Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound Doppler
Clinical narrative: dvt; pain in her hips and legs; pain in her hips; body aches; chills; fatigued; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (dvt) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (001B21A, 1st dose) on 11-Feb-2021, Moderna COVID-19 Vaccine (030B21A, 2nd dose) on 08-Apr-2021, Moderna COVID-19 Vaccine (031H21A, 3rd dose) on 02-Dec-2021, Moderna COVID-19 Vaccine (005M21A, 4th dose) on 13-Jun-2022, Moderna COVID-19 Bivalent Vaccine (062F22A and 5th dose) on 22-Nov-2022; for Product used for unknown indication: RSV (2 weeks ago) in November 2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Bivalent Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and RSV. Concurrent medical conditions included Rheumatoid arthritis, Osteoarthritis and Sjogren's disease.    On 01-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Dec-2023, the patient experienced PAIN IN EXTREMITY (pain in her hips and legs), ARTHRALGIA (pain in her hips), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigued). On 04-Dec-2023, the patient experienced DEEP VEIN THROMBOSIS (dvt) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 04-Dec-2023 at an unspecified dose and frequency and RIVAROXABAN (XARELTO) at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (dvt), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigued) had not resolved and PAIN IN EXTREMITY (pain in her hips and legs) and ARTHRALGIA (pain in her hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2023, Ultrasound Doppler: showed a DVT.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that afternoon she had bad chills and turned the heat up. She felt super fatigued like she had to sit down. She  had the worst body aches she's had in her entire life. She still had some chills and aches at the time of reporting. Friday night she had pain in her hips and legs. On Saturday her right lower leg was very tight. Didn't think much of it, but next day her leg swelled up and she went to urgent care. Yesterday had a doppler which showed a DVT.  Company comment: This spontaneous case concerns a 70-year-old, female patient with medical history of rheumatoid arthritis, Osteoarthritis and Sjogren's disease, who experienced the unexpected serious (medically significant) AESI of deep vein thrombosis along with other non serious events. The events occurred 3 days after the sixth dose of SPIKEVAX 2023-2024. As reported, in afternoon after vaccination patient had bad chills, felt super fatigued, had the worst body aches. Afterwards patient had pain in her hips and legs. Day after right lower leg was very tight but next day her leg swelled up and patient went to urgent care and patient had a doppler which showed a DVT. No further information about the events was provided. Above mentioned medical hisotry is a confounder for DVT and arthralgia (ostehoarthritis). The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.