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Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.
Malden, Deborah E; Gee, Julianne; Glenn, Sungching; Li, Zhuoxin; Mercado, Cheryl; Ogun, Oluwaseye A; Kim, Sunhea; Lewin, Bruno J; Ackerson, Bradley K; Jazwa, Amelia; Weintraub, Eric S; McNeil, Michael M; Tartof, Sara Y.
  • Malden DE; Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA, USA; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA. Electronic address: debbie.e.malden@kp.org.
  • Gee J; Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Glenn S; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
  • Li Z; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
  • Mercado C; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
  • Ogun OA; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
  • Kim S; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
  • Lewin BJ; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA; Kaiser Permanente Bernard J. Tyson School of Medicine, CA, USA.
  • Ackerson BK; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
  • Jazwa A; Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Weintraub ES; Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • McNeil MM; Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Tartof SY; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA; Kaiser Permanente Bernard J. Tyson School of Medicine, CA, USA.
Vaccine ; 2022 Nov 03.
Article in English | MEDLINE | ID: covidwho-2232916
ABSTRACT

BACKGROUND:

Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety.

METHODS:

We conducted an observational study using data from a digital survey and EHR of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 mRNA vaccine across Kaiser Permanente Southern California during November 4, 2021-February 28, 2022. Parents/guardians who enrolled their children were sent a 14-day survey on reactions. Survey results were combined with EHR, and medical encounters were described for children whose parents or guardians indicated seeking medical care for vaccine-related symptoms. This study describes self-reported reactions (local and systemic) and additional symptoms (chest pain, tachycardia, and pre-syncope).

RESULTS:

The study recruited 7,077 participants aged 5-11 years who received the Pfizer-BioNTech COVID-19 mRNA vaccine. Of 6,247 participants with survey responses after dose 1, 2,176 (35 %) reported at least one systemic reaction, and 1,076 (32 %) of 3,401 respondents following dose 2 reported at least one systemic reaction. Local reactions were reported less frequently following dose 2 (1,113, 33 %) than dose 1 (3,140, 50 %). The most frequently reported reactions after dose 1 were pain at the injection site (48 %), fatigue (20 %), headache (12 %), myalgia (9 %) and fever (5 %). The most frequently reported symptoms after dose 2 were also pain at the injection site (30 %), fatigue (19 %), headache (13 %), myalgia (10 %) and fever (9 %). Post-vaccination reactions occurred most frequently-one day following vaccination. Chest pain or tachycardia were reported infrequently (1 %). EHR demonstrated that parents rarely sought care for post-vaccination symptoms, and among those seeking care, the most common symptoms documented in EHR were fever and nausea, comprising<0.5 % of children. No encounters were related to myocarditis.

CONCLUSION:

While post-vaccination reactions to the Pfizer-BioNTech COVID-19 mRNA vaccine were common in children aged 5-11 years, our data showed that in most cases they were transient and did not require medical care.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Observational study / Prognostic study Topics: Vaccines Language: English Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Observational study / Prognostic study Topics: Vaccines Language: English Year: 2022 Document Type: Article