Sex: F
Vaccine: COVID19, RSV, UNK
Symptoms: Feeling abnormal, Injection site bruising, Malaise, Nausea, Personality change
Clinical narrative: Feeling terrible/ Feeling abnormal; Injection site bruising / The bruise has turned to a purple at this point; Malaise; Nausea; Patient's persona began to decline; Vomited once; This spontaneous case, initially received on 07-Jan-2025, was reported by a health authority via Vaccine Adverse Event Reporting System (VAERS) (reference number 2813840-1) and concerns an elderly female patient.  Past medical history included Blood test, Positive airway pressure therapy / CPAP. At the time of the event the patient stated none other than possible seasonal allergies., Chronic obstructive pulmonary disease (COPD), restless leg syndrome.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 19-Nov-2024, the patient vaccinated Fluad (TIV) for influenza immunization, dose regimen: not reported, dose: 1, Route of administration: Intramuscular, anatomical location: right arm Lot number: 33T4PAB0B1. batch number reported as 33T4PAB0B1. CSL Seqirus Batch number unable to be matched.  Non-company suspect drugs: On 19-Nov-2024, the patient received Arexvy (RSV vaccine prot. subunit PreF3) for an unknown indication. Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical location: Left arm. Lot number: 5H1GY99SAY. On 19-Nov-2024, the patient received Novavax COVID-19 Vaccine for COVID-19 immunization. Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical location: Left arm. Lot number: JIRJ22I041PQLNM.  Adverse reactions/events and outcomes: On 21-Nov-2024, 2 days after vaccination, the patient experienced feeling terrible (hospitalized, outcome: not recovered / not resolved), injection site bruising / the bruise has turned to a purple at this point (hospitalized, outcome: not recovered / not resolved), malaise (hospitalized, outcome: not recovered / not resolved), nausea (hospitalized, outcome: not recovered / not resolved), patient's persona began to decline (hospitalized, outcome: not recovered / not resolved), vomited once (hospitalized, outcome: not recovered / not resolved). Patient was hospitalized for 4 days.  Patient received three vaccines, RSV and covid in left arm and flu in the right arm. 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 have been trying blood tests to try to figure out what has been going on, with no clear diagnosis. Patient has been in hospital since Saturday (23-Nov-2024) or Sunday (24-Nov-2024) at this point. They are suspecting possible carbon monoxide excess per husband as they have patient on a CPAP machine. she has been feeling less nauseated, although she is still in hospital under medical care. The bruise has turned to a purple at this point.  Lab Data: no actual labs, just word from husband.  Fluad (TIV) action taken: Not Applicable  Reporter assessment: The reporter considered the events as serious (hospitalization) and did not provide a causality assessment.  Follow-up (13-Jan-2025) received from consumer: New reporter added, Co-suspect (Novavax COVID-19 Vaccine) details updated and narrative updated accordingly.; Reporter's Comments: Causality Related for all events Due to the spontaneous nature of the case, it is considered related for the reporting purpose. Plausible temporal relationship (onseton 3rd day after the Flaud TIV administration). However, reported medical history, co-suspect medicines and concomitant medications are considered as possible confounders.