Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4440676-00.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (ongoing) (Batch/Lot number: unknown), all subcutaneous for crohn's disease, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "recovered" and all described as "COVID-19"; PNEUMONIA (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage not changed. Clinical course: on unknown dates, the patient experienced covid-19 and pneumonia. On unknown dates, covid-19 and pneumonia resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient was hospitalized (Involved or prolonged inpatient hospitalization) for covid-19 and pneumonia with missed dosages. It was unknown if patient was enrolled in a covid-19 vaccine trial. The events abate after stopping drug.   Causality for humira (adalimumab): The reporter's causality for the event(s) of covid-19 and pneumonia was not provided. Agency's opinion is that there is no reasonable possibility that the events of covid-19 and pneumonia are related to humira(adalimumab). Causality for Covid-19: Causality as per reporter (drug/vaccine): not reported; Causality as per mfr.(drug/vaccine): no reasonable possibility and causality for Pneumonia: Causality as per reporter (drug/vaccine): not reported; Causality as per mfr.(drug/vaccine): no reasonable possibility   Causality for Covid-19 vaccine:  Causality for covid-19: Causality as per reporter (drug/vaccine): possible and causality for pneumonia: Causality as per reporter (drug/vaccine): not reported.   The reporter considered "covid-19" related to BNT162b2. The reporter's assessment of the causal relationship of "pneumonia" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective, Covid 19 and Pneumonia and the suspect product BNT162B2 cannot be ruled out.  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.