Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Paraesthesia, Pyrexia, Ultrasound Doppler
Clinical narrative: EXCRUCIATING CHEST PAIN; DEEP VEIN THROMBOSIS; NUMBNESS IN EXTREMITIES; TINGLING IN EXTREMITIES; FEVER; FELT SICK; This spontaneous report received from a health care professional (patient's daughter) concerned a 92 year old female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer (over last 7 years), hypothyroidism, and sulfa allergy. The patient experienced drug allergy when treated with Aspirin (acetylsalicylic acid) for an unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on right arm on 21-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-APR-2021 (a day after vaccination), the patient felt sick and had a fever for first 2 days and spent time in bed. On 23-APR-2021 (on the third day after vaccination), she got up and experienced numbness and tingling in her extremities, mainly arms but then she said that her feet and leg were also tingling and numb. As per reporter, all these symptoms might have started at the same time. The tingling and numbness feeling went on for a few weeks. The patient took the vaccination as she was due for a surgery in MAY-2021. On an unspecified day, in APR-2021, the patient's pre-operation lab showed elevated Fibrin D dimer, very high like 5 times than normal (value and NR: not provided). On an unspecified day, in MAY-2021, she had a second Fibrin D dimer test which was at 1.34 (unit unspecified) and she underwent a 15 minutes bladder surgery, urethra and to laser out tumors in urethra. On an unspecified day, in JUN-2021, the patient had little bit of pain in her leg but the patient and her daughter did not think anything about it. On an unspecified day, in JUL-2021, the patient experienced excruciating chest pain and called her daughter and said she thought she was having a heart attack, however, after about 20 minutes, the pain went away but the patient stated it was the worst pain she's ever had. The patient was taken to a doctor where an Electrocardiogram (EKG) was done which came back normal. The doctors did not known what was wrong. A month later, on an unspecified day, in AUG-2021, the patient's left leg swelled up. The patient's daughter called the cardiologist and on 12-AUG-2021, the patient had an ultrasound doppler done, which diagnosed 3 deep vein thrombosis (DVT) in her left leg, 1 iliac (large),1 popliteal, 1 calf (lower leg). From 12-AUG-2021 onwards, the patient started treatment with Eliquis (apixaban). On 19-AUG-2021, the patient saw the cardiologist. The reporter (healthcare professional) hypothesized with doctor that the chest pain event was probably was a pulmonary embolism (PE). The urologist stated that bladder surgery had nothing to do with DVT. The reporter voiced being convinced that DVT was related to vaccine but that d-dimer should have been followed up on by Doctor of Medicine (MDs). The patient was scheduled for another doppler by the end of NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating chest pain on JUL-2021, felt sick, and fever on 24-APR-2021, and numbness in extremities, and tingling in extremities, and the outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211039884-COVID-19 VACCINE AD26.COV2.S-deep vein thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY