Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Pulmonary thrombosis
Clinical narrative: blood clots in lungs; rheumatoid arthritis pain; Shortness of breath/Harder to breathe/inability to catch breath; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY THROMBOSIS (blood clots in lungs) in a 65-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) 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 use) 40 milligram. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In 2022, the patient experienced DYSPNOEA (Shortness of breath/Harder to breathe/inability to catch breath). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clots in lungs) (seriousness criterion medically significant) and ARTHRALGIA (rheumatoid arthritis pain). At the time of the report, PULMONARY THROMBOSIS (blood clots in lungs) and ARTHRALGIA (rheumatoid arthritis pain) had not resolved and DYSPNOEA (Shortness of breath/Harder to breathe/inability to catch breath) outcome was unknown.            No concomitant medications were reported.  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.  The reporter's causality for the events of shortness of breath/harder to breathe/inability to catch breath and blood clots in lungs with Moderna covid-19 vaccine was reasonable possibility.  The reporter's causality for the event of rheumatoid arthritis pain with adalimumab solution for injection was reasonable possibility.  The reporter's causality for the event of blood clots in lungs with adalimumab solution for injection was no reasonable possibility.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 65-year-old, female patient with current condition of Rheumatoid arthritis under treatment with etanercept, who experienced the unexpected serious (medically significant) AESI of Pulmonary thrombosis and non-serious events of Dyspnoea and arthralgia. The patient experienced dyspnoea after the first and second dose of SPIKEVAX COVID-19 VACCINE NOS. 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. In one of those two episodes, the patient had to go to the emergency room due to her inability to catch her breath and she was diagnosed with two blood clots in her lungs. No further information was available in the report. Concomitant medication of etanercept is a confounder for the event Pulmonary thrombosis. Underlying condition of Rheumatoid arthritis is a contributor risk. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.