Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin, Platelet count, Red blood cell count, Ultrasound scan, White blood cell count
Clinical narrative: DEEP VEIN THROMBOSIS OF LEFT PERONEAL VEIN; This spontaneous self-report was received from a patient, female 24 years of age. Initial information received from the patient on 13-APR-2021 was processed with additional information received from      on 14-APR-2021 and from the patient via telephone follow up on 16-APR-2021. The patient's weight was 180 pounds, height 69 inches and BMI 26.6 kg/m2. Past medical history was insignificant with no prior history of blood clots, does not smoke, and does not use birth control. The patient was reportedly active and working as a teacher. Family medical history included clotting disorder (unspecified) on mother's side; mother does not have clotting disorder. In DEC-2020, COVID-19 test was negative. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805018, expiry: unknown) administered on 13-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were taken. On 13-MAR-2021, the patient experienced deep vein thrombosis of left peroneal vein (also reported as 2 blood clots). The pain started the day after vaccination on 14-MAR-2021, and she thought it was muscle soreness.  On 20-MAR-2021, her physician sent an order for ultrasound, and on 21-MAR-2021, the blood clot was confirmed (also reported as 2 blood clots), report not provided. Laboratory tests included Platelet count (NR: not provided) 316,000 (units not provided), White blood cell count (NR: not provided) 9.1 (units not provided), Red blood cell count (NR: not provided) 5.19 (units not provided), Hemoglobin (NR: not provided) 14.6 (units not provided), Hematocrit (NR: not provided) 41.9 (units not provided), Alanine aminotransferase (NR: not provided) 15 (units not provided) and Aspartate aminotransferase (NR: not provided) 15 (units not provided). Antiplatelet PF4 antibodies was not performed. The patient was prescribed XARELTO (rivaroxaban) for 6 months. At the time of the report, the patient was still in pain described as throbbing with some improvement with treatment and no redness.  The patient agreed to send medical records. The patient considered the blood clots to be caused by the vaccine. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from deep vein thrombosis of left peroneal vein. The suspected product quality complaint number 90000176260 was evaluated and voided; based on the PQC evaluation/investigation performed, it was confirmed that no product quality complaint was identified within the report. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: The case concerns a 24-year-old overweight female patient (BMI 26.6 kg/m2) who developed deep vein thrombosis of left peroneal vein 7 days after Janssen COVID-19 vaccine was administered intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection.  The subject does not report any significant medical history or prior history of blood clots. She is a teacher, does not smoke and is active. Her family history is significant for clotting disorder in maternal family, but her mother does not have it. She does not take any medication or birth control. Last COVID-19 test 3 months prior was negative. The pain in the left leg started on the day of vaccination and was thought to be a muscle soreness. A week later her medical doctor ordered a diagnostic ultrasound, and the blood clot was confirmed (report not provided). Platelet count was 316, 000, WBC 9.1, RBC 5.19, HGB 14.6, HCT 41.9, ALT 15, AST 15 (D-dimer, platelet PF4 antibodies not available). The patient was prescribed rivaroxaban for deep vein thrombosis for 6 months. Leg redness had resolved, she is still in pain, but has some improvement with the prescribed treatment. Given short temporal relationship (with first symptoms on the day of vaccination), subject's risk factors of being overweight and a family history of blood clotting disorder, the event of deep vein thrombosis of left peroneal vein is considered to have an indeterminate causal association to immunization, per the WHO causality classification for adverse events following immunization (Level 3 of diagnostic certainty, per the Brighton Collaboration case definition). The company causality is considered not related to Janssen COVID-19 vaccine.