Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fatigue, SARS-CoV-2 test positive, Taste disorder
Clinical narrative: Tested that evening, and it was positive; Feeling tired; No problems other the taste; This spontaneous case was retrieved on 27-Mar-2023 from the Vaccine Adverse Event Reporting System (VAERS) (reference number: 2594774-1), reported by other non-healthcare professional (consumer), and concerned a 62-year-old, female patient.  The patient's concurrent conditions included pre-diabetes and obesity. The patient's concomitant medications included propafenone, diltiazem, Xarelto (rivaroxaban), and metformin, all used for unreported indications.   On 08-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: injection (reported as 'SYR'), anatomical location: left arm, indication: not reported). The batch number reported was 942377. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with Moderna COVID-19 Vaccine, Bivalent (elasomeran, imelasomeran; dose: reported as 'five', route of administration: injection (reported as 'SYR'), anatomical location: right arm, indication: not reported). The batch number reported was AS7140C.    On 17-Dec-2022, three months and nine days after receiving Flucelvax Quadrivalent and Moderna COVID-19 Vaccine, Bivalent, the patient started feeling tired, she had no other feeling than that. The patient took a (COVID-19) test that morning, it was negative, but she knew that her husband was positive, so she knew it was coming and tested again that evening, and it was positive.   The patient contacted a primary care provider (PCP) the day before and wanted to have a plan because of her current medications and decided that day to go off of her medications and it was called in for Paxlovid (nirmatrelvir, ritonavir), but the patient waited another 12 hours to start the Paxlovid, in total 36 hours. The patient stayed on Paxlovid for five days.  On an unspecified date in Dec-2022, the patient experienced problems with taste. The patient was having no problems other than taste.   With her cardiologist, the patient researched when to start her medication again waiting additional 12 days and went back on to her medication with no problem.  At the time of initial reporting, the patient had not recovered from the events of COVID-19, tiredness and taste disorder.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 62-year-old female patient experienced fatigue and was tested positive for COVID-19 three months and nine days after vaccination with Flucelvax Quadrivalent and Moderna COVID-19 bivalent vaccine. The patient also developed taste disorder. Information regarding the related diagnostic findings was not provided. Causality is assessed as not related for all three events (fatigue, COVID-19 and taste disorder) due to temporal and biological implausibility.; Sender's Comments: A 62-year-old female patient experienced fatigue and was tested positive for COVID-19 three months and nine days after vaccination with Flucelvax Quadrivalent and Moderna COVID-19 bivalent vaccine. The patient also developed taste disorder. Information regarding the related diagnostic findings was not provided. Causality is assessed as not related for all three events (fatigue, COVID-19 and taste disorder) due to temporal and biological implausibility.