Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Personality change, Vomiting
Clinical narrative: Injection site bruising; Feeling abnormal/ out of it/ feeling terrible; Malaise; Nausea; Personality change/ persona began to decline; Vomiting; This serious case was reported by a consumer via other manufacturer and described the occurrence of injection site bruising in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5H1GY99SAY) for prophylaxis.   Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for prophylaxis and Influenza vaccine inact sAg 3v (Fluad) (batch number 33T4PAB0B1) for prophylaxis.   The patient's past medical history included chronic obstructive pulmonary disease (COPD) and restless legs syndrome. Concurrent medical conditions included seasonal allergy (possible). Concomitant products included umeclidinium bromide (Incruse Ellipta), pramipexole, potassium chloride and acetylsalicylic acid (Baby Aspirin).   On 19-NOV-2024, the patient received Arexvy (intramuscular, left arm), the 1st dose of Novavax COVID-19 Vaccine (intramuscular, left arm) .5 ml and Fluad (intramuscular, right arm). On 21-NOV-2024, 2 days after receiving Arexvy, the patient experienced injection site bruising (Verbatim: Injection site bruising) (serious criteria hospitalization), feeling abnormal (Verbatim: Feeling abnormal/ out of it/ feeling terrible) (serious criteria hospitalization), malaise (Verbatim: Malaise) (serious criteria hospitalization), nausea (Verbatim: Nausea) (serious criteria hospitalization), personality change (Verbatim: Personality change/ persona began to decline) (serious criteria hospitalization) and vomiting (Verbatim: Vomiting) (serious criteria hospitalization). The outcome of the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting were not resolved.   It was unknown if the reporter considered the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting to be related to Arexvy.     The company considered the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was vaccinated with Arexvy, Fluad and Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), lot number was reported as JIRJ22I041PQLNM on 19 Nov 2024. On 21-Nov-2024, on 3rd day after vaccination the patient experienced feeling abnormal, injection site bruising, malaise, nausea, personality change and vomiting. A discrepancy was identified in the source document where Novavax lot number JIRJ22I041PQLNM was not captured in the structured field as this lot number does not pertain to Novavax. However, this case was processed as confirmed exposure to Nuvaxovid as Novavax was mentioned under the Manufacturer section of the source document. Patient received three vaccines, RSV and covid in left arm and flu in the right arm. On day 1 patient was fine, by day 3 patient had developed a bruise where RSV shot was given and began to feel nausea and out of it. Vomited once, and experienced nausea. Over the course of ten days patient's persona began to decline. Her husband decided to take her to the hospital after several days of feeling terrible. They had been trying blood tests to try to figure out what has been going on, with no clear diagnosis. The patient had been in hospital since Saturday or Sunday at this point. They were suspecting possible carbon monoxide excess per husband as they have patient on a cpap machine. She had been feeling less nauseated, although she was still in hospital under medical care. The bruise had turned to a purple at this point. The event feeling abnormal, injection site bruising, malaise, nausea, personality change, and vomiting was reported as serious. Based on the spontaneous nature of the report, the causal relationship between the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) and feeling abnormal, injection site bruising, malaise, nausea, personality change, and vomiting was considered possible. It was unknown if the reporter considered the feeling abnormal, injection site bruising, malaise, nausea, personality change and vomiting to be related to Fluad.; Sender's Comments: Malaise and Nausea are listed events which, due to the following criteria (Suspected carbon monoxide excess  patient was on a cpap machine and insufficient information provided about the clinical description) are considered unrelated to GSK vaccine Arexvy.  Injection site bruising, Feeling abnormal, Personality change and Vomiting are unlisted events which are considered unrelated to GSK vaccine Arexvy.