Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 72R4G | — |
large black lump on her arm; swelling on her arm; bruising on her arm; Shingrix vaccine into the arm but way below the deltoid muscle but not the deltoid; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of mass in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 72R4G, expiry date 05-JUN-2027) for prophylaxis. On 10-OCT-2025, the patient received Shingrix (unknown arm). On 10-OCT-2025, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Shingrix vaccine into the arm but way below the deltoid muscle but not the deltoid). On 14-OCT-2025, the patient experienced mass (Verbatim: large black lump on her arm), swelling arm (Verbatim: swelling on her arm) and bruising of arm (Verbatim: bruising on her arm). The outcome of the mass, swelling arm and bruising of arm were not resolved and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the mass, swelling arm and bruising of arm to be related to Shingrix. It was unknown if the company considered the mass, swelling arm and bruising of arm to be related to Shingrix. Additional Information: GSK Receipt Date: 14-OCT-2025 A patient received a Shingrix vaccine in the arm but not the deltoid. The reporter wanted to know if the patient need to bed re-dosed in the arm literally midway between the shoulder and the elbow. The injection was into the arm but way below the deltoid muscle. From examination of the area, the injection site felt to be primarily fat with little to no muscle superficially. The patient returned to the pharmacy today (on the day of reporting) to show the swelling, bruising and large black lump on her arm.