Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Computerised tomogram, Deep vein thrombosis, Pain in extremity, Pulmonary embolism
Clinical narrative: PEs; bilateral DVTs in her legs; 2 weeks after the booster dose she started to have some leg pain/Leg pain; Accidental overdose; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (PEs) and DEEP VEIN THROMBOSIS (bilateral DVTs in her legs) in a 70-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.     The patient's past medical history included Leg pain.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 100 microgram. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose). In November 2021, the patient experienced PAIN IN EXTREMITY (2 weeks after the booster dose she started to have some leg pain/Leg pain). On 04-Dec-2021, the patient experienced PULMONARY EMBOLISM (PEs) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (bilateral DVTs in her legs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-Dec-2021 due to DEEP VEIN THROMBOSIS, and then for 3 days due to PULMONARY EMBOLISM. The patient was treated with HEPARIN SODIUM (DECLOT [HEPARIN SODIUM]) at an unspecified dose and frequency and APIXABAN (ELIQUIS) at an unspecified dose and frequency. On 29-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) had resolved. At the time of the report, PULMONARY EMBOLISM (PEs), DEEP VEIN THROMBOSIS (bilateral DVTs in her legs) and PAIN IN EXTREMITY (2 weeks after the booster dose she started to have some leg pain/Leg pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Computerised tomogram: abnormal (abnormal) PEs secondary to "bilateral DVTs". In December 2021, Ultrasound scan: abnormal (abnormal) bilateral DVTs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   She presented to the emergency room on 4DEC2021 with that leg pain where she was T scan, Echo, and Ultrasound of her legs, and was placed on a heparin drip while admitted. She was then discharged on Eliquis. She was admitted for 3 days. Echocardiogram was performed, but results were not reported. No relevant concomitant medications were reported  Company comment: This spontaneous case concerns a 70-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (hospitalization and medically significant) events/AESI of Deep vein thrombosis and Pulmonary embolism after the booster mRNA- 1273 Moderna vaccine. Additionally, accidental overdose occurred (booster dose was reported as 100 micrograms). The events were diagnosed approximately 36 days after the booster dose of mRNA- 1273 vaccine. Clinical manifestations included leg pain, which started 2 weeks after the third dose. Leg ultrasound and Computer tomogram were performed, which showed bilateral deep vein thrombosis and pulmonary embolism. The patient was admitted for 3 days. Echocardiogram was also performed, but results are not available. Treatment with heparin was prescribed, and later switched to Apixaban. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (hospitalization and medically significant) events/AESI of Deep vein thrombosis and Pulmonary embolism after the booster mRNA- 1273 Moderna vaccine. Additionally, accidental overdose occurred (booster dose was reported as 100 micrograms). The events were diagnosed approximately 36 days after the booster dose of mRNA- 1273 vaccine. Clinical manifestations included leg pain, which started 2 weeks after the third dose. Leg ultrasound and Computer tomogram were performed, which showed bilateral deep vein thrombosis and pulmonary embolism. The patient was admitted for 3 days. Echocardiogram was also performed, but results are not available. Treatment with heparin was prescribed, and later switched to Apixaban. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.