Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration (injection), administered in the right arm on 12Feb2021 at 13:00 (batch/lot number: EL9267) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 1991 and ongoing (diagnosed 30 years ago; doctor said that he didn't know if she has RA because she's taken all of those infusions and it may just be severe osteoarthritis), ongoing thyroid (disorder), thyroid was removed, knee replacement left leg from 2020 (she had knee replacement last year on her left knee), Achilles tendon tear - reported that she had to have surgery last to repair her right Achilles tendon as it tore, cholesterol (abnormal) from 1991 and ongoing (diagnosed with cholesterol problems 30 years ago), ongoing depression (diagnosed with depression a couple years ago), ongoing sleep problems (experienced sleep problems for a long time), blood pressure (abnormal) from 2013 and ongoing (diagnosed with blood pressure problems 8 years ago), physical therapy, lymphedema, and unable to recall exact dates. There was no family medical history. No prior vaccinations (within 4 weeks). Concomitant medications included amitriptyline taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); folic acid taken for arthritis from an unspecified start date and ongoing (she has been taking this medication for years and years); levothyroxine taken for thyroid, start and stop date were not reported (she has been taking this medication for years and years); chlordiazepoxide (LIBRIUM) taken for sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); losartan taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); meloxicam taken for arthritis from an unspecified start date and ongoing (began taking for 10 or 15 years after switching from celecoxib); metoprolol taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); omeprazole taken for stomach from an unspecified start date and ongoing (helps her stomach with all of the medications she has to take); pravastatin taken for cholesterol from an unspecified start date and ongoing (she has been taking this medication for years and years); desvenlafaxine succinate (PRISTIQ) taken for depression from an unspecified start date and ongoing (she started taking over a year ago, a year and a half or maybe two years ago); levothyroxine sodium (SYNTHROID) taken since thyroid was removed from an unspecified start date and ongoing (she has been taking since 15 years ago, for a long time); temazepam taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); cholecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (she has been taking this medication for years and years). The patient previously took BNT162B2 first dose on 21Jan2021 via injection in the right arm (lot number: EL3047 or EL3247; expiration date unknown) for COVID-19 immunization; and celecoxib (CELEBREX). The patient experienced extensive deep vein thrombosis on 06Apr2021; leg pain and feet swollen/ leg was like a balloon/ leg started to swell on 05Apr2021; throat hurts and tired on an unspecified date. The patient was calling about the Pfizer Covid-19 vaccine. She reported that she and her husband received both doses of the Pfizer Covid-19 vaccine. She received her first dose of the Covid-19 vaccine on 21Jan2021 and her second dose on 12Feb2021. She reported that she has had no complications before such as blood clots or problems with her blood or anything. She reported that on Monday, 05Apr2021, her leg started to swell. She reported that on the following day, 06Apr2021, her leg was so swollen that she couldn't put it down. She reported that she went to the emergency room on 06Apr2021 and was found to have an extremely extensive deep vein thrombosis. She reported that she was calling to complete a safety report. She stated that she doesn't want a deep vein thrombosis to happen to anyone else if her thrombus was from the Covid-19 vaccine. She reported that she and her husband thought they were so lucky as they had no side effects whatsoever following the Covid-19 vaccine doses. She reported that she was not saying that the deep vein thrombosis was from the Covid-19 vaccine but she has never had any blood or clotting problems in her life. Throat hurts: She reported that she thinks that when she was intubated, that whoever intubated her caught her tongue and cut it. She reported that she and her son and husband had been seeing news stories about the (Company name) vaccine. She reported that she has friends that were waiting for the (Company name) vaccine. She reported that her son wanted to send a text message so that others could be aware of the problems they might have. Leg pain: She reported that she went to the dentist on 05Apr2021 and was fine. She reported that when she got home from the dentist, her husband asked if she wanted to the take dog for walk. She reported that she put a leash on her dog and walked to the end of her driveway and said to her husband that she couldn't walk because her leg hurt so much. She reported that she had 2 surgeries last year, a knee replacement in her left leg and an Achilles tendon repair in her right leg. She reported that when she was released from physical therapy that the therapist told the caller that she might have lymphedema. She reported that the physical therapist directed her to go to a clinic that had no doctor where the clinic staff wanted her to buy a (dollar)10,000 piece of equipment to pump up her legs in the morning and at night. She reported that she came home from the clinic and called the podiatrist that repaired her Achilles tendon. She reported that she went to see the podiatrist that day and that the podiatrist ordered an ultrasound. She reported that a vascular surgeon called her regarding the ultrasound and stated that there was nothing wrong with the veins in her legs. She reported that the surgeon stated that they could tell there was nothing wrong with the her because her feet weren't swollen and instructed her to follow up in 9 months. She reported that on 05Apr2021, she went back into her house after experiencing the leg pain. She reported that her feet were not swollen and she was not that concerned. She reported that she thought maybe she was just tired and laid down. She reported that when she woke up the next morning, 06Apr2021, that her feet were like balloons. She reported that her son called a friend of his who was an orthopod. She reported that her son's friend instructed her son to take her to the emergency room, recommending that they bypass a certain hospital. She reported that she went to the emergency room on 06Apr2021. She reported that the emergency room staff did an ultrasound as soon as the caller arrived. She reported that the emergency room staff called the vascular surgeon. She reported that the vascular surgeon stated that if he had been in the caller's hospital room 5 minutes earlier that the would have done the surgery then, but that he had to lay her on her stomach to perform the surgery and she had eaten some cookies and drank diet soda. She reported that on the following day, 07Apr2021, the vascular surgeon put a scope in her vein and pulled out the clot. She reported that the physician was extremely concerned because the clots were very extensive. Leg pain: She reported that the leg pain was still ongoing. She reported that it hurts when she walks. She reported that she doesn't know if the leg pain has gotten worse. She reported that her leg pain on 06Apr2021 was excruciating and off the charts. Feet swollen: She reported that the swelling in her feet has maybe gotten slightly better. She reported that her feet were wrapped tightly with ace bandages. Leg swollen like a balloon: She reported that her leg was still swollen but it's gotten better, maybe about 90%. Extensive deep vein thrombosis: She reported that the deep vein thrombosis was removed on 07Apr2021 from her left leg. She reported that she was at end of her life and she had trips planned. She reported that she had a trip planned recently to go to Las Vegas with her daughter. She reported that her daughter was not able to take the trip, and stated she didn't know what would have happened if she had experienced the blood clot while in Las Vegas. She reported that she received both doses of the Covid-19 vaccine in her right arm, as she was in the car and her husband was driving. First dose: Date: 21Jan2021; Lot Number: She reported the lot number as EL3047, then stated that the handwriting was hard to read and that the lot number was either EL3247 or EL3047. She stated when reporting on her history that she has no concept of time and was unable to recall exact dates. She reported that while in the emergency room and during admission, the hospital staff did labs, but she has no idea what the results were. Vaccination facility type was drive through clinic at (clinic name). Vaccine administered at military facility: No. The adverse events leg pain, swelling in feet and leg, extensive deep vein thrombosis required a visit to the emergency room. Did not require a visit to the physician's office. The patient was hospitalized for 6 days for extensive deep vein thrombosis from 06Apr2021 to 12Apr2021. The patient underwent lab tests and procedures which included CT scan of chest: normal on an unspecified date, ultrasound: there was nothing wrong with the veins in her legs on an unspecified date, ultrasound: unknown results on an unspecified date. The outcome was not recovered for the event leg pain; recovering for the event feet swollen/ leg was like a balloon/ leg started to swell; and unknown for the rest of the events.; Sender's Comments: Reported events are assessed as intercurrent medical conditions probably associated to patients underlying conditions and are therefore unlikely related to BNT162B2.