PMID- 31064675 OWN - NLM STAT- MEDLINE DCOM- 20200928 LR - 20210109 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 37 IP - 25 DP - 2019 May 31 TI - Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project. PG - 3296-3302 LID - S0264-410X(19)30568-7 [pii] LID - 10.1016/j.vaccine.2019.04.080 [doi] AB - OBJECTIVES: We evaluate safety of routine vaccination among adults infected with human immunodeficiency virus (HIV) in five healthcare organizations in the United States. METHODS: We conducted a retrospective cohort study of HIV-infected adults who received inactivated influenza vaccines, hepatitis B vaccines, pneumococcal vaccines, or tetanus, diphtheria, and acellular pertussis vaccines between 2002 and 2013. We conducted self-controlled case series analysis to estimate the relative risk (RR) for 11 pre-specified adverse events (AEs) requiring medical attention. RESULTS: Among 20,417 HIV-infected adults (90.2% male), a total of 137,674 vaccine doses were administered. Based on ICD-9 codes, we detected an increased risk of cellulitis and infection (RR: 1.18, 95% CI: 1.03-1.35) among all patients, and an increased risk of stroke/cerebrovascular diseases among patients with an HIV viral load >10,000 copies/ml (adjusted RR: 3.94, 95% CI: 1.32-11.72). Further analyses on chart confirmed cases of stroke/cerebrovascular diseases indicated no statistically significant increased risk (adjusted RR: 1.72, 95% CI: 0.41-7.24). There was no evidence of increased risk for other AEs following routine vaccination in HIV-infected adults. CONCLUSIONS: Routinely administered vaccines are generally safe for HIV-infected adults. CI - Copyright (c) 2019 Elsevier Ltd. All rights reserved. FAU - Hechter, Rulin C AU - Hechter RC AD - Kaiser Permanente Southern California, USA. Electronic address: Rulin.C.Hechter@kp.org. FAU - Qian, Lei AU - Qian L AD - Kaiser Permanente Southern California, USA. Electronic address: Lei.X.Qian@kp.org. FAU - Tartof, Sara Y AU - Tartof SY AD - Kaiser Permanente Southern California, USA. Electronic address: Sara.Y.Tartof@kp.org. FAU - Sy, Lina S AU - Sy LS AD - Kaiser Permanente Southern California, USA. Electronic address: Lina.S.Sy@kp.org. FAU - Klein, Nicola P AU - Klein NP AD - Kaiser Permanente Northern California, USA. Electronic address: Nicola.Klein@kp.org. FAU - Weintraub, Eric AU - Weintraub E AD - Immunization Safety Office, Centers for Disease Control and Prevention, USA. Electronic address: eiw8@cdc.gov. FAU - Mercado, Cheryl AU - Mercado C AD - Kaiser Permanente Southern California, USA. Electronic address: Cheryl.M.Carlson@kp.org. FAU - Naleway, Allison AU - Naleway A AD - Kaiser Permanente Northwest, USA. Electronic address: Allison.Naleway@kpchr.org. FAU - McLean, Huong Q AU - McLean HQ AD - Marshfield Clinic Research Institute, USA. Electronic address: mclean.huong@marshfieldresearch.org. FAU - Jacobsen, Steven J AU - Jacobsen SJ AD - Kaiser Permanente Southern California, USA. Electronic address: Steven.J.Jacobsen@kp.org. LA - eng GR - CC999999/ImCDC/Intramural CDC HHS/United States PT - Journal Article PT - Multicenter Study PT - Research Support, U.S. Gov't, P.H.S. DEP - 20190504 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Influenza Vaccines) RN - 0 (Vaccines) RN - 0 (Vaccines, Combined) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Cerebrovascular Disorders/etiology MH - Electronic Health Records MH - Female MH - HIV Infections/complications/*immunology MH - Humans MH - Immunization Schedule MH - Influenza Vaccines/adverse effects MH - Male MH - Middle Aged MH - Retrospective Studies MH - Stroke/etiology MH - United States MH - Vaccination/*adverse effects/*statistics & numerical data MH - Vaccines/*adverse effects MH - Vaccines, Combined/adverse effects MH - Vaccines, Inactivated/administration & dosage/adverse effects MH - Viral Load MH - Young Adult PMC - PMC6538462 MID - NIHMS1029007 OTO - NOTNLM OT - HIV OT - Vaccine Safety Datalink OT - Vaccine safety COIS- Conflicts of interest disclosures Hechter has received research support from Novartis and GSK for unrelated studies. Tartof has received research support from GSK and Merck for unrelated studies. Sy has received research support from Novartis, GlaxoSmithKline, Novavax, and Dynavax. Klein has received research support from Merck, Pfizer, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), GSK, MedImmune, and Dynavax. Mercado and Jacobsen have received research support from Dynavax. Naleway has received research support from Pfizer and Merck for unrelated studies. Qian, McLean, and Weintraub report no conflict of interest. EDAT- 2019/05/09 06:00 MHDA- 2020/09/29 06:00 PMCR- 2019/06/30 CRDT- 2019/05/09 06:00 PHST- 2019/01/16 00:00 [received] PHST- 2019/04/22 00:00 [revised] PHST- 2019/04/25 00:00 [accepted] PHST- 2019/05/09 06:00 [pubmed] PHST- 2020/09/29 06:00 [medline] PHST- 2019/05/09 06:00 [entrez] PHST- 2019/06/30 00:00 [pmc-release] AID - S0264-410X(19)30568-7 [pii] AID - 10.1016/j.vaccine.2019.04.080 [doi] PST - ppublish SO - Vaccine. 2019 May 31;37(25):3296-3302. doi: 10.1016/j.vaccine.2019.04.080. Epub 2019 May 4.