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Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; O2 LEVEL 85%; This spontaneous report received from a patient concerned a 64-year-old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included Crohn''s disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn''s disease. On an unspecified date in 2021, the patient experienced flu-like symptoms (fever 100F for about two days, very torturous and unusual headache, body aches). It was reported that the patient spent five days sick in bed. On an unspecified date in 2021, the patient took Tylenol but it did not relieve the pain and nothing seemed to help patient except getting some rest. After the vaccine administration, the patient stayed at home for 14 days, she double-masked, she had not been going out very much. On 11-APR-201, the patient experienced oxygen level 85%, felt ill and went to instant care and did Polymerase chain reaction test (PCR). On 13-APR-2021, the test result came positive. The patients Covid-19 symptoms included cough, fever (100F low grade fever) and oxygen (O2) level 85%. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 85 %. Laboratory data included: PCR (NR: not provided) Positive. In 2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from O2 level 85%, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210427837-covid-19 vaccine ad26.cov2.s-Confirmed 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
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