Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COLD SWEATS; This spontaneous report received from a patient concerned a 56 year old male. Initial information was processed along with the additional information received on 25-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included heart disease, and heart stent (in 2019), and concurrent conditions included psoriasis, penicillin allergy (penicillin breaks out in a rash), non-alcohol user, non-smoker, sleep apnea, diabetes, and high blood pressure. The patient was previously received with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 06-MAY-2021 for prophylactic vaccination on right arm. It was unknown if the patient experienced adverse events after vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total administered on 02-NOV-2021 for prophylactic vaccination on left arm. Concomitant medications included metformin for pre-diabetic, and humira (adalimumab) for psoriasis. Patient received an email that he was in close contact with someone at work who tested positive for COVID-19. Patient's symptoms started on 17-JAN-2022 and he was a little achy. Patient experienced symptoms like nasal and throat being congested, cold sweats in neck, chills, cold shivering, lethargic and a little tiredness. On 19-JAN-2022, Laboratory data included: COVID-19 antigen test (Binax now home test) (NR: not provided) negative. On 20-JAN-2022, Laboratory data included: COVID-19 antigen test (Binax now home test) (NR: not provided) negative. On 24-JAN-2022, the patient experienced sore throat, headache, chills, and diarrhea. On 25-JAN-2022, the patient experienced congestion. On 25-JAN-2022, the patient's Laboratory data included: COVID-19 antigen test (home test) (NR: not provided) positive (suspected clinical vaccination failure and suspected covid-19 infection) (dose number in series 2). Patient reported that 2 of his coworkers tested positive for COVID 19. Patient was in close contact with one of them for about 6 hours at the office. Patient had a ride in the same car with the other coworker and was in close contact with him for a total of about 2.5 hours. Patient had other health conditions so he was concerned about his exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure and cold sweats were not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213713 and 90000213795.; Sender's Comments: V0: 20220140627- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. 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