pfizer vaccine side effects released march 2022
Effectiveness of Covid-19 vaccines in ambulatory and inpatient care settings. URL addresses listed in MMWR were current as of NEW YORK and MAINZ, GERMANY, March 1, 2023 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years). 2021 Feb;25(3):1663-1669. doi: 10.26355/eurrev_202102_24877. El-Shitany NA, Bagher AM, Binmahfouz LS, Eid BG, Almukadi H, Badr-Eldin SM, El-Hamamsy M, Mohammedsaleh ZM, Saleh FM, Almuhayawi MS, Alghamdi SA, Arab RA, Ali SS, Harakeh S, Alghamdi BS. Partners contributing data on medical events were in California (vaccine availability: April 30, 2021), Colorado (May 22, 2021), Indiana (April 27, 2021), Minnesota and Wisconsin (April 21, 2021), New York (April 27, 2021), Oregon and Washington (April 28, 2021), Texas (March 29, 2021), Utah (April 9, 2021). WATCH: Dr Gcina Mhlophe welcomed to ECR by East Coast Breakfast. The findings in this report also align with studies among adults that report lower VEs during Omicron variant predominance (9,10) and an increase in VE after receipt of a third vaccine dose (9,10). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Thompson MG, Natarajan K, Irving SA, et al. Reports of no adverse event were often accompanied by product storage error, inappropriate schedule of product administration, expired product administered, or underdose. Zakes Bantwini talks about how it feels to bring a Grammy home and repre "This is the start of many things to come for KZN" -Dr Gcina Mhlophe. Finally, although the facilities in this study serve heterogeneous populations in 10 states, the findings might not be generalizable to the U.S. population. Reactions were mostly mild to moderate in severity and most frequently reported the day immediately after vaccination. Updated March 11, 2022, 3:47 p.m. Burden of RSV The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 511, 1215, and 1617 years (13). Hause AM, Baggs J, Marquez P, et al. Abbreviations: ED=emergency department; NC=not calculated; Ref = referent group; UC=urgent care; VE=vaccine effectiveness. First, v-safe is a voluntary program; therefore, data might not be representative of the vaccinated population. 2023 Jan 5;23(1):5. doi: 10.1186/s12879-022-07974-3. MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services. 2020;382:727733. The Adverse Reactions of Pfizer BioNTech COVID-19 Vaccine Booster Dose are Mild and Similar to the Second Dose Responses: A Retrospective Cross-Sectional Study. WEDNESDAY, March 1, 2023 (HealthDay News) -- In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used regarding Pfizer/BioNTech'sproposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for ourinvestigational COVID-19 Vaccine (BNT162b2). ** The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for persons aged 16 years on December 11, 2020 (https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19external icon), and CDC recommended the Pfizer-BioNTech vaccine on December 12, 2020 (https://www.cdc.gov/media/releases/2020/s1213-covid-vaccine.html). Local reactions in persons aged 6-23 months, Pfizer BioNTech BNT162b2 COVID-19 vaccine and placebo a Mild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only) Does it make a difference knowing that these are the other side effects of the vaccine? and/or the original MMWR paper copy for printable versions of official text, figures, and tables. You can review and change the way we collect information below. Hause AM, Baggs J, Marquez P, Myers TR, Gee J, Su JR, Zhang B, Thompson D, Shimabukuro TT, Shay DK. part 46, 21 C.F.R. The U.S. Centers for Disease Control and Prevention has more on RSV. Among adolescents aged 1217 years during the full study period including pre-Delta, Delta, and Omicron predominant periods, 2-dose VE estimates were higher (76%83%) 14149 days after receipt of a second dose, and significantly lower (38%46%) at 150 days postvaccination. One code in any of the four categories was sufficient for inclusion. Inability to attend school was more frequently reported after a booster dose than after dose 2; however, for many in this age group, receipt of dose 2 occurred during a period of remote learning or summer vacation, which might have affected reporting. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. Second, it is possible that vaccinees who experience an adverse event could be more likely to respond to v-safe surveys. N Engl J Med 2021;385:135571. 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Prof Tulio explains, "Because I have had COVID-19 I will not get it for three months after I've had it?" Local reactions like pain at the injection site are the most common. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after a homologous Pfizer-BioNTech booster vaccination and that serious adverse events are rare. and Terms of Use. Anaphylactic shock or severe reactions are rare. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. For adolescents aged 1617 years, the study period began when COVID-19 vaccines became available to all persons aged 16 years at each study site. part 46; 21 C.F.R. Study selection process using preferred. Your email address is used only to let the recipient know who sent the email. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on Wednesday. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). Myocarditis was less frequently reported after a booster dose than a second primary dose. sharing sensitive information, make sure youre on a federal We take your privacy seriously. The study period began in September 2021 for partners located in Texas. It kills up to 10,000 adults ages 65 or older each year, according to the U.S. Centers for Disease Control and Prevention. Most hospitalizations of adolescents aged 1215 years (613 [82.7%]) and 1617 years (476 [70.7%]) occurred during Delta predominance, whereas two thirds of hospitalizations among children aged 511 years (190 [66.7%]) occurred during Omicron predominance. Compared with the Delta predominant period, estimated 2-dose VE for adolescents aged 1215 and 1617 years declined significantly once Omicron became the predominant variant: among adolescents aged 1617 years, VE of 2 doses received 150 days earlier against COVID-19associated ED and UC encounters declined from 77% during Delta predominance to a null VE (3%) during Omicron predominance; however, effectiveness of a third dose received 7 days earlier against COVID-19associated ED and UC encounters during Omicron predominance was 81%. In a multistate analysis of 39,217 ED and UC encounters with COVID-19like illness among nonimmunocompromised patients aged 517 years through January 29, 2022, estimates of Pfizer-BioNTech VE against COVID-19associated ED and UC encounters varied by time since vaccination and by predominant circulating SARS-CoV-2 variant. MMWR Morb Mortal Wkly Rep 2022;71:24954. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 1217 Years United States, December 9, 2021February 20, 2022. Among persons aged 1217 years, reactions after Pfizer-BioNTech booster vaccination were generally mild to moderate and transient; the frequency of local and systemic reactions reported to v-safe after a booster dose were equal to or slightly higher than after the second primary dose. For general feedback, use the public comments section below (please adhere to guidelines). and/or the original MMWR paper copy for printable versions of official text, figures, and tables. All information these cookies collect is aggregated and therefore anonymous. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare. Estimated date of Delta and Omicron predominance at contributing sites: California (Delta: June 23, 2021; Omicron: December 21, 2021); Colorado (Delta: June 3, 2021; Omicron: December 19, 2021); Indiana (Delta: June 23, 2021; Omicron: December 26, 2021); Minnesota and Wisconsin (Delta: June 28, 2021; Omicron: December 25, 2021); New York (Delta: June 30, 2021; Omicron: December 18, 2021); Oregon and Washington (Delta: June 30, 2021; Omicron: December 24, 2021); Texas (Delta: July 3, 2021; Omicron: December 16, 2021); Utah (Delta: June 1, 2021; Omicron December 24, 2021). The Pfizer-BioNTech vaccine is the first mRNA-based vaccination that enhances immunity. PRAC hi ghlights of March 2022. Stunningly, Pfizer submitted falsified mRNA analytical reports to multiple health authorities. She was in general good health and was three months postpartum. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. Medical events with an encounter or discharge code consistent with COVID-19like illness were included, using International Classification of Disease, Ninth Revision and International Classification of Diseases, Tenth Revision (ICD-10). "At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. The vaccine's potential association with a rare neurological disorder known as Guillain-Barr syndrome (GBS) was a concern for those who voted against approval because of safety. Ou X, Liu Y, Lei X, et al. Prof Tulio answers. Finally, assessment of myocarditis reports to VAERS is ongoing, and counts are subject to change. Tee Xaba welcomes back the South African Grammy Award winner Zakes Bantwini! Among adolescents aged 1215 and 1617 years, VE 14149 days after dose 2 was 92% and 94%, respectively; VE 150 days after dose 2 was 73% and 88%, respectively. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. provided as a service to MMWR readers and do not constitute or imply These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 2020;382:17081720. They help us to know which pages are the most and least popular and see how visitors move around the site. Accorsi EK, Britton A, Fleming-Dutra KE, et al. MMWR Morb Mortal Wkly Rep 2021;70:10538. The vaccines have been said to give you the best protection against COVID-19. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 1217 years.. The U.S. Centers for Disease Control and Prevention would also need to recommend the single shot before it could become available to Americans. By Darren, Keri and Sky. Thank you for taking the time to confirm your preferences. Adults aged 18 years reported adverse reactions less frequently after receipt of a homologous Pfizer-BioNTech COVID-19 booster dose than after the second primary dose. These cookies may also be used for advertising purposes by these third parties. The list notes 1,291 different adverse events following the Pfizer Covid vaccine. The documents were first released in November last year reporting vaccine adverse events. The study period began in September 2021 for partners located in Texas. This conversion might result in character translation or format errors in the HTML version. and transmitted securely. Reports of myocarditis were identified using a combination of MedDRA PTs; in some cases, reports of myocarditis (identified by fulfilling criteria of the CDC working case definition of myocarditis) did not have the MedDRA PT myocarditis assigned to them. A total of 107 PubMed and Google Scholar publications were screened for Pfizer-BioNTech COVID-19 vaccine side effects. Pfizer's new RSV vaccine for older adults may trigger the potentially deadly Guillain-Barre syndrome, the Food and Drug Administration has warned.. Medical events with an encounter or discharge code consistent with COVID-19like illness were included, using International Classification of Disease, Ninth Revision and International Classification of Diseases, Tenth Revision. Vaccination was defined as having received the listed number of doses of COVID-19 Pfizer-BioNTech BNT162b2 vaccine 14 days (for 2 doses) or 7 days (for 3 doses) before the medical event index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before medical event or the admission date if testing only occurred after the admission. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. On March 1, 2022, this report was posted online as an MMWR Early Release. The study noted: There have been three reports of patients having hepatic failure, with one case being acute, after receiving the Pfizer/BioNTech BNT162b2 mRNA vaccine in the United Kingdom between September 12, 2020, and September 4, 2021. Hepatotoxicity is the medical term fordamage to the liver caused by a medicine, chemical, or herbal or dietary supplement. Vaccines (Basel). Vaccinations prevented severe clinical complications of COVID-19. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The number of observations was insufficient to estimate 3-dose VE for adolescents aged 1215 years. Reactions reported after both dose 2 and booster dose vaccination were mostly mild to moderate in severity. During December 9, 2021February 20, 2022, VAERS received and processed 914 reports of adverse events after receipt of a Pfizer-BioNTech booster dose for adolescents; the median age was 16 years, and 459 (50.2%) reports were for adolescent girls. Average of the most frequent side effects of 14 studies were injection site pain 77.34%, fatigue 43%, muscle pain 39.67%, local swelling 33.57%, headache 33.27%, joint pain 25.75%, chills 18.34%, fever 18%, itching 9.38%, lymph nodes swelling 7.86%, nausea 7.58%, dyspnea 7.86%,and diarrhea 6.36%. The number of participants in each study who received the Pfizer-BioNTech vaccine and, MeSH These findings are consistent with previously published data showing high effectiveness of the Pfizer-BioNTech vaccine among adolescents before Omicron became the predominant variant (46), and with data from adults demonstrating relatively higher protection against more severe outcomes (7). 2022 Nov 25;10(12):2012. doi: 10.3390/vaccines10122012. On March 1, 2022, this report was posted online as an MMWR Early Release. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Questions or messages regarding errors in formatting should be addressed to Disclaimer. During Omicron predominance, VE of a second dose received 14149 days earlier was 45% and 34% for adolescents aged 1215 and 1617 years, respectively, suggesting that the lower VE observed among children aged 511 years was likely driven by the predominant variant rather than differences in VE across age groups. However, a third vaccine dose restored VE against COVID-19associated ED or UC encounters to 86% among adolescents aged 1617 years. In clinical trials, two participants in their . It was considered a vital component of living endemically with COVID-19. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6 . ** Estimated date of Delta and Omicron predominance at contributing sites: California (Delta: June 23, 2021; Omicron: December 21, 2021); Colorado (Delta: June 3, 2021; Omicron: December 19, 2021); Indiana (Delta: June 23, 2021; Omicron: December 26, 2021); Minnesota and Wisconsin (Delta: June 28, 2021; Omicron: December 25, 2021); New York (Delta: June 30, 2021; Omicron: December 18, 2021); Oregon and Washington (Delta: June 30, 2021; Omicron: December 24, 2021); Texas (Delta: July 3, 2021; Omicron: December 16, 2021); Utah (Delta: June 1, 2021; Omicron December 24, 2021). Among adolescents aged 1617 years, VE increased to 86% 7 days after dose 3 (booster dose). Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Your feedback is important to us. Pre-Delta refers to the period before Delta predominance. Safety monitoring of COVID-19 vaccine booster doses among adultsUnited States, September 22, 2021February 6, 2022. Among 1,699 eligible hospitalizations at 164 hospitals, 16.8%, 43.6%, and 39.6% were among children and adolescents aged 511, 1215 and 1617 years, respectively (Table 3). Please select the most appropriate category to facilitate processing of your request. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. On 1 March 2022 Pfizers documents were made publicly available due to a judicial ruling. Prevalence and Risk Factors of Adverse Effects and Allergic Reactions after COVID-19 Vaccines in a Mexican Population: An Analytical Cross-Sectional Study. ** VE during the period of Delta predominance was not calculated for children aged 511 years because of the short eligibility interval in this age group during that time. CDC twenty four seven. Common side effects of both the Pfizer and the GSK vaccines were injection site and muscle pain and fatigue. It was considered a vital component of living endemically with COVID-19. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic. During Omicron predominance, there was no evidence of protection for adolescents aged 1217 years from 2 doses received 150 days earlier; however, a third vaccine restored VE to 81% among adolescents aged 1617 years. Two doses protect against COVID-19associated emergency department and urgent care encounters among children and adolescents. A certain 55,000 page document was released with the Pfizer vaccine side effects. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. For adolescents aged 1617 years, the study period began when COVID-19 vaccines became available to all those aged 16 years at each study site. It is created by eHealthMe based on reports of 286,220 people who have side effects when getting Pfizer BioNTech Covid vaccine from the CDC and the FDA, and is updated regularly., READ MORE:Cancer warning: The persistent toilet sign signalling a tumour growing inside the colon, We use your sign-up to provide content in ways you've consented to and to improve our understanding of you. "We are encouraged by the outcome of today's meeting, as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market.". Everything you need to know about #EveryCallerWins and how to win! A Pfizer document recently released by the Food and Drug Administration describes adverse events reported following vaccination and attests to the continued safety of the company's COVID-19. Please enable it to take advantage of the complete set of features! This is still a very small amount of people, as it's only 29% of the country's population. Study selection process using preferred reporting items for systematic reviews and meta-analyses (PRISMA). We hope that our results will reassure the public that the benefits of vaccination far exceed the dangers. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 1217 years. This was afterthe U.S. Food and Drug Administrations (FDAs) Center for Biologics Evaluation and Research (CBER) allowed the public access to data that Pfizer submitted to the FDA from its clinical trials in support of a COVID-19 vaccine licence. Zhu N, Zhang D, Wang W, et al. It is important to stress that millions of people have received a Covid vaccine shot without experiencing any adverse side effects. A 35-year-old woman developed an acute hepatitis with autoimmune features one to two weeks after receiving a first dose of the Pfizer COVID-19 vaccine. This site uses cookies to assist with navigation, analyse your use of our services, collect data for ads personalisation and provide content from third parties. Among adolescents aged 1215 and 1617 years, VE of 2 doses 14149 days earlier against COVID-19associated ED and UC encounters was 83% and 76%, respectively; VE was significantly lower for 2 doses received 150 days earlier (38% and 46%, respectively). Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age. Adverse events are health problems that occur after vaccination but aren't necessarily caused by the vaccine. Department of Health and Human Services. VAERS is a U.S. national passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination (2). A peer reviewed case report detailed a case of hepatotoxicity after receiving a COVID-19 vaccine. Reports of serious adverse events receive follow-up by VAERS staff to obtain additional information, including medical records and, for reports of death, death certificates and autopsy reports, if available. This study was reviewed and approved by the institutional review boards at participating sites or under a reliance agreement with the Westat, Inc. institutional review board.. Among adolescents aged 1215 and 1617 years, VE of 2 doses received 14149 days earlier was 92% and 94%, respectively, and VE of 2 doses received 150 days earlier was 73% and 88%, respectively. No potential conflicts of interest were disclosed. Each VAERS report might be assigned more than one MedDRA preferred term. Pfizer's document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. mmwrq@cdc.gov. For children aged 511 and persons aged 1215 years, the study period began 5 weeks after the Pfizer-BioNTech vaccine was authorized for each age group (November 2, 2021, and May 12, 2021, respectively). eCollection 2022. Keywords: considered spontaneously reported cases of suspected side effects, i.e. COVID-19-Related Burnout and Intention of Fully Vaccinated Individuals to Get a Booster Dose: The Mediating Role of Resilience. Bookshelf The study period at Baylor Scott and White Health began on September 11, 2021. part 56. Indicates the reference group used for standardized mean or proportion difference calculations for dichotomous variables. This is still a very small. CDC recommended a booster dose for adolescents aged 1617 years on December 9, 2021(https://www.cdc.gov/media/releases/2021/s1208-16-17-booster.html). Speaking during the Webinar, Sahpra CEO Dr Boitumelo Semete-Makokotlela says they are examining the veracity of the document. 2020;26:39. See this image and copyright information in PMC. On. Unauthorized use of these marks is strictly prohibited. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. However, we do not guarantee individual replies due to the high volume of messages. In a study cited on health platform EHealthME, Pfizer BioNTech Covid vaccine and kidney stones were further investigated. Views equals page views plus PDF downloads. An absolute SMD 0.20 indicates a nonnegligible difference in variable distributions between medical events for vaccinated versus unvaccinated patients; single SMD calculated by averaging pair-wise comparisons of each vaccinated category versus unvaccinated and separately for patients with SARS-CoV-2positive versus SARS-CoV-2negative test results. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Use this form if you have come across a typo, inaccuracy or would like to send an edit request for the content on this page. It noted: Kidney stones are found among people who get Pfizer BioNTech Covid Vaccine, especially for people who are female, 60+ old, and after 30 days of getting the vaccine. Food and Drug Administration. For example, the age SMD calculation comparing unvaccinated versus different vaccinated categories was generated by averaging the pairwise SMD calculations for unvaccinated and 2 doses (14149 days earlier), unvaccinated and 2 doses (150 days earlier), and unvaccinated and 3 doses (7 days). Centers for Disease Control and Prevention. To characterize the safety of Pfizer-BioNTech booster doses among persons aged 1217 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphonebased safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. 241(d); 5 U.S.C. CDC will follow up on myocarditis reports at 36 months after onset to assess health and functional status. In brief, eligible medical encounters were defined as ED and UC encounters and hospitalizations among persons aged 5 years with a COVID-19like illness diagnosis who had received SARS-CoV-2 molecular testing (primarily by reverse transcriptionpolymerase chain reaction assay) during the 14 days before through 72 hours after the encounter. DOI: http://dx.doi.org/10.15585/mmwr.mm7109e3external icon. ** VAERS reports are classified as serious based on the Code of Federal Regulations Title 21 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?frexternal icon). VAERS accepts reports from health care providers, vaccine manufacturers, and members of the public. VAERS reports are classified as serious if there are any reports of hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. Abbreviations: ED=emergency department; ICD-9=International Classification of Diseases, Ninth Revision; ICD-10=International Classification of Diseases, Tenth Revision; SMD=standardized mean or proportion difference; UC=urgent care. Among children aged 511 years during the full study period, VE of 2 doses (1467 days earlier) against COVID-19associated ED or UC encounters was 46%, which was significantly lower than overall estimates for adolescents aged 1217 years.
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pfizer vaccine side effects released march 2022