A peer reviewed case report detailed a case of hepatotoxicity after receiving a COVID-19 vaccine. All dose 2 and booster dose comparisons were statistically significant, except any systemic reaction and needed medical care. Approximately 0.9% (32) of adolescents reportedly received medical care during the week after booster dose vaccination; most (15; 0.4%) care was received via a clinic appointment. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html (Accessed January 11, 2022). This is a report, we are still in discussions with Pfizer, the local office, that is the applicants in the country as well as the FDA, to understand the authenticity of this report, to understand the status of the report. 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). ; C4591001 Clinical Trial Group. Please select the most appropriate category to facilitate processing of your request. eCollection 2022. Sixty-four preliminary reports of myocarditis were received, among which 47 were considered serious; 32 (68.1%) of these reports were confirmed by provider interview or medical record review to meet the CDC working definition of myocarditis. Thompson MG, Stenehjem E, Grannis S, et al. 2020;92:14841490. This is still a very small. In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up. The odds of reporting an event after dose 2 and booster dose were compared for registrants who completed at least one v-safe health check-in survey on days 07 after each vaccination using a multivariable generalized estimating equations model. "At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. 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. This report provides findings from v-safe and VAERS data collected during the first 711 weeks of administration of homologous Pfizer-BioNTech booster doses to persons aged 1217 years, during which time approximately 2.8 million booster doses were administered. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 1217 years. -, A novel coronavirus from patients with pneumonia in China, 2019. Views equals page views plus PDF downloads. 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. The study noted: Adverse events have been mild-to-moderate local reactions and transient systemic symptoms such as fatigue, nausea and headache. This systematic review was undertaken to assess the Pfizer-BioNTech vaccine side effects by reviewing the previous studies. The FDA turned over thousands of documents related to its review of Pfizer-BioNTech's COVID-19 vaccine last week, marking the first of several releases mandated by a court in Texas earlier this year. However, vaccine effectiveness (VE) was lower during Omicron predominance and decreased with time since vaccination; a booster dose restored VE to 81% among adolescents aged 1617 years. Day 1: 21 Big Favours for 21 Years of Gateway, #ECR26 WEEK 3: 26 Years Of Community Service. The U.S. Centers for Disease Control and Prevention has more on RSV. and transmitted securely. You can unsubscribe at any time and we'll never share your details to third parties. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. Clinician-ordered molecular assays (e.g., real-time reverse transcriptionpolymerase chain reaction) for SARS-CoV-2 occurring 14 days before to <72 hours after the encounter date were included. Users are referred to the electronic PDF version (https://www.cdc.gov/mmwr) If the FDA follows the recommendation of its advisors, which it typically does, Pfizer's vaccine would be the first shot to guard against RSV infection, NBC News reported. 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. Finally, although the facilities in this study serve heterogeneous populations in 10 states, the findings might not be generalizable to the U.S. population. Centers for Disease Control and Prevention. ** 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). ; C4591001 Clinical Trial Group. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 1217 years (referred to as adolescents in this report) have also indicated high levels of protection against SARS-CoV-2 (the virus that causes COVID-19) infection and COVID-19associated hospitalization (46); however, data on VE against the SARS-CoV-2 B.1.1.529 (Omicron) variant and duration of protection are limited. V-safe is a voluntary, smartphonebased U.S. active safety surveillance system established to monitor adverse events after COVID-19 vaccination (https://vsafe.cdc.gov/en/). Hause AM, Gee J, Baggs J, et al. Because of the autoantibodies and liver histology suggestive of an autoimmunity, prednisone [20 mg daily] was administered which showed a prompt improvement and after six weeks. SAS software (version 9.4; SAS Institute) was used to conduct all analyses. Vaccination was defined as having received the listed number of doses of an mRNA-based COVID-19 Pfizer-BioNTech 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. Preliminary safety findings for booster doses among adolescents are generally similar to those reported after a primary series in this age group. 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. The average side effects after the first dose were 79% compared with 84% after the second dose. The odds of reporting an adverse reaction or health impact after dose 2 and booster dose were compared using a multivariable generalized estimating equations model; p<0.05 was defined as statistically significant. VAERS reports for adolescents who received a Pfizer-BioNTech booster dose during December 9, 2021February 20, 2022, were described by serious and nonserious classification, demographic characteristics (i.e., sex and age), and MedDRA preferred terms. ** For children aged 511 years and adolescents aged 1215 years, the study period began 5 weeks after the Pfizer-BioNTech vaccine was recommended for their age group. The dates when the Delta and Omicron variants became predominant (accounted for >50% of sequenced viruses) were determined for each study site based on state and national surveillance data. Patients were excluded if they 1) were vaccinated before the CDC recommendation date for their age group, 2) received a third dose before booster doses were recommended for their age group, 3) received a booster dose <5 months after dose 2, 4) received 1 or >3 doses of the vaccine, or 5) if <14 days had elapsed since receipt of dose 2 or <7 days since dose 3. 3501 et seq. Reactions reported after both dose 2 and booster dose vaccination were mostly mild to moderate in severity. The authors have declared that no competing interests exist. Click here to sign in with This document is subject to copyright. part 46; 21 C.F.R. COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna Vaccines. VE point estimates for second dose received 150 days earlier were 73% to 88%; however, differences by time since vaccination were not statistically significant. CDC will follow up on myocarditis reports at 36 months after onset to assess health and functional status. 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. N Engl J Med 2022;386:71323. -, Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-reactivity with SARS-CoV. N Engl J Med 2021;385:21013. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of First, comparison of VE estimates between age groups should be made with caution because of differences in the timing of vaccine availability and predominant variants when the vaccine became available to different age groups. of pages found at these sites. FDA advisors were also split, 7-4 with one abstention, on the safety for the Pfizer vaccine. N Engl J Med 2021;385:23950. 2020;382:727733. However, in adolescents aged 1617 years, VE during the Omicron predominant period increased to 81% 7 days after a third booster dose. Pre-Delta refers to the period before Delta predominance. During December 9, 2021February 20, 2022, v-safe recorded a total of 3,418 Pfizer-BioNTech booster doses administered to adolescents, including 1,952 administered to persons aged 1215 years and 1,466 to those aged 1617 years. Pfizer's document is dated April 2021, and the FDA recently released it in response to a Freedom of Information Act (FOIA) request from Public Health and Medical Professionals for Transparency,. Advisory Committee on Immunization Practices meeting; September 22, 2021; Atlanta, Georgia. March 8, 2022 - Side effects from the Pfizer and Moderna vaccines in the United States have largely been mild and short-lived, a large new study of the first 6 months of vaccinations shows . 2022 Dec 27;11(1):62. doi: 10.3390/vaccines11010062. On March 1, 2022, this report was posted online as an MMWR Early Release. 8600 Rockville Pike Association of COVID-19 vaccination with symptomatic SARS-CoV-2 infection by time since vaccination and Delta variant predominance. 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). The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Among adolescents aged 1617 years, VE increased to 86% 7 days after dose 3 (booster dose). * Funded by CDC, the VISION Network includes Baylor Scott & White Health (Texas), Columbia University Irving Medical Center (New York), HealthPartners (Minnesota and Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California (California), Kaiser Permanente Northwest (Oregon and Washington), Regenstrief Institute (Indiana), and University of Colorado (Colorado). 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. No other potential conflicts of interest were disclosed. Get weekly and/or daily updates delivered to your inbox. That vaccine reduced the risk of severe illness in infants by 82% through the first 90 days of life, NBC News reported. Unable to load your collection due to an error, Unable to load your delegates due to an error. Pre-Delta refers to the period before Delta predominance. ** 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). However, a third vaccine dose restored VE against COVID-19associated ED or UC encounters to 86% among adolescents aged 1617 years. The Advisory Committee on Immunization Practices recommends that all persons aged 12 years receive a booster dose of COVID-19 vaccine 5 months after the second dose of the mRNA vaccine primary series (9). 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Generalized boosted regression trees were used to estimate the propensity to be vaccinated based on sociodemographic characteristics, underlying medical conditions, and facility characteristics. Department of Health and Human Services. Frenck RW Jr, Klein NP, Kitchin N, et al. All statistical analyses were conducted using R software (version 4.1.2; R Foundation). The Pfizer-BioNTech vaccine is the first mRNA-based vaccination that enhances immunity. Vaccine 2015;33:4398405. COVID-19 vaccine side effects commonly include arm soreness, headaches, fatigue, or light flu-like symptoms for a few days after the shotif any at all. The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3).Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age . Resulting in various adverse effects that may emerge after vaccination. Indicates the reference group used for standardized mean or proportion difference calculations for dichotomous variables. 45 C.F.R. This is still a very small amount of people, as it's only 29% of the country's population. In partnership with CDC, the VISION Network* examined 39,217 emergency department (ED) and urgent care (UC) encounters and 1,699 hospitalizations among persons aged 517 years with COVID-19like illness across 10 states during April 9, 2021January 29, 2022, to estimate VE using a case-control test-negative design. The v-safe platform allows current registrants to report receipt of a booster dose of COVID-19 vaccine and new registrants to enter information about all doses received. VISION Network VE methods have been previously published (7). The list notes 1,291 different adverse events following the Pfizer Covid vaccine. Local injection site reactions were more commonly reported after booster dose (82.0%) than dose 2 (77.8%) (p<0.001), and systemic reactions were similarly reported after booster dose (77.8%) and dose 2 (77.2%) (p = 0.48) (Figure). Fourteen articles met the study inclusion criteria. Clipboard, Search History, and several other advanced features are temporarily unavailable. Cookies used to make website functionality more relevant to you. 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. Accessibility We await the expertise and qualified information from Prof Tulio to confirm if this is anything the vaccinated should be concerned about. You may have also noted that there were reports that there was an intention to suppress the data, explains Semete-Makokotlela. More info. What are the implications for public health practice? of pages found at these sites. Suggested citation for this article: Klein NP, Stockwell MS, Demarco M, et al. Daily science news on research developments and the latest scientific innovations, The latest engineering, electronics and technology advances, The most comprehensive sci-tech news coverage on the web. HHS Vulnerability Disclosure, Help This conversion might result in character translation or format errors in the HTML version. For general inquiries, please use our contact form. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. allergic reaction; biontech covid-19 vaccine; bnt162b2 vaccine. Health surveys are sent daily during the first week after administration of each dose and include questions about local injection site and systemic reactions and health impacts. CDCs v-safe call center contacts registrants who indicate that medical care was sought after vaccination and encourages completion of a VAERS report, if indicated. Effectiveness of a third dose of mRNA vaccines against COVID-19associated emergency department and urgent care encounters and hospitalizations among adults during periods of Delta and Omicron variant predominanceVISION Network, 10 states, August 2021January 2022. BNT162b2 [COMIRNATY (COVID-19 vaccine, mRNA)] booster (third) dose. Speaking during the Webinar, Sahpra CEO Dr Boitumelo Semete-Makokotlela says they are examining the veracity of the document. COVID-19: a global challenge with old history, epidemiology and progress so far. References to non-CDC sites on the Internet are The information was only released on 8 March, Tuesday, in a 38-page report. On January 3, 2022, authorization was expanded to include persons aged 1215 years, and for all persons aged 12 years, the interval between dose 2 and booster dose was shortened to 5 months (1). PFIZER vaccine adverse events pertaining to the liver and kidney are extremely rare. They "may not have any causal relationship" to each. She had no history of liver disease and her only medications were labetalol which had been started for gestation hypertension and was continued after delivery. Department of Health and Human Services. *** With a test-negative design, vaccine performance is assessed by comparing the odds of antecedent vaccination among case-patients with acute laboratory-confirmed COVID-19 and control-patients without acute COVID-19. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. Neither your address nor the recipient's address will be used for any other purpose. 1CDC COVID-19 Emergency Response Team; 2Food and Drug Administration, Silver Spring, Maryland. Approximately one week after receiving the COVID-19 vaccine, she developed pruritus followed by dark urine and then jaundice, noted the study. Thompson MG, Natarajan K, Irving SA, et al. medical events that have been observed after vacci nation, but which are not necessarily related to or caused by the vaccine. Local reactions like pain at the injection site are the most common. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of 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. Please enable it to take advantage of the complete set of features! 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. 2022 Dec 25;11(1):46. doi: 10.3390/vaccines11010046. endorsement of these organizations or their programs by CDC or the U.S. Gruber WC. "This is a bombshell," said Children's Health Defense (CHD) president and general counsel Mary Holland. 241(d); 5 U.S.C. N Engl J Med 2020;383:260315. An FDA decision on that is expected in August. A monoclonal antibody injection designed for babies is also under FDA review. The vast majority of side effects from Pfizer and Moderna Covid vaccines are mild and subside within a day or two, according to a CDC study in the Lancet Infectious Diseases medical journal,. Effectiveness of BNT162b2 vaccine against critical Covid-19 in adolescents. 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.. They help us to know which pages are the most and least popular and see how visitors move around the site. The FDA licensed the Pfizer vaccine on Aug. 23, 2021, just 108 days after Pfizer started producing the records to the agency. It was considered a vital component of living endemically with COVID-19. Alamer E, Alhazmi A, Qasir NA, Alamer R, Areeshi H, Gohal G, Qadri M, Hashem AM, Algaissi A. Reports of no adverse event were often accompanied by product storage error, inappropriate schedule of product administration, expired product administered, or underdose. VE was not calculated for exposure categories with fewer than 20 encounters or with no SARS-CoV-2 testpositive cases. 2023 Jan 15;11(1):182. doi: 10.3390/vaccines11010182. READ MORE:"Because I have had COVID-19 I will not get it for three months after I've had it?" Four categories of codes were considered: 1) acute respiratory illness, including COVID-19, respiratory failure, viral or bacterial pneumonia, asthma exacerbation, influenza, and viral illness not otherwise specified; 2) nonrespiratory COVID-19like illness diagnoses including cause-unspecified gastroenteritis, thrombosis, and acute myocarditis; 3) respiratory signs and symptoms consistent with COVID-19like illness, including hemoptysis, cough, dyspnea, painful respiration, or hypoxemia; and 4) signs and symptoms of acute febrile illness. 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). One code in any of the four categories was sufficient for inclusion. 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). GlaxoSmithKline's version would lower risk of symptomatic illness by 83% and of severe illness by 94% in adults 60 and up, according to trial data that was published in February in the New England Journal of Medicine. If approved, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine. 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). Sect. One code in any of the four categories was sufficient for inclusion. Walter EB, Talaat KR, Sabharwal C, et al. From the VAERS data, the CDC received more than 340,000 reports of adverse events after vaccination, with 92% registered as mild The most common side effects were headaches, fatigue, fever and. Chronic respiratory condition was defined as the presence of discharge code for asthma, sleep apnea, or other lung disease using ICD-9 and ICD-10 diagnosis codes. MMWR Morb Mortal Wkly Rep 2021;70:10538. PMC 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. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. Most encounters among adolescents aged 1215 years and 1617 years occurred during the Delta predominant period (14,491 [79.9%] and 8,800 [74.0%], respectively); among children aged 511 years, most (6,424 [70.0%]) occurred during the Omicron predominant period, reflecting differences in the dates when vaccines became available for the respective age groups. The documents were first released in November last year reporting vaccine adverse events. Contact our traffic hotline: (031) 570 9400. FOIA This report provides real-world evidence of protection by the Pfizer-BioNTech vaccine against COVID-19associated ED and UC encounters and hospitalizations among children and adolescents aged 517 years and supports the role of third (booster) doses in maintaining high levels of VE in the setting of Omicron predominance. 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). The number of participants in each study who received the Pfizer-BioNTech vaccine and, MeSH MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services. 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. mmwrq@cdc.gov. ** 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). Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other not listed, and multiple races. She denied taking other medications including over-the-counter agents and herbal supplements. 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. 2021 Nov 9;9(11):1297. doi: 10.3390/vaccines9111297. 2021, filed with the SEC on March 30, 2022, . Abbreviations: MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; VAERS=Vaccine Adverse Event Reporting System. Third ) dose first dose were 79 % compared with 84 % the... Wraps for 75 years published ( 7 ) receiving a COVID-19 vaccine bnt162b2... To moderate in severity Klein NP, Kitchin N, et al months. E, Grannis S, et al vaccine adverse events following the Pfizer Covid vaccine accepts reports from care... ; to each and/or the original MMWR paper copy for printable versions of official text, figures, and.. Study noted: adverse events pertaining to the agency with one abstention, on the safety for the is! As fatigue, nausea and headache your address nor the recipient 's address will be for. ( 031 ) 570 9400 to the liver and kidney are extremely rare et al dose were. Endorsement of these organizations or their programs by cdc or the U.S. Centers Disease. Receiving the COVID-19 vaccine, mRNA ) ] booster ( third ) dose least now we know the... Providers, vaccine manufacturers, and members of the document first released in November year... Been observed after vacci nation, but which are not necessarily related or. On CDC.gov through third party social networking and other websites % compared with 84 % after the first 90 of... Cdc is not responsible for the content the content is provided for information purposes only RW,., but which are not necessarily related to or caused by the vaccine pfizer vaccine side effects released march 2022 jaundice, noted the study and! 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