Journal Article
Research Support, U.S. Gov't, P.H.S.
Add like
Add dislike
Add to saved papers

Safety profile of smallpox vaccine: insights from the laboratory worker smallpox vaccination program.

BACKGROUND: The frequency of mild-to-moderate adverse events following smallpox vaccination was not well documented or reported during the pre-eradication era. This report describes the frequency of such symptoms among 936 adult smallpox vaccinees with and without a history of prior smallpox vaccination.

METHODS: Diary cards were distributed to 1006 laboratory workers and members of the Centers for Disease Control and Prevention (CDC) smallpox response team who received smallpox vaccination under an investigational new drug protocol during 2001-2002. Vaccinees were requested to complete the diary card daily and return it to the CDC 28 days after vaccination. The proportion of vaccinees reporting symptoms was determined and compared among subgroups.

RESULTS: Ninety-three percent of the diary cards were returned. The most common symptom reported was "itching at vaccination site." Primary vaccines reported statistically higher proportions of the following 11 symptoms: joint pain (25% vs. 11%; P=.0011), muscle pain (46% vs. 19%; P<.0001), fatigue (43% vs. 29%; P=.0161), swelling at vaccination site (58% vs. 33%; P<.0001), itching on the body (31% vs. 17%; P=.0048), abdominal pain (11% vs. 2%; P=.0012), swollen or tender lymph nodes (71% vs. 33%; P<.0001), pain at injection site (48% vs. 30%; P=.0018), headache (40% vs. 25%; P=.0088), backache (17% vs. 7%; P=.0090), and fever (temperature, >or=100 degrees F [37.7 degrees C]; 20% vs. 9%; P=.0047).

CONCLUSIONS: This analysis suggests that previously unvaccinated persons aged <30 years experienced more symptoms than did previously vaccinated persons. The findings of increased proportions with joint pain, abdominal pain, backache, and difficulty breathing were unexpected. As with recently described cardiac adverse events, these symptoms are suggestive of systemic involvement and warrant further study.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

Related Resources

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app