Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | C9X3R | — |
Rash/ large blotchy patches/ rash flared about four times over 5 to 6 days/bloody patches; Welts/ welts under both arms, in the groin area, down the top of both legs, some on his buttocks, and some on his back; Itchy/ small itchy patch on his foot; lips were swollen twice; uncomfortable; This non-serious case was reported by a other health professional via call center representative and described the occurrence of blotchy rash in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number C9X3R, expiry date 05-JUN-2027) for prophylaxis. The patient's past medical history included rash (patient had a similar rash to a wasp sting two months ago). Concomitant products included aspirin, atorvastatin, lisinopril, metoprolol, dorzolamide, latanoprost, vitamin c and vitamin d. On 17-SEP-2025, the patient received the 1st dose of Shingrix. In SEP-2025, an unknown time after receiving Shingrix, the patient experienced welts (Verbatim: Welts/ welts under both arms, in the groin area, down the top of both legs, some on his buttocks, and some on his back), pruritus (Verbatim: Itchy/ small itchy patch on his foot), lip swelling (Verbatim: lips were swollen twice) and discomfort (Verbatim: uncomfortable). On 20-SEP-2025, the patient experienced blotchy rash (Verbatim: Rash/ large blotchy patches/ rash flared about four times over 5 to 6 days/bloody patches). The patient was treated with diphenhydramine hydrochloride (Benadryl). On 25-SEP-2025, the outcome of the blotchy rash was resolved. The outcome of the welts, pruritus and lip swelling were resolving and the outcome of the discomfort was not reported. It was unknown if the reporter considered the blotchy rash, welts, pruritus, lip swelling and discomfort to be related to Shingrix. It was unknown if the company considered the blotchy rash, welts, pruritus, lip swelling and discomfort to be related to Shingrix. Additional Information: GSK Receipt Date: 29-SEP-2025 A retired pharmacist reported that the patient, had experienced a dermatologic reaction to his first dose of Shingrix. The rash had first appeared on 20th September 2025. The reporter had stated that the large blotchy patches on the patient's skin. Patient had developed a rash and welts under both arms, in the groin area, down the top of both legs, on his buttocks, and on his back. Additionally, the patient had a small itchy patch on his foot. Patient presented with bloody patches under both arms growing area, up of both legs, some on back and a little bit one foot. It is an all over. The rash had come and gone over the next 5 to 6 days and had flared about four times. The patient's lips had been swollen twice. The reaction had worsened when the patient was hot, such as after golfing or working in the yard. On a scale of 1 to 5, the patient had rated his discomfort as a five when the rash was most severe. Patient had experienced a similar rash resembling a wasp sting two months earlier. She had taken Benadryl for his symptoms, which had subsided after taking the medication. The patient had not experienced any further rash since 25th September 2025. The reporter had not known the route or location of administration but had confirmed that the patient had received his first dose of Shingrix from his pharmacist.
Medical History/Concurrent Conditions: Rash (patient had a similar rash to a wasp sting two months ago)
ASPIRIN; ATORVASTATIN; LISINOPRIL; METOPROLOL; DORZOLAMIDE; LATANOPROST; VITAMIN C; VITAMIN D NOS