Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Pain in extremity, Peripheral arterial occlusive disease, Swelling, X-ray
Clinical narrative: Pain in foot; swelling on the right side from the foot up to the hand; there is plaque in one of his arteries in his foot; Immune system fighting the vaccine; This is a spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 02Feb2021 at 13:00, reported as between 13:00 and 14:00, (at 63-years-old) as a single dose for COVID-19 immunisation. Medical history included having no cartilage in his right knee from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number unknown) in the left arm on 12Jan2021 reported as between 13:00 and 14:00 (at 63-years-old) for COVID-19 immunisation. The patient had no events following prior vaccinations, no additional vaccines on the same date and no prior vaccinations within 4 weeks. The patient called to report side effects from the vaccine. He reported his immune system was fighting the vaccine and he didn't know which one was winning. The patient reported he thought his first dose was 12Jan2021 and both vaccinations were given in the left arm. The patient reported swelling on the right side from the foot up to the hand which started after the second dose later in Feb2021; around 25Feb2021. He had a doctor's appointment and was told he should have the doctor look at his ankle because it was a little swollen. He went in wearing flip flops and sweats and the doctor had him roll up his pants then removed them, and it was then noticed the swelling was from the foot up to his hand. The doctor told him that he thought it was his body fighting the vaccine. The patient stated "well who is winning because obviously it isn't his immune system and the shot is taking over." The patient reported 3 to 4 weeks ago (as of 06Aug2021) he went to the doctor because he was having pain in his foot. They took X-rays because the swelling was still there in the right foot since Feb2021. The X-ray showed that there was plaque in one of his arteries in his foot and that was where the pain was coming from. The caller stated "we" might say different, but he is saying that until having the second shot, he never had any of this there or any problems. He reported he had no cartilage in his right knee, which was before the vaccine. At first he thought maybe this was the cause of the swelling in his foot, that the fluid was moving down to his foot, but the knee doctor told him that was not the case. There was no fluid in his knee and that the swelling in his foot was just swelling. There was no treatment received for the events. The clinical outcomes of swelling on the right side from the foot up to the hand, and pain in his foot were not recovered; the outcomes of the other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: 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