Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myocardial necrosis marker, Speech disorder, Thrombosis
Clinical narrative: Some procedure to open his veins, there is a clot; Heart is not functioning 100%; now he can talk, he was out for two days; Hospitalized due to COVID/diagnosed with COVID in the lungs; Very painful chest pain, like a heart attack; Heart infection due to COVID; Trouble breathing; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Some procedure to open his veins, there is a clot), CHEST PAIN (Very painful chest pain, like a heart attack), CARDIAC INFECTION (Heart infection due to COVID), DYSPNOEA (Trouble breathing), CARDIAC DISORDER (Heart is not functioning 100%), SPEECH DISORDER (now he can talk, he was out for two days) and COVID-19 (Hospitalized due to COVID/diagnosed with COVID in the lungs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 013A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy (does not have spleen, it was removed after a car accident when he was 19 years old). Concomitant products included SILDENAFIL CITRATE (VIAGRA) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced CHEST PAIN (Very painful chest pain, like a heart attack) (seriousness criterion hospitalization), CARDIAC INFECTION (Heart infection due to COVID) (seriousness criterion hospitalization), DYSPNOEA (Trouble breathing) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). 04-Jan-2022, the patient experienced COVID-19 (Hospitalized due to COVID/diagnosed with COVID in the lungs) (seriousness criterion hospitalization). On 05-Jan-2022, the patient experienced SPEECH DISORDER (now he can talk, he was out for two days) (seriousness criterion hospitalization). On 07-Jan-2022, the patient experienced THROMBOSIS (Some procedure to open his veins, there is a clot) (seriousness criteria hospitalization and medically significant) and CARDIAC DISORDER (Heart is not functioning 100%) (seriousness criterion hospitalization). The patient was hospitalized on 04-Jan-2022 due to CARDIAC DISORDER, CARDIAC INFECTION, CHEST PAIN, COVID-19, DYSPNOEA, SPEECH DISORDER and THROMBOSIS. The patient was treated with OXYGEN for Difficulty breathing, at an unspecified dose and frequency. On 07-Jan-2022, SPEECH DISORDER (now he can talk, he was out for two days) had resolved. At the time of the report, THROMBOSIS (Some procedure to open his veins, there is a clot), CHEST PAIN (Very painful chest pain, like a heart attack), CARDIAC INFECTION (Heart infection due to COVID), DYSPNOEA (Trouble breathing), CARDIAC DISORDER (Heart is not functioning 100%) and COVID-19 (Hospitalized due to COVID/diagnosed with COVID in the lungs) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Myocardial necrosis marker: 0.8 blood was taken to monitor heart enzymes every 3 hours: heart enzymes were 0.8, increased to 1 Increased to 1, increased to 2 Increased to 2 and stabilized at a lower number stabilized at a lower number.         It was stated that on 07 Jan 2022 they would be performing some procedure to open patient's veins (unclog his veins). It was stated that the doctors thought that patient heart problem was prior to the COVID infection. Treatment included COVID treatment, two drugs were given against coronavirus, antiviral and another drug, also blood thinners were used. The cause determined was COVID, but probably heart condition was previous. There was no previous diagnosis of COVID. Patient was not had a history of myocarditis/pericarditis.  Company comment: This case concerns  a 67-year-old male patient with history of splenectomy who experienced serious unexpected THROMBOSIS,  CHEST PAIN, CARDIAC INFECTION, DYSPNOEA, CARDIAC DISORDER,  SPEECH DISORDER and COVID-19, and was hospitalized approximately five months after the third dose of mRNA-1273. Lack of drug effect was also reported.  At the time of the report, SPEECH DISORDER was resolved while THROMBOSIS, CHEST PAIN,  CARDIAC INFECTION, DYSPNOEA, CARDIAC DISORDER and COVID-19 had not resolved. The patient's medical history of splenectomy remains a confounding factor in addition to concomitantly administered sildenafil. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Non significant follow up received.; Sender's Comments: This case concerns  a 67-year-old male patient with history of splenectomy who experienced serious unexpected THROMBOSIS,  CHEST PAIN, CARDIAC INFECTION, DYSPNOEA, CARDIAC DISORDER,  SPEECH DISORDER and COVID-19, and was hospitalized approximately five months after the third dose of mRNA-1273. Lack of drug effect was also reported.  At the time of the report, SPEECH DISORDER was resolved while THROMBOSIS, CHEST PAIN,  CARDIAC INFECTION, DYSPNOEA, CARDIAC DISORDER and COVID-19 had not resolved. The patient's medical history of splenectomy remains a confounding factor in addition to concomitantly administered sildenafil. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.