Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Skin weeping
Clinical narrative: she experienced injection site pain; a hard spot that was very small at the injection site; had a large bruise appear at the injection site; injection site swelling; injection site skin felt hot; injection site weeping with yellow fluid; secondary infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-APR-2024, the patient received the 1st dose of Arexvy (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: she experienced injection site pain), injection site induration (Verbatim: a hard spot that was very small at the injection site), injection site bruising (Verbatim: had a large bruise appear at the injection site), injection site swelling (Verbatim: injection site swelling), injection site warmth (Verbatim: injection site skin felt hot), injection site discharge (Verbatim: injection site weeping with yellow fluid) and injection site infection (Verbatim: secondary infection). The patient was treated with mupirocin. The outcome of the injection site pain, injection site induration, injection site bruising, injection site swelling, injection site warmth and injection site discharge were unknown and the outcome of the injection site infection was not reported.   It was unknown if the reporter considered the injection site pain, injection site induration, injection site bruising, injection site swelling, injection site warmth, injection site discharge and injection site infection to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site induration, injection site bruising, injection site swelling, injection site warmth, injection site discharge and injection site infection to be related to Arexvy.   Additional Information: GSK receipt date: 06-JUN-2024 The patient received Arexvy vaccine at pharmacy in her left arm.   Consumer noted that in the first few days she experienced injection site pain.   She then reported after a few days the injection site pain was worse and had a hard spot that was very small at the injection site.   The hard spot grew over time to 4 inches in diameter.   She then had a large bruise appear at the injection site, swelling and her skin felt hot to the touch at the injection site.   She was examined by a doctor at urgent care and prescribed antibiotics.   The injection site pain, swelling, bruise and skin feeling hot did not clear up with use of the antibiotic.   The consumer then went to see a dermatologist and an ointment was prescribed to apply to the area.   The dermatologist prescribed Mupirocin ointment for what was diagnosed as a secondary infection.   The consumer stated that the site was about 3/4th of the way healed.   The site did weep at times with yellow fluid.   Consumer described her experience as having the vaccine from hell.   Consumer stated that she had a general check up with her internist on 6th June 2024 and would follow up with GSK if the doctor reports anything new.