Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Off label use, SARS-CoV-2 test, Suspected COVID-19, Syncope
Clinical narrative: FAINTED; SUSPECTED COVID-19; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer by a other manufacturer (Pfizer Inc.) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: gout, weight control, joint health, and penicillin allergy. The patient previously received first dose of Pfizer (tozinameran) (dose number in series 1) (form of admin and route of admin was not reported, batch number: EN6200, expiry: unknown) dose was not reported, administered at left arm on 24-FEB-2021 for covid-19 prophylaxis.  The patient received second dose of Pfizer (tozinameran) (dose number in series 1) (form of admin and route of admin was not reported, batch number: EN6200, expiry: unknown) dose was not reported, administered at left arm on 17-MAR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following both doses of Pfizer (tozinameran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) 1 total dose was not reported, administered to left arm on 12-OCT-2021 16:00 for covid-19 prophylaxis. The drug was associated with Off label use.(dose number in series 2). It was unknown whether patient had any adverse events following the dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) . The patient additionally received non-company suspect vaccine dose of Moderna/Spikevax (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: 011B22A expiry: UNKNOWN) dose was not reported, administered to right arm on 03-AUG-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included allopurinol for gout treatment, chondroitin sulfate sodium/glucosamine hydrochloride/manganese gluconate for joint health, acetylcarnitine/ascorbyl palmitate/phenylalanine/taurine/tyrosine for supplement, oxitriptan for supplement, semaglutide for weight control, and loratadine.  On JUL-2023, laboratory data included: COVID-19 virus test negative. Patient reported as 8 days after testing negative for covid ,on 27-JUL-2023 13:00, the patient experienced foul taste and diarrhea and covid-19 infection( Suspected covid-19) (Dose number in series 3)  and patient started treatment with non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) ( form of admin, route of admin, and batch number were not reported expiry: UNKNOWN) dose and frequency were not reported from 27-JUL-2023 to 31-JUL-2023 for treatment of covid-19. On 29-JUL-2023, the patient fainted (Dose number in series 3). The patient was hospitalized on an unspecified date for covid-19 infection( Suspected covid-19) and fainting for 1 day.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable, and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from Suspected covid-19, and fainted, and the outcome of revaccination with different covid-19 vaccine and off label dosing frequency was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230830835-Fainted. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. 20230830835- Suspected covid-19. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.