Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Myocarditis
Clinical narrative: Myocarditis due to COVID-19 vaccination; Stomach pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-UGNX-22-00505.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; triheptanoin (DOJOLVI), (ongoing) (Batch/Lot number: unknown), oral for carnitine palmitoyltransferase deficiency. The patient's relevant medical history included: "Carnitine palmitoyltransferase deficiency" (ongoing), notes: Carnitine palmoiltransterase II (CPT II) deficiency; "Long chain Fatty acid oxidation disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myocarditis due to COVID-19 vaccination"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "Stomach pain". The action taken for triheptanoin was dosage not changed.  Clinical course: It was reported that the patient experienced myocarditis due to COVID-19 vaccination and stomach pain, while receiving Dojolvi (triheptanoin) for the treatment of long chain fatty acid oxidation disorder: Carnitine palmitoyltransferase II (CPT II) deficiency. The patient was previously enrolled in study. As per the patients mother report, received on 25Jul2022, the patient was hospitalized for myocarditis due to COVID-19 vaccination (data was not provided). The patients mother also reported that the patient had stomach pain with increased Dojolvi dose during the hospitalization. Reportedly, for Dojolvi the causality of the event Myocarditis due to COVID-19 vaccination (Myocarditis) as per reporter was not reported and as per Mfr. was not related. The causality of the event Stomach pain (Abdominal pain upper) as per reporter was not reported and as per Mfr. was possible. Reportedly, for BNT162B2 the causality of the event Myocarditis due to COVID-19 vaccination (Myocarditis) as per reporter was not reported and per Mfr. was possible. The causality of the event Stomach pain (Abdominal pain upper) as per reporter was not reported and as per Mfr. was Not related.  Sender's comments: Company comment: Myocarditis is unexpected; Abdominal pain upper is a known adverse drug reaction for Dojolvi, however the serious event of abdominal pain upper is assessed as unexpected for Dojolvi. The Company assessed the above events as serious due to hospitalization. The Company considers causality for the event of myocarditis as not related to Dojolvi and due to COVID -19 vaccination. The event of abdominal pain upper is assessed as possibly related to Dojolvi, however more information including patient's clinical course and etiology for the reported events is needed to enable full causality assessment.  The reporter's assessment of the causal relationship of "myocarditis due to covid-19 vaccination" and "stomach pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.