Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Bronchitis, Dizziness, Immediate post-injection reaction, Impaired work ability, Influenza
Clinical narrative: Acute bronchitis with yellow-orange mucus; Got dizzy; Flu; Fever at 103; Immediately got sick; This is a spontaneous case reported by other non-health professional (consumer) to agency (reference number: SEQ20-00398) with additional documents received on the same day (being processed together, reference number: SEQ20-00398) and initially received on 27-Jan-2020, concerning a 57-year-old male patient.  The patient's medical history included prostate issues.  The patient's concomitant medication included tamsulosin for prostate.  On 20-Dec-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 263334, expiration date: 30-Jun-2020) for influenza prophylaxis.  On the same day, immediately after vaccination, the patient got sick like he had never been sicker in his life.  On 23-Dec-2019, three days after vaccination, the patient had fever 103, and had to go to the emergency room (ER) where he was tested for the flu and was positive. The patient started treatment with Tamiflu (oseltamivir phosphate) for five days. It was reported that the patient had not been working since.   On an unspecified date, right after the flu went away, the patient developed acute bronchitis with yellow-orange mucus. The patient was treated with Z-PAK (azithromycin), but it did not work. The patient stated that doctor had not given him anything for the viral but only for the bacterial acute bronchitis.  In addition, on 27-Jan-2020, reported as this morning, the patient got dizzy when going out. No further information was provided.  At the time of initial report, the outcome of 'sickness', 'acute bronchitis' and 'dizzy' was not resolved, while the outcome of 'fever' was not reported.  The events of 'flu' and bronchitis' were considered serious due criterion of medical significance, per company.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.  Follow up received from other non-health professional on 13-Mar-2020: Dates for lab tests updated from '19-Dec-2019' to '23-Dec-2019'. Start date for vaccination updated from '19-Dec-2019' to '20-Dec-2019'. Facility type updated. Start date for Tamiflu updated to '23-Dec-2019'. Start date for events flu and fever updated from '19-Dec-2019' to '23-Dec-2019', and for the event of sickness start date updated from '19-Dec-2019' to '20-Dec-2019'. Narrative amended accordingly.  Company comment: The patient experienced malaise on the same day after receiving Flucelvax Quadrivalent and developed pyrexia and influenza three days later. The patient also developed dizziness one month after vaccination. Reportedly, on an unspecified date, the patient developed acute bronchitis with yellow-orange mucus. The patient was treated with Z-PAK (azithromycin), although it did not work. Yellow-orange mucus and antibiotic treatment suggest bacterial bronchitis, therefore the event is assessed as serious. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for bronchitis and dizziness (defaults to "related" in the safety database for reporting purposes). Considering plausible chronology, causality is assessed as possibly related for malaise, influenza and pyrexia.; Sender's Comments: The patient experienced malaise on the same day after receiving Flucelvax Quadrivalent and developed pyrexia and influenza three days later. The patient also developed dizziness one month after vaccination. Reportedly, on an unspecified date, the patient developed acute bronchitis with yellow-orange mucus. The patient was treated with Z-PAK (azithromycin), although it did not work. Yellow-orange mucus and antibiotic treatment suggest bacterial bronchitis, therefore the event is assessed as serious. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for bronchitis and dizziness (defaults to "related" in the safety database for reporting purposes). Considering plausible chronology, causality is assessed as possibly related for malaise, influenza and pyrexia.