Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: LOW GRADE FEVER OF 99.3F; DIARRHEA; STOMACH CRAMPING; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 32 year adult male.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. S (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 17-AUG-2022) dose was not reported, 1 total administered on 28-OCT-2021 at left arm for prophylactic vaccination. Age at time of vaccination 32 years old. No concomitant medications were reported.  On 05-DEC-2021, patient experienced runny nose which turned into a sinus infection (confirmed covid-19 infection) which led to confirmed clinical vaccination failure (Dose number in series 2). On 06-DEC-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative (Dose number in series 2). On 08-DEC-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative (Dose number in series 2). On 12-DEC-2021 three test were performed, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative, Laboratory data included: COVID-19 rapid POC test (rapid PCR) (NR: not provided) which was positive and Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 14-DEC-2021, Laboratory data included: COVID-19 rapid POC test ( rapid antigen) (NR: not provided) Negative (Dose number in series 2). On 15-DEC-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative (Dose number in series 2). The patient was quarantined during that time. On 27-FEB-2022, Laboratory data included: COVID-19 rapid POC test (rapid antigen) (NR: not provided) positive and Laboratory data included: COVID-19 PCR test (NR: not provided) Negative (Dose number in series 2).  The patient additionally received booster dose of Spikevax (elasomeran) (Dose number in series 3) (form of admin, route of admin not reported, batch number: 001M21A, expiry: 10-JUL-2022) dose was not reported, administered on 08-APR-2022 at left arm for prophylactic vaccination. On 21-APR-2022, the patient experienced stomach cramping (Dose number in series 3). On 24-APR-2022, the patient experienced diarrhea and cramping (Dose number in series 3). On 25-APR-2022, the patient experienced cramping and low grade fever 99.3 F (Dose number in series 3). Laboratory data included: Body temperature (NR: not provided) 99.3 F (Dose number in series 3). On 26-APR-2022, Laboratory data included: COVID-19 rapid POC test (rapid antigen) (NR: not provided) positive and Laboratory data included: COVID-19 PCR test (NR: not provided) not reported (waiting for the results) after received Spikevax (Dose number in series 3).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from stomach cramping, diarrhea, and low grade fever of 99.3f on 26-APR-2022, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000228220; Sender's Comments: V0:20220452890-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive 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.