Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone densitometry, COVID-19, Computerised tomogram, Drug ineffective, Pulmonary thrombosis
Clinical narrative: Pulmonary thrombosis; COVID-19; COVID-19; 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-163-4400131-00 (Agency).  A 78-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1154441) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "recovered" and all described as "COVID-19"; PULMONARY THROMBOSIS (medically significant), outcome "unknown". The event "pulmonary thrombosis" required physician office visit. The event "covid-19" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Bone densitometry: Unknown results; Computerised tomogram: Unknown results. The action taken for adalimumab was dosage permanently withdrawn.  Clinical course: On unknown dates, she experienced blood clots in lungs and had lingering cough. In 2021, she experienced covid. on an unknown date, covid resolved. Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. She had covid in 2021 and was sick for four days with headache, diarrhea, vomiting. She was very sick this was after getting the two vaccines and doctor advised against getting the booster. She had pneumonia and went off Humira medication for two weeks. She had a very bad cough that kept her awake at night. She knew when she got a bad cough that it would turn into pneumonia because she had blood clots in her lungs. She had to do two rounds of antibiotics to get better and cough medicine to help. She still had a lingering cough so she was treated with Prednisone. She felt much better. She went to urgent care and had a computed axial tomography scan. The physician was pleased with her progress and the bone density test. She went back to her physician on 12Jul2022 and he listened to her chest and said it was good. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporters causality with suspect product Humaira for the events Pulmonary thrombosis and Covid-19 was Not related, Cough was not reported and causality as per Manufacturer for the events Pulmonary thrombosis and Covid-19 was no reasonable possibility, cough was Reasonable possibility. The reports causality with suspect product Covid-19 Vaccine (BNT162b2) for the events Pulmonary thrombosis, cough, was not reported and covid-19 was not related.  The reporter's assessment of the causal relationship of "pulmonary thrombosis", "covid-19" and "persistent cough" 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 current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events drug ineffective, COVID-19; pulmonary thrombosis and cough cannot be excluded.  The case will be reassessed if additional information becomes available. 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.