Adverse reactions after measles vaccination in India.

BACKGROUND: One hundred and sixty million doses of measles vaccine have been used since the Expanded Programme of Immunization began in 1985. Mild-to-moderate vaccine reactions are not infrequent and are accepted by parents but occasionally severe reactions and even death occur. We studied these severe reactions.
METHODS: From 1986 to 1994, 1762 batches of measles vaccine were tested and found to be satisfactory by the World Health Organization criteria. These were released for mass immunization.
RESULTS: After 40 reported incidents of severe reactions or deaths in the field, 59 intact samples of vaccine produced by different manufacturers were tested and found to be safe, i.e. they were not toxic and were sterile. However, on testing reconstituted or used vials a few were found to be toxic and many were unsterile. Reactions occurred in 115 vaccinees resulting in death of 79 children. These reactions were characterized by high fever, vomiting and profuse watery diarrhoea resulting in death within 24 hours.
CONCLUSIONS: Reactions to the vaccines were more likely to be related to the toxic shock syndrome due to the use of unsterile syringes and needles and perhaps the use of reconstituted vaccines beyond their specified time for administration resulting in contamination.