Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: Feeling bad; COVID-19; This spontaneous case was retrieved on 26-Jan-2023 from Reporting System (reference number: 2554876-1), reported by other healthcare professional and concerned a 73-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included Lipitor (atorvastatin calcium), used for an unreported indication.  On 08-Oct-2022, the patient was vaccinated with Afluria Quadrivalent vaccine (influenza vaccine inact split 4v; dose: as reported 'one,' route of administration: injection (SYR), anatomical location: left arm and indication: not reported). The batch number was 346336. The reported batch number was identified by Seqirus to be linked to the suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Afluria Quadrivalent vaccine. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On the same day, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent (tozinameran, riltozinameran; dose reported as 'five'; route of administration: injection (SYR); anatomical location: right arm; indication: not reported). The batch number reported was GH9703.  On 17-Dec-2022, two months and ten days after receiving Fluad Quadrivalent vaccine and non-company co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient contracted COVID-19 infection. The patient's home COVID-19 test came back positive.  On an unspecified date in Dec-2022, the patient called primary doctor, who prescribed Paxlovid (nirmatrelvir, ritonavir).  On 25-Dec-2022, reported as eight days after, the patient took another home COVID-19 test, which returned negative.  On an unspecified date, reported as a few days after the negative COVID-19 test, the patient started feeling bad again.  On an unspecified date, the patient's home COVID-19 test returned positive. Patient rested and was isolated.  On an unspecified date, the patient recovered from the events.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 73-year-old female patient was vaccinated with Afluria Quadrivalent and with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, on the same day. Two months and 10 days following vaccination, patient was tested positive for Covid-19. A few days after that, patient was feeling abnormal. Considering unsuggestive temporal relationship for the event feeling abnormal and biological implausibility for the event Covid-19, causality of the suspect vaccine is assessed as not related.; Sender's Comments: A 73-year-old female patient was vaccinated with Afluria Quadrivalent and with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, on the same day. Two months and 10 days following vaccination, patient was tested positive for Covid-19. A few days after that, patient was feeling abnormal. Considering unsuggestive temporal relationship for the event feeling abnormal and biological implausibility for the event Covid-19, causality of the suspect vaccine is assessed as not related.