Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Still have horrible nerve damage in my eye forehead, ear, side to center of skull; hard to deal with the heat; Suspected Vaccination failure; got the worse case shingles the right side of my head the whole quarter from my eye all the way back; 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 shingles (several times, usually just a little patch on neck or shoulder), back pain (bit of pain in back) and shoulder pain (bit of pain in back up to shoulder). On an unknown date, the patient received Shingles vaccine. On 26-NOV-2024, 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: got the worse case shingles the right side of my head the whole quarter from my eye all the way back). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Still have horrible nerve damage in my eye forehead, ear, side to center of skull) and skin warm (Verbatim: hard to deal with the heat). The outcome of the vaccination failure, shingles and skin warm were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and skin warm 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, post herpetic neuralgia and skin warm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles several times, usually just a little patch on neck or shoulder and the patient could always felt them coming on with a bit of pain in his/her back up to shoulder. Then the patient got the vaccine a couple years ago and got the worse case of shingles and that had been a nightmare and the right side of head the whole quarter from eye all the way back. The patient still had horrible nerve damage in his/her eye, forehead, ear, side to center of skull and felt like a little guy in there with a pick axe trying to get out. It was very hard to deal with the heat and the pain and had been 4 months and still in pain. Nothing helped and stated he/she wouldn't wish this on anyone. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Medical History/Concurrent Conditions: Back pain (bit of pain in back); Shingles (several times, usually just a little patch on neck or shoulder); Shoulder pain (bit of pain in back up to shoulder)