Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
nerve pain; Suspected vaccination failure; diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled; 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 16-APR-2025, 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: diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the nerve pain was resolved. It was unknown if the reporter considered the vaccination failure, shingles and nerve pain 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 nerve pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The patient reported he/she was diagnosed with Shingles on arm today. It started on vacation and waited to come home to their own doctor. It was a white swollen line at first and next day had 6 red spots that bled and nerve pain. The patient had both shingles shots so did not think they could get it, but still can get it (Shingles). The patient reported it as a mild case and did not need the antibiotics and if it spreads they will be put on antibiotics. The patient reported he/she was not in pain and putting antibiotic cream on it twice a day. The patient suggested to others get the vaccine shots. The patient stated he/she so glad they did got vaccine or I would be in pain and have a bad case. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).