Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM / RA |
Infection; a scab on her right arm at the injection site; Fluid came out from scab; a dark spot on her right arm at the injection site; area around the injection site of her right arm was tender; terrible pain in her right arm; her right arm was a little black and blue at this point; area around the scab was was red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site scab in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On 05-DEC-2024, the patient received Arexvy (intramuscular, right arm) and Influenza vaccine (left arm). In DEC-2024, less than a month after receiving Arexvy and less than 2 weeks after receiving Influenza vaccine, the patient experienced injection site scab (Verbatim: a scab on her right arm at the injection site), injection site discharge (Verbatim: Fluid came out from scab), injection site discoloration (Verbatim: a dark spot on her right arm at the injection site), injection site tenderness (Verbatim: area around the injection site of her right arm was tender), pain in arm (Verbatim: terrible pain in her right arm), skin discoloration (Verbatim: her right arm was a little black and blue at this point) and erythema (Verbatim: area around the scab was was red). On an unknown date, the patient experienced infection (Verbatim: Infection). The patient was treated with amoxicillin;clavulanic acid and paracetamol (Tylenol). The outcome of the injection site scab, injection site discoloration, injection site tenderness and pain in arm were resolved and the outcome of the injection site discharge, skin discoloration and erythema were not reported and the outcome of the infection was not resolved. It was unknown if the reporter considered the injection site scab, injection site discharge, injection site discoloration, injection site tenderness, pain in arm, skin discoloration, erythema and infection to be related to Arexvy. It was unknown if the company considered the injection site scab, injection site discharge, injection site discoloration, injection site tenderness, pain in arm, skin discoloration, erythema and infection to be related to Arexvy. Linked case(s) involving the same patient: US2020202279 Additional Information: GSK Receipt Date: 28-JAN-2025 The patient received Arexvy in her right arm and a high dose Flu Vaccine (Unknown Product Information) in her left arm, both on 5 December 2024. The patient reported that the nurse administrator did swab both arms before administering the injections. The area around the injection site of her right arm was tender for the first day or two (no specific dates provided). A week after receiving Arexvy, she experienced terrible pain in her right arm. Her right arm was a little black and blue at this point, and her physician told her to take Tylenol, and to ice the area. The patient had no more pain the day after icing the area, and has had no pain since that time. Two weeks after, she noticed a dark spot, the size of a quarter, like a scab on her right arm at the injection site, the area around the scab was red. The patient did call her physician at this point, but was not seen. The patient reported that a week later, when she pressed on the scab, it felt odd, there was a ridge around the scab, and some sort of fluid came out, her physician prescribed Augmentin 500/125 MG tablets to take one twice a day for seven days, along with a probiotic. The patient reported that on the fifth day of the Augmentin medication, on 27 January 2025, the scab fell off the area, and the area looked like a piece of raw meat on her arm. The patient seen her physician on 27 January 2025, and the physician added three more days to her Augmentin duration of therapy, to make a total of ten days and, referred the patient to see a wound specialist. It was unknown if the reporter considered the injection site scab, injection site discharge, injection site discoloration, injection site tenderness, pain in arm, skin discoloration, erythema and infection to be related to Flu Vaccine. The consent to follow-up was not provided. The case is linked with US2020202279 for same patient.; Sender's Comments: US-GSK-US2020202279:same patient