Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pulmonary embolism
Clinical narrative: Pulmonary embolism, coughing, chest pain and haemoptysis; small DVT in the popliteal fossa of the non-operated leg; arm was sore; sore joints; felt very lousy; myalgias/ sore muscles; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism, coughing, chest pain and haemoptysis) and DEEP VEIN THROMBOSIS (small DVT in the popliteal fossa of the non-operated leg) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (7.5 weeks earlier. Had taken anticoagulation with that. Had leg pumps for 4 weeks and was moving around. Was asymptomatic from any DVT symptoms.) in September 2023. Previously administered products included for Product used for unknown indication: FLUZONE [INFLUENZA VACCINE] on 05-Nov-2023 and COVID-19 VACCINE (4 previous doses of COVID-19 vaccines). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and FLUZONE [INFLUENZA VACCINE].    On 11-Nov-2023 at 4:00 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023 at 10:00 PM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (arm was sore). On 14-Nov-2023, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism, coughing, chest pain and haemoptysis) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (small DVT in the popliteal fossa of the non-operated leg) (seriousness criterion medically significant). In November 2023, the patient experienced FEELING ABNORMAL (felt very lousy), MYALGIA (myalgias/ sore muscles) and ARTHRALGIA (sore joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In November 2023, MYALGIA (myalgias/ sore muscles) and ARTHRALGIA (sore joints) outcome was unknown. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism, coughing, chest pain and haemoptysis), DEEP VEIN THROMBOSIS (small DVT in the popliteal fossa of the non-operated leg), FEELING ABNORMAL (felt very lousy) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2023, Computerised tomogram thorax: diagnosed him with a pulmonary embolism. On 14-Nov-2023, Laboratory test: diagnosed him with a pulmonary embolism.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that six hours after receiving the vaccine patient's arm was sore. He had myalgias, sore muscles, sore joints, and felt very lousy for a couple of days, but had no fever. He took some Non-steroidal anti-inflammatory drugs (NSAIDs). On 14-NOV-2023 he was on his way to a physio appointment when he had a lot of coughing with chest pain and hemoptysis. During his Emergency visit he noted he had a small DVT in the popliteal fossa of the non-operated leg.  Company comment:  This spontaneous case concerns a 67  year  old male patient, with medical history of knee arthroplasty (approximately 2 months prior the onset of the events), who experienced the unexpected, serious (medically significant) AESI deep vein thrombosis (DVT) and pulmonary embolism. The events occurred 3 days after a dose of Spikevax 2023  2024 vaccine (Andusomeran) reported as fifth dose of his COVID  19 immunization schedules (no information about previous doses was provided). The report stated that 6 hours after receiving the vaccine the patient experienced arm sore, myalgias, sore joints, and felt very lousy for a couple of days. He took some non-steroidal anti-inflammatory drugs and Tylenol. Three days after vaccination he had a lot of coughing with chest pain and haemoptysis. He went to the emergency room where unspecified labs and a computed tomography angiography diagnosed him with a pulmonary embolism. It was also noted that he had a small DVT in the popliteal fossa of the non-operated leg. No further clinical details were provided for medical reviewing. Patient´s medical history remains as confounder for deep vein thrombosis and pulmonary embolism. The benefit-risk relationship of Spikevax 2023  2024 vaccine (Andusomeran) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-751196 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751196:Different patient