Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LA |
Hives; arm was sore; breaking out under my cheek bone and right arm; it itches like crazy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Previously administered products included Zostavax (received on an unknown date). On 09-JAN-2025, the patient received the 1st dose of Shingles vaccine (intramuscular, left arm) .5 ml and RSV vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced pruritus (Verbatim: it itches like crazy). On an unknown date, the patient experienced hives (Verbatim: Hives), pain in arm (Verbatim: arm was sore) and skin breakout (Verbatim: breaking out under my cheek bone and right arm). The outcome of the hives, pruritus and skin breakout were not resolved and the outcome of the pain in arm was resolved. It was unknown if the reporter considered the hives, pruritus, pain in arm and skin breakout to be related to Shingles vaccine and RSV vaccine. It was unknown if the company considered the hives, pruritus, pain in arm and skin breakout to be related to Shingles vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter reported that a patient received Shingles and RSV vaccine and experienced hives, sore arm and itching. She received many years ago a shingles vaccine (Zostavax). The reporter states that her health care professional recommended Shingrix and she received her 1st dose on January 9th, 2025, at her health care professional office. The patient reports she received the vaccine in her left arm. The lot number and expiry date was unknown. The patient reports that she received an RSV vaccine on the same date. The reporter did not know the brand name of the RSV formulation. The patient reports her arm was sore at the beginning but has resolved. The patient reports 2 weeks ago had a breaking of a strange hive on one hand and right wrist and it itches like crazy. The reporter states she was given a steroid shot (unknown name). Now breaking out under cheek bone and right arm and it itches like fire. The patient reports it was not resolved. When asked about sharing other medical history or medications she states not at this time. No additional event was reported.