BACKGROUND:In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States.

OBJECTIVE:To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

METHODS:We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV.

RESULTS:VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination.

CONCLUSIONS:This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.

The case of a 21-year-old male taking over-the-counter pseudoephedrine for weight loss who died suddenly during exercise shortly after inoculation with Japanese encephalitis and phenol-inactivated typhoid vaccines is presented. The patient collapsed in mild weather while exercising 75 minutes after his vaccinations. He presented in asystole with a core temperature of 42.2 degrees C (108 degrees F). There was no evidence of urticaria or angioedema. It is likely that the combined pyrogenic effects of the vaccines, pseudoephedrine, exercise, and mild obesity contributed to a failure of the thermoregulatory system. Fever is still a common side effect of numerous other vaccines. Military physicians should consider administrative controls on thermogenic activities for a period after inoculations. Additionally, the dangers of ephedrine-containing compounds need to be more widely publicized.

A previously healthy 33-year-old Australian male died suddenly and unexpectedly 8 h after a typhoid-cholera vaccination. Such fatalities are extreme rarities and the present case is the first in which postmortem measurement of serum immunoglobulins has been undertaken. The clinical course and necropsy findings suggest that death was the result of a slowly evolving systemic anaphylactic reaction which terminated in hypotension and right heart failure. The deceased was probably atopic. The current recommendations for the vaccination of international travellers against typhoid and cholera are discussed.