Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: gluten allergy, crohn's disease, and depression. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered at left arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 34 years old. On 29-OCT-2021, the patient received non-company suspect vaccine included: Moderna/ spikevax (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered at left arm for prophylactic vaccination. Age at time of vaccination 34 years old. It was unknown whether patient had any adverse events following vaccination with Moderna/ spikevax (elasomeran) (dose number in series 2). On 25-MAR-2022, the patient received additional non-company suspect vaccine included: Moderna/ spikevax (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered at left arm for prophylactic vaccination. Age at time of vaccination 35 years old. Concomitant medications included bupropion for antidepressant.  On an unspecified date, the patient had covid infection (dose number in series 3). The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 28-MAY-2022 and last dose on 01-JUN-2022 for treatment of covid 19 and was recovered. On 25-MAY-2022, the patient underwent COVID-19 virus (initial) test which was positive that led to confirmed clinical vaccination failure (dose number in series 1). On 08-JUN-2022 at 07:00, the patient experienced confirmed covid-19 infection and return of symptoms which includes mostly congestion and extreme fatigue (dose number in series 3). On 08-JUN-2022 the patient again underwent Laboratory data included: COVID-19 virus test which was positive (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000236609.; Sender's Comments: V0: 20220634514 -Covid-19 vaccine ad26.cov2.s -CONFIRMED CLINICAL VACCINATION FAILURE . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.