Age: 77.0
Sex: M
Vaccine: FLUX, RSV
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: COVID-19; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 77-year-old male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in left deltoid for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Former smoker", stop date: 1985, notes: 5 pack-year history; No smoking since 1985; "Prostatic hypertrophy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose 6 (booster), single, time: 10:30 AM, lot number: GJ6743, vaccine location: right arm), administration date: 20Apr2023, when the patient was 77-year-old, for COVID-19 immunisation; Covid-19 vaccine (Dose 5, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (hospitalization) with onset 07Oct2023, outcome "recovered" (Oct2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: In 6 days; (08Oct2023) Positive, notes: COVID rapid antigen test. Therapeutic measures were taken as a result of covid-19. Clinical course: Vaccination facility type was Pharmacy or drug store. The patient has no other active illness. The reporter did not consider the Pfizer product had a causal effect to the adverse event. The patient had COVID infection, onset date: 07Sep2023 (as reported), not serious, treatment included Paxlovid from 08Oct2023 to 12Oct2023. AE Onset date also reported as 07Oct2023. The patient have a positive test for SARS-COV2. It was unknown if patient has SARS-CoV2 antibodies at diagnosis. The patient was hospitalized. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or EMCO) or receive mechanical ventilation. The patient had no Multiorgan failure, no Respiratory, no Cardiovascular, no Gastrointestinal/Hepatic, no Vascular, no Renal, no Neurological, no Altered Consciousness, no Hematological and no Dermatological. The event did not require the initiation of new medication or other treatment or procedure. Around 6 but 8 days later patient experienced rebound of symptoms and newly positive antigen test. Symptoms cleared in 3 days and antigen test negative in 6 days. The patient did not have any pre-existing disease worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination.  The reporter considered "covid-19" not related to rsv vaccine prot.subunit pref 2v.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.