Received May 16, 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 | — |
Suspected vaccination failure; I have it again for the second time; 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 upadacitinib (Rinvoq) for product used for unknown indication. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Rinvoq. 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: I have it again for the second time). The action taken with Rinvoq was unknown. 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: 12-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that had it again for the second time. It was so bad after the first time that he/she had the two vaccines so he/she would not get it again. Find out it was from Rinvoq that caused it this time. No more vaccines for him/her. It was unknown if the reporter considered the vaccination failure and shingles to be related to Rinvoq.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Medical History/Concurrent Conditions: Shingles
RINVOQ