Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
slightly sore arm; feel a bit under the weather; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Zostavax with an associated reaction of pruritus (received in 2012 and had arm itch for a week), Shingrix with an associated reaction of malaise (received first dose in 2018 for tolerance of first dose refer case US2025AMR070529), Pneumovax 23 with an associated reaction of pain in extremity and Prevenar 20 with an associated reaction of pain in extremity. On an unknown date, the patient received the 2nd dose of Shingrix and Arexvy. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Arexvy, the patient experienced feeling unwell (Verbatim: feel a bit under the weather) and pain in arm (Verbatim: slightly sore arm). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 36 hrs) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Arexvy. It was unknown if the company considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Arexvy. Linked case(s) involving the same patient: US2025AMR070529 Additional Information: GSK Receipt Date: 28-MAY-2025 Patient received both Zostavax in 2012 and two doses of Shingrix in 2018. Zostavax, which is not much used these days, made her arm itch for a week and Shingrix made her feel a bit under the weather the day. She was fine after 24-36 hours, and after watching what her husband's mother went through with multiple bouts of shingles, she consider it was completely worth it. She had two different pneumonia vaccines, Pneumovax 23 and Prevnar 20. She was also in the Pfizer adult RSV clinical trial a few years back, but since they were not ready to unblind her, she just went ahead and got the Arexvy shot a year later. None of those shots gave her anything worse than a slightly sore arm. This case is linked with case US2025AMR070488, reporter by the same reporter.; Sender's Comments: US-GSK-US2025AMR070488:same reporter/male patient