Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
Records 1-12 (of 12 Records) |
Query Trace: Hibbs BF [original query] |
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Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017
Hibbs BF , Ng CS , Museru O , Moro PL , Marquez P , Woo EJ , Cano MV , Shimabukuro TT . Vaccine 2019 38 (5) 1137-1143 BACKGROUND: Vaccines administered into or too close to underlying joint structures have the potential to cause shoulder injuries. Limited data exist on the epidemiology of such events. OBJECTIVE: To describe case reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine (IIV). METHODS: We searched the Vaccine Adverse Event Reporting System (VAERS) database from July 2010 to June 2017 for reports of atypical shoulder pain and dysfunction following IIV. When identifying reports, we made no assumptions about true incident injury or causality with respect to vaccination. Pain had to begin <48 h after vaccination and signs and symptoms had to continue for >7 days to differentiate from self-limited local reactions. We conducted descriptive analysis. RESULTS: We identified 1220 reports that met our case definition (2.0% of all IIV reports, range 1.5%-2.5% across influenza seasons). Median age was 52 years (range 16-94) and most patients (82.6%) were female. Shoulder pain (44.1%), injected limb mobility decreased (40.8%), joint range of motion decreased (21.2%), rotator cuff syndrome (9.2%), and bursitis (9.0%) were frequently reported. In 86.6% of reports, signs and symptoms had not resolved by the time of report submission. In reports that included descriptions suggesting contributing factors (n = 266), vaccination given "too high" on the arm was cited in 81.2%. Nearly half (n = 605, 49.6%) of reports described a healthcare provider evaluation. Treatments included non-narcotic analgesics, physical therapy, and corticosteroid injection. Vaccinations were most commonly administered in a pharmacy or retail store (41.0%) or doctor's office or hospital (31.6%). CONCLUSIONS: Reports of atypical shoulder pain and dysfunction following IIV were uncommon, considering the amount of IIV use, and stable across influenza seasons. While specific etiology of cases is unknown, improperly administered vaccine, which is preventable, might be a factor. Prevention strategies include education, training, and adherence to best practices for vaccine administration. |
Shoulder injury related to vaccine administration (SIRVA): Petitioner claims to the National Vaccine Injury Compensation Program, 2010-2016
Hesse EM , Atanasoff S , Hibbs BF , Adegoke OJ , Ng C , Marquez P , Osborn M , Su JR , Moro PL , Shimabukuro T , Nair N . Vaccine 2019 38 (5) 1076-1083 BACKGROUND: Since 2010, petitioner claims of shoulder injury related to vaccine administration (SIRVA) to the National Vaccine Injury Compensation Program (VICP) have been increasing. OBJECTIVE: To conduct a scientific review of clinical characteristics of SIRVA petitions to the VICP. METHODS: We queried the VICP's Injury Compensation System database for medical reports of alleged SIRVA and SIRVA-like injuries. Medical reports are summaries of petitioner claims and supporting documentation along with a VICP clinician reviewer diagnosis and assessment of criteria for concession. We conducted a descriptive analysis of SIRVA petitioner claims recommended by the VICP for concession as SIRVA injuries. RESULTS: We identified 476 petitioner claims recommended for concession. Claims per year increased from two in 2011, the first full year in the analytic period, to 227 in 2016. Median age was 51 years, 82.8% were women, and median body mass index was 25.1 (range 17.0-48.9). Four hundred cases (84.0%) involved influenza vaccine. Pharmacy or store (n = 168; 35.3%) was the most common place of vaccination followed by doctor's office (n = 147; 30.9%). Fewer than half of cases reported a suspected administration error; 172 (36.1%) reported 'injection too high' on the arm. Shoulder pain, rotator cuff problems, and bursitis were common initial diagnoses. Most (80.0%) cases received physical or occupational therapy, 60.1% had at least one steroid injection, and 32.6% had surgery. Most (71.9%) healthcare providers who gave opinions on causality considered the injury was caused by vaccination. A minority (24.3%) of cases indicated that symptoms had resolved by the last visit available in medical records. CONCLUSIONS: Most conceded claims for SIRVA were in women and involved influenza vaccines. Injection too high on the arm could be a factor due to the risk of injecting into underlying non-muscular tissues. Healthcare providers should be aware of proper injection technique and anatomical landmarks when administering vaccines. |
Notes from the field: Administration of expired injectable influenza vaccines reported to the Vaccine Adverse Event Reporting System - United States, July 2018-March 2019
Hesse EM , Hibbs BF , Cano MV . MMWR Morb Mortal Wkly Rep 2019 68 (23) 529-530 Influenza vaccination is recommended annually for persons aged ≥6 months for the prevention and control of influenza (1). Every year, injectable inactivated influenza vaccine (IIV) has a standard expiration date of June 30 for the upcoming influenza season (i.e., July 1–June 30 of the following year). Vaccination with an expired influenza vaccine might not protect against influenza infection because different influenza virus strains can be included in the vaccine each year; in addition, protection against viruses included in the vaccine could wane if vaccine potency decreases over time. During July 11, 2018–March 29, 2019 in the United States, the Vaccine Adverse Event Reporting System (VAERS) received 125 reports of 192 patients receiving expired IIV during the 2018–19 influenza season (2), during which time 169.1 million doses of seasonal influenza vaccine were distributed (3). Dates of vaccination were documented for 102 patients and ranged from July 2, 2018, to January 16, 2019. The number of expired vaccine doses administered increased in September and decreased after October, coinciding with dates when influenza vaccine is typically given (Figure). Ages were available for 103 vaccine recipients. Seventy-three recipients (70.1%) were identified as being in high-risk age groups for influenza; eight were aged <5 years, and 65 were aged >50 years (1). An additional six reports specified that the patient had been pregnant at time of vaccination; pregnancy outcomes were not reported. Adverse events after the administration of an expired IIV were rarely reported (four of 125 reports; 3.2%). None were serious, and adverse events were consistent with adverse events for seasonal IIV. |
Is there any harm in administering extra-doses of vaccine to a person Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007-2017
Moro PL , Arana J , Marquez PL , Ng C , Barash F , Hibbs BF , Cano M . Vaccine 2019 37 (28) 3730-3734 BACKGROUND: The administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine. OBJECTIVE: To assess for the presence of adverse events (AEs) most commonly reported following the administration of excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched VAERS for US reports where an excess dose of vaccine was administered to a person received from 1/1/2007 through 1/26/2018. We reviewed medical records for all serious reports and a random sample of non-serious reports. The most common AEs among reports of excess dose of vaccine administered were compared with the corresponding AEs for all vaccines reported to VAERS during the same period. RESULTS: Out of 366,815 total VAERS reports received, 5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did not describe an adverse health event (AHE). The most common vaccines reported were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only AHEs were reported, the most common were pyrexia (12.8%), injection site erythema (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs among these reports was comparable to all reports submitted to VAERS during the same study period. CONCLUSION: More than three-fourths of reports of an excess dose of vaccine did not describe an AHE. Among reports where an AHE event was reported, we did not observe any unexpected conditions or clustering of AEs. |
Postlicensure safety surveillance of recombinant Zoster vaccine (Shingrix) - United States, October 2017-June 2018
Hesse EM , Shimabukuro TT , Su JR , Hibbs BF , Dooling KL , Goud R , Lewis P , Ng CS , Cano MV . MMWR Morb Mortal Wkly Rep 2019 68 (4) 91-94 Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged >/=50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged >/=60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials. |
Notes from the field: Vaccine administration errors involving recombinant zoster vaccine - United States, 2017-2018
Shimabukuro TT , Miller ER , Strikas RA , Hibbs BF , Dooling K , Goud R , Cano MV . MMWR Morb Mortal Wkly Rep 2018 67 (20) 585-586 Two vaccines for the prevention of herpes zoster (shingles) are licensed for use in the United States and recommended by the Advisory Committee on Immunization Practices (ACIP). Zoster vaccine live (ZVL; Zostavax, Merck), licensed in 2006,* is a live attenuated virus vaccine administered as a single subcutaneous (SQ) dose. Although the Food and Drug Administration (FDA) approved ZVL for adults aged ≥50 years, ACIP recommends ZVL for immunocompetent adults aged ≥60 years (1). Recombinant zoster vaccine (RZV; Shingrix, GlaxoSmithKline), licensed October 2017,† is also approved by the FDA for adults aged ≥50 years and is recommended by ACIP for immunocompetent adults aged ≥50 years (2). RZV is administered as a 2-dose intramuscular (IM) series, with the second dose given anytime from 2 to 6 months after the first. RZV is preferentially recommended by ACIP over ZVL (2). Furthermore, ACIP recommends that persons previously vaccinated with ZVL receive the full 2-dose RZV series (2). |
Notes from the field: Errors in administration of an excess dosage of yellow fever vaccine - United States, 2017
McNeil MM , Hibbs BF , Miller ER , Cano MV . MMWR Morb Mortal Wkly Rep 2018 67 (3) 109-110 Yellow fever vaccine (YF-VAX, Sanofi Pasteur, Swiftwater, Pennsylvania) is a live, attenuated virus vaccine recommended for persons aged ≥9 months who are traveling to or living in areas with risk for yellow fever virus transmission (1). For persons of all ages for whom vaccination is indicated, a single subcutaneous injection of 0.5 mL of reconstituted vaccine is used. Because no specific treatment for yellow fever exists, prevention through vaccination is critical to reduce yellow fever–associated morbidity and mortality (2). YF-VAX is the only yellow fever vaccine licensed in the United States, and approximately 500,000 doses are distributed annually to vaccinate military and civilian travelers. Yellow fever vaccine is supplied only to designated Yellow Fever Vaccination Centers authorized to issue certificates of yellow fever vaccination. YF-VAX is available in single-dose and 5-dose vials. Single-dose vials of lyophilized (freeze-dried) vaccine are supplied in a package of five vials of vaccine (Figure); five vials of diluent are provided separately (each vial of diluent contains 0.6 mL sodium chloride for injection USP). Five-dose vials are supplied in a package containing one vial (Figure), and diluent is supplied separately in one vial containing 3 mL sodium chloride for injection USP. The manufacturer’s instructions specify that the vaccine is to be used within 60 minutes of reconstituting either the single-dose or the 5-dose vial. |
Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012
Hibbs BF , Miller E , Shi J , Smith K , Lewis P , Shimabukuro TT . Vaccine 2017 36 (4) 553-558 BACKGROUND: Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of recommended temperatures. OBJECTIVE: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) involving vaccines inappropriately stored outside of recommended temperatures and/or exposed to temperatures outside of manufacturer specifications for inappropriate amounts of time. METHODS: We searched the VAERS database (analytic period 2008-2012) for reports describing vaccines kept outside of recommended temperatures. We analyzed reports by vaccine type, length outside of recommended temperature and type of temperature excursion, AE following receipt of potentially compromised vaccine, and reasons for cold chain breakdown. RESULTS: We identified 476 reports of vaccines kept outside of recommended temperatures; 77% described cluster incidents involving multiple patients. The most commonly reported vaccines were quadrivalent human papillomavirus (n=146, 30%), 23-valent pneumococcal polysaccharide (n=51, 11%), and measles, mumps, and rubella (n=45, 9%). Length of time vaccines were kept outside of recommended temperatures ranged from 15mins to 6months (median 51h). Most (n=458, 96%) reports involved patients who were administered potentially compromised vaccines; AE were reported in 32 (7%), with local reactions (n=21) most frequent. Two reports described multiple patients contracting diseases they were vaccinated against, indicating possible influenza vaccine failure. Lack of vigilance, inadequate training, and equipment failure were reasons cited for cold chain management breakdowns. CONCLUSIONS: Our review does not indicate any substantial direct health risk from administration of vaccines kept outside of recommended temperatures. However, there are potential costs and risks, including vaccine wastage, possible decreased protection, and patient and parent inconvenience related to revaccination. Maintaining high vigilance, proper staff training, regular equipment maintenance, and having adequate auxiliary power are important components of comprehensive vaccine cold chain management. |
Cognitive testing to evaluate revisions to the Vaccine Adverse Event Reporting System (VAERS) reporting form
Suragh TA , Miller ER , Hibbs BF , Winiecki SK , Zinderman C , Shimabukuro TT . Vaccine 2017 35 (18) 2295-2297 INTRODUCTION: The Vaccine Adverse Event Reporting System (VAERS) is the spontaneous (passive) reporting system CDC and FDA use to monitor vaccine safety. We used cognitive testing to evaluate proposed revisions to the current VAERS form. METHODS: We conducted in-person cognitive interviews with 22 volunteers to evaluate proposed revisions in a prototype VAERS 2.0 form (new VAERS form). We analyzed data using thematic analysis. RESULTS: Repeating themes included preferences for: brevity, simplicity and clarity; features to minimize time requirements and facilitate ease of completion; logical ordering of questions by topic and importance; and visual cues like color-coded highlighting. Interviews identified instances of discordance between the intended meaning questions (from the perspective of CDC and FDA) and interpretation by volunteers. CONCLUSIONS: Cognitive testing yielded useful information to guide further revisions of the VAERS form. Cognitive testing can be an effective tool for public health programs interested in developing surveys and reporting forms. |
Vaccine safety resources for nurses
Miller ER , Shimabukuro TT , Hibbs BF , Moro PL , Broder KR , Vellozzi C . Am J Nurs 2015 115 (8) 55-8 Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention's (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. |
Vaccination errors reported to the Vaccine Adverse Event Reporting System, United States, 2000-2013
Hibbs BF , Moro PL , Lewis P , Miller ER , Shimabukuro T . Vaccine 2015 33 (28) 3171-8 IMPORTANCE: Vaccination errors are preventable events. Errors can have impacts including inadequate immunological protection, possible injury, cost, inconvenience, and reduced confidence in the healthcare delivery system. OBJECTIVES: To describe vaccination error reports submitted to the vaccine adverse event reporting system (VAERS) and identify opportunities for prevention. METHODS: We conducted descriptive analyses using data from VAERS, the U.S. spontaneous surveillance system for adverse events following immunization. The VAERS database was searched from 2000 through 2013 for U.S. reports describing vaccination errors and categorized reports into 11 error groups. We analyzed numbers and types of vaccination error reports, vaccines involved, reporting trends over time, and descriptions of errors for selected reports. RESULTS: We identified 20,585 vaccination error reports documenting 21,843 errors. Annual reports increased from 10 in 2000 to 4324 in 2013. The most common error group was "Inappropriate Schedule" (5947; 27%); human papillomavirus (quadrivalent) (1516) and rotavirus (880) vaccines were most frequently involved. "Storage and Dispensing" errors (4983; 23%) included mostly expired vaccine administered (2746) and incorrect storage of vaccine (2202). "Wrong Vaccine Administered" errors (3372; 15%) included mix-ups between vaccines with similar antigens such as varicella/herpes zoster (shingles), DTaP/Tdap, and pneumococcal conjugate/polysaccharide. For error reports with an adverse health event (5204; 25% of total), 92% were classified as non-serious. We also identified 936 vaccination error clusters (i.e., same error, multiple patients, in a common setting) involving over 6141 patients. The most common error in clusters was incorrect storage of vaccine (582 clusters and more than 1715 patients). CONCLUSIONS: Vaccination error reports to VAERS have increased substantially. Contributing factors might include changes in reporting practices, increasing complexity of the immunization schedule, availability of products with similar sounding names or acronyms, and increased attention to storage and temperature lapses. Prevention strategies should be considered. |
Notes from the field: rotavirus vaccine administration errors - United States, 2006-2013
Hibbs BF , Miller ER , Shimabukuro T . MMWR Morb Mortal Wkly Rep 2014 63 (4) 81 Two live rotavirus oral vaccines, RotaTeq (RV5) (Merck & Co., Inc.) and Rotarix (RV1) (GlaxoSmithKline Biologicals), are approved for prevention of rotavirus gastroenteritis and recommended at ages 2, 4 (RV5/RV1), and 6 (RV5) months by the Advisory Committee on Immunization Practices. Because most childhood vaccines are injectable, vaccination providers might have less experience administering oral vaccines. To assess that hypothesis, CDC searched for reports to the Vaccine Adverse Event Reporting System (VAERS) of rotavirus vaccine administration errors involving injection and eye splashes in the United States during the period January 1, 2006-August 1, 2013. A total of 66 reports were found. |
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