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Introduction
Pedro L Moro currently works at the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention. Pedro does research in surveillance of vaccine safety a specific studies to asses potential safety concerns in vaccines. Current projects include safety surveillance of maternal vaccines and monitoring the safety of influenza vaccines in the US during the 2017-2018 influenza season'.
Current institution
Publications
Publications (153)
Objective:
To characterize adverse events (AEs) after Haemophilus influenzae type b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
Study design:
We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990, to December 1, 2013. We r...
Before October 2024, the Advisory Committee on Immunization Practices (ACIP) recommended use of a pneumococcal conjugate vaccine (PCV) for all adults aged ≥65 years, as well as for those aged 19-64 years with risk conditions for pneumococcal disease who have not received a PCV or whose vaccination history is unknown. Options included either 20-vale...
We assessed the safety of hexavalent vaccine (DTaP-IPV-Hib-HepB) in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from pre-licensure st...
As of May 7, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) recommends that all children aged 6 months-5 years receive at least 1 age-appropriate bivalent mRNA COVID-19 vaccine dose. Depending on their COVID-19 vaccination history and history of immunocompromise, these children might also need additional doses* (1-3). Initial vacci...
Background:
Following the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety.
Methods:
We describe...
Purpose:
Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS fo...
Background:
Since 2012, reports of primary ovarian insufficiency (POI) temporally associated with receipt of human papillomavirus (HPV) vaccine have been published leading to questions about a potential causal association. A Vaccine Safety Datalink study did not find an increased risk for POI after vaccination. We reviewed the Vaccine Adverse Even...
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-administra...
JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) is recommended in the United States for persons exposed to or at high risk for exposure to Monkeypox virus during the 2022 monkeypox (mpox) outbreak (1). JYNNEOS is a live, nonreplicating viral vaccine licensed for the prevention of smallpox and mpox in adults aged ≥18 years, administered...
Background:
. The Vaccine Adverse Event Reporting System (VAERS) is the United States national passive vaccine safety surveillance system. We updated the data on the safety of single-antigen varicella vaccine (VAR) and assessed the safety of combination measles, mumps, rubella, and varicella vaccine (MMRV) licensed in the United States using VAERS...
The 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer, Inc]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Merck Sharp & Dohme LLC]) have been recommended for U.S. children, and the recommendations vary by age group and risk group (1,2). In 2021, 15-valent pneumococcal c...
Background
Data on medium-term outcomes in indivduals with myocarditis after mRNA COVID-19 vaccination are scarce. We aimed to assess clinical outcomes and quality of life at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults.
Methods
In this follow-up surveillance study, we conducted surveys i...
Objective:
To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant people who received a booster dose of mRNA coronavirus disease 2019 (COVID-19) vaccine.
Methods:
We searched VAERS for U.S. reports of adverse events in pregnant people who received a booster do...
Background
Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS).
Objective
To provide information and context about reports of death to VAERS...
Nursing homes (NH) provide care in a congregate setting for residents at high risk of severe outcomes from SARS-CoV-2 infection. In spring 2020, NH were implementing new guidance to minimize SARS-CoV-2 spread among residents and staff.
Objective
To assess whether telephone and video-based infection control assessment and response (TeleICAR) strate...
Background
Pregnant persons are at increased risk of severe illness from COVID-19 infection, including ICU admission, mechanical ventilation, and death compared with non-pregnant persons of reproductive age. Limited data are available on the safety of COVID-19 vaccines administered during and around the time of pregnancy.
Objective
To evaluate and...
On November 4, 2019, the Food and Drug Administration approved high-dose quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent; QIV-HD) for active immunization for the prevention of influenza disease in individuals 65 years of age and older. A prelicensure randomized, active-controlled, modified double-blind trial did not reveal any major...
( New Engl J Med . 2021;384:2273–2282)
When the Moderna and Pfizer-BioNTech COVID-19 vaccines were granted Emergency Use Authorization by the Food and Drug Administration in December 2020, there was limited data concerning the safety of these vaccines during pregnancy. Pregnant individuals with COVID-19 are at higher risk for severe illness, death...
(Abstracted from N Engl J Med 2021;384:2273–2282)
The first coronavirus disease (COVID-19) vaccines in the United States were the messenger RNA (mRNA) vaccines BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). Pregnant persons were excluded from the original Emergency Use Authorization (EUA) issued by the Federal Drug Administration (FDA) in Dece...
Pregnant persons are at increased risk of severe illness from COVID-19. The first COVID-19 vaccines in the U.S. were authorized for emergency use in December 2020 and pregnant persons were eligible and could get vaccinated despite scarce safety data in this population. To monitor the safety of COVID-19 vaccination during pregnancy, four surveillanc...
The Coronavirus Disease 2019 (COVID-19) pandemic has had a devastating impact on global health, and has resulted in an unprecedented, international collaborative effort to develop vaccines to control the outbreak, protect human lives, and avoid further social and economic disruption. Mass vaccination campaigns are underway in multiple countries and...
Background
Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy.
Methods
From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy reg...
On October 7, 2016, the Food and Drug Administration approved recombinant hemagglutinin quadrivalent influenza vaccine (RIV4) (Spodoptera frugiperda cell line; Flublok Quadrivalent) for active immunization for the prevention of influenza disease in individuals 18 years of age and older. Clinical trials did not reveal any major differences in advers...
Background
In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the United States for adults aged ≥18 years. A quadrivalent version (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or ccIIV4 (ccIIV) was not assessed for pre...
Background
Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after...
Introduction
In 2006 and 2008, two live, oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced into the routine immunization program in the United States. A previous rotavirus vaccine, RotaShield, was associated with an increased risk of intussusception, with data suggesting an age-dependent variation in risk. Advisory Committee...
Background
On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged ≥65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011–2019.
Methods
We searched VAERS for reports after IIV3-HD during 1/1/2011–06/30/2019 in persons a...
Background
Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM197 conjugate vaccine (MenACWY-CRM)....
Cystic hydatid disease, caused by Echinococcus granulosus , is a zoonotic disease principally transmitted between dogs and domestic livestock, particularly sheep. Humans are infected when they ingest tapeworm eggs, with disease occurring in most parts of the world where sheep are raised and dogs are used to herd livestock. The most common clinical...
Since 2005, a single dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine has been recommended by the Advisory Committee on Immunization Practices (ACIP) for adolescents and adults (1,2). After receipt of Tdap, booster doses of tetanus and diphtheria toxoids (Td) vaccine are recommended every 10 years or when in...
Introduction:
The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Eve...
Background:
Vaccines administered into or too close to underlying joint structures have the potential to cause shoulder injuries. Limited data exist on the epidemiology of such events.
Objective:
To describe case reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine (IIV).
Methods:
We searched t...
Introduction: Vaccination is one of the most successful and cost-effective public health interventions. Although vaccines undergo extensive safety and efficacy evaluations prior to licensure, vaccine safety assessment post-licensure is essential for detecting rare and longer-term adverse events (AEs) and maintaining public confidence in vaccines an...
Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient nu...
Background:
The administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refu...
Background:
Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination.
Objective:
We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016.
Methods:
We identified domestic reports of anaphylaxis within VAERS using...
Introduction:
9-valent human papillomavirus vaccine (9vHPV) was approved by the Food and Drug Administration (FDA) in December 2014. 9vHPV is not recommended during pregnancy, but some women of childbearing age may be inadvertently exposed. This study aims to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS) of pregn...
Background:
Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65 years and has been in use since the 2016-17 influenza season.
Methods:
We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS),...
Objective:
Tetanus toxoid, reduced diphtheria toxoid, and acellular pertusiss (Tdap) vaccine is recommended during each pregnancy, regardless of prior receipt. Data on reactogenicity and immunogenicity, particularly after repeated Tdap, are limited. We compared local injection-site and systemic reactions and serologic response following Tdap in (1...
Objective:
To assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the United States by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
Methods:
We searched VAERS for US reports of DTaP vaccinations occurring from January 1, 1991, throug...
This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of tetanus, diphtheria, and pertussis in the United States. As a comprehensive summary of previously published recommendations, this report does not contain any new recommendations and replaces all...
Background: Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years.
Methods: We analyzed U.S. reports of adverse events (AE...
Introduction:
Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system.
Methods:
We searche...
Purpose
Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS).
Methods
We searched the VAERS da...
Background:
The safety of hepatitis B vaccination during pregnancy has not been well studied.
Objective:
We characterized adverse events (AEs) after hepatitis B vaccination of pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
Methods:
We searched VAERS for AEs reports in...
Background
In February 2010, the Food and Drug Administration (FDA) licensed the 13-valent pneumococcal conjugate vaccine (PCV13) for use in children aged 6 weeks through 59 months. The Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 for all children ages 2, 4, and 6 months with a booster at 12–15 months. For in...
On January 16, 2013, the Food and Drug Administration approved recombinant hemagglutinin influenza vaccine (RIV3) (Spodoptera frugiperda cell line; Flublok), which is the first completely egg-free flu vaccine licensed in the United States. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized reports to the...
Background:
Major birth defects are important infant outcomes that have not been well studied in the postmarketing surveillance of vaccines given to pregnant women. We assessed the presence of major birth defects following vaccination in the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system used to monitor the...
Background:
Major birth defects are important infant outcomes that have not been well studied in the postmarketing surveillance of vaccines given to pregnant women. We assessed the presence of major birth defects following vaccination in the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system used to monitor the...
Introduction:
Routine immunization of pregnant women with seasonal inactivated influenza vaccines (IIVs) is recommended in all trimesters of pregnancy. A review of the Vaccine Adverse Event Reporting System (VAERS) during 1990-2009 did not find any unexpected patterns of pregnancy complications or fetal outcomes after administration of IIV or live...
Background:
The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65years.
Methods:
We assessed adverse events (AEs) repo...
Author
In 1980, human diploid cell rabies vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for US reports after HDCV among persons vacci...
Introduction:
Annual influenza vaccine safety monitoring is an important component of the influenza vaccination program in the United States to ensure that vaccines are safe, which is important for maintaining public trust in the national vaccination program. This is specially the case for influenza vaccines since the antigen composition of the vi...
Background:
23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted.
Objective:
To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) fol...
Background:
In October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine.
Objectives:
We characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pr...
Background:
Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013-14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses.
Methods:
We searched the Vaccine Adverse Event Reporting System (VAERS) fo...
Background:
In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the US for adults aged ≥18 years.
Objective:
To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surv...
In 2010, in response to a widespread pertussis outbreak and neonatal deaths, California became the first state to recommend routine administration of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during pregnancy. In 2011, the Advisory Committee on Immunization Practices (ACIP) followed with a similar recommendat...
Safety data from countries with experience in the use of inactivated poliovirus vaccine (IPV) are important for the global polio eradication strategy to introduce IPV into the immunisation schedules of all countries. In the USA, IPV has been included in the routine immunisation schedule since 1997. We aimed to analyse adverse events after IPV admin...
The CDC supports nurses in promoting vaccination.
Echinococcosis (hydatid disease) is the infection of humans by the larval stages of taeniid cestodes of the genus Echinococcus. Three species of public health importance, Echinococcus granulosus, E. multilocularis, and E. vogeli respectively, cause cystic, alveolar and polycystic echinococcosis respectively, and are the subject of this review. Seve...
Background:
Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting S...
Background:
Vaccines are among the safest medical products in use today. Hundreds of millions of vaccinations are administered in the United States each year. Serious adverse reactions are uncommon. However, temporally associated deaths can occur following vaccination. Our aim was to characterize main causes of death among reports submitted to the...
Vaccines are rigorously tested and monitored and are among the safest medical products we use. Millions of vaccinations are given to children and adults in the United States each year. Serious adverse reactions are rare. However, because of the high volume of use, coincidental adverse events including deaths, that are temporally associated with vac...
In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co., Inc.) vaccine was licensed in the US for use in females aged 9-26 years. HPV4 is not recommended during pregnancy; however, inadvertent administration during pregnancy may occur.
To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnan...
Background:
Limited data exist on the safety of the measles, mumps, and rubella (MMR) vaccine in adults. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in this previously understudied group.
Methods:
VAERS is the national spontaneous vaccine safety surveillance system coadminist...
Background:
Quadrivalent live attenuated influenza vaccine (LAIV4) was approved in 2012 for healthy persons aged 2-49 years. Beginning with the 2013-2014 influenza season, LAIV4 replaced trivalent live attenuated influenza vaccine (LAIV3).
Methods:
We analyzed LAIV4 reports to VAERS, a national spontaneous reporting system. LAIV4 reports in 2013...
Background. The first trivalent live-attenuated influenza vaccine (LAIV3) was licensed in 2003 for use in healthy persons 5–49 years of age. In 2007, the US Food and Drug Administration expanded its indication to healthy children 2–4 years of age. Methods. We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 fro...
This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of Haemophilus influenzae type b (Hib) disease in the United States. As a comprehensive summary of previously published recommendations, this report does not contain any new recommendations; it is i...
Background:
The first trivalent live-attenuated influenza vaccine (LAIV3) was licensed in 2003 for use in healthy persons 5-49 years of age. In 2007, the US Food and Drug Administration expanded its indication to healthy children 2-4 years of age.
Methods:
We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3...
Inactivated influenza vaccines have been given to pregnant women since 1964. Since 2004, the Advisory Committee on Immunization Practices has recommended that pregnant women receive trivalent inactivated influenza vaccine at any time during pregnancy. Studies conducted before 2009 did not identify any safety concerns after trivalent inactivated inf...
To characterize adverse events (AEs) after Hepatitis A vaccines (Hep A) and Hepatitis A and Hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
We searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from 01/0...
To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events.
We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 20...
Background:
Vaccine adverse event (VAE) reporting during routine practice helps identify rare or unexpected complications of immunizations and can aid in quantifying the risk of known adverse events. We created an electronic health record (EHR) module to facilitate VAE detection and reporting by clinicians.
Methods:
EHR Support for Public hea...
Objective:
We characterized reports to the Vaccine Adverse Event (AE) Reporting System (VAERS) of pregnant women who received meningococcal polysaccharide-protein conjugate vaccine Menactra (MenACWY-D; Sanofi Pasteur Inc., Swiftwater, PA).
Study design:
We searched VAERS for reports of pregnant women who received MenACWY-D from Jan. 1, 2005 thro...
We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap).
We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of report...
