Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Injection site breakout; Pain in arm; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On 25-JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: Injection site breakout), pain in arm (Verbatim: Pain in arm) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site reaction, pain in arm and diarrhea were not resolved. It was unknown if the reporter considered the injection site reaction, pain in arm and diarrhea to be related to Shingrix. It was unknown if the company considered the injection site reaction, pain in arm and diarrhea to be related to Shingrix. Additional Information: GSK receipt date: 30-JUN-2025 The patient reported that he had experienced diarrhea, arm pain, and a breakout at the injection site after receiving the second shot of Shingrix.