Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest X-ray, Influenza A virus test, Influenza B virus test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; UNABLE TO SLEEP LYING DOWN AND HAD TO SIT IN BED TO  SLEEP; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bilateral pneumonia, and concurrent conditions included: asthma, non smoker, and abstains from alcohol, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 07-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 20-DEC-2021, the patient experienced confirmed clinical vaccination failure. The patient experienced very bad symptoms that started on (monday) 20-DEC-2021: difficulty breathing, fever of 101.9 F, could not sleep down and had to sit in bed to sleep, headaches and body aches and went to Emergency room on same day. On 20-DEC-2021 Laboratory data included: Body temperature (NR: not provided) 101.9 F, Influenza A virus test (NR: not provided) Not reported., Influenza B virus test (NR: not provided) Not reported., Laboratory test (NR: not provided) Not reported., and Mycoplasma test (NR: not provided) Not reported. The doctors said that it was probably related to history of asthma and was discharged home with treatment medications dextromethorphan hydrobromide/promethazine hydrochloride, and prednisolone.  The patient stated that symptoms were getting worse, and went to emergency room again on 22-DEC-2021, there laboratory data included: Chest X-ray (NR: not provided). Physicians stated that lungs were very inflamed but no liquid present, so they ruled out pneumonia. Treatment medications included: dexamethasone. On 23-DEC-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The patient stated that difficulty breathing and the fact he needs to sit up to sleep are still present until 25-DEC-2021. Fever, body aches and headache gone since 23-DEC-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and unable to sleep lying down and had to sit in bed to sleep, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208727.; Sender's Comments: V0. 20211256656-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