Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pulmonary thrombosis
Clinical narrative: rheumatoid arthritis pain; blood clots in lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (blood clots in lungs) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: Enbrel. Past adverse reactions to the above products included No adverse event with Enbrel. Concurrent medical conditions included Rheumatoid arthritis.   In September 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a day. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced PULMONARY THROMBOSIS (blood clots in lungs) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (rheumatoid arthritis pain). At the time of the report, PULMONARY THROMBOSIS (blood clots in lungs) and ARTHRALGIA (rheumatoid arthritis pain) had not resolved.            Concomitant medication was not reported.  It was reported that patient administered Adalimumab Solution for Injection, Single Dose Pen. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. In January 2022, the patient had to go to the emergency room due to her inability to catch her breath. She was diagnosed with 2 blood clots in her lungs. After further testing it was determined that the blood clots were due to the Moderna Covid vaccine. She stated that after her first dose she was having shortness of breath while walking and after the second dose it was much harder to breathe.  event dyspnoea subsumed under the diagnosis of Pulmonary thrombosis  Treatment drug was not reported.  Company comment: This is a spontaneous case concerning a 65 year-old, female patient with a history of rheumatoid arthritis, who experienced the serious (due to medically important condition) unexpected, AESI of Pulmonary thrombosis, related to the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on vaccination date. The patient reported she had to go to the emergency room due to her inability to catch her breath and she was diagnosed with 2 blood clots in her lungs. The outcome was reported as not recovered. The mentioned medical history remains as a risk factor for the event. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-658070 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65 year-old, female patient with a history of rheumatoid arthritis, who experienced the serious (due to medically important condition) unexpected, AESI of Pulmonary thrombosis, related to the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on vaccination date. The patient reported she had to go to the emergency room due to her inability to catch her breath and she was diagnosed with 2 blood clots in her lungs. The outcome was reported as not recovered. The mentioned medical history remains as a risk factor for the event. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.