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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| Veröffentlicht in: | Vaccine 2023-01, Vol.41 (2), p.315-322 |
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| creator | 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. |
| description | 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 |
| doi_str_mv | 10.1016/j.vaccine.2022.10.079 |
| format | Article |
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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 <0.5 % of children. No encounters were related to myocarditis.
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.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2022.10.079</identifier><identifier>PMID: 36351861</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adverse events ; BNT162 Vaccine ; California ; Chest ; Chest Pain ; Child ; Children ; Consent ; Coronaviruses ; COVID-19 ; COVID-19 infection ; 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 ; injection site ; Medical laboratories ; mRNA ; mRNA vaccines ; Myalgia ; Myocarditis ; nausea ; Observational studies ; Pain ; Parents ; Parents & parenting ; Polls & surveys ; Population ; RNA, Messenger ; Self report ; Severe acute respiratory syndrome coronavirus 2 ; Surveillance ; Surveys ; Syncope ; Tachycardia ; telemedicine ; Text messaging ; Vaccination ; Vaccination - adverse effects ; Vaccine safety ; Vaccines</subject><ispartof>Vaccine, 2023-01, Vol.41 (2), p.315-322</ispartof><rights>2022</rights><rights>Published by Elsevier Ltd.</rights><rights>Copyright Elsevier Limited Jan 9, 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c528t-2c7141bc7fcf0edd4efdb6f85c23dbd607f448ef34288015aaeec18b06074903</citedby><cites>FETCH-LOGICAL-c528t-2c7141bc7fcf0edd4efdb6f85c23dbd607f448ef34288015aaeec18b06074903</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X22013615$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36351861$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Malden, Deborah E.</creatorcontrib><creatorcontrib>Gee, Julianne</creatorcontrib><creatorcontrib>Glenn, Sungching</creatorcontrib><creatorcontrib>Li, Zhuoxin</creatorcontrib><creatorcontrib>Mercado, Cheryl</creatorcontrib><creatorcontrib>Ogun, Oluwaseye A.</creatorcontrib><creatorcontrib>Kim, Sunhea</creatorcontrib><creatorcontrib>Lewin, Bruno J.</creatorcontrib><creatorcontrib>Ackerson, Bradley K.</creatorcontrib><creatorcontrib>Jazwa, Amelia</creatorcontrib><creatorcontrib>Weintraub, Eric S.</creatorcontrib><creatorcontrib>McNeil, Michael M.</creatorcontrib><creatorcontrib>Tartof, Sara Y.</creatorcontrib><title>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</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>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 <0.5 % of children. No encounters were related to myocarditis.
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.</description><subject>Adverse events</subject><subject>BNT162 Vaccine</subject><subject>California</subject><subject>Chest</subject><subject>Chest Pain</subject><subject>Child</subject><subject>Children</subject><subject>Consent</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 infection</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Delivery of Health Care, Integrated</subject><subject>Disease control</subject><subject>Electronic health records</subject><subject>Electronic medical records</subject><subject>Emergency medical care</subject><subject>Ethnicity</subject><subject>Fatigue</subject><subject>Fever</subject><subject>Headache</subject><subject>Health care</subject><subject>Health services</subject><subject>Health services utilization</subject><subject>Heart diseases</subject><subject>Humans</subject><subject>Immunization</subject><subject>Infections</subject><subject>Injection</subject><subject>injection site</subject><subject>Medical laboratories</subject><subject>mRNA</subject><subject>mRNA vaccines</subject><subject>Myalgia</subject><subject>Myocarditis</subject><subject>nausea</subject><subject>Observational studies</subject><subject>Pain</subject><subject>Parents</subject><subject>Parents & parenting</subject><subject>Polls & surveys</subject><subject>Population</subject><subject>RNA, Messenger</subject><subject>Self report</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Surveillance</subject><subject>Surveys</subject><subject>Syncope</subject><subject>Tachycardia</subject><subject>telemedicine</subject><subject>Text messaging</subject><subject>Vaccination</subject><subject>Vaccination - 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adverse effects</topic><topic>Delivery of Health Care, Integrated</topic><topic>Disease control</topic><topic>Electronic health records</topic><topic>Electronic medical records</topic><topic>Emergency medical care</topic><topic>Ethnicity</topic><topic>Fatigue</topic><topic>Fever</topic><topic>Headache</topic><topic>Health care</topic><topic>Health services</topic><topic>Health services utilization</topic><topic>Heart diseases</topic><topic>Humans</topic><topic>Immunization</topic><topic>Infections</topic><topic>Injection</topic><topic>injection site</topic><topic>Medical laboratories</topic><topic>mRNA</topic><topic>mRNA vaccines</topic><topic>Myalgia</topic><topic>Myocarditis</topic><topic>nausea</topic><topic>Observational studies</topic><topic>Pain</topic><topic>Parents</topic><topic>Parents & parenting</topic><topic>Polls & surveys</topic><topic>Population</topic><topic>RNA, Messenger</topic><topic>Self report</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Surveillance</topic><topic>Surveys</topic><topic>Syncope</topic><topic>Tachycardia</topic><topic>telemedicine</topic><topic>Text messaging</topic><topic>Vaccination</topic><topic>Vaccination - 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Academic</collection><collection>AGRICOLA</collection><collection>AGRICOLA - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Malden, Deborah E.</au><au>Gee, Julianne</au><au>Glenn, Sungching</au><au>Li, Zhuoxin</au><au>Mercado, Cheryl</au><au>Ogun, Oluwaseye A.</au><au>Kim, Sunhea</au><au>Lewin, Bruno J.</au><au>Ackerson, Bradley K.</au><au>Jazwa, Amelia</au><au>Weintraub, Eric S.</au><au>McNeil, Michael M.</au><au>Tartof, Sara Y.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2023-01-09</date><risdate>2023</risdate><volume>41</volume><issue>2</issue><spage>315</spage><epage>322</epage><pages>315-322</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>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 <0.5 % of children. No encounters were related to myocarditis.
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.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>36351861</pmid><doi>10.1016/j.vaccine.2022.10.079</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2023-01, Vol.41 (2), p.315-322 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9630154 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adverse events BNT162 Vaccine California Chest Chest Pain Child Children Consent Coronaviruses COVID-19 COVID-19 infection 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 injection site Medical laboratories mRNA mRNA vaccines Myalgia Myocarditis nausea Observational studies Pain Parents Parents & parenting Polls & surveys Population RNA, Messenger Self report Severe acute respiratory syndrome coronavirus 2 Surveillance Surveys Syncope Tachycardia telemedicine Text messaging Vaccination Vaccination - adverse effects Vaccine safety Vaccines |
| title | 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 |
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