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

Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety. We conducted an observational study using data from a digital survey and EHR of children aged 5–11 years vaccinated with Pfizer-BioNTech COVID-...

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Bibliographic Details
Published in:Vaccine 2023-01, Vol.41 (2), p.315-322
Main Authors: 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.
Format: Article
Language:English
Subjects:
Adverse events
BNT162 Vaccine
Chest
Chest Pain
Child
Children
Consent
Coronaviruses
COVID-19
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Delivery of Health Care, Integrated
Disease control
Electronic health records
Electronic medical records
Emergency medical care
Ethnicity
Fatigue
Fever
Headache
Health care
Health services
Health services utilization
Heart diseases
Humans
Immunization
Infections
Injection
Medical laboratories
mRNA
mRNA vaccines
Myalgia
Myocarditis
Pain
Parents
Parents & parenting
Polls & surveys
Population
RNA, Messenger
Self report
Severe acute respiratory syndrome coronavirus 2
Surveillance
Surveys
Syncope
Tachycardia
Text messaging
Vaccination
Vaccination - adverse effects
Vaccine safety
Vaccines
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Summary:Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety. 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). 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
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2022.10.079