporter has discovered a gel that takes all the burning out. I just had them down the side of nose down to jaw.  The reporter put this gel on them several times a day the burning was gone. It was truly amazing. This case was considered as suspected vaccination failure as details regarding completion of primary 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 regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; She still got shingles when she was in the hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: She still got shingles when she was in the hospital). 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 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: 08-APR-2025 This case was reported by a Consumer via interactive digital media. The reporter reported that his/her mother got the Shingrix vaccine 2 doses. The patient still got shingles when she was in the hospital. The vaccines were never a guarantee. Also her immune system was low and she was getting medications, steroids, antibiotics ,so it might had  triggered it. 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 vaccine Shingrix (Dose 1 & 2)..
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 3L339) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this). The outcome of the inappropriate schedule of vaccine administered 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: 31-MAR-2025 A registered nurse contacted GlaxoSmithKline to report that they were having issues interpreting the information that was presented in the prescribing information for Bexsero, as it stated that two doses of Bexsero could be given at least one month apart but in the (CDC) Centers for Disease Control and Prevention it stated that the interval had to be a zero- and six-month schedule.  The prescribing information was revised, using the most up-to-date version which included the zero- and six-month vaccination schedule or the 0, 1 to 2- and six-month vaccination schedule.  The health care professional stated that the reason for which they used the incorrect vaccination schedule was due to the fact that the package insert that had been included in their vaccine container was the prescribing information before the 2024 revision, which led to an inappropriate schedule of vaccine administered They mentioned that approximately 20 patients, about 50 by 50 male and female, were affected by this. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2025038577:same reporter different patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, 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 was not reported and the outcome of the shingles was resolved (duration 3 months).   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: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient had Shingles vaccine and still got shingles. They hurt and itched for 3 months.  Probably would had killed if  had not received vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patients were getting Shingrix (2nd dose) a year later; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient had first dose a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patients were getting Shingrix (2nd dose) a year later). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 31-MAR-2025 Pharmacist reported that during COVID, patients were getting Shingrix (2nd dose) a year later. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: can you still administer the second dose as part of the series; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 14-AUG-2024).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim:  can you still administer the second dose as part of the series). 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: 02-APR-2025 The nurse reported that a patient had a dose 7 months prior, could still administer the second dose as part of the series.  Health care professional states that patient was there today to receive 2nd dose of Bexsero.  The reporter disconnected chat prior to data being provided.  Unknown if patient received 2nd dose on 02-APR-2025. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Extra dose (Potential); This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Rota (Rotarix) for prophylaxis.   Previously administered products included rotarix (received the 1st dose of Rotarix vaccine on unknown date) and rotarix (received the 2nd dose of Rotarix on unknown date).   On an unknown date, the patient received the 3rd dose of Rotarix. On an unknown date, an unknown time after receiving Rotarix, the patient experienced extra dose administered (Verbatim: Extra dose (Potential)). The outcome of the extra dose administered 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 The reporter reported that we accidentally gave a baby a third dose of Rotarix, which led to extra dose administered.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: 48 years of age has a prescription to receive a Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 48-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: 48 years of age has a prescription to receive a Bexsero). 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: 03-APR-2025 The pharmacist reported patient 48 years of age has a prescription to receive a Bexsero vaccine after splenectomy.  The vaccines was not administered at the moment of the reporting which led to intercepted drug prescribing error.  The Vaccine Administration Facility was the same as Primary Reporter.