Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Interchange of vaccine products, Pulmonary embolism, Thrombosis
Clinical narrative: Pulmonary embolism /  blood clots in the lungs/ back pain / dyspnea / cough; Thrombosis in leg / blood clots in the leg/pain in extremity/ groin pain/ limb discomfort/ joint swelling; Patient got COVID-19 months after receiving the Moderna Booster; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism /  blood clots in the lungs/ back pain / dyspnea / cough) and THROMBOSIS (Thrombosis in leg / blood clots in the leg/pain in extremity/ groin pain/ limb discomfort/ joint swelling) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065AT21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 16-Jan-2022. Previously administered products included for COVID-19 vaccination: Pfizer vaccine (EM8200) on 26-Feb-2021 and Pfizer vaccine (ER2613) on 19-Mar-2021; for Product used for unknown indication: Flu shot (Flu shot within 1 month prior to Moderna COVID-19 vaccine) in 2021. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Cholesterol. Concomitant products included LOVASTATIN (ROSTATIN [LOVASTATIN]) for Cholesterol.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 16-Jan-2022, the patient experienced COVID-19 (Patient got COVID-19 months after receiving the Moderna Booster). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism /  blood clots in the lungs/ back pain / dyspnea / cough) (seriousness criterion medically significant) and THROMBOSIS (Thrombosis in leg / blood clots in the leg/pain in extremity/ groin pain/ limb discomfort/ joint swelling) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. On 22-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism /  blood clots in the lungs/ back pain / dyspnea / cough), THROMBOSIS (Thrombosis in leg / blood clots in the leg/pain in extremity/ groin pain/ limb discomfort/ joint swelling) and COVID-19 (Patient got COVID-19 months after receiving the Moderna Booster) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood clots in the leg and lungs blood clots in the leg and lungs. On an unknown date, Ultrasound scan: blood clots in the leg and lungs blood clots in the leg and lungs.         Acute and Chronic illnesses at the time of vaccination. Patient has not experienced a similar event in the past. On 10 Feb 2022 patient went to see his primary doctor, did some blood work and ultrasound on his leg .On 11Feb2022  doctor confirmed that patient  had blood clots in the leg and lungs so patient  immediately went to the ER. Doctor prescribed medication for blood clots: Eliquis.  Company comment: This is a spontaneous case concerning a 47-year-old, male patient with no reported medical history and vaccine history of receiving 2 doses of another brand of Covid-19 vaccine (Covid-19 vaccine Pfizer) as primary doses, who experienced the unexpected, serious, AESI events of Covid-19, thrombosis in leg and pulmonary embolism. The event Covid-19 occurred  55 days after the booster dose of mRNA-1273 vaccine administration while the events thrombosis in leg and pulmonary embolism exact occurrence unknown but stated that the patient was confirmed with thrombosis in leg and pulmonary embolism 81 days after the booster dose of mRNA-1273 vaccine administration. The patient was prescribed with Eliquis. The outcome of the event Covid-19 was unknown while the events thrombosis in leg and pulmonary embolism the outcome were not resolved from the time of last observation. The vaccine history of receiving 2 doses of another brand of Covid-19 vaccine (Covid-19 vaccine Pfizer) remain confounder to the event Covid-19 and the event Covid-19 remain confounder for the events thrombosis in leg and pulmonary embolism. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47-year-old, male patient with no reported medical history and vaccine history of receiving 2 doses of another brand of Covid-19 vaccine (Covid-19 vaccine Pfizer) as primary doses, who experienced the unexpected, serious, AESI events of Covid-19, thrombosis in leg and pulmonary embolism. The event Covid-19 occurred  55 days after the booster dose of mRNA-1273 vaccine administration while the events thrombosis in leg and pulmonary embolism exact occurrence unknown but stated that the patient was confirmed with thrombosis in leg and pulmonary embolism 81 days after the booster dose of mRNA-1273 vaccine administration. The patient was prescribed with Eliquis. The outcome of the event Covid-19 was unknown while the events thrombosis in leg and pulmonary embolism the outcome were not resolved from the time of last observation. The vaccine history of receiving 2 doses of another brand of Covid-19 vaccine (Covid-19 vaccine Pfizer) remain confounder to the event Covid-19 and the event Covid-19 remain confounder for the events thrombosis in leg and pulmonary embolism. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.