Sex: U
Vaccine: FLU4, HEPA, IPV
Symptoms: Pericarditis
Clinical narrative: This case was reported in a literature article and described the occurrence of pericarditis in a adult subject who received Hepatitis A vaccine. Co-suspect products included Seasonal Influenza vaccine, yellow fever vaccine, tetanus diphtheria vaccine, Meningococcal Vaccine and Inactivated Polio Vaccine. On an unknown date, 32 days after receiving Hepatitis A vaccine, the subject developed pericarditis. Serious criteria included GSK medically significant. The outcome of pericarditis was unknown. It was unknown if the investigator considered the pericarditis to be related to Hepatitis A vaccine. Other possible cause(s) of the pericarditis included Influenza Virus Vaccine Polyvalent. Additional information was provided. This case was reported in a literature article and described the occurrence of probable pericarditis in patient aged 18 years and above of unspecified gender who was vaccinated with unspecified hepatitis A vaccine and unspecified influenza vaccine (manufacturer unknown for both). The patient was a part of the study that sought to determine the risk of myocarditis and pericarditis following the administration of non-smallpox, live viral vaccinations among adults. The study identified a retrospective cohort of adults 18 years and older who received a MMR, VZV, OPV, or YFV between 1 January 1996 and 31 December 2007 at four integrated healthcare delivery organizations. The cohort was restricted to patients with at least 6 months of health plan enrollment prior to their first live viral vaccination. A cardiology nurse and physician then classified cases with validated diagnoses as definite, probable or possible per surveillance case definitions for myocarditis and pericarditis developed by the agency and CDC for their smallpox vaccine program. No information on patient's medical or family history or concurrent condition was provided. On unspecified dates between 1 January 1996 and 31 December 2007, the patient received unspecified YFV; unspecified Td and unspecified meningococcal vaccine. On unspecified dates, in the four days after unspecified YFV, the patient also received unspecified hepatitis A; unspecified influenza vaccines (administration route and site unspecified; dosages unknown; batch number not provided for both) along with unspecified polio vaccine. The age of vaccinations was not provided. On an unspecified date, between 32 and 35 days after vaccination with unspecified hepatitis A and unspecified influenza vaccines (36 days after unspecified YFV), the patient developed probably pericarditis. Treatment was unknown. The outcome of the event was not reported. The author did not comment on relationship between unspecified hepatitis A vaccine; unspecified influenza vaccine and probable pericarditis. However, author commented, "our study does not speak to risk related to smallpox vaccination, our results provide evidence for the lack of an association between other commonly-administered live viral vaccines and these cardiac outcomes." The author concluded, "Our study focused on non-smallpox, live viral vaccines recommended for previously unvaccinated adults, those without documented immunity, or those at increased risk for exposure or transmission, such as healthcare personnel or international travelers. Although a live attenuated influenza vaccine was licensed in 2003 for use in adults, we did not include it in our analysis since use of the vaccine in adults during most of the study period was limited in the VSD. A herpes zoster vaccine was licensed and recommended for adults 60 years of age and older in 2006, but also was not included in this analysis; a separate VSD study reported no increased risk of myocarditis or pericarditis in the 1-42 days following zoster vaccination. We found that the rate of myocarditis and pericarditis in the 42 days following VZV, YFV, OPV, or MMR vaccination was very low and was not statistically different than the rate of these events during unexposed, control intervals. These findings confirm that cardiovascular complications related to commonly administered, live viral vaccination are rare in adults."