Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure, Weight
Clinical narrative: EXTREME SWEATING; WEIGHT LOSS 15 POUNDS IN 10 DAYS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old male  and unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, expiry: unknown) dose was not reported, 1 total administered in left arm on 15-MAR-2021 for prophylactic vaccination. Age at time of vaccination 60 years old. No concomitant medications were reported.  On an unspecified date in AUG-2021 patient had covid-19. The patient experienced a very high fever and shortness of breath (suspected covid-19 infection) (dose number in series 1). On an unspecified date, patient was pretty sick and had extreme sweating and ended up losing 15 pounds in 10 days. Laboratory data (dates unspecified) included: Weight (NR: not provided) losing 15 pounds.(dose number in series 1).  On 03-AUG-2021 or 04-AUG-2021, the patient tested positive for covid-19 with an at home test, at that time then his doctor confirmed his diagnosis with covid-19 (suspected clinical vaccination failure) (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, extreme sweating, and weight loss 15 pounds in 10 days, and the outcome of suspected clinical vaccination failure was not reported. On 03-NOV-2021, the patient received additional booster dose of pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination of pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2). On 11-APR-2022 the patient received booster dose of moderna covid-19 vaccine (Elasomeran) (dose number in series 3) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination of moderna covid-19 vaccine (Elasomeran) (dose number in series 3). It was reported that, on 14-MAY-2022, the patient had exposure to his mother in law and he was not experiencing any symptoms and on 17-MAY-2022, he tested negative for covid-19 (dose number in series 3). This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231729.; Sender's Comments: V0: 20220537842 -Covid-19 vaccine ad26.cov2.s -Suspected 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.