Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in both legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The patient's past medical history included Thrombosis leg (since 2016) in 2016. Concurrent medical conditions included Blood pressure high, Cancer, Diabetes, Tobacco user, Alcohol use and Rheumatoid arthritis (moderate to severe). In February 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced PAIN (Soreness after taking both Covid). On 19-Oct-2021, the patient experienced THROMBOSIS (Blood clots in both legs) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (had surgery on 09 Dec 2021 to remove blood clots) for Thrombosis. In 2021, PAIN (Soreness after taking both Covid) had resolved. At the time of the report, THROMBOSIS (Blood clots in both legs) was resolving. The concomitant medication was not reported by reporter. The patient had been suffering from blood clots in both legs since 2016. On 19-Oct-2021, she had blood clots that landed her in hospital. She had soreness after taking both vaccines. She had surgery on 09-Dec-2021 to remove blood clots in both legs. The reporter's causality for the event(s) of blood clots and soreness after taking both Covid vaccine with Humira (adalimumab) was no reasonable possibility. The formulation for Humira was reported as Solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient did not use illicit drug use. The treatment medication was not reported by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment. This spontaneous case concerns a 59-year-old female patient, with medical history of rheumatoid arthritis, blood pressure high, cancer, diabetes, tobacco user, and thrombosis in legs, who experienced the unexpected serious (medically significant and hospitalization) AESI of thrombosis, which occurred approximately 6 months after the second dose of mRNA - 1273 vaccine. The report mentioned the patient was hospitalized due to blood clots and approximately 8 months after vaccination required surgery. No further clinical information was available for medical reviewing. Patient´s medical history and co-suspect product Adalimumab remains as risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Live follow-up documents received contains patient demographics, event information, suspect drug information, narrative description updated. The event of Blood Clots was updated to Blood Clots in Both Legs. On 12-Jan-2022: Live follow up document received and contains patient demographics, event information, medical history and narrative description updated; Sender's Comments: This spontaneous case concerns a 59-year-old female patient, with medical history of rheumatoid arthritis, blood pressure high, cancer, diabetes, tobacco user, and thrombosis in legs, who experienced the unexpected serious (medically significant and hospitalization) AESI of thrombosis, which occurred approximately 6 months after the second dose of mRNA - 1273 vaccine. The report mentioned the patient was hospitalized due to blood clots and approximately 8 months after vaccination required surgery. No further clinical information was available for medical reviewing. Patient´s medical history and co-suspect product Adalimumab remains as risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.