Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pruritus
Clinical narrative: Pulmonary thrombosis; Post procedural complication; Vaccination site pruritus; Vaccination site erythema; Vaccination site papule; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Pulmonary thrombosis) and POST PROCEDURAL COMPLICATION (Post procedural complication) in a 67-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 and Ulcerative colitis.    There was no reported medical history.  The patient's past medical history included Knee surgery NOS (Recovering/resolving) from April 2021 to 04-Oct-2021.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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) CF. In 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAPULE (Vaccination site papule) and VACCINATION SITE PAIN (Vaccination site pain). In October 2021, the patient experienced PULMONARY THROMBOSIS (Pulmonary thrombosis) (seriousness criterion medically significant) and POST PROCEDURAL COMPLICATION (Post procedural complication) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Pulmonary thrombosis), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PAPULE (Vaccination site papule) was resolving and POST PROCEDURAL COMPLICATION (Post procedural complication) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that the patient had two large blood clots one in each lung and had many small ones. The patient also had itchy and raised area on arm from covid shot.  On 25-Oct-2021, the patient went to emergency room and found two large blood clots on one in each lung and had many small ones as well. The physician said the small ones would break up. They put the patient on blood thinners. The physician said that blood clots was a possibility after surgery complication. The patient did not get a booster vaccine they actually recommended a third full shot and it was Moderna.  CC- This spontaneous case concerns a 67-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis and Moderate-to-severe Rheumatoid Arthritis Ulcerative colitis treated with the co-suspect product Humira (adalimumab), and status post Right Knee surgery (Oct2021), who experienced the unexpected, serious (medically significant) events of pulmonary thrombosis (AESI) and post procedural complication, and other expected, non-serious events. The events pulmonary thrombosis and post procedural complication occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not treported and the vaccination date of the second dose of the mRNA-1273 vaccine was reported as unspecified date in Mar2021 while the event onset dates were reported as unspecified dates in Oct2021, hence, the onset latency could not be assessed. The start dates of the non-serious events were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. Approximately 6 to 7 months after receving the second dose of the mRNA-1273 vaccine, the patient underwent Right Knee surgery which was a revision surgery (date of initial surgery and indication of surgery were not provided). After 21 days, the patient sought consultation at the Emergency room (unspecified symptom/s) where two large blood clots, one in each lung, were found. There were also many small blood clots found. The physician said that the small clots would break up. The patient was placed on anticoagulants (unspecified). The doctors also said that the blood clots were a possible complication after surgery. On unspecified dates, the patient experienced red, raised, sore and itchy area on her arm from the vaccination. Treatment information was not provided. The history of Right Knee surgery remains a confounder for the events pulmonary thrombosis and post procedural complication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  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.; Sender's Comments: This spontaneous case concerns a 67-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis and Moderate-to-severe Rheumatoid Arthritis Ulcerative colitis treated with the co-suspect product Humira (adalimumab), and status post Right Knee surgery (Oct2021), who experienced the unexpected, serious (medically significant) events of pulmonary thrombosis (AESI) and post procedural complication, and other expected, non-serious events. The events pulmonary thrombosis and post procedural complication occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not treported and the vaccination date of the second dose of the mRNA-1273 vaccine was reported as unspecified date in Mar2021 while the event onset dates were reported as unspecified dates in Oct2021, hence, the onset latency could not be assessed. The start dates of the non-serious events were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. Approximately 6 to 7 months after receving the second dose of the mRNA-1273 vaccine, the patient underwent Right Knee surgery which was a revision surgery (date of initial surgery and indication of surgery were not provided). After 21 days, the patient sought consultation at the Emergency room (unspecified symptom/s) where two large blood clots, one in each lung, were found. There were also many small blood clots found. The physician said that the small clots would break up. The patient was placed on anticoagulants (unspecified). The doctors also said that the blood clots were a possible complication after surgery. On unspecified dates, the patient experienced red, raised, sore and itchy area on her arm from the vaccination. Treatment information was not provided. The history of Right Knee surgery remains a confounder for the events pulmonary thrombosis and post procedural complication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.