Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Headache, Investigation
Clinical narrative: ELEVATED AND ABNORMAL POSSIBLE BLOOD CLOT ON THE RIGHT SIDE; Chest pain/pain lower ribs; HORRIBLE HEADACHE; Radiated down to right arm; Horrible pain shot up to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (ELEVATED AND ABNORMAL POSSIBLE BLOOD CLOT ON THE RIGHT SIDE) in a 40-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) for Hidradenitis suppurativa and Crohn's disease.    The patient's past medical history included Skin graft. Concurrent medical conditions included Hidradenitis suppurativa and Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 04-Nov-2021, the patient experienced THROMBOSIS (ELEVATED AND ABNORMAL POSSIBLE BLOOD CLOT ON THE RIGHT SIDE) (seriousness criterion medically significant), CHEST PAIN (Chest pain/pain lower ribs), HEADACHE (HORRIBLE HEADACHE), PAIN IN EXTREMITY (Radiated down to right arm) and ARTHRALGIA (Horrible pain shot up to shoulder). At the time of the report, THROMBOSIS (ELEVATED AND ABNORMAL POSSIBLE BLOOD CLOT ON THE RIGHT SIDE), CHEST PAIN (Chest pain/pain lower ribs), HEADACHE (HORRIBLE HEADACHE), PAIN IN EXTREMITY (Radiated down to right arm) and ARTHRALGIA (Horrible pain shot up to shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: blood work for blood came back elevated and abnormal. On an unknown date, Investigation: no heart attack or stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  No concomitant medication were reported.  It was reported that the reporters causality for the events of SKIN GRAFT SURGERY and ELEVATED AND ABNORMAL BLOOD CLOT ON THE RIGHT SIDE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporters causality for the events of PAIN IN CHEST AND TOWARD THE BACK UNDER RIB CAGE SHOT UP TO SHOULDER AND RADIATED TO FRONT OF CHEST AND WENT DOWN RIGHT ARM and HEADACHE was not provided.  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  CC: This spontaneous case concerns a 40-year-old, female patient with concurrent conditions of hidradenitis suppurativa and Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant AESI Thrombosis in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with an unknown vaccination date. After a week from her skin graft surgery, patient had possible blood clot on her right side with horrible pain in her chest that radiated toward the back, shoulder, and her right arm as well as a horrible headache. Unspecified lab tests showed no heart attack or stroke. Unspecified blood work was elevated. Patient's underlying Crohn's disease, treatment with adalimumab, and recent skin graft surgery remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 40-year-old, female patient with concurrent conditions of hidradenitis suppurativa and Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant AESI Thrombosis in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with an unknown vaccination date. After a week from her skin graft surgery, patient had possible blood clot on her right side with horrible pain in her chest that radiated toward the back, shoulder, and her right arm as well as a horrible headache. Unspecified lab tests showed no heart attack or stroke. Unspecified blood work was elevated. Patient's underlying Crohn's disease, treatment with adalimumab, and recent skin graft surgery remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.