Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Irritation skin; hurts like he has been scratched; Welts; Headache; Tiredness; Fever; Chills/shivering; Soreness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included pulled muscle (on his right flank). Concomitant products included alfuzosin. On 26-APR-2025, the patient received the 1st dose of Shingrix (left arm). In APR-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), tiredness (Verbatim: Tiredness), fever (Verbatim: Fever), chills (Verbatim: Chills/shivering), injection site pain (Verbatim: Soreness at injection site), skin pain (Verbatim: hurts like he has been scratched) and welts (Verbatim: Welts). On 30-APR-2025, the patient experienced skin irritation (Verbatim: Irritation skin). The patient was treated with methoxamine hydrochloride, neomycin sulfate, polymyxin b sulfate (Neosporin). The outcome of the headache, tiredness, fever and chills were unknown and the outcome of the injection site pain was resolved and the outcome of the skin irritation, skin pain and welts were not resolved. It was unknown if the reporter considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix. It was unknown if the company considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the patient. The patient received the first dose of Shingrix on 26th April 2025. The patient experienced headache, tiredness, fever, chills, shivering, and soreness at the injection site (Left arm). On the day of reporting, 30th April 2025, the patient noticed that he was experiencing skin irritation on the right side of his abdomen. The patient stated that the skin irritation looks like there were cuts/thin lines across his abdomen, they look like scratches or claw marks. The irritation also hurts like he had been scratched. The patient stated he had welts on his right side. The patient put Neosporin to the skin irritation, which he believed initially irritated the area even more, but towards the end of the call it calmed down. The patient stated that he had been sleeping on a heating pad to alleviate a pulled muscle on his right flank. The pulled muscle happened prior to receiving Shingrix.
Pulled muscle (on his right flank)
Alfuzosin