chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Drug exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nurse via registry and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number L5229, expiry date 19-APR-2027) for prophylaxis.   On 25-MAR-2025, the patient received the 1st dose of Boostrix. On 25-MAR-2025, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug exposure during pregnancy). The outcome of the vaccine exposure during pregnancy was not applicable.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-MAR-2025 Other HCP stated that pregnant woman received Boostrix which led to vaccine exposure during pregnancy.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shingles on my left side of the face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the shingles on my left side of the face while I was in mid 70's) and post herpetic neuralgia (was excruciating).   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) and herpes zoster (Verbatim: I had the shingles on my left side of the face). The outcome of the vaccination failure and herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.     The company considered the vaccination failure and herpes zoster to be unrelated to Shingrix.   Additional Information: GSK Receipt Date : 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient gotten the shingle shot 8 years before but that did not help him/her any.  Since he/she read you could got the shingles more than once he/she got the Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix."
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got 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 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: 25-MAR-2025 The case was received from the patient via interactive digital media. The patient had both singles shots and still got 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 Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I 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: I got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles after receiving the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Psoriasis
Clinical narrative: psoriasis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of psoriasis 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 psoriasis (Verbatim: psoriasis). The outcome of the psoriasis was not reported.   It was unknown if the reporter considered the psoriasis to be related to Shingles vaccine.     It was unknown if the company considered the psoriasis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2025 This case was reported by a patient via interactive digital media. The patient never had psoriasis until got the shingles vaccine, just saying.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: awful case of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: awful case of shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2025 The reporter reported one of her/his friends did vaccination and 3 weeks later she had an awful case of shingles. Went to physician and said gave me the vaccine and now get shingles.  He said had a different strain could give another vaccine for that.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; noticing shingles and mine lasted for 6 to 8 weeks; 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: noticing shingles and mine lasted for 6 to 8 weeks). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 8 weeks).   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: 26-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the medication within two days of noticing shingles and it lasted for 6 to 8 weeks.  The patient also had the series of two shingles shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Supected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 85-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Supected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2025 This case was reported by consumer via interactive digital media. The patient (reporter's aunt) and physician talked her into getting a shingles vaccine. The patient got her shingles so severely after the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shots hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shots hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-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 stated that shorts hurt them.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Exposure during pregnancy, Feeling of body temperature change, Influenza like illness
Clinical narrative: blood pressure got sky high; woke up burning up/freezing at the same time; aching like I had the flu; Vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of blood pressure high 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 blood pressure high (Verbatim: blood pressure got sky high), feeling hot and cold (Verbatim: woke up burning up/freezing at the same time), pain (Verbatim: aching like I had the flu) and vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the blood pressure high was resolving and the outcome of the feeling hot and cold and pain were not reported and the outcome of the vaccine exposure during pregnancy was not applicable.   The reporter considered the blood pressure high, feeling hot and cold and pain to be related to Shingrix.     The company considered the blood pressure high, feeling hot and cold and pain to be related to Shingrix.    Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 27-MAR-2025  This case was reported by a patient via interactive digital media. The patient took the Shingrix shot and had a bad reaction to it and blood pressure got sky high and now I am on 2 blood pressure meds. The patient woke up burning up and freezing at the same time and aching like I had the flu . Blood pressure still acts up but so for not as bad as it once was. This case has been linked to the US2025AMR037928 case reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR037928:Same Reporter/Different Patient
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 4 times since; 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 COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 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 shingles 4 times since). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2025 The case was received from the patient via interactive digital media. The patient had Covid shots and Shingles shots have had shingles 4 times since. It was unknown if the reporter considered the shingles to be related to COVID-19 vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; had shots as well and still get them/they go away in matter of a couple of days/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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shots as well and still get them/they go away in matter of a couple of days/shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was 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: 26-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shots as well and still get them. The patient mentioned that sometime not so bad, but other time his/her doctor gave him/her medicines that helps get rid of them and it works great. They went away in matter of a couple of days but he/she still take the antibiotic for them. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine 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 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: Pain in extremity
Clinical narrative: sore arm; 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.   Family history included shingles (sister had shingles right now) and depression (sister was suffering and depressed).   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: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that shingles can last for years for some people. He/she just had a sore arm from the 2 shots.  His /her  sister had shingles right now and is suffering and depressed. It's awful to have. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; got the shingles vaccine and 6 months later got the 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, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles vaccine and 6 months later got the 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: 26-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that he/she knew a person who got the shingles vaccine and 6 months later got the shingles. 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 about the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; internal shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: internal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved.   It was unknown if the reporter considered the vaccination failure and zoster sine herpete 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 zoster sine herpete to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine twice and have had internal shingles for 7 months now (till the time of reporting). This case was considered as suspected vaccination failure as details regarding time to onset for zoster sine herpete and laboratory confirmation regarding zoster sine herpete 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 dose 2)
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got them/ shingles; I had 1 shot and 2 of the lifetime 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 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. On an unknown date, 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), shingles (Verbatim: still got them/ shingles) and extra dose administered (Verbatim: I had 1 shot and 2 of the lifetime vaccines). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2025 This case was reported by a patient via interactive digital media.  Patient had 1 shot and 2 of the lifetime vaccines and still got them (shingles). Patient stated it was a shame that there was no cure. 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 is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2025 This case was reported by the friend of the patient via interactive digital media. The reporter stated his/her friend (patient) got the shot and now had the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding 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, VARZOS
Symptoms: Dry eye, Eye pain, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; severe pain in eye, diagnosed with a big dry patch on cornea, treated with Valtrex like it was Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: severe pain in eye, diagnosed with a big dry patch on cornea, treated with Valtrex like it was Shingles) (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was resolving.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 28-Mar-2025 This case was reported by a patient via interactive digital media. The patient got shingles vaccine and had no complications or after effects. Two months ago, the patient had severe pain in eye. The patient went to the ophthalmologist and was diagnosed with a big dry patch on cornea so they treated the patient with Valtrex like it was shingles. And it felt better in a few days. The patient had these shots two years before this episode. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Ophtalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). 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 Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got it after the shot; 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: got it after the shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles after the shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  the completion of primary vaccination schedule, clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Herpes zoster oticus, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: nerve pain; Suspected Vaccination failure; Have them in my right ear and face; Have them in my right ear and face /plisters were all around my ear and in my hair /My face half way over and my lips and neck stay numb, like a hundred needles are jabbing me; 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 24-DEC-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Have them in my right ear and face) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Have them in my right ear and face /plisters were all around my ear and in my hair /My face half way over and my lips and neck stay numb, like a hundred needles are jabbing me). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: nerve pain). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa, facial herpes zoster and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported to have shingles started on 24 December 2024.  The patient had them right ear and face .  The blisters were all around the ear and in my hair.  The pain was so bad.  The patient stated his/her face was half way over and my lips and neck stay numb, like a hundred needles are jabbing.  The patient had the Shingles shot 4 years ago.  Had been on medication for the virus, and Gabapentin for the nerve pain.  This has been 4 months already and still have a lot of pain. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Paraesthesia, Vaccination failure
Clinical narrative: nerve pain; Suspected Vaccination failure; Have them in my right ear and face; Have them in my right ear and face /plisters were all around my ear and in my hair /My face half way over and my lips and neck stay numb, like a hundred needles are jabbing me; 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 24-DEC-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Have them in my right ear and face) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Have them in my right ear and face /plisters were all around my ear and in my hair /My face half way over and my lips and neck stay numb, like a hundred needles are jabbing me). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: nerve pain). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa, facial herpes zoster and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported to have shingles started on 24 December 2024.  The patient had them right ear and face .  The blisters were all around the ear and in my hair.  The pain was so bad.  The patient stated his/her face was half way over and my lips and neck stay numb, like a hundred needles are jabbing.  The patient had the Shingles shot 4 years ago.  Had been on medication for the virus, and Gabapentin for the nerve pain.  This has been 4 months already and still have a lot of pain. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Fibromyalgia, Herpes zoster, Neuropathy peripheral, Pain
Clinical narrative: neuropathy; Fibromyalgia; COVID-19; Shingles; Suspeceted vaccination failure; 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.   The patient's past medical history included mastectomy (right mastectomy), surgery and illness. Concurrent medical conditions included cancer (stage 4 cancer) and decreased immune responsiveness.   On an unknown date, the patient received Shingles vaccine. In SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), fibromyalgia (Verbatim: Fibromyalgia) and covid-19 (Verbatim: COVID-19). The outcome of the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 to be related to Shingles vaccine.     The company considered the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine years ago and right after stage 4 cancer and her right mastectomy was healing, her immune system was weak, and shingles down her back, right arm and in her new mastectomy scar. The patient got neuropathy and fibromyalgia from damaged nerves and chemo, the patient had a lot of surgeries and illnesses the patient believed shingles were probably one of the worst pains patient ever had. The reporter stated that if you had the vaccine and your immune system was way low like them then you could get anything. The patient spent 10 days in isolation for covid and the next day shingles and in isolation another 9 days total of 19 days in isolation. That was last September. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about   time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster, Neuropathy peripheral, Fibromyalgia, and COVID-19  are unlisted events which are considered unrelated to GSK Shingles vaccine."
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: neuropathy; Fibromyalgia; COVID-19; Shingles; Suspeceted vaccination failure; 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.   The patient's past medical history included mastectomy (right mastectomy), surgery and illness. Concurrent medical conditions included cancer (stage 4 cancer) and decreased immune responsiveness.   On an unknown date, the patient received Shingles vaccine. In SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), fibromyalgia (Verbatim: Fibromyalgia) and covid-19 (Verbatim: COVID-19). The outcome of the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 to be related to Shingles vaccine.     The company considered the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine years ago and right after stage 4 cancer and her right mastectomy was healing, her immune system was weak, and shingles down her back, right arm and in her new mastectomy scar. The patient got neuropathy and fibromyalgia from damaged nerves and chemo, the patient had a lot of surgeries and illnesses the patient believed shingles were probably one of the worst pains patient ever had. The reporter stated that if you had the vaccine and your immune system was way low like them then you could get anything. The patient spent 10 days in isolation for covid and the next day shingles and in isolation another 9 days total of 19 days in isolation. That was last September. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about   time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster, Neuropathy peripheral, Fibromyalgia, and COVID-19  are unlisted events which are considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; around one eye, the virus infected my eye; I am now legally blind in that eye; developed shingles on my face; 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), ophthalmic herpes zoster (Verbatim: around one eye, the virus infected my eye) (serious criteria GSK medically significant), unilateral blindness (Verbatim: I am now legally blind in that eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: developed shingles on my face). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported and the outcome of the unilateral blindness was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unilateral blindness and facial herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure, ophthalmic herpes zoster and unilateral blindness to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient had a shingles vaccine years ago that was supposed to last a lifetime.  Four years ago developed shingles on face, and around one eye.  The virus infected eye to the point where patient now legally blind in that eye. The patient still in the care of an ophthalmologist after numerous expensive treatments to reduce the damage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster and Blindness unilateral are unlisted event which is considered unrelated to GSK Shingles vaccine.