Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cough, Echocardiogram, Pain in extremity, Pneumonia
Clinical narrative: diagnosed with blood clots in the lungs; Coughing; diagnosed with pneumonia; She thinks that he had a blood clot in his leg that travelled. He was having leg pain, so he probably had a blood clot then; really, really sleeping; really bad leg pain; This is a spontaneous report from a contactable pharmacist (patient's wife). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, initially reported as FR8729 then stated it is an E) via an unspecified route of administration on 03Apr2021 around 10:00 or 11:00 am (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure (also reported as family medical history), ongoing eurofibromatosis (Has had all of his life), varicose veins, overweight, rheumatoid arthritis. Concomitant medications included ongoing etanercept (ENBREL) for rheumatoid arthritis (Has been on a few years but does not remember how long exactly). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration at arm on 13Mar2021 (68-year-old at time of vaccination) for COVID-19 immunization. The patient previously received flu vaccines in Oct2021 (67-year-old at time of vaccination). There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. The wife states her husband (patient) got 2 doses of the Pfizer vaccine. The middle of last month, he was complaining of really bad leg pain (from middle of May2021). He does have varicose veins and is on Enbrel and is overweight. He was really, really sleeping. She told him that he really needed to go see a doctor. The wife states she is in a rehab facility and is a pharmacist who worked at the hospital for over 34 years, mentions licenses in (states name). The wife stated she sent him to urgent care and they said he had varicose veins but had no problems with his leg. They did diagnose him with pneumonia. They sent him home on an antibiotic, Doxycycline 100mg, she didn't actually see the prescription, it was either for 7 or 10 days. He was down to one dose the day before yesterday. While he was at home, she heard him coughing (from 03Jun2021) and he couldn't stop coughing for about 5 minutes. She asked him when his follow up was and he told her not until Friday. She said he needed to see somebody so yesterday, he went to urgent care again. Three hours later they transferred him by ambulance to the hospital, he had blood clots in his lungs (from 03Jun2021). She is highly suspect of the Covid vaccine because he has never had problems like blood clots before. He was just admitted on the day before reporting (hospitalization for coughing and blood clots in the lungs from 03Jun2021 and ongoing). The wife is thinking maybe they misdiagnosed him approximately 10 days ago. She thinks that he had a blood clot in his leg that travelled. He was having leg pain, so he probably had a blood clot then, and they misdiagnosed him as pneumonia. The wife does not remember exact date but that it was in middle of May. His first trip to urgent care was 10 days before going to the hospital. Coughing started the same night, she asked him to go to the doctor Thursday morning and they sent him from urgent care to the hospital. He was admitted to the hospital and is still there now. Adverse events did not result in physician office visit; coughing and blood clots in the lungs resulted in emergency room visits; patient went to urgent care twice, second time was sent to emergency room via ambulance. Tests: They have been doing tests on him all day. They did an echocardiogram on the day of reporting (on 04Jun2021) and they are doing blood work on him. The wife does not know the results, she is a rehab facility a half a mile away. Treatment: They gave him some kind of shot. He doesn't give medication to himself. She has no idea, maybe something like Lovenox or something like that but she just doesn't know. Therapeutic measures were taken as a result of the event coughing and blood clots in the lungs and included some kind of shot; therapeutic measures were taken as a result of the event pneumonia and included antibiotic, Doxycycline. The outcome of the events was unknown. Causality assessment: The pharmacist (patient's wife) states she was highly suspect, as soon as they told him it was a blood clot in his lungs. Relatedness was assessed as related for all events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported serious events cannot be totally 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.