Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Drug level decreased, Pneumonia
Clinical narrative: Pneumonia; Coughing; Low drug level; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4519878-00 (Agency).  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1164842) at unk (cf) and second regimen (ongoing) (Lot number: 1164842) at weekly (unk, weekly (1 in 7 d)), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PNEUMONIA (hospitalization, medically significant), outcome "recovered"; COUGH (hospitalization), outcome "not recovered", described as "Coughing"; DRUG LEVEL DECREASED (non-serious), outcome "unknown", described as "Low drug level". The action taken for adalimumab was dosage not changed.  Clinical information: On unknown dates, the patient experienced pneumonia, Humira not stayed in patient system so upped it to once a week and coughing with Humira. On an unknown date, pneumonia resolved. The patient stated that Humira was not staying in her system so her physician upped it to once a week. Seven days after Covid vaccine she was in the intensive care unit for a month, for a severe case of pneumonia. She was coughing during call, and stated she smoked. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Pneumonia was not provided. The reporter's causality for the event(s) of Humira not stayed in patient system so upped it to once a week with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of coughing with Humira (Adalimumab) was no reasonable possibility.  Causality of Humira: Causality for Pneumonia as per reporter (Drug/Vaccine): Not reported and Causality as per Mfr. (Drug/vaccine): Reasonable possibility. Action(s) taken with drug: Dose not changed Dechallenge: N/A. Causality for Low drug level (Drug level decreased). Action(s) taken with drug: Dose increased. Causality as per reporter (Drug/Vaccine): Probable. Causality as per Mfr. (Drug/vaccine): No reasonable possibility. Dechallenge: N/A. Causality for Coughing (Cough). Action(s) taken with drug: Dose not changed. Causality as per reporter (Drug/Vaccine): Not related. Causality as per Mfr. (Drug/vaccine): Reasonable possibility. Dechallenge: N/A.  Causality of Tozinameran: Causality for Pneumonia (Pneumonia). Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Possible. Dechallenge: N/A. Causality for Low drug level (Drug level decreased). Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not reported. Dechallenge: N/A. Causality for Coughing (Cough). Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not reported. Dechallenge: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Pneumonia, cough , drug level decreased with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.