Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Extensive swelling of vaccinated limb, Fatigue, Headache, Injection site erythema
Clinical narrative: fever of 100.5F; Headache; Diarrhea; Fatigued; Swollen injection site about 3x4 inches in size; Tender Injection site/Shot hurt; Red injection site; Arm warm at injection site; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included covid-19 (had Covid in May 2023), sickness and fever.   On 05-SEP-2023, the patient received Arexvy (right arm). On 05-SEP-2023, less than a day after receiving Arexvy, the patient experienced extensive swelling of vaccinated limb (Verbatim: Swollen injection site about 3x4 inches in size), injection site pain (Verbatim: Tender Injection site/Shot hurt), injection site erythema (Verbatim: Red injection site), injection site warmth (Verbatim: Arm warm at injection site) and fatigue (Verbatim: Fatigued). On 06-SEP-2023, the patient experienced fever (Verbatim: fever of 100.5F), headache (Verbatim: Headache) and diarrhea (Verbatim: Diarrhea). In SEP-2023, the patient experienced pain in arm (Verbatim: Sore arm).  The patient was treated with paracetamol (Tylenol). On 06-SEP-2023, the outcome of the diarrhea was resolved. The outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, headache, fatigue and pain in arm were not resolved and the outcome of the injection site warmth was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, fever, headache, diarrhea, fatigue and pain in arm to be related to Arexvy.     It was unknown if the company considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, fever, headache, diarrhea, fatigue and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-SEP-2023 The patient self-reported this case. The patient reported that she received the Arexvy vaccine in her right arm (she thought in the muscle but was not sure) and the shot hurt when she received it.  The patient reported that afternoon, within a couple of hours of receiving the vaccine, her arm was a little warm and tender at the injection site.  That same evening, the patient reported that she had a swollen, red, and tender area at the injection site about 3x4 inches in size.  The patient reported that her arm was still sore and red at the time of reporting, and it was too tender to lie on it in bed.  The patient also reported that that she was fatigued and was still feeling fatigue at the time of reporting.  The patient reported that she had diarrhea the day before reporting, which only lasted that one day.  The patient reported that she had a headache starting on and still had a headache at the time of reporting.  The patient reported that she had a fever of 100.5-degree F starting on 6th September 2023, that was gone this morning, but came back this afternoon on the day of reporting of 100.3 degree F.  The patient reported that she had taken 2 - 500 mg Tylenol the day before reporting in afternoon, 6th September 2023 and this afternoon, 7th September 2023. The patient was unable to supply any lot/expiry information for her vaccine.  The reporter did not consent to follow-up.