Sex: M
Vaccine: MENB
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Palpitations, Sinus rhythm
Clinical narrative: palpitations and chest pain; palpitations and chest pain; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 13-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Anxiety", start date: 04Mar2021 (ongoing); "Depression", start date: 05Apr2018 (ongoing); "PTSD", start date: 25Mar2018 (ongoing); "Cough or Wheezing" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Anxiety depression" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE HFA taken for cough, start date: 06Aug2013 (ongoing); FLOMAX [TAMSULOSIN HYDROCHLORIDE] taken for hypersensitivity, start date: 06Aug2013 (ongoing); CETRIZINE taken for hypersensitivity, start date: 06Aug2013 (ongoing); SERTRALINE taken for depression, start date: 29Nov2021 (ongoing); HYDROXYZINE taken for anxiety, start date: 04Mar2021 (ongoing). Vaccination history included: menabcwy vaccine (Regimen dose number: 1, Expiration date: 31Oct2023, Anatomical Location: left Deltoid, Time Vaccination: 14:10, Generic name Trade name Number Formulation Indication: Menabcwy), administration date: 28Aug2020, for Immunization; menabcwy vaccine (Regimen dose number: 2, Expiration date: 31Oct2023, Anatomical Location: left Deltoid, Time Vaccination: 11:48), administration date: 03Sep2021, for Immunization. The following information was reported: PALPITATIONS (hospitalization), CHEST PAIN (hospitalization) all with onset 29Nov2021, outcome "recovered" (30Nov2021) and all described as "palpitations and chest pain". The events "palpitations and chest pain" required physician office visit and emergency room visit. Investigator (or Designee) SAE Awareness date was 01Dec2021. Causality assessment was Yes or No must be checked for each question even if causality is preliminary Men ABCWY visit 1: No, Men ABCWY visit 2: No. Prior Vaccination within 4 weeks was reported as None. prior vaccinations within 4 weeks as noted above was None. Family medical history Relevant to AE: Early cardiac death include died age 34. Narrative provide any information regarding the circumstances, sequence, diagnosis and treatment of the event (s) not otherwise reported on this form include details of previous treatments with the study drugs. Complete once only for each report; do not repeat for each event. Avoid abbreviations except for standard units. Patient was seen in the ED on 29Nov2021, for palpitations and chest pain, ECG showed normal sinus rhythm, chest x ray was normal. Cardiology was consulted and wants the patient to follow up in clinic. Per cardiology patient cardiac exam was normal. The patient underwent the following laboratory tests and procedures: Chest X-ray: (29Nov2021) Normal; Electrocardiogram: (29Nov2021) Normal sinus rhythm.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.