VAERS ID: 1796857

Description

consciousness recovered; generalization of partial epilepsy associated with hypoxic-ischaemic encephalopathy; generalization of partial epilepsy associated with hypoxic-ischaemic encephalopathy; seizure; Jitteriness in the jaw and the arms; ankylosis in the arms; interstitial fibrosis; Acute myocarditis; myocarditis developed again after vaccination; cardiac function decreased (LVEF 10%).; abdominal pain; feeling of dyspnoea developed while walking; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is v21129980. The patient was a 15-year and 8-month-old male. Body temperature before the vaccinations was 36.2 Centigrade. The patient had no family history. The patient had medical history included fulminant myocarditis, covid-19 infection, atrioventricular block complete after myocarditis. History of ventricular fibrillation. Previous implantation of biventricular pacemaker with function of defibrillator. Attention deficit hyperactivity disorder. Mild intellectual disorder. Concomitant medications included enalapril 10 mg, amiodarone 300 mg, furosemide 20 mg, spironolactone (ALDACTONE-A) 25 mg, carvedilol 20 mg, atomoxetine 20 mg, valproate sodium(DEPAKENE [VALPROATE SODIUM]) 600 mg, risperidone 2 mg, ramelteon (ROZEREM) 8 mg. On 26Aug2021 at 15:30 (the day of the vaccination), the patient received the first dose of bnt162b2 (at the age of 15-years-old) (COMIRNATY, Lot number FF3622, Expiration date 30Nov2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 08Sep2021 at 21:30 (13 days after the vaccination), the patient experienced acute myocarditis. On 08Sep2021 (13 days after the vaccination), the patient was admitted to hospital. On 12Oct2021 (46 days after the vaccination) the outcome of the event was not recovered. The reporter classified the event as serious (Life-threatening, likely disability, hospitalization) and assessed the causality between the event and the vaccines as unassessable. There was no other possible cause of the event such as any other diseases. The course of the event was as follows:The patient experienced pyrexia on 05Jan2021 and Covid-19 PCR test showed positive result and was admitted to PRIVACY Hospital. However, as cardiomegaly was found on 09Jan2021, the patient was transferred to the reporting hospital. Severe cardiac function decreased (LVEF 10s%), atrioventricular block complete and non-sustained ventricular tachycardia were found. Acute myocarditis (fulminant myocarditis) was diagnosed. Since treatment under ECMO was considered necessary, the patient was transferred to another hospital and was treated with VA-ECMO, artificial ventilator, dexamethasone and remdesivir. As atrioventricular block complete persisted and the cardiac function was poor, the patient was transferred again to the reporting hospital in Feb2021 and underwent implantation of a cardiac resynchronization therapy defibrillator (CRT-D). Long-term rehabilitation for disuse was required. The patient was discharged in Mar2021. After that, no sign of cardiac failure was seen. When the patient visited outpatient consultation, improvement of the LVEF 45% and the BNP 39.9 pg/mL was found. On 26Aug2021, the patient received the first dose of COMIRNATY (BNT162b2). The patient had no preceding infectious symptom such as pyrexia and nasal discharge. On 05Sep2021, feeling of dyspnoea developed while walking. On 08Sep2021, the patient had abdominal pain, cardiac function decreased (LVEF 10%). Increase in the cardiac enzyme levels was seen. Acute myocarditis was diagnosed and the patient was admitted to hospital on that day. High-dose gamma-globulin therapy was started. On 10Sep2021, the patient underwent orotracheal intubation. On 11Sep2021, IMPELLA was introduced. After that, the circulation collapsed and VA-ECMO was started. As the circulation collapsed, steroid pulse therapy was started on the same day. On 13Sep2021, myocardial biopsy was performed. Severe myocarditis mainly with T lymph cells and interstitial fibrosis were seen. Finding suggestive of acute myocarditis was shown. The cardiac function improved and ECMO was withdrawn under support with IMPELLA on 17Sep2021. IMPELLA was withdrawn on 22Sep2021. Jitteriness in the jaw and the arms were seen on 29Sep2021. The patient could have communication. After that, the patient had ankylosis in the arms, ankylosis stopped and consciousness recovered after treatment with intravenous diazepam, seizure was found. It was considered generalization of partial epilepsy associated with hypoxic-ischaemic encephalopathy. Although treatment with valproic acid that he had received before was restarted, seizure occurred again. Therefore, levetiracetam was given concomitantly. Extubation was performed on 30Sep2021. Catecholamine could be discontinued on 01Oct2021. The reporter commented as follows: This is a rare case in which Covid-19 infection resulted in fulminant myocarditis. In the case, myocarditis developed again after vaccination. It is guessed that excessive immune reaction to covid-19 virus might develop in some patients who receive the vaccine. However, it is difficult to prove it. The patient has not recovered from the events.

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