Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SLEPT UNTIL 8:30 IN MORNING, USUALLY UP BY 6AM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: walking pneumonia in OCT-2019. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 02-MAY-2021 for prophylactic vaccination on left arm. The concomitant medications included multivitamin injection, vitamin C, vitamin D3, and zinc to help with immune. On 05-AUG-2021, Laboratory data included: COVID-19 virus test (swab test) (NR: not provided) Positive for covid-19. On 05-AUG-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. On 09-AUG-2021, the patient experienced slept until 8:30 in morning, usually up by 6am. On Wednesday, 04-AUG-2021, the patient was up at corporate for a meeting. The patient was tested for COVID-19 on Thursday, 05-AUG-2021 and the patient was asymptomatic at that time. The test results came back positive on 06-AUG-2021. The patient's colleague who were present for the meeting the previous week were also tested covid-19 positive. The patient thought buffet-style lunch was not the best thing that they did at Headquarters. The patient stated that he was asymptomatic, but his wife wasn't feeling well, from the grandkids who were sick. The patient's wife underwent swab test for covid-19 on 07-AUG-2021 and was tested negative on 08-AUG-2021. The patient further stated that he had symptoms starting night of 08-AUG-2021, symptoms of fevers. Exact temperature was not known. On the day of reporting the patient slept until 8:30 in morning which was unusual since the patient would usually be up by 6:00. A while ago, the patient's brother was tested covid-19 positive. On 08-AUG-2021, the patient had doctor appointment who suggested the patient to monitor the oxygen level and report to him if it dropped below 93%. The patient was waiting for his oxymeter and manometer and was quarantined alone at home. The patient was advised to stay at home for 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and slept until 8:30 in morning, usually up by 6am was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189148.; Sender's Comments: V0: 20210817957-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