Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 55KB9 | IM / RA |
she developed a big lump on her right arm; that was raised; hot; red; This non-serious case was reported by a consumer via call center representative and described the occurrence of mass in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 55KB9, expiry date 26-APR-2027) for prophylaxis. Previously administered products included Shingles with an associated reaction of injection site erythema (received 1st dose on 16th April 2025 via intramuscular on left arm refer case US2025126508) and Povidone (allergic to it). Concomitant products included metformin, hydrochlorothiazide, lisinopril and atorvastatin. On 29-SEP-2025, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 29-SEP-2025, less than a day after receiving Shingrix, the patient experienced mass (Verbatim: she developed a big lump on her right arm), swelling (Verbatim: that was raised), skin warm (Verbatim: hot) and erythema (Verbatim: red). The outcome of the mass, swelling, skin warm and erythema were not resolved. It was unknown if the reporter considered the mass, swelling, skin warm and erythema to be related to Shingrix. It was unknown if the company considered the mass, swelling, skin warm and erythema to be related to Shingrix. Linked case(s) involving the same patient: US2025126508 Additional Information: GSK Receipt Date: 02-OCT-2025 The patient reported that she received her second dose of Shingrix on Monday, 29-SEP-2025, and that same afternoon she developed a big lump on her right arm, the size of half of a golf ball, that was raised, hot, and red. These adverse effects have been ongoing since Monday, 29-SEP-2025. The patient reports that this morning, 2-OCT-2025, the area was still hot, raised, and the redness has spread and is about a 4 into 5 sized area, but the lump was not as big. The patient stated she was allergic to povidone (pre-existing Shingrix) and her first reaction to Povidone was in her early 20 years of age.; Sender's Comments: US-GSK-US2025126508:Same patient/Dose 1
METFORMIN; HYDROCHLOROTHIAZIDE; LISINOPRIL; ATORVASTATIN