Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome; Woke up with an erratic pulse. Mild myocarditis was diagnosed; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4236625.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2020 as dose 1, single (Batch/Lot number: unknown) and on 01Apr2020 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown) at single (unk, single), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Sep2020, outcome "unknown", described as "Woke up with an erratic pulse. Mild myocarditis was diagnosed"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "not recovered".  Clinical course: Solicited report from by a consumer of a adult male with events of and non-serious Postural orthostatic tachycardia syndrome, and myocarditis with Risankizumab Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard. Pfizer BioNTech COVID-19 vaccine was also considered suspect. In Mar2020 and Apr2020, the patient reported he had covid vaccines. In Sep2020, he woke up with an erratic pulse. Mild myocarditis was diagnosed, but he said no one was willing to state that it was from vaccine. His cardiologist said he in inundated with patients with this problem. He said his heart was constantly inflamed. He was convinced that this was vaccine related.   Causalities: The reporter's causality for the event(s) of Postural orthostatic tachycardia syndrome with Risankizumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of myocarditis with Risankizumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of myocarditis with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Postural orthostatic tachycardia syndrome with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. AbbVie's opinion was that the causality for the event(s) of Postural orthostatic tachycardia syndrome and myocarditis with Risankizumab Solution for Injection was Not Provided. AbbVie's opinion was that the causality for the event(s) of Postural orthostatic tachycardia syndrome and myocarditis with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Primary reporter did not have the lot number information, because the packaging was discarded.  Assessment Results: Skyrizi- Postural orthostatic tachycardia syndrome, Regulatory Authority; Skyrizi- Postural orthostatic tachycardia syndrome, Non-Health Care Professional, Global Introspection, Not Related; Skyrizi - Myocarditis, Regulatory Authority; Skyrizi - Myocarditis, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Myocarditis, Regulatory Authority; Pfizer BioNTech COVID-19 vaccine - Myocarditis, Non-Health Care Professional, Global Introspection, Probable; Pfizer BioNTech COVID-19 vaccine - Postural orthostatic tachycardia syndrome, Regulatory Authority; Pfizer BioNTech COVID-19 vaccine - Postural orthostatic tachycardia syndrome, Non-Health Care Professional, Global Introspection, Not Reported.  The reporter considered "woke up with an erratic pulse. mild myocarditis was diagnosed" related to BNT162b2.  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 available information in the case, an association between the reported events  MYOCARDITIS  & POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME and The suspected drug cannot be ruled out.  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.