Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 75GZ7 | — |
shingles outbreak on back, base of spine; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 75GZ7) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix), duloxetine hydrochloride (Cymbalta), gabapentin, metformin hydrochloride (Metformin), carvedilol, sitagliptin phosphate (Januvia), empagliflozin (Jardiance), sacubitril, valsartan (Entresto), nitrazepam and oxybutynin hydrochloride (Oxybutynin). On 08-MAR-2025, the patient received the 2nd dose of Shingrix. On 08-MAR-2025, less than a day after receiving Shingrix, the patient experienced shingles (Verbatim: shingles outbreak on back, base of spine). Rechallenge with Shingrix was positive. The outcome of the shingles was resolving. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Linked case(s) involving the same patient: US2025035987 Additional Information: GSK Receipt Date: 25-MAR-2025 Patient reported that there was shingles outbreaks within 48 hours of second injection of Shingirx. The 2nd outbreak was on back, about 3 times the size of first outbreak at the base of spine.; Sender's Comments: US-GSK-US2025035987:SAME PATIENT
SHINGRIX; Cymbalta; GABAPENTIN; METFORMIN; CARVEDILOL; JANUVIA; JARDIANCE; ENTRESTO; NITRAZEPAM; OXYBUTYNIN