Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Got myocarditis form the Moderna vaccines and had chest pain, sleepiness and shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Got myocarditis form the Moderna vaccines and had chest pain, sleepiness and shortness of breath) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 206L20A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot (he has never had any side effects from previous flu shots.). Past adverse reactions to the above products included No adverse reaction with Flu shot.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYOCARDITIS (Got myocarditis form the Moderna vaccines and had chest pain, sleepiness and shortness of breath) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDITIS (Got myocarditis form the Moderna vaccines and had chest pain, sleepiness and shortness of breath) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. patient's current age was reported as 78 years. Patient stated that she got myocarditis form the Moderna vaccines and had chest pain, sleepiness and shortness of breath with the most current Pfizer booster dose. The patient received third dose of Moderna vaccine on 11-Nov-2021 (lot number: 034F21A). It was reported that the patient had received the first Pfizer vaccine shot on 23jun2022, lot number FJ4991 and the most recent shot on 23Dec2022, lot number GH9697 in left arm via intramuscular injection. It was reported that after receiving the most recent dose, when patient started to leave the room, she felt funny. She was told to wait for 10-15 minutes. However, the patient didn't felt well and went on to home. While she was reading the leaflet information, which she was provided with at the vaccination room, she realized that she had myocarditis in April 2021. patient also reported that she felt that she had a bunch of PVCs in a row. It was further reported that the event wasn't completely gone, however, it was not like as it was first time. Patient reported that she still feels the myocarditis and she gets a pain in her heart and gets sleepy. Patient further stated that she was not hospitalized for the event.   Patient denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. Patient was going to visit the hospital for check-up related to her myocarditis in March where possibly they'll recommend an echo to her.  Company comment:  This spontaneous case report concerns a 76-year-old female patient with no medical history provided, who experienced serious (life-threatening and medically significant) unexpected event of Myocarditis. The exact start date of the event was not clearly stated, as information was ambiguously reported. As per current available information the patient experienced myocarditis during April 2021 and she received the second dose of the vaccine during February 2021. The reporter stated that the event was life-threatening, however, she did not confirm that the event required hospitalization. No specific details regarding laboratory investigations and diagnostic procedures were provided. It was only stated that the patient would go for a checkup related to her myocarditis. Further information regarding this case is expected and the case will be reassessed upon receipt of additional details. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a 76-year-old female patient with no medical history provided, who experienced serious (life-threatening and medically significant) unexpected event of Myocarditis. The exact start date of the event was not clearly stated, as information was ambiguously reported. As per current available information the patient experienced myocarditis during April 2021 and she received the second dose of the vaccine during February 2021. The reporter stated that the event was life-threatening, however, she did not confirm that the event required hospitalization. No specific details regarding laboratory investigations and diagnostic procedures were provided. It was only stated that the patient would go for a checkup related to her myocarditis. Further information regarding this case is expected and the case will be reassessed upon receipt of additional details. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.