tetano
Editor, Senior Moderator
Vaccine
. 2023 Jan 9;S0264-410X(23)00016-6.
doi: 10.1016/j.vaccine.2022.12.069. Online ahead of print.
Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021-June 30, 2022
Pedro L Moro[SUP] 1 [/SUP], Bicheng Zhang[SUP] 2 [/SUP], Carol Ennulat[SUP] 2 [/SUP], Margaret Harris[SUP] 2 [/SUP], Rachel McVey[SUP] 2 [/SUP], Gina Woody[SUP] 2 [/SUP], Paige Marquez[SUP] 2 [/SUP], Michael M McNeil[SUP] 2 [/SUP], John R Su[SUP] 2 [/SUP]
Affiliations
Abstract
Background: COVID-19 vaccines may be co-administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.
Objective: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of mRNA COVID-19 and seasonal influenza vaccines.
Methods: We searched the VAERS database for reports of adverse events (AEs) following co-administration of mRNA COVID-19 and seasonal influenza vaccines and following a first booster dose mRNA COVID-19 vaccine alone, during July 1, 2021-June 30, 2022. We assessed the characteristics of these reports and described the most frequently reported MedDRA preferred terms (PTs). Clinicians reviewed available medical records for serious reports and reports of adverse events of special interest (AESI) and categorized the main diagnosis by system organ class.
Results: From July 1, 2021 through June 30, 2022, VAERS received 2,449 reports of adverse events following co-administration of mRNA COVID-19 and seasonal influenza vaccines. Median age of vaccinees was 48 years (IQR: 31, 66); 387 (15.8%) were classified as serious. Most reports (1,713; 69.3%) described co-administration of a first booster dose of an mRNA COVID-19 vaccine with seasonal influenza vaccine. The most common AEs among non-serious reports were injection site reactions (193; 14.5%), headache (181; 13.6%), and pain (171; 12.8%). The most common AEs among reports classified as serious were dyspnea (38; 14.9%), COVID-19 infection (32; 12.6%), and chest pain (27; 10.6%).
Discussion: This review of reports to VAERS following co-administration of mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19 disease) was expected. CDC will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines, including co-administration involving bivalent mRNA COVID-19 booster vaccines that have been recommended for people ages ≥ 6 months in the United States.
Keywords: Adverse events; COVID-19; Co-administration; Coronavirus; Epidemiology; Influenza vaccines; SARS-CoV-2; Surveillance; Vaccine safety; mRNA vaccines.
. 2023 Jan 9;S0264-410X(23)00016-6.
doi: 10.1016/j.vaccine.2022.12.069. Online ahead of print.
Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021-June 30, 2022
Pedro L Moro[SUP] 1 [/SUP], Bicheng Zhang[SUP] 2 [/SUP], Carol Ennulat[SUP] 2 [/SUP], Margaret Harris[SUP] 2 [/SUP], Rachel McVey[SUP] 2 [/SUP], Gina Woody[SUP] 2 [/SUP], Paige Marquez[SUP] 2 [/SUP], Michael M McNeil[SUP] 2 [/SUP], John R Su[SUP] 2 [/SUP]
Affiliations
- PMID: 36669964
- DOI: 10.1016/j.vaccine.2022.12.069
Abstract
Background: COVID-19 vaccines may be co-administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.
Objective: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of mRNA COVID-19 and seasonal influenza vaccines.
Methods: We searched the VAERS database for reports of adverse events (AEs) following co-administration of mRNA COVID-19 and seasonal influenza vaccines and following a first booster dose mRNA COVID-19 vaccine alone, during July 1, 2021-June 30, 2022. We assessed the characteristics of these reports and described the most frequently reported MedDRA preferred terms (PTs). Clinicians reviewed available medical records for serious reports and reports of adverse events of special interest (AESI) and categorized the main diagnosis by system organ class.
Results: From July 1, 2021 through June 30, 2022, VAERS received 2,449 reports of adverse events following co-administration of mRNA COVID-19 and seasonal influenza vaccines. Median age of vaccinees was 48 years (IQR: 31, 66); 387 (15.8%) were classified as serious. Most reports (1,713; 69.3%) described co-administration of a first booster dose of an mRNA COVID-19 vaccine with seasonal influenza vaccine. The most common AEs among non-serious reports were injection site reactions (193; 14.5%), headache (181; 13.6%), and pain (171; 12.8%). The most common AEs among reports classified as serious were dyspnea (38; 14.9%), COVID-19 infection (32; 12.6%), and chest pain (27; 10.6%).
Discussion: This review of reports to VAERS following co-administration of mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19 disease) was expected. CDC will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines, including co-administration involving bivalent mRNA COVID-19 booster vaccines that have been recommended for people ages ≥ 6 months in the United States.
Keywords: Adverse events; COVID-19; Co-administration; Coronavirus; Epidemiology; Influenza vaccines; SARS-CoV-2; Surveillance; Vaccine safety; mRNA vaccines.