First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021
Open accessAbstract
The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.
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The favorable safety profile of BNT162b2 seen in adults in the pivotal trial and through pharmacovigilance was also observed in 12-to-15-year-old recipients.
“The favorable safety profile of BNT162b2, which was seen in adults in the pivotal trial and through ongoing pharmacovigilance after vaccine introduction, was also observed in 12-to-15-year-old recipients.5,23”
From Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents (2021) · cites this paper as [23]
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Cites
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)
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Self-citationRisk of anaphylaxis after vaccination in children and adults.
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Development and Validation of the Nursing Home Minimum Data Set 3.0 Mortality Risk Score (MRS3)
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Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents
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Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women
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- Authors
- Gee, J., Marquez, P., Su, J., Calvert, G. M., Liu, R., Myers, T., Nair, N., Martin, S., Clark, T., Markowitz, L., Lindsey, N., Zhang, B., Licata, C., Jazwa, A., Sotir, M., & Shimabukuro, T.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Gee, Julianne
- ORCID
- Venue
- MMWR. Morbidity and Mortality Weekly Report
- Published
- 2021-02-26
- Volume
- 70
- Issue
- 8
- Pages
- 283-288
- ISSN
- 0149-2195 (ISSN-L)
- 1545-861X
- PMC
- PMC8344985
- OpenAlex
- W3130815000
- Cited by
- 395
- References
- 7
- Citations by year
- 2026: 9 · 2025: 23 · 2024: 31 · 2023: 73 · 2022: 120 · 2021: 137
- FWCI
- 28.58
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- MMWR Morbidity and Mortality Weekly Report (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- COVID-19 vaccines, vaccine safety, vaccine adverse events, VAERS, anaphylaxis, BNT162b2, Moderna vaccine, long-term care residents, vaccine side effects
- MeSH terms
- COVID-19 Vaccines, Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, United States, Adverse Drug Reaction Reporting Systems, Young Adult
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