Age: 52.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Nasal congestion, Product administration error, Pyrexia, SARS-CoV-2 test
Clinical narrative: Breakthrough covid case/tested positive; Nasal congestion; Cough; Fever; Loss of smell and taste; Loss of smell and taste; SOB; Afluria Quadrivalent and Moderna COVID-19 vaccine were administered in the same arm at the same time; This spontaneous case from was retrieved on 14-Jul-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2339216-1), reported by other healthcare professional and concerned a 52-year-old, female patient.  The patient's concurrent conditions included allergy to fish oil, allergy to Motrin (ibuprofen), allergy to non-steroidal anti-inflammatory drugs (NSAID) and allergy to tomatoes. The patient's concomitant medications were not reported. The patient's historical vaccines included first two doses of Moderna COVID-19 vaccine (elasomeran).  On 07-Dec-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular, anatomical location: left arm, dose: 'one' as reported, and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was P100367237.  On the same date, the patient was vaccinated with non-company co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 'three' as reported, intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 012H21B.  On an unspecified date in Jan-2022, the patient had SARS-COV-2 test and the result was positive.  On an unspecified date in 2022, an unknown amount of time after receiving Afluria Quadrivalent and non-company co-suspect Moderna COVID-19 vaccine, the patient experienced nasal congestion, loss of smell and taste, cough, shortness of breath (SOB) and fever. Also, the patient experienced covid (reported as 'breakthrough covid case').  On 25-Jun-2022, the patient was presented to emergency room with complain of nasal congestion, loss of smell and taste, cough, SOB and fever. The patient was prescribed Paxlovid (nirmatrelvir, ritonavir) and was discharged home.  On the same date, the patient underwent unspecified influenza test, streptococcal A test, covid test and urine analysis (UA), but results were not reported.  The outcome for all events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 52-year-old patient received the suspect product Afluria Quadrivalent and non-company co-suspect Moderna COVID-19 vaccine on the same day and in the same anatomical location: left arm (explicitly coded as 'product administration error'). The patient was COVID-19 positive about a month after vaccination. Thereafter the patient experienced anosmia, ageusia, dyspnoea, nasal congestion, cough, and fever. More information regarding patient's diagnostic findings and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 52-year-old patient received the suspect product Afluria Quadrivalent and non-company co-suspect Moderna COVID-19 vaccine on the same day and in the same anatomical location: left arm (explicitly coded as 'product administration error'). The patient was COVID-19 positive about a month after vaccination. Thereafter the patient experienced anosmia, ageusia, dyspnea, nasal congestion, cough, and fever. More information regarding patient's diagnostic findings and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related. Product administration error is assessed as unrelated per company's conventions.