Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain of skin, Photosensitivity reaction, Pyrexia
Clinical narrative: PHOTOSENSITIVITY/FELT SKIN ON FIRE/EXTREMELY SENSITIVE TO THE SUN; Arthritic pains; Clot blood; Skin pain; Vascular pain; Vaccination site pain; Fever; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) in a 53-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 Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC) and Psoriatic arthritis.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In June 2021, the patient experienced INSOMNIA (Insomnia), VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (Fever). In January 2022, the patient experienced PAIN OF SKIN (Skin pain) and VASCULAR PAIN (Vascular pain). On 22-Jan-2022, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOSENSITIVITY REACTION (PHOTOSENSITIVITY/FELT SKIN ON FIRE/EXTREMELY SENSITIVE TO THE SUN) and ARTHRALGIA (Arthritic pains). At the time of the report, THROMBOSIS (Clot blood), PHOTOSENSITIVITY REACTION (PHOTOSENSITIVITY/FELT SKIN ON FIRE/EXTREMELY SENSITIVE TO THE SUN), VASCULAR PAIN (Vascular pain) and ARTHRALGIA (Arthritic pains) was resolving and INSOMNIA (Insomnia), PAIN OF SKIN (Skin pain), VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (Fever) outcome was unknown.            It was reported that, no known allergies.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the events pain, Insomnia and fever was not provided with HUMIRA(ADALIMUMAB). The reporter causality for the events thrombosis, photosensitivity reaction was reasonable possibility with HUMIRA(ADALIMUMAB)  No treatment medications were reported.  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 53  year  old female patient, with medical history of plaque psoriasis, who experienced the unexpected serious medically significant AESI of thrombosis, which occurred approximately 7 months after the second dose of mRNA  1273 vaccine. Exact vaccination date was not provided; hence latency and temporal association cannot be properly assessed. 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 26-Apr-2022: Follow-up received wherein new events added. Outcome of the event, co suspect drug and suspect vaccine information updated. Narrative description updated.; Sender's Comments: This spontaneous case concerns a 53  year  old female patient, with medical history of plaque psoriasis, who experienced the unexpected serious medically significant AESI of thrombosis, which occurred approximately 7 months after the second dose of mRNA  1273 vaccine. Exact vaccination date was not provided; hence latency and temporal association cannot be properly assessed. 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.