Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site mass, Myalgia, Palpitations, Peripheral swelling, Pyrexia
Clinical narrative: heart palpitations; has a knot in her arm at the injection site; arm was swollen; headache; fatigue/Exhaustion/system was probably run down, as she has been extremely busy; low grade fever; violent chills; Diarrhea; muscle and joint pain; muscle and joint pain; wavy feeling in her head; arm was swollen and sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-SEP-2023, the patient received Arexvy. In SEP-2023, 5 days after receiving Arexvy, the patient experienced head discomfort (Verbatim: wavy feeling in her head), diarrhea (Verbatim: Diarrhea), muscle pain (Verbatim: muscle and joint pain) and joint pain (Verbatim: muscle and joint pain). On 21-SEP-2023, the patient experienced low grade fever (Verbatim: low grade fever) and chills (Verbatim: violent chills). On 22-SEP-2023, the patient experienced injection site lump (Verbatim: has a knot in her arm at the injection site), swelling arm (Verbatim: arm was swollen), fatigue (Verbatim: fatigue/Exhaustion/system was probably run down, as she has been extremely busy) and headache (Verbatim: headache). On 06-OCT-2023, the patient experienced palpitation (Verbatim: heart palpitations). On an unknown date, the patient experienced pain in arm (Verbatim: arm was swollen and sore).  On 22-SEP-2023, the outcome of the chills was resolved.  On 23-SEP-2023, the outcome of the low grade fever was resolved and the outcome of the headache was resolved (duration 1 day).  On 05-OCT-2023, the outcome of the swelling arm was resolved (duration 2 weeks). The outcome of the injection site lump, head discomfort, fatigue, muscle pain and joint pain were not resolved and the outcome of the pain in arm was resolved (duration 2 weeks) and the outcome of the palpitation and diarrhea were resolved.   It was unknown if the reporter considered the injection site lump, swelling arm, pain in arm, palpitation, head discomfort, fatigue, low grade fever, headache, chills, diarrhea, muscle pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site lump, swelling arm, pain in arm, palpitation, head discomfort, fatigue, low grade fever, headache, chills, diarrhea, muscle pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt date: 09-OCT-2023 The patient reported she received her Arexvy vaccine in September and on that evening she had violent chills and low grade fever. The following day she began to have headache which lasted only one day.  The patient was still experiencing the fatigue. Over the following few days she experienced muscle and joint pain, fatigue and diarrhea. Lat week patient had colonoscopy. The diarrhea of patient lasted for several days which began before the colonoscopy procedure. For two weeks she had her arms swollen and sore. The patient stated the knot in her arm at the injection site was still present. For the past 3 to 4 days she began to have heart palpitations which lasts only a few minutes at a time and seem to subside when she drinks water. The patient also admits that her system was probably run down, as she has been extremely busy.  The patient was feeling exhausted.  The patient stated that she has stayed home today (09 Oct 2023) from work due to the wavy feeling in her head.