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, Epidemiology, Coronavirus, Co-administration, COVID-19, mRNA vaccines, SARS-CoV-2, Influenza vaccines, Surveillance, Vaccine safety
1. Introduction
The first COVID-19 vaccines authorized for use in the United States were messenger RNA (mRNA)-based vaccines, BNT162b2 from Pfizer Inc/BioNTech and mRNA-1273 from Moderna [1], [2]. These vaccines have been authorized or licensed for use in persons aged 6 months or older [3]. On August 31, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to include bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination [4]. On October 12, 2022, the Centers for Disease Control and Prevention (CDC) recommended use of bivalent boosters for children 5 through 11 years [5], [6]. ACIP also recommends that everyone aged 6 months and older receive an annual influenza vaccine [7]. COVID-19 vaccines may be administered without regard to the timing of other vaccines. This includes co-administration of a COVID-19 vaccine and other vaccines at the same healthcare visit [8]. Co-administration of recommended vaccines during the same healthcare visit increases the likelihood that people will be protected against vaccine-preventable diseases in a timely manner and improves efficiency in preventive healthcare services [8]. However, there are limited data on the safety of co-administration of mRNA COVID-19 and influenza vaccines [9]. In this study, we assessed the safety of the co-administration of the mRNA COVID-19 and seasonal influenza vaccines using data from the Vaccine Adverse Event Reporting System (VAERS).
2. Material and Methods
2.1. VAERS
VAERS is a U.S. national vaccine safety surveillance system created in 1990 and co-administered by the CDC and the FDA [9]. VAERS is a spontaneous reporting system that serves primarily for signal detection and hypothesis generation and generally cannot determine whether an AE is causally associated with vaccination [10]. VAERS accepts reports from healthcare providers, vaccine manufacturers, vaccine recipients, and other reporters. The VAERS report form collects information on sex, age, type of vaccine(s) administered, vaccine dose and lot number, the AE experienced, and medical history. Upon receipt, VAERS reports are coded by trained personnel using the Medical Dictionary for Regulatory Activities (MedDRA), a clinically validated, internationally standardized terminology [11]. A VAERS report may be assigned one or more MedDRA Preferred Terms (PTs) within a System Organ Class (SOC). A MedDRA PT is a distinct descriptor for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, surgical, or medical procedure, or medical, social, or family history characteristic [10]; however, MedDRA PTs are not necessarily medically confirmed diagnoses. Vaccination errors not describing an AE may also be reported [12]. Reporting requirements for reports after COVID-19 vaccines have been described [13]. A report is considered serious based on the Code of Federal Regulations (21-CFR) definition if one or more of the following are reported: death, life-threatening illness, hospitalization or prolongation of existing hospitalization, congenital anomaly, permanent disability, or medical intervention to prevent the aforementioned outcomes [12]. For non-manufacturer serious reports, medical records are routinely requested and made available to VAERS personnel; vaccine manufacturers are required to investigate serious AEs that they report to VAERS, and to submit additional information that they receive as part of their investigation. Medical records may also be requested for AEs of special interest (AESI), irrespective of the serious status. AESIs are AEs selected for further scrutiny, for reasons including their occurrence in pre-authorization clinical trials (or in post-marketing data), general historical interest (e.g., Guillain Barré syndrome (GBS)), or general interest applicable to any vaccine (e.g., anaphylaxis).
We searched the VAERS database for U.S. reports of co-administration of mRNA COVID-19 and seasonal influenza vaccines or for reports following administration of mRNA COVID-19 vaccine alone, among persons vaccinated during July 1, 2021–June 30, 2022. We assessed the characteristics of these reports, which included the types of influenza vaccines co-administered with a mRNA COVID-19 vaccine. To describe the most common MedDRA PTs by serious status, and by vaccine combination (either mRNA COVID-19 vaccine co-administered with quadrivalent inactivated influenza vaccine (IIV4), or first booster dose mRNA COVID-19 vaccine alone), we excluded cell-based quadrivalent influenza vaccine (ccIIV4), adjuvanted quadrivalent influenza vaccine (aIIV4), and recombinant quadrivalent influenza vaccine (RIV4). We excluded these vaccines, as they use technologies other than conventional growth in chicken eggs or include an adjuvant.
2.2. Clinical review of serious reports and adverse events of special interest (AESIs)
Clinicians reviewed reports after co-administration of mRNA COVID-19 and seasonal influenza vaccines that were AESI or that were classified as serious. Based upon the primary diagnosis (i.e., the event that appeared to trigger the reporter to report to VAERS), the reviewer categorized reports by SOC or diagnostic category [11]. For death reports, the primary cause of death was obtained from reviewing the autopsy report, death certificate, and/or available medical records; absent these documents, a preliminary impression of cause of death was made based upon the initial report.
We searched for and reviewed reports and any associated available medical records for the following AESIs: anaphylaxis, Bell’s palsy,GBS,and myocarditis. We used the Brighton Collaboration case definitions for anaphylaxis [14], Bell’s palsy [15], and GBS [16], and CDC case definitions for Multisystem Inflammatory Syndrome in Children (MIS-C), myocarditis, and pericarditis [17]. Reports were considered to meet the case definition for a given AESI if details of the initial report were confirmed by interview with a provider who participated in the reported person’s care and/or by medical record review, and the reported case met the respective case definition for that AESI.
2.3. Institutional review
This activity was reviewed by the CDC and was considered to be consistent with applicable federal law and CDC policy. The activities herein were confirmed to be non-research under the Common Rule in accordance with institutional procedures and therefore were not subject to institutional review board requirements. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC §241(d), 5 USC §552a, and 44 USC §3501 et seq.
3. Results
During the period of this review, VAERS received 2,449 reports following co-administration of mRNA COVID-19 and seasonal influenza vaccines; 387 (15.8%) were considered serious, including 47 deaths. Table 1 summarizes the main demographic characteristics of vaccinees. Ages ranged from 3 to 99 years (median: 48 years, IQR: 31, 66 years). Female patients (1,532; 62.6%) accounted for most reports. The most commonly reported races and ethnicities were non-Hispanic white (1,292, 52.8%) and not reported (726, 29.6%). BNT162b2 (1,663; 67.9%) was more commonly co-administered with seasonal influenza vaccine than mRNA-1273 (786; 32.1%). Median time to symptom onset was one day after vaccination (IQR, 0,6 days), ranging from the day of vaccination to 292 days after vaccination. Most reports (1,650; 67.4%) comprised co-administration of a booster dose (dose 3) of mRNA COVID-19 vaccine with a seasonal influenza vaccine. The most common types of IIV4 co-administered were Fluzone® quadrivalent (409; 16.7%), Afluria® quadrivalent (368; 15.0%), and Fluzone High dose® quadrivalent (317; 12.9%). For 336 (13.7%) reports, no specific brand of influenza vaccine was reported.
Table 1.
Characteristics of reports of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines among persons vaccinated during July 1, 2021 – June 30,2022 in VAERS.
| Characteristic | n (%) |
|---|---|
| Seriousa | 387 (15.8) |
| Maleb | 909 (37.1) |
| Female | 1,532 (62.6) |
| Median onset (range) daysc | 1 (0 – 292) |
| Interquartile range onset days | 0, 6 |
| Median age (range) yearsd | 48 (3 – 99) |
| Interquartile range age years | 31, 66 |
| Type of reporter | |
| Provider | 1,082 (44.2) |
| Patient | 929 (37.9) |
| Manufacturer | 240 (9.8) |
| Othere | 155 (6.3) |
| Parent/guardian/caregiver | 43 (1.8) |
| Recovered from the adverse event | 873 (35.7) |
| Type of co-administered influenza vaccines | |
| Quadrivalent inactivated influenza (IIV4) vaccines | 1587 (64.8) |
| Unknown type of influenza vaccine | 336 (13.7) |
| Cell-based quadrivalent influenza vaccine | 222 (9.1) |
| Quadrivalent adjuvanted influenza vaccine | 207 (8.5) |
| Quadrivalent recombinant influenza vaccine | 86 (3.5) |
| Type of co-administered COVID-19 vaccines | |
| BNT162b2 | 1663 (67.9) |
| mRNA-1273 | 786 (32.6) |
| Race/Ethnicityf | |
| Non-Hispanic white | 1292 (52.8) |
| Hispanic/Latino | 202 (8.3) |
| Non-Hispanic Black | 100 (4.1) |
| Non-Hispanic Asian | 59 (2.4) |
| Non-Hispanic Multiple | 25 (1.0) |
| Non-Hispanic AI/AN | 17 (0.7) |
| Non-Hispanic NHOPI | 1 (0.04) |
| Non-Hispanic Other | 27 (1.1) |
| Race not reported | 726 (29.6) |
| Total | 2449 |
a A report is considered serious based on the Code of Federal Regulations (21-CFR) definition if one or more of the following are reported: death, life-threatening illness, hospitalization or prolongation of existing hospitalization, congenital anomaly, permanent disability, or medical intervention to prevent the aforementioned outcomes .
b Sex was not reported for 8 reports (0.3%).
c Time to symptom onset was unknown for 27 reports.
d Age was not reported in 9 reports.
e Pharmacist.
f Hispanic includes people of known Hispanic ethnicity and unreported race; AI/AN: American Indian/Alaska Native; NHOPI: Native Hawaiian/Other Pacific Islander.
Among 340 non-death serious reports, 164 (49.7%) were among females. The most common diagnoses by SOC categories were cardiac disorders (63; 18.5%), infections and infestations (57; 16.8%), and vascular disorders (46; 13.5%) (Table 2 ). COVID-19 disease was the condition most commonly reported as the main diagnosis in 45 (13.2%) serious reports. Among all reports of co-administration (serious and non-serious) the following reports of AESIs were identified: Bell’s palsy (18), myocarditis or pericarditis (16), anaphylaxis (6), Multisystem Inflammatory Syndrome in Children (MIS-C) (2), and GBS (1). Eighteen reports (16 non-serious) of Bell’s palsy were submitted, but none had medical records available for review (i.e., none of these reports met the Brighton Collaboration case definition for Bell’s palsy). Three reports of myocarditis and one of pericarditis met the CDC case definitions [17]. One report met criteria for Brighton Level 3 diagnostic certainty for anaphylaxis [14]. The single report of GBS occurred in a female aged 39 years who received the second dose of BNT162b2 and Fluzone® IIV4 vaccine, and approximately 10 days later presented with neurological symptoms which required hospitalization for 21 days. Subsequently, the patient was discharged in stable and improved condition and met criteria for Brighton Level 2 diagnostic certainty for GBS [16].
Table 2.
Diagnostic categoriesa for non-death serious reports (N = 340) after co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines among persons vaccinated July 1, 2021 through June 30, 2022.
| Diagnostic category | N (%) |
|---|---|
| Cardiac disorders | 63 (18.5) |
| Infections and infestations | 57 (16.8) |
| Vascular disorders | 46 (13.5) |
| General disorders and administration site conditions | 26 (7.6) |
| Gastrointestinal disorders | 24 (7.1) |
| Nervous system disorders | 23 (6.8) |
| Respiratory, thoracic and mediastinal disorders | 14 (4.1) |
| Musculoskeletal and connective tissue disorders | 12 (3.5) |
| Immune system disorders | 10 (2.9) |
| Ear and labyrinth disorders | 9 (2.6) |
| Renal and urinary disorders | 7 (2.1) |
| Injury, poisoning and procedural complications | 7 (2.1) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 7 (2.1) |
| Psychiatric disorders | 5(1.5) |
| Eye disorders | 4 (1.2) |
| Skin and subcutaneous tissue disorders | 4 (1.2) |
| Surgical and medical procedures | 4 (1.2) |
| Blood and lymphatic system disorders | 4 (1.2) |
| Hepatobiliary disorders | 3 (0.9) |
| Otherb | 11 (3.2) |
| Total | 340 |
Non-death serious reports were classified into system organ class categories.
Other includes: unevaluable serious events (6), endocrine disorders (2), and one each of pregnancy, puerperium, and perinatal conditions; metabolism and nutrition disorders; and congenital, familial, and genetic disorders.
There were 47 deaths reported; 24 among females and 23 among males, with ages ranging from 26 to 99 years (median: 73 years, IQR: 62, 84 years). Forty-three (91.4%) reported deaths were in persons aged ≥ 50 years. IIV4 was most commonly reported among death reports (27;57.4%) and of these Fluzone High-dose® vaccine (17; 36.2%) was most common. Death certificates or autopsy reports documenting cause of death were available for 10 reports; other medical records were available for 16 reports; only initial reports to VAERS were available for 21 reports. Most deaths were associated with diseases of the circulatory system (20; 42.6%) or unevaluable causes (14, 29.8%); infectious causes, like COVID-19 or sepsis (8, 17.0%); and respiratory causes including respiratory failure or a neoplasm of the lung (4, 8.5%).
The most common AEs among non-serious and serious reports of co-administration of a mRNA COVID-19 and IIV4 vaccine are shown in Table 3a . Injection site and systemic reactions were the most common AEs among non-serious reports and the proportions of these AEs were very similar to that of the safety profile of reports where only mRNA COVID-19 vaccine was administered (Table 3b ).
Table 3a.
Most commonly reported MedDRA preferred terms after non-serious (n = 1,332) and serious (n = 253) reports of co-administration of mRNA COVID-19 and quadrivalent inactivated influenza vaccinesa.
| MedDRA preferred term | Non-serious, n (%) | MedDRA preferred term | Serious, n (%) |
|---|---|---|---|
| Injection Site Reaction Groupb | 193 (14.5) | Dyspnoea | 38 (14.9) |
| Headache | 181 (13.6) | COVID-19 | 32 (12.6) |
| Pain | 171 (12.8) | Chest Pain | 27 (10.6) |
| Pyrexia | 169 (12.7) | Condition Aggravated | 26 (10.2) |
| Fatigue | 167 (12.5) | Fatigue | 22 (8.7) |
| Chills | 124 (9.3) | Pain | 21 (8.3) |
| Dizziness | 121 (9.1) | Death | 19 (7.5) |
| Nausea | 102 (7.7) | Asthenia | 16 (6.3) |
| Pain In Extremity | 88 (6.6) | Headache | 16 (6.3) |
| COVID-19 | 87 (6.5) | Nausea | 16 (6.3) |
Quadrivalent cell culture (ccIV4), adjuvanted (aIIV4), and recombinant inactivated influenza (RIV4) vaccines were excluded; however the safety profile of these vaccines are very similar to the adverse events shown in this table.
Group of injection site PTs which may include any of the following: injection site erythema, injection site swelling, injection site warmth, injection site pain, injection site induration, injection site pruritus, injection site rash, injection site reaction, local reaction, injection site urticaria, injection site vesicles, injection site cellulitis, injection site oedema, injection site mass, erythema, rash, rash erythematous, rash generalised, blister, rash vesicular, rash papular, rash macular, rash maculo-papular, rash pruritic.
Table 3b.
Most common MedDRA preferred terms among reports of co-administration of mRNA COVID-19 and quadrivalent inactivated influenza vaccinesa (n = 1,585) and administration of mRNA COVID-19 vaccines alone (n = 188,740).
| MedDRA preferred term |
Co-administration of mRNA COVID-19 and IIV4 vaccines, n (%) |
Administration of mRNA COVID-19 vaccine alonen(%) |
|---|---|---|
| Injection Site Reaction Groupb | 201 (12.7) | 23,139 (12.3) |
| Headache | 197 (12.4) | 21,483 (11.4) |
| Fatigue | 189 (11.9) | 18,993 (10.1) |
| Pyrexia | 183 (11.5) | 18,952 (10.0) |
| Pain | 192 (12.1) | 17,713 (9.4) |
| COVID-19 | 119 (7.5) | 15,394 (8.2) |
| Dizziness | 133 (8.4) | 13,949 (7.4) |
| Chills | 136 (8.6) | 12,864 (6.8) |
| Pain in extremity | 96 (6.1) | 12,794 (6.8) |
| Nausea | 118 (7.4) | 12,049 (6.4) |
| Dyspnoea | 94 (5.9) | 10,359 (5.5) |
Quadrivalent cell culture (ccIV4), adjuvanted (aIIV4), and recombinant inactivated influenza (RIV4) vaccines were excluded.
Group of injection site PTs which may include any of the following: injection site erythema, injection site swelling, injection site warmth, injection site pain, injection site induration, injection site pruritus, injection site rash, injection site reaction, local reaction, injection site urticaria, injection site vesicles, injection site cellulitis, injection site oedema, injection site mass, erythema, rash, rash erythematous, rash generalised, blister, rash vesicular, rash papular, rash macular, rash maculo-papular, rash pruritic.
We compared reports where a booster dose of mRNA COVID-19 vaccine was co-administered with IIV4 vaccine, and where a booster dose of mRNA COVID-19 vaccine was administered alone (Fig. 1 ). Systemic reactions were slightly more frequent for reports where a booster dose was given with IIV4 vaccine, compared to reports where a booster dose was given alone. Injection site reactions, and COVID-19 infection were slightly more frequent among reports where only a mRNA COVID-19 vaccine booster dose was administered compared to co-administration of a booster dose and IIV4 vaccine.
Fig. 1.
Most common reported MedDRA preferred terms after co-administration of mRNA COVID-19 booster dose and quadrivalent inactivated influenza (IIV4) vaccines (n = 1,019), and after mRNA COVID-19 booster dose vaccines administered alone (n = 59,384).
4. Discussion
We conducted a review of AEs reported to VAERS after co-administration of mRNA COVID-19 and seasonal influenza vaccines among persons vaccinated during July 1, 2021 through June 30, 2022. Our review included automated analyses of all reports, reports of AESI, and clinical review of all death and non-death serious reports. We observed no unusual or unexpected clusters of AEs among non-death serious reports of AESIs. Among non-serious reports, the most common AEs reported were local and systemic reactions as described in other studies with similar vaccines given separately or together [8]. Some conditions may have been reported due to the EUA requirement for providers to report them (e.g., COVID-19 infection) or to a known established association with mRNA COVID-19 vaccines (e.g., myocarditis) [17]. Among death reports, the leading causes of death were diseases of the circulatory system (e.g., myocardial infarction), and infectious diseases (e.g., SARS-CoV-2), consistent with the leading causes of death in the United States [18]. Similar to other published studies of reactogenicity [8], we found a greater frequency of systemic reactions when a booster dose of mRNA COVID-19 was co-administered with an IIV4 vaccine compared to administration of a booster dose of mRNA COVID-19 vaccine alone.
Important strengths of VAERS include its broad national scope and timeliness [10]. VAERS is useful for rapidly detecting rare AEs that, if new or unexpected, can be studied in other more robust vaccine safety surveillance systems (e.g., the CDC’s Vaccine Safety Datalink) or special epidemiological studies [19]. This strength has been demonstrated during the current COVID-19 immunization program with AEs such as myocarditis after mRNA COVID-19 vaccines, and GBS and Thrombosis with Thrombocytopenia Syndrome (TTS) after the Janssen adenoviral vector vaccine [17], [20], [21]. Importantly, as a passive surveillance system, VAERS has several inherent limitations which call for careful interpretation of the findings. Some of these limitations include biased reporting (over- or under-reporting) and inconsistency in quality and completeness of reports [10]. In addition, VAERS data generally cannot be used to assess if a specific vaccine caused an AE.
5. Conclusion
Our assessment of the safety data of co-administration of mRNA COVID-19 and seasonal influenza vaccines did not identify any new or unexpected safety issues and is consistent with the safety profile following either vaccine when given alone or from published studies on co-administration of these vaccines [9]. The safety of co-administration of mRNA COVID-19 and other COVID-19 vaccines should continue to be assessed in future influenza seasons to ensure the safety of these vaccines and maintain public confidence in the vaccination program.
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgments
Acknowledgements
We thank the staff of the Immunization Safety Office, and General Dynamics Information Technology, for their work and dedication to public health during the COVID-19 pandemic. No funding from any organization, agency or entity was received for this study.
Disclaimer
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC). Mention of a product or company name is for identification purposes only and does not constitute endorsement by CDC.
Data availability
VAERS data is available to the public in the VAERS wonder database but the identity of medical reviews is confidential and protected.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
VAERS data is available to the public in the VAERS wonder database but the identity of medical reviews is confidential and protected.