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Write-up: BRONCHITIS; SHORTNESS OF BREATH; BODY ACHES; COUGHING; HEADACHE; FEVER; This spontaneous report received from a patient by a Business partner on 24-JUN-2021 was received on 24-JUN-2021 and concerned a 67 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included incision and drainage, covid-19, covid-19 pneumonia, cyst on middle of breast, slurred speech, difficulty in walking, and several ear infection, and concurrent conditions included penicillin allergy, moderate to severe rheumatoid arthritis, heart murmur, no tobacco use, abstains from alcohol, high blood pressure, back pain, and diabetes, and other pre-existing medical conditions included the patient had sulpha drugs allergy manifested by difficulty of breathing. The patient experienced drug allergy (cannot breathe/chest pain, bronchitis) when treated with infliximab. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tramadol for back pain, glimepiride for diabetes, metformin for diabetes, lisinopril for high blood pressure, and adalimumab for moderate to severe rheumatoid arthritis. On 22-JUL-2020, Laboratory data included: Body temperature (NR: not provided) 104 F, Chest X-ray (NR: not provided) Pneumonia, and Culture nose (NR: not provided) Positive for covid-19. On JUN-2021, the subject experienced bronchitis. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, bronchitis, headache, coughing, fever and body aches was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
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