Age: 43.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray, SARS-CoV-2 test
Clinical narrative: COVID-19 Virus; Pneumonia; This is a non-interventional study (Mfr. Control No.: 21K-163-4051457-00).  A 43-year-old male patient received bnt162b2 (Pfizer Biontech Covid-19 Vaccine, also reported as Tozinameran), dose 1 intramuscular on 30Jul2021 (Batch/Lot Number: EW0181; Expiration Date: Aug2021) as DOSE 1, SINGLE for covid-19 immunisation and adalimumab (HUMIRA), subcutaneous from 2014 (Batch/Lot number was not reported) to 19Jul2021, at 40 mg, and subcutaneous from 13Sep2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ankylosing Spondylitis. Medical history included One pack of Cigarettes from 1992 to 2014 (Tobacco Use: One pack of Cigarettes per Day); alcohol use from 1992 to 12Jun2021 (Alcohol Use: 22 Ounces of beer every weekdays and hard alcohol during the weekends);  hospitalisation from Mar2001 to an unknown date and Acid Reflux from an unknown date and unknown if ongoing. Concomitant medication included pantoprazole (PANTOPRAZOLE) taken for Acid Reflux, start and stop date were not reported. It was reported that the patient experienced events of COVID-19 VIRUS and PNEUMONIA with HUMIRA 40MG/0.4ML (ADALIMUMAB). On 02Aug2021, the patient experienced COVID-19 VIRUS. On 05Aug2021, the patient experienced PNEUMONIA. On 03Sep2021, the PNEUMONIA resolved. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. It was further described that: the patient reported that three days after he took his Covid-19 vaccine shot on 02Aug2021 he had cough and was not able to breath. He was sent to urgent care in 05Aug2021 and had been checked for his nasal swab test and chest X-ray. The result showed that he was positive for the Covid-19 virus and pneumonia. He was hospitalized and was admitted for nine days. While being hospitalized, he was treated with antibiotics for one week, intravenous fluids, cough medications, blood thinners and Remdesivir for his Covid-19 virus. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent laboratory tests which includes: CHEST X-RAY: Pneumonia on 05Aug2021, NASAL SWAB TEST: Positive for the Covid-19 virus on 05Aug2021, and NASAL SWAB TEST: Negative for the Covid-19 virus on 13Aug2021. The outcome of the event COVID-19 was recovered on 13Aug2021 for the event pneumonia was recovered on 03Sep2021. The action taken in response to the event adalimumab was temporarily withdrawn (however still ongoing) on an unspecified date.   The reporter's causality for the event(s) of COVID-19 VIRUS and PNEUMONIA with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  Company's opinion is that there is no reasonable possibility that the events of COVID-19 VIRUS and PNEUMONIA are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).   For Pfizer Biontech Covid-19 Vaccine: not reported by the reporter for the event COVID-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Covid-19 and Pneumonea BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.