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  • American Academy of Pediatrics (AAP)  (4)
  • Nelson, Jennifer C.  (4)
  • 1
    Online Resource
    Online Resource
    Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine
    American Academy of Pediatrics (AAP) ; 2019
    In:  Pediatrics Vol. 144, No. 6 ( 2019-12-01)
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 144, No. 6 ( 2019-12-01)
    Abstract: Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink. METHODS: Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses. RESULTS: During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events. CONCLUSIONS: After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.2019-1808
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2019
    detail.hit.zdb_id: 1477004-0
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  • 2
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    Injection Site and Risk of Medically Attended Local Reactions to Acellular Pertussis Vaccine
    American Academy of Pediatrics (AAP) ; 2011
    In:  Pediatrics Vol. 127, No. 3 ( 2011-03-01), p. e581-e587
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 127, No. 3 ( 2011-03-01), p. e581-e587
    Abstract: To assess whether the risk of medically attended local reactions to the fifth dose of the diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine varies according to injection site (arm versus thigh). METHODS: We conducted a retrospective cohort study of children aged 4 through 6 years in the Vaccine Safety Datalink population who received a DTaP vaccination during the period from 2002 through 2006. Medically attended local reactions to the DTaP vaccine were presumptively identified from administrative data and were confirmed by medical record review. RESULTS: Among the 233 616 children in the study population, 1017 (0.4%) had a confirmed medically attended local reaction to the fifth dose of the DTaP vaccine. The rate of those reactions was significantly higher with vaccinations given in the arm (47.4 per 10 000 vaccinations) compared with vaccinations given in the thigh (32.1 per 10 000 vaccinations) (P & lt; .001). In a multivariable analysis adjusted for age, gender, and study site, children vaccinated in the arm had a 78% higher risk of a local reaction (relative risk: 1.78 [95% confidence interval: 1.43–2.21]). CONCLUSIONS: Local reactions to the fifth dose of the DTaP vaccine that require medical evaluation are uncommon, but the risk of those reactions is significantly higher when the vaccine is injected in the arm. These findings suggest that the thigh should be considered as an acceptable site of injection for this vaccination.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.2010-1886
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2011
    detail.hit.zdb_id: 1477004-0
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  • 3
    Online Resource
    Online Resource
    Vaccination Site and Risk of Local Reactions in Children 1 Through 6 Years of Age
    American Academy of Pediatrics (AAP) ; 2013
    In:  Pediatrics Vol. 131, No. 2 ( 2013-02-01), p. 283-289
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 131, No. 2 ( 2013-02-01), p. 283-289
    Abstract: Our objective was to assess whether the occurrence of medically attended local reactions to intramuscularly administered vaccines varies by injection site (arm versus thigh) in children 1 to 6 years of age. METHODS: This is a retrospective cohort study of children in the Vaccine Safety Datalink population from 2002 to 2009. Site of injection and the outcome of medically attended local reactions were identified from administrative data. RESULTS: The study cohort of 1.4 million children received 6.0 million intramuscular (IM) vaccines during the study period. The primary analyses evaluated the IM vaccines most commonly administered alone, which included inactivated influenza, hepatitis A, and diphtheria-tetanus-acellular pertussis (DTaP) vaccines. For inactivated influenza and hepatitis A vaccines, local reactions were relatively uncommon, and there was no difference in risk of these events with arm versus thigh injections. The rate of local reactions after DTaP vaccines was higher, and vaccination in the arm was associated with a significantly greater risk of this outcome compared with vaccination in the thigh, both for children 12 to 35 months (relative risk: 1.88 [95% confidence interval: 1.34–2.65]) and 3 to 6 years of age (relative risk: 1.41 [95% confidence interval: 0.84–2.34] ), although this difference was not statistically significant in the older age group. CONCLUSIONS: Injection in the thigh is associated with a significantly lower risk of a medically attended local reaction to a DTaP vaccination among children 12 to 35 months of age, supporting current recommendations to administer IM vaccinations in the thigh for children younger than 3 years of age.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.2012-2617
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2013
    detail.hit.zdb_id: 1477004-0
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  • 4
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    Online Resource
    Prophylaxis With Acetaminophen or Ibuprofen for Prevention of Local Reactions to the Fifth Diphtheria-Tetanus Toxoids-Acellular Pertussis Vaccination: A Randomized, Controlled Trial
    American Academy of Pediatrics (AAP) ; 2006
    In:  Pediatrics Vol. 117, No. 3 ( 2006-03-01), p. 620-625
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 117, No. 3 ( 2006-03-01), p. 620-625
    Abstract: BACKGROUND. The frequency of local vaccination reactions increases with successive doses of diphtheria-tetanus toxoids-acellular pertussis (DTaP) vaccine, and local reactions occur for the majority of children receiving the fifth DTaP vaccination. It is not known whether these reactions can be prevented with prophylactic use of acetaminophen or ibuprofen. METHODS. In this 3-group, randomized, blinded, controlled trial, 372 children were assigned randomly, in a 2:2:1 ratio, to receive 3 doses of acetaminophen, ibuprofen, or placebo. The first dose of study medication was administered within 2 hours before the fifth DTaP vaccination, and the remaining 2 doses were given at 6-hour intervals. The primary outcome measures included a local reaction with an area of redness or discoloration ≥5 cm in diameter on the evening of or during the 2 days after vaccination, an increase in mid-limb circumference of ≥2 cm on the evening of or during the 2 days after vaccination, and a persistent local reaction, defined as an area of redness or discoloration present on the third day after vaccination. RESULTS. Local reactions with a ≥5-cm area of redness or discoloration were reported for 35% of children in the placebo group, compared with 33% of children in the acetaminophen group and 37% of children in the ibuprofen group. There was also no significant difference between the placebo and treatment groups in the proportions of children with a ≥2-cm increase in mid-limb circumference or with a persistent local reaction. CONCLUSIONS. We did not find evidence that prophylaxis with acetaminophen or ibuprofen offers a clinically significant benefit in prevention of local reactions to the fifth DTaP vaccination.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.2005-1217
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2006
    detail.hit.zdb_id: 1477004-0
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