Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; was having mini strokes; This is the 4th time with shingles/sharp pain going from right side of head to neck and eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Family history included ophthalmic herpes zoster (mother went blind with shingles in her eye). 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), ministroke (Verbatim: was having mini strokes) (serious criteria GSK medically significant) and shingles (Verbatim: This is the 4th time with shingles/sharp pain going from right side of head to neck and eye). The outcome of the vaccination failure, ministroke and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ministroke and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ministroke 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-OCT-2025 This case was reported by a patient via interactive digital media. The patient said that this was the 4th time with shingles, and he/she had all the Shingles shots and had no breaking out this time, but sharp pains going from right side of his/her head to neck and eye. The physician assistant (PA) gave the patient CT of entire head and was negative and they gave medication. The patient was going to his/her ophthalmologist tomorrow to check the eyes. The patient thought maybe he/she was having mini strokes. 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. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Transient ischaemic attack , an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Medical History/Concurrent Conditions: Ophthalmic herpes zoster (mother went blind with shingles in her eye)
Test Name: CT head; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)