Myocarditis and pericarditis recovery following smallpox vaccine 2002-2016: A comparative observational cohort study in the military health system.

OBJECTIVES: (1) Characterize the initial clinical characteristics and long-term outcomes of smallpox vaccine-associated hypersensitivity myocarditis and pericarditis (MP) in United States service members. (2) Describe the process of case identification and adjudication using the 2003 CDC nationally defined myocarditis/pericarditis epidemiologic case definitions to include consideration of case-specific diversity and evolving evidence. BACKGROUND: Between 2002 and 2016, 2.546 million service members received a smallpox Vaccinia vaccine. Acute MP is associated with vaccinia, but the long-term outcomes have not been studied. METHODS: Records of vaccinia-associated MP reported to the Vaccine Adverse Event Reporting System by vaccination date were adjudicated using the 2003 MP epidemiologic case definitions for inclusion in a retrospective observational cohort study. Descriptive statistics of clinical characteristics, presentation, cardiac complications, and time course of clinical and cardiac recovery were calculated with comparisons by gender, diagnosis and time to recovery. RESULTS: Out of over 5000 adverse event reports, 348 MP cases who survived the acute illness, including 276 myocarditis (99.6% probable/confirmed) and 72 pericarditis (29.2% probable/confirmed), were adjudicated for inclusion in the long-term follow-up. Demographics included a median age of 24 years (IQR 21,30) and male predominance (96%). Compared to background military population, the myocarditis and pericarditis cohort had a higher percentage of white males by 8.2% (95% CI: 5.6, 10.0) and age <40 years by 4.2% (95% CI: 1.7,5.8). Long-term follow-up documented full recovery in 267/306 (87.3%) with 74.9% recovered in less than a year (median ~3 months). Among patients with myocarditis, the percentage who had a delayed time to recovery at time of last follow-up was 12.8% (95% CI: 2.1,24.7) higher in those with an acute left ventricular ejection fraction (EF) of ≤50% and 13.5% (95% CI: 2.4,25.7) higher in those with hypokinesis. Patient complications included 6 ventricular arrhythmias (2 received implanted defibrillators) and 14 with atrial arrhythmias (2 received radiofrequency ablation). Three of 6 patients (50%) diagnosed with cardiomyopathy had clinical recovery at their last follow-up date. CONCLUSIONS: Hypersensitivity myocarditis/pericarditis following the smallpox vaccine is associated with full clinical and functional ventricular recovery in over 87% of cases (74.9% <1 year). A minority of MP cases experienced prolonged or incomplete recovery beyond 1 year.

Revisiting Influenza Vaccination Exemption.

Serious adverse events after immunizations are rare. We review the case of a man who, 50 years earlier, experienced a serious adverse neurologic event 2 weeks after receiving influenza vaccine. He had received no subsequent seasonal influenza vaccinations, but after the risks and benefits were considered, he was vaccinated without adverse event that season.

Military healthcare providers reporting of adverse events following immunizations to the vaccine adverse event reporting system.

OBJECTIVES: We studied military health care provider (HCP) practices regarding reporting of adverse events following immunization (AEFI). METHODS: A convenience sample of HCP was surveyed to assess familiarity with Vaccine Adverse Event Reporting System (VAERS), AEFI they were likely to report, methods used and preferred for reporting, and perceived barriers to reporting. We analyzed factors associated with HCP reporting AEFI to VAERS. RESULTS: A total of 547 surveys were distributed with 487 completed and returned for an 89% response rate. The percentage of HCP aware of VAERS (54%) varied by occupation. 47% of respondents identified knowledge of at least one AEFI with only 34% of these indicating that they had ever reported to VAERS. More serious events were more likely to be reported. Factors associated with HCP reporting AEFIs in bivariate analysis included HCP familiarity with filing a paper VAERS report, HCP familiarity with filing an electronic VAERS report, HCP familiarity with VAERS, and time spent on immunization tasks. In a multivariable analysis, only HCP familiarity with filing a paper VAERS report was statistically significant (Odds ratio = 115.3; p < 0.001). CONCLUSIONS: Specific educational interventions targeted to military HCP likely to see AEFIs but not currently filing VAERS reports may improve vaccine safety reporting practices.

Systemic inflammatory reaction after pneumococcal vaccine: a case series.

BACKGROUND: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. OBSERVATIONS: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. CONCLUSIONS: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine.