Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain lower, Chills, Cough
Clinical narrative: severe very swollen arm; Severe very sore arm; coughing; abdominal pain; raising phlegm; fever/high fever; chills; vomiting; nausea; higher than usual blood pressure; eyes running; nose running; sweating at night mostly; lower abdominal pain; some bloating; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling arm in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included diverticulitis. Previously administered products included Antibiotics.   On 20-SEP-2023, the patient received Arexvy (intramuscular) .5 ml. In SEP-2023, less than a month after receiving Arexvy, the patient experienced swelling arm (Verbatim: severe very swollen arm), pain in arm (Verbatim: Severe very sore arm), cough (Verbatim: coughing), abdominal pain (Verbatim: abdominal pain), phlegm (Verbatim: raising phlegm), fever (Verbatim: fever/high fever), chills (Verbatim: chills), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea), blood pressure high (Verbatim: higher than usual blood pressure), eye discharge (Verbatim: eyes running), runny nose (Verbatim: nose running), sweating (Verbatim: sweating at night mostly), lower abdominal pain (Verbatim: lower abdominal pain) and bloating (Verbatim: some bloating).  The patient was treated with antiemetics and antinauseants (Anti Nausea Tablet (Nos)). In SEP-2023, the outcome of the swelling arm, pain in arm, cough, abdominal pain, phlegm, chills, vomiting, nausea, blood pressure high, eye discharge and runny nose were resolved (duration 4 days) and the outcome of the fever, sweating, lower abdominal pain and bloating were resolved (duration 6 days).   The reporter considered the swelling arm, pain in arm, cough, abdominal pain, phlegm, fever, chills, vomiting, nausea, blood pressure high, eye discharge, runny nose, sweating, lower abdominal pain and bloating to be related to Arexvy.     The company considered the swelling arm, pain in arm, cough, abdominal pain, phlegm, fever, chills, vomiting, nausea, blood pressure high, eye discharge, runny nose, sweating, lower abdominal pain and bloating to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-SEP-2023 It was reported that initial 4.5 days of duration after vaccination, patient experienced severe very sore swollen arm, coughing, abdominal pain, raising phlegm, fever, chills, vomiting and was better with anti nausea medication. The patient experienced higher than usual blood pressure, eyes and nose running, high fever, chills, sweating at night mostly, then broke and had mild chills. Additionally, lasting the next 2 days patient reported fever, sweats, no chills, lower abdominal pain, some bloating not as bad. The reporter did believed the event was related to the product The reporter stated that the patient had previously been treated for diverticulitis, including antibiotics. This was during the summer months. The patient was feeling great when she went to be vaccinated. The reporter consented to follow up.