Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | F35YS | — |
a little bit of redness; a little bit of swelling; warm to the touch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of redness in a female patient who received Herpes zoster (Shingrix) (batch number F35YS, expiry date 31-MAR-2027) for prophylaxis. On 26-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced redness (Verbatim: a little bit of redness), swelling (Verbatim: a little bit of swelling) and skin warm (Verbatim: warm to the touch). The outcome of the redness, swelling and skin warm were unknown. It was unknown if the reporter considered the redness, swelling and skin warm to be related to Shingrix. It was unknown if the company considered the redness, swelling and skin warm to be related to Shingrix. Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist reported that female patient received Shingrix first dose. The patient started with a little bit of redness and swelling, and then it did sort of continue in the Sunday. It was pretty warm to the touch and the border has expanded over those few days. On Monday, Doctor checked the patient and it was treated as cellulitis and now was trying to determine whether this was vaccine severe reaction or a formal culture infection. They want to know it had been other reports to this lot number. The vaccine administration facility was the same as primary reporter.