Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination failure, X-ray
Clinical narrative: COVID-19 RELATED PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ASTHMA AGITATED; BURNING SENSATION IN FINGERS; TINGLING OF FINGERS AND TOES; BELL'S PALSY; This spontaneous report received from a 58-year-old male patient. The patient's height and weight were not reported. The patient's concurrent conditions included high cholesterol, high triglycerides, mold allergy, alcohol use (6 to 8 beers in the weekend) and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 08-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient started experiencing bell's palsy. His mouth was dropping on the left side and he didn't have any feeling or nerve feeling on that area of mouth. His eyes and rest of the body was fine. He visited the physician. On an unspecified date in MAY-2021, Laboratory data included: CT scan result was Negative and Blood test was Negative. Patient was given a Steroid shot as treatment and it resolved. On 12-MAY-2021, he experienced low grade fever, fatigue and kind of illness. On 15-May-2021, he visited hospital with breathing problem and coughing. In the hospital patient was tested positive for covid-19 (suspected clinical vaccination failure). The chest X-ray showed that the lungs were clear. On 19-MAY-2021, he again had trouble breathing and was unable to breathe despite trying hard and was hospitalized for 5 days. Patient had another X-ray and was diagnosed with a COVID-19 related Pneumonia. He was put on Remdesivir and oxygen as treatment. Laboratory data included: Oxygen saturation was around 80. After 3 and half days, he was able to breathe on his own and was taken off oxygen. On an unspecified date in MAY-2021, while at hospital, patient experienced asthma agitated and was prescribed prednisone also. On 24-MAY-2021, he was discharged from hospital for 5 days. Non-company suspect drugs included: tyrosine (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from JUN-2021 for mental alertness. Since 29-JUN-2021, he experienced tingling in his fingers and toes. He reported that the physician had put him on D-Tyrosine for last one month and has experienced the event since then. On 08-JUL-2021, he stopped the supplement as the physician had asked him to stop but still have the event and symptoms were getting worse. On JUL-2021, he experienced burning sensation in fingers. He stated that it was not all the finger and toes in general but noticed more issue on the left side than the right side. The left side was worse for the toes but for the fingers issue progressed from right index to his left hand. At the time of reporting, He had tingling and burning sensation in both hands and was continuing and not getting any better. Physician was aware but did not prescribe him any medication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bell's palsy, suspected covid-19 infection, covid-19 related pneumonia and asthma agitated, had not recovered from tingling of fingers and toes, and burning sensation in fingers, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000185884. The suspected product quality complaint had been confirmed to be not voided.; Sender's Comments: V0: 20210727746-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 V0: 20210727746-covid-19 vaccine ad26.cov2.s-Bell's palsy, Covid 19 pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210727746-covid-19 vaccine ad26.cov2.s-Asthma aggravated. 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: MEDICAL HISTORY