Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Injection site pain, Intensive care, Muscular weakness, Myalgia
Clinical narrative: blood clots in his lungs/pulmonary embolism; pain in the chest but not a bad pain, it felt like a pressure; cough; cough, which got worse; felt unwell after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots in his lungs/pulmonary embolism) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MALAISE (felt unwell after getting the vaccine). In April 2021, the patient experienced CHEST PAIN (pain in the chest but not a bad pain, it felt like a pressure), COUGH (cough) and COUGH (cough, which got worse). In June 2021, the patient experienced PULMONARY EMBOLISM (blood clots in his lungs/pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in June 2021 due to PULMONARY EMBOLISM. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and XYLOMETAZOLINE HYDROCHLORIDE (DECONGESTANT [XYLOMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clots in his lungs/pulmonary embolism), MALAISE (felt unwell after getting the vaccine), CHEST PAIN (pain in the chest but not a bad pain, it felt like a pressure), COUGH (cough) and COUGH (cough, which got worse) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Computerised tomogram: abnormal (abnormal) blood clots in his lungs -pulmonary embolism..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient has been pretty much sick since he got the 2nd dose of the Moderna Covid-19 vaccine on 20Mar2021. He was administered with the vaccine at their workplace, lot number 014M20A with no other information provided on the vaccination card.  He felt unwell after getting the vaccine and 10-14 days after, he started having cough and it got worse at the beginning of Apr2021. He had pain in the chest but not a bad pain, it felt like a pressure. He went to see a doctor last weekend of April and after a week went back to an Urgent Care (1st week of May). He was given more of the same treatment - Prednisone, decongestant and antibiotics. These offered no relief and he consulted many doctors - a general practitioner and pulmonologists. He did not experience relief of his symptoms and it seemed that nobody seemed to help him.  It was when he saw a nurse practitioner  in the middle of June, who got concerned and got him an immediate CT Scan of the lungs. On his way home, they called him and requested him to go to the emergency room as they saw blood clots in his lungs - pulmonary embolism. He was admitted to the hospital to be treated. He is now being followed up by many specialists, his hema-onco he states knows his medical condition best.  Company comment: This case concerns a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine)  with no relevant medical history who experienced the serious unexpected event (AESI) of pulmonary embolism approximately 3 months after the second dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report   This case was linked to MOD-2021-378213 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine)  with no relevant medical history who experienced the serious unexpected event (AESI) of pulmonary embolism approximately 3 months after the second dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report