Sex: U
Vaccine: COVID19, FLUC3
Symptoms: Anosmia, Cough, Polymerase chain reaction, Pyrexia, Rhinorrhoea
Clinical narrative: Loss of smell; Cough; Rhinorrhea; Fever; This spontaneous case was received on 05-Feb-2024 via Pfizer (reference number: 202400019616) with additional information received on 13-Feb-2024 (being processed together), reported by other healthcare professional (nurse) and concerned a patient of unspecified age and gender.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included two doses of an unspecified COVID-19 vaccine for unspecified indication.    On 10-Oct-2023, the patient was vaccinated with influenza virus vaccine (brand not specified; anatomical location: right deltoid (RD); dose, route of administration, and indication: not reported). The batch number reported was 944457. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v), instead of reported suspect product influenza virus vaccine. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.   On the same date, the patient was vaccinated with a non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; route of administration: intramuscular (IM); anatomical location: left arm (LA); dose and indication: not reported). The batch number reported was HT9275.  On 10-Jan-2024, three months after receiving the influenza virus vaccine and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient's polymerase chain reaction (PCR) test was positive.   On 11-Jan-2024, three months and one day after receiving the influenza virus vaccine and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced mild fever, cough, rhinorrhea, and loss of smell.  On an unspecified date in Jan-2024, the patient recovered from all events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.   Case correction (19-Apr-2024): After internal review of information Report Sent to Regulatory Authority by Reporter? and Intermediary were removed on General tab so report to FDA can be generated. No changes in the narrative.  Company comment: The patient was vaccinated with influenza vaccine and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. Three months after the vaccination, the patient's polymerase chain reaction (PCR) test was positive (unspecified which one). On the next day, three months and one day after the vaccination, patient experienced mild fever, cough, rhinorrhoea and loss of smell. Considering the fact that it was not specified which PCR test was positive (influenza/Covid..) causality for all reported events is unassessable based on currently available information.; Reporter's Comments: The patient was vaccinated with influenza vaccine and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. Three months after the vaccination, the patient's polymerase chain reaction (PCR) test was positive (unspecified which one). On the next day, three months and one day after the vaccination, patient experienced mild fever, cough, rhinorrhoea and loss of smell. Considering the fact that it was not specified which PCR test was positive (influenza/Covid..) causality for all reported events is unassessable based on currently available information.