Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Clostridium difficile infection, Pulmonary thrombosis, Thrombosis
Clinical narrative: Blood clots in lung; Blood clots in leg; clostridioides difficile infection; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4323739-00.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (caused and prolonged hospitalization, medically significant), outcome "not recovered", described as "Blood clots in lung"; THROMBOSIS (caused and prolonged hospitalization, medically significant), outcome "not recovered", described as "Blood clots in leg"; CLOSTRIDIUM DIFFICILE INFECTION (caused and prolonged hospitalization, medically significant) with onset Oct2021, outcome "not recovered", described as "clostridioides difficile infection". The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of the (Blood clots in lung, Blood clots in leg, clostridioides difficile infection) with the suspect product 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 reporter's causality for the event(s) of Blood clots in lung and Blood clots in leg with Humira (Adalimumab) was no reasonable possibility.The reporter's causality for the event(s) of Clostridioides difficile infection was not provided. Agency opinion is that the events of Blood clots in lung and Blood clots in leg are not assessable. Agency opinion is that there is no reasonable possibility that the event of Clostridioides difficile infection is related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the temporal association, a causal role of the suspect drug cannot be completely denied for the reported events of thrombosis and pulmonary thrombosis.  Reported event of clostridium difficile infection could be due to an intercurrent medical condition, unrelated to the suspect drug. 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.