H1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink Project

Lee, Grace M.; Greene, Sharon K.; Weintraub, Eric; Baggs, James; Kulldorff, Martin; Fireman, Bruce; Baxter, Roger; Jacobsen, Steven J.; Irving, Stephanie A.; Daley, Matthew F.; Yin, Ruihua; Naleway, Allison L.; Nordin, James D.; Li, Lingling; McCarthy, Natalie L.; Vellozzi, Claudia; DeStefano, Frank; Lieu, Tracy A.; Datalink, Vaccine Safety

doi:10.1016/j.amepre.2011.04.004

Cited by 118 publications

(113 citation statements)

References 39 publications

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“…Specific outcomes and windows were selected a priori based on biologic plausibility and past Vaccine Safety Datalink research on influenza vaccine safety in nonpregnant populations. [25][26][27][28] For the first 3 days after vaccination, outcomes included allergic reactions, cellulitis, fever or malaise, limb soreness or swelling, rash, seizures, and altered mental status.…”

Section: Methodsmentioning

confidence: 99%

Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women

Nordin

Kharbanda

Benitez

et al. 2013

Obstetrics &Amp; Gynecology

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Section: Methodsmentioning

confidence: 99%

Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women

Nordin

Kharbanda

Benitez

et al. 2013

Obstetrics &Amp; Gynecology

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“…Of the three million doses, 5 percent were coded as live compared to the Vaccine Safety Datalink's finding of 17 percent. 16 Classification As A Public Health Surveillance Activity H1N1 PRISM illustrates how clinical information, health plan claims data, and immunization registries can be integrated to produce policy-relevant information. The Department of Health and Human Services' Office for Human Research Protections determined that the department's human subject regulations did not apply to the program's H1N1 vaccine safety evaluation.…”

Section: Exhibitmentioning

confidence: 99%

Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance

et al. 2012

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In response to the 2009 H1N1 pandemic and subsequent vaccination program, the Department of Health and Human Services and collaborators developed the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program as a demonstration project to detect rare adverse events rapidly. The program monitored three million people who had received the H1N1 vaccine by linking data from large private health plans and from public immunization registries that had originally not been designed to share data, and on a larger scale than had been previously attempted. The program generated safety data in two weeks rather than three to six monty 10ths-the standard time frame achievable using health plan data. PRISM substantially contributed to the understanding of the safety of H1N1 vaccines. Its use in the case of H1N1 highlights the necessity of proactive planning, scalable infrastructure, and public-private partnerships in tracking adverse events after vaccination in epidemics. It also illustrates how data could be integrated to produce policy-relevant information for other medical products.

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“…Like all passive surveillance systems, VAERS is limited by stimulated or underreporting, and reports may contain incomplete [36]. Moreover, recently the Institute of Medicine concluded that evidence favors rejection of a causal relationship between seasonal TIV and Bell's palsy [37].…”

Section: Discussionmentioning

confidence: 99%