Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
3"x5" red patch about 3" below injection site. Swollen, hot,; 3"x5" red patch about 3" below injection site. Swollen, hot,; 3"x5" red patch about 3" below injection site. Swollen, hot,; A lump under my skin, like a tennis ball; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 85-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-AUG-2025, the patient received the 2nd dose of Shingles vaccine. In AUG-2025, less than a week after receiving Shingles vaccine, the patient experienced mass (Verbatim: A lump under my skin, like a tennis ball). On 21-AUG-2025, the patient experienced injection site swelling (Verbatim: 3"x5" red patch about 3" below injection site. Swollen, hot,), injection site erythema (Verbatim: 3"x5" red patch about 3" below injection site. Swollen, hot,) and injection site warmth (Verbatim: 3"x5" red patch about 3" below injection site. Swollen, hot,). The patient was treated with apixaban (Eliquis), furosemide (Lasix), gabapentin, allopurinol and escitalopram oxalate (Lexapro). The outcome of the injection site swelling, injection site erythema and injection site warmth were not resolved and the outcome of the mass was not reported. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and mass to be related to Shingles vaccine. It was unknown if the company considered the injection site swelling, injection site erythema, injection site warmth and mass to be related to Shingles vaccine. Additional Information: GSK receipt date: 23 Aug 2025 The case was reported by patient itself. The patient had a lump under her skin, like a tennis ball and she enquired whether it was a normal reaction? Should she need to seek medical attention? The patient received treatment with malbeq.