Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Pulmonary thrombosis, Vaccination site pain
Clinical narrative: Blood clot in right lung; Sore left arm at injection site; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscular, administered in the left upper arm on 03Feb2021 at 09:00 (batch/lot number: EL3248) as a single dose for COVID-19 immunisation (prevention). Medical history included rheumatoid arthritis from Dec2009 to an unknown date (takes daily pills for rheumatoid arthritis), squamous cell lung cancer early stage from Aug2018 to an unknown date, lung surgery to remove small portion of that and went on chemo in Aug2018, skin cancers prior to getting the vaccine, reading glasses (he needed prior to getting vaccine), blood pressure (abnormal) (takes blood pressure medication; takes daily pills). Family medical history was reported as none. Concomitant medications included nivolumab (OPDIVO) taken for squamous cell lung cancer early stage from 17Jan2019 to an unspecified stop date (getting it every 4 weeks for 2 years and 3 months; the bag was 480 ml); and unspecified blood pressure medication and rheumatoid arthritis medication. The patient experienced blood clot in right lung on 25Feb2021, sore left arm at injection site on 03Feb2021 and shortness of breath on Feb2021. The patient had the first Pfizer COVID vaccine on 03Feb2021 and second one on 01Mar2021. He did not really have any special events but then he had a CT scan on 23Feb2021, which was about 20 days after first shot. When he went in for doctor's meeting a couple of days later, they said he had a blood clot in right lung. He later stated he was not positive it was in the right lung. He told his doctor that he just got the shot, but they said they had not heard of any reports from Pfizer of people getting blood clots in their lungs after getting it. He thought about reporting then, but did not. He has no evidence that the blood clot in his lung was related to the vaccine. He was also a lung cancer patient and was on an immune therapy drug nivolumab from (name). He has been on it for over 2 years and started Jan2019. He was diagnosed with cancer back in Aug2018. It was squamous cell lung cancer early stage. He had lung surgery to remove small portion of that in Aug2018 and went on chemo. On 17Jan2019, he started on nivolumab immune therapy drug. Fortunately, it worked extremely well. He immediately started recovering and was feeling better. The last few CT scans indicated he had no sign of disease. It does not mean he was cured, but was healthy otherwise. The nivolumab spurred his immune system to eat the cancer cells. It stimulates your immune system. It has been a pretty successful drug and has been on the market for about 5-6 years. He and his wife both got shot on same date. The word on the street was that you should ask for Pfizer because it seems to have less side effects that people can get for vaccines. Pfizer's reputation has been known for having less common serious side effects. He had a sore arm and it went away about a day later. They prescribed rivaroxaban (XARELTO), a blood thinner, for his blood clot which he went on and got on a day or two later. He was hoping it was gone. He feels better. At the time, he did not know he had the blood clot. He visits his doctor for treatment for nivolumab every 4 weeks and every 4 months, they do a CT scan. At his last visit, he reported that he was still fine but lately experienced some shortness of breath. It was occasional and it comes and goes and was not all the time. He plays golf and noticed the shortness of breath during his game. He quit a couple of holes early and did not want to take any chances. The doctor later told him that a blood clot in your lung can contribute to shortness of breath. When he started rivaroxaban it was 2 pills a day for about 2-3 weeks and it was a starter dose. It was a little more in the beginning. He thinks it was 10 mg twice daily and then it went to 1 tablet a day for the last week at dinner and now it was 15 mg once daily. The two combined were greater to jump start you. It was not a special dose. He then corrected dose to 15 mg rivaroxaban twice daily for the starter dose for 2-3 weeks and one tablet daily for the last week of the starter. Then he switched to maintenance dose of 20 mg daily. He did not have a lot or expiration for the previous dose of 15 mg. The lot and expiration for the 20 mg was unknown because he believes the label was covering it. He stated he needed to get his glasses to read bottle. They were reading glasses and he needed prior to getting vaccine. Nothing has changed with his vision. He was hoping to get off of them and has never been on them. He hopes it was not a long term thing. Second dose was given 01Mar2021, Pfizer COVID vaccine, BNT162B2, expiration was unknown. Injected in left upper arm in the muscle (intramuscularly). Second dose administered at 09:20-09:30. He takes blood pressure medication and did not see it was relevant. Takes daily pills for that and rheumatoid arthritis. In the past, he had a few skin cancers. All were prior to getting the vaccine. They were some squamous and basal cell. He has had nothing in quite a while. Nivolumab was helping skin issues. Squamous cell skin cancer was the same family as lung cancer. He did not have a lot or expiration for the nivolumab. He received it by IV infusion. Shortness of breath was mid Feb2021, on and off for a couple of weeks prior to doctor visit on 25Feb2021. He usually does not have much to report and mentioned it. It did not prevent him from doing anything and was not debilitating. One of his fellow golfers said he was huffing and puffing and he just poo pooed it away. He had a flu vaccine in Oct2021 (as reported). No further details provided. Blood clots in right lung morning time, unknown time. Sore left arm at injection site noon - to late in the day of the shot. Shortness of breath - sometimes he feels it in the morning or midday if active. He cannot say a straight time. No emergency room (ER) or physician's office visit required. Vaccination facility type was clinic. Not a military facility. On 25Feb2021, normally scheduled office visit and did the CT scan on 23Feb2021. He went in separate for that. He had the treatment on Thursday. He has another CT scan scheduled in third week of May2021. They were doing it early because of the blood clot. Hopefully, it was gone by then. Prior vaccinations (within 4 weeks): 1st and 2nd Pfizer COVID vaccine as mentioned above. CT scan on 23Feb2021, positive for small blood clot in single vessel in what he thinks was his right lung. All of his previous trouble with the lung cancer was in his right lung. He has never heard of anyone else having blood clots related to the Pfizer COVID vaccine. He does not think he has heard of any and wanted to know if there were any. He knows there was something in the press about the (name) vaccine with blood clots. When you do 120 million and have a handful of people, you may have a few things. He did not have any information on the people for (name) to report on. He knows of others who have had the vaccine and no one had any symptoms. No further details provided. The outcome was recovered on 04Feb2021 for the event "sore left arm at injection site"; recovering for the event "shortness of breath"; and unknown for the event "blood clot in right lung".