Sex: M
Vaccine: MEN
Symptoms: Chest pain, Electrocardiogram abnormal, Fatigue, Myocarditis, Pericarditis
Clinical narrative: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case issued from a literature article extracted through eVAERS (country of incidence) in another country (reporter country). This case is linked to cases 2018SA268096, 2018SA268091, 2018SA268809, 2018SA268794, 2018SA268154, 2018SA268054, 2018SA268813, 2018SA268136, 2018SA268803, 2018SA268144, 2018SA268066, 2018SA268116, 2018SA268028, 2018SA268849, 2018SA268965, 2018SA268180, 2018SA268046, 2018SA268839, 2018SA268077, 2018SA268046 and 2018SA268864. Abstract- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods: Cases were extracted from VAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95%CI. Other agency was also searched. Results: In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were: 15 cases in 'YOUNGER GROUP' (YG; b18 years old) and 35 in 'OLDER GROUP' (OG; N18 years old). Main reported vaccines were against Human Papilloma Virus (n = 6) in YG and influenza (n = 16) in OG. Causality always resulted "undeterminate" for YG, whereas either "undetermined" (30 cases) or "correlated" (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR = 3.55; 95%CI = 1.23-10.24) and in OG for typhoid vaccine (11.13; 7.73-16.03), Japanese encephalitis vaccine (8.54; 2.7-27.01), anthrax (25.5; 18.8-34.5), and, as expected, smallpox (71.88; 49.25-104.89). In agency, 91 articles were found: positive/possible causality was frequently reported. Conclusions: MC and PC after immunization appear extremely rare; only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcal warrant monitoring. This case involves a 19 years old male patient who experienced myocarditis or clinically suspected myocarditis and pericarditis, while he received vaccine MENINGOCOCCAL VACCINE. The patient's past medical history included Asthma and Hypersensitivity. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious myocarditis/clinically suspected myocarditis 1 day following the administration of MENINGOCOCCAL VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious pericarditis 1 day following the administration of MENINGOCOCCAL VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious chest pain 1 day following the administration of MENINGOCOCCAL VACCINE. On an unknown date, the patient developed a non-serious fatigue 1 day following the administration of MENINGOCOCCAL VACCINE. (Other relevant tests included patient relevant test include: test name: EKG result: abnormal test name: ECE.) Final diagnosis was pericarditis and myocarditis or clinically suspected myocarditis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for chest pain, as Unknown for myocarditis/clinically suspected myocarditis, as Unknown for pericarditis, as Unknown for fatigue and as Unknown for pyrexia. The Causality assessment (AEFI) was Undetermined. List of documents held by sender: none. Sender's Comments: This literature article concerns a 19 year old male patient presented with myocarditis and pericarditis infarction along with the symptoms of Chest pain, Fatigue and pyrexia 1 days after vaccination with MENINGOCOCCAL VACCINE (from an unknown manufacturer). The time to onset in compatible with the role of vaccine. However, patient's past history, condition at time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.