Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 2m7gr | — |
severe swelling; Erythema; Headache; severe arm pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 2m7gr, expiry date 31-JAN-2027) for prophylaxis. On 01-AUG-2025, the patient received the 1st dose of Shingrix .5 ml. In AUG-2025, less than a week after receiving Shingrix, the patient experienced swelling (Verbatim: severe swelling), erythema (Verbatim: Erythema), headache (Verbatim: Headache) and pain in arm (Verbatim: severe arm pain). The outcome of the swelling, erythema, headache and pain in arm were not resolved. It was unknown if the reporter considered the swelling, erythema, headache and pain in arm to be related to Shingrix. It was unknown if the company considered the swelling, erythema, headache and pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 04-AUG-2025 The reporter stated that an 80 year old female had her first dose of Shingrix administered on 1 AUG 2025 and reported having severe swelling, erythema approximately 4 inches wide and 5 inches long moving towards the armpit, headache and severe arm pain (onset of adverse events not disclosed). No further information was obtained/provided.