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Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010.
Clin Infect Dis. 2012 Jun; 54(11):1608-14.CI

Abstract

BACKGROUND

In December 2009, a new high-dose, trivalent, inactivated influenza vaccine (TIV-HD) was licensed for adults aged ≥65 years. We characterized clinical patterns of reports to the Vaccine Adverse Event Reporting System (VAERS) among older adults who received TIV-HD.

METHODS

We searched VAERS for reports involving persons aged ≥65 years who received TIV-HD or TIV (standard dose) from 1 July 2010 through 31 December 2010. Medical records were requested for serious reports (ie, those associated with death, hospitalization or prolonged hospitalization, life-threatening illness, or disability). Clinicians reviewed information and assigned a diagnostic category to each report. Empirical Bayesian data mining was used to identify disproportional reporting following TIV-HD in VAERS. Reporting rates were calculated for reports of Guillain-Barré syndrome and anaphylaxis.

RESULTS

VAERS received 606 reports after TIV-HD in persons aged ≥65 years (8.2% of reports involved serious events). The number of reports yielded by searches using the terms "ocular hyperemia" and "vomiting" exceeded the data mining threshold; >80% of these reports were nonserious. Clinical review of serious reports found that a greater proportion involving gastrointestinal events were made after TIV-HD receipt (5 of 51 [9.8%]) than after TIV receipt (1 of 123 [0.8%]). Four persons who received TIV-HD had gastroenteritis, and 1 had multiple gastrointestinal symptoms; all recovered. A higher proportion of cardiac events were noted after receipt of TIV-HD (9 of 51 [17.6%]) than after receipt of TIV (6 of 123 [4.9%]). No concerning clinical pattern was apparent. The reporting rates of Guillain-Barré syndrome and anaphylaxis after TIV-HD receipt were 1.4 and 1.0 reports per million doses distributed, respectively.

CONCLUSIONS

During the first year after US licensure of TIV-HD, no new serious safety concerns were identified in VAERS. Our analyses suggested a clinically important imbalance between the reported and expected number of gastrointestinal events after TIV-HD receipt. Future studies should assess this potential association.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. psm9@cdc.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22441652

Citation

Moro, Pedro L., et al. "Postlicensure Safety Surveillance for High-dose Trivalent Inactivated Influenza Vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 54, no. 11, 2012, pp. 1608-14.
Moro PL, Arana J, Cano M, et al. Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010. Clin Infect Dis. 2012;54(11):1608-14.
Moro, P. L., Arana, J., Cano, M., Menschik, D., Yue, X., Lewis, P., Haber, P., Martin, D., & Broder, K. (2012). Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 54(11), 1608-14. https://doi.org/10.1093/cid/cis256
Moro PL, et al. Postlicensure Safety Surveillance for High-dose Trivalent Inactivated Influenza Vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010. Clin Infect Dis. 2012;54(11):1608-14. PubMed PMID: 22441652.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010. AU - Moro,Pedro L, AU - Arana,Jorge, AU - Cano,Maria, AU - Menschik,David, AU - Yue,Xin, AU - Lewis,Paige, AU - Haber,Penina, AU - Martin,David, AU - Broder,Karen, Y1 - 2012/03/22/ PY - 2012/3/24/entrez PY - 2012/3/24/pubmed PY - 2012/8/30/medline SP - 1608 EP - 14 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 54 IS - 11 N2 - BACKGROUND: In December 2009, a new high-dose, trivalent, inactivated influenza vaccine (TIV-HD) was licensed for adults aged ≥65 years. We characterized clinical patterns of reports to the Vaccine Adverse Event Reporting System (VAERS) among older adults who received TIV-HD. METHODS: We searched VAERS for reports involving persons aged ≥65 years who received TIV-HD or TIV (standard dose) from 1 July 2010 through 31 December 2010. Medical records were requested for serious reports (ie, those associated with death, hospitalization or prolonged hospitalization, life-threatening illness, or disability). Clinicians reviewed information and assigned a diagnostic category to each report. Empirical Bayesian data mining was used to identify disproportional reporting following TIV-HD in VAERS. Reporting rates were calculated for reports of Guillain-Barré syndrome and anaphylaxis. RESULTS: VAERS received 606 reports after TIV-HD in persons aged ≥65 years (8.2% of reports involved serious events). The number of reports yielded by searches using the terms "ocular hyperemia" and "vomiting" exceeded the data mining threshold; >80% of these reports were nonserious. Clinical review of serious reports found that a greater proportion involving gastrointestinal events were made after TIV-HD receipt (5 of 51 [9.8%]) than after TIV receipt (1 of 123 [0.8%]). Four persons who received TIV-HD had gastroenteritis, and 1 had multiple gastrointestinal symptoms; all recovered. A higher proportion of cardiac events were noted after receipt of TIV-HD (9 of 51 [17.6%]) than after receipt of TIV (6 of 123 [4.9%]). No concerning clinical pattern was apparent. The reporting rates of Guillain-Barré syndrome and anaphylaxis after TIV-HD receipt were 1.4 and 1.0 reports per million doses distributed, respectively. CONCLUSIONS: During the first year after US licensure of TIV-HD, no new serious safety concerns were identified in VAERS. Our analyses suggested a clinically important imbalance between the reported and expected number of gastrointestinal events after TIV-HD receipt. Future studies should assess this potential association. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/22441652/Postlicensure_safety_surveillance_for_high_dose_trivalent_inactivated_influenza_vaccine_in_the_Vaccine_Adverse_Event_Reporting_System_1_July_2010_31_December_2010_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/cis256 DB - PRIME DP - Unbound Medicine ER -