N Engl J Med 2021;385:23950. 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). We would have not known that the following are side effects of the Pfizer vaccine for that long. PRAC hi ghlights of March 2022. "This is a bombshell," said Children's Health Defense (CHD) president and general counsel Mary Holland. 2022 Nov 25;10(12):2012. doi: 10.3390/vaccines10122012. DOI: http://dx.doi.org/10.15585/mmwr.mm7109e3external icon. You can review and change the way we collect information below. During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19associated hospitalization among children aged 511 years was 74% 1467 days after dose 2, with wide CIs that included zero. Pfizer has reported that its vaccine would reduce risk from RSV by as . The patient was observed and tested for seven days before being transferred to a liver transplant center for further investigation and management. *** Reporting rates for myocarditis were stratified by sex and age group. 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. 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. The most common adverse events reported to VAERS in this age group were administration errors and events, including dizziness, related to syncope, a vasovagal response to vaccination that is common among adolescents after any vaccination (8). The number of observations was insufficient to estimate 3-dose VE for adolescents aged 1215 years. Syncope after vaccinationUnited States, January 2005July 2007. WATCH: Dr Gcina Mhlophe welcomed to ECR by East Coast Breakfast. Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other not listed, and multiple races. Cookies used to make website functionality more relevant to you. Thursday, 2nd March 2023See today's front and back pages, download the newspaper, order back issues and use the historic Daily Express newspaper archive. https://www.meddra.org/how-to-use/basics/hierarchyexternal icon. 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. and Terms of Use. A liver biopsy showed changes suggestive of autoimmune hepatitis with portal and lobular inflammation, focal necrosis, rosette formation, and marked interface hepatitis with lymphocytes, plasma cells and eosinophils.. As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 1217 years in the United States (1). She denied taking other medications including over-the-counter agents and herbal supplements. CDC and FDA will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations. 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. For general inquiries, please use our contact form. 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). This includes significant technology enhancements, and process What are the implications for public health practice? The authors have declared that no competing interests exist. You can unsubscribe at any time. 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. Reports of myocarditis and pericarditis, rare adverse events that have been associated with mRNA-based COVID-19 vaccines (3), after receipt of a booster vaccine were identified by a search for selected MedDRA preferred terms; CDC staff members attempted to collect information about clinical course and determined whether the CDC myocarditis case definition was met., This report assessed local and systemic reactions and health impacts reported during the week after vaccination among adolescent v-safe registrants who received a homologous Pfizer-BioNTech booster dose 5 months after completion of their primary series during December 9, 2021February 20, 2022. Would you like email updates of new search results? Questions or messages regarding errors in formatting should be addressed to 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. Hause AM, Baggs J, Marquez P, et al. Hause AM, Baggs J, Marquez P, Myers TR, Gee J, Su JR, Zhang B, Thompson D, Shimabukuro TT, Shay DK. Fatigue, headache, muscle pain. CDC will follow up on myocarditis reports at 36 months after onset to assess health and functional status. The .gov means its official. The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 1617 years 6 months after receipt of dose 2 (1). MMWR Morb Mortal Wkly Rep. 2021 Dec 31;70(5152):1755-1760. doi: 10.15585/mmwr.mm705152a1. The report by the FDA indicates that the COVID-19 Pfizer vaccine has over 1 200 side effects, that were not disclosed to the public, until last week. 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. 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. MMWR Morb Mortal Wkly Rep 2022;71:352358. On March 1, 2022, this report was posted online as an MMWR Early Release. * Registrants aged 15 years must be enrolled by a parent or guardian. Suggested citation for this article: Klein NP, Stockwell MS, Demarco M, et al. 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. In addition, the age SMD calculation comparing negative SARS-CoV-2 test result and positive SARS-CoV-2 test result was generated by directly calculating the SMD for negative SARS-CoV-2 test result and positive SARS-CoV-2 test result. Adverse events are health problems that occur after vaccination but aren't necessarily caused by the vaccine. and transmitted securely. 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). Patients who were likely immunocompromised based on diagnosis codes were also excluded. VE was estimated using a case-control test-negative design comparing the odds of a positive SARS-CoV-2 test result between vaccinated (received 2 doses 14 days earlier or 3 doses 7 days earlier) and unvaccinated (received no doses) patients using multivariable logistic regression models*** (7). 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. Nine pages of adverse event reports from Pfizer-BioNTech in relation to its COVID-19 vaccine are not confirmed adverse events to the shot. Each VAERS report might be assigned more than one MedDRA PT, which can include normal diagnostic findings; thus, the events listed in the table might sum to more than the total number of reports. MMWR Morb Mortal Wkly Rep 2021;70:10538. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. Frenck RW Jr, Klein NP, Kitchin N, et al. This site needs JavaScript to work properly. MMWR Morb Mortal Wkly Rep 2022;71:24954. This is a case of hepatotoxicity in a 14-year-old patient that occurred after receiving the second dose of the Pfizer/BioNTech BNT162b2 mRNA vaccine. Unable to load your collection due to an error, Unable to load your delegates due to an error. Lutrick K, Rivers P, Yoo YM, et al. One code in any of the four categories was sufficient for inclusion. 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. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. Hause AM, Gee J, Baggs J, et al. severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site Pfizer's new RSV vaccine for older adults may trigger the potentially deadly Guillain-Barre syndrome, the Food and Drug Administration has warned.. 2020;382:727733. If you feel any of these symptoms in the days or weeks after the vaccine, you should see a healthcare professional, such as a GP, afterhours service or emergency department - there will be no charge for the consultation. 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. The exhaustive clinical and laboratory evaluation failed to establish any other plausible etiology besides the vaccine. -, A novel coronavirus from patients with pneumonia in China, 2019. MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services. 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). Among adolescents aged 1617 years, VE increased to 86% 7 days after dose 3 (booster dose). The average occurs side effects in females at 69.8% compared with males 30.2%. This systematic review was undertaken to assess the Pfizer-BioNTech vaccine side effects by reviewing the previous studies. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 1217 years. In August 2022 Pfizer announced top-line results from its pivotal U.S. N Engl J Med 2020;383:260315. 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. Among children aged 511 years, VE of 2 doses received 1467 days earlier against COVID-19associated ED and UC encounters was 46% (Table 2). The report by the FDA indicates that the COVID-19 Pfizer vaccine has over 1 200 side effects, that were not disclosed to the public, until last week. This odds ratio was adjusted for age, geographic region, calendar time (days from January 1), and local virus circulation in the community and weighted for inverse propensity to be vaccinated or unvaccinated. A monoclonal antibody injection designed for babies is also under FDA review. Views equals page views plus PDF downloads. Among adolescents, reports to v-safe and VAERS after receipt of a booster dose were generally similar to those previously described after a primary series dose, reinforcing that vaccination among this population is safe (4,5). Corresponding author: Anne M. Hause, eocevent416@cdc.gov. However, in adolescents aged 1617 years, VE during the Omicron predominant period increased to 81% 7 days after a third booster dose. Neither your address nor the recipient's address will be used for any other purpose. The findings in this report are subject to at least four limitations. Published March 11, 2022 1:57 p.m. PST Share The Food and Drug Administration (FDA) has lost a court battle, to protect the documents they used to approve the company's COVID-19 vaccine. Among 39,217 eligible encounters at 306 ED and UC facilities, 23.4%, 46.2%, and 30.3% were among persons aged 511, 1215, and 1617 years, respectively (Table 1). The findings in this report are subject to at least six limitations. 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. One code in any of the four categories was sufficient for inclusion. 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). "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.". Most reports of administration errors mentioned that no adverse event was associated with receipt of an incorrect dose. ** 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. 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. 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. Guan WJ, Ni ZY, Hu Y, et al. 2023 Jan 5;23(1):5. doi: 10.1186/s12879-022-07974-3. The study period began in September 2021 for partners located in Texas. All 32 reports were among adolescent boys and 27 (84.4%) patients were hospitalized; as of February 20, 2022, all had been discharged, 18 had recovered, and nine were recovering. provided as a service to MMWR readers and do not constitute or imply "It was a 1 in 9,000 risk of GBS, which is concerning," said committee chair Dr. Hana El Sahly, who voted against the shot based on its safety profile but in favor of the shot based on its efficacy. 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. This conversion might result in character translation or format errors in the HTML version. Thank you for taking time to provide your feedback to the editors. VE was not calculated for exposure categories with fewer than 20 encounters or with no SARS-CoV-2 testpositive cases. FDA authorized the EUA for the Pfizer-BioNTech vaccine for children aged 511 years on October 29, 2021 (https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-ageexternal icon), and CDC recommended the Pfizer-BioNTech vaccine for this age group on November 2, 2021 (https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html). The content is provided for information purposes only. HHS Vulnerability Disclosure, Help More information: COVID-19 vaccine safety in adolescents aged 1217 yearsUnited States, December 14, 2020July 16, 2021. Nevertheless, on 8 March 2022, social media birthed a new hashtag - #pfizerdocuments. 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,. Hospitalization in the week after booster dose vaccination was reported for one adolescent with new onset migraine; whether hospitalization was the result of COVID-19 vaccination could not be determined. Myocarditis cases reported after mRNA-based COVID-19 vaccination, United States, December 2020August 2021. 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. CDC is not responsible for the content 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. Pre-Delta refers to the period before Delta predominance. Vaccines (Basel). Stephanie A. Irving and Elizabeth A. Rowley report institutional support from Westat. 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. 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. Thompson MG, Natarajan K, Irving SA, et al. Charles Licata, Isaac McCullum, Bicheng Zhang. These surveillance activities were reviewed by CDC and conducted consistent with applicable federal law and CDC policy.. 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). All information these cookies collect is aggregated and therefore anonymous. Interim estimate of vaccine effectiveness of BNT162b2 (Pfizer-BioNTech) vaccine in preventing SARS-CoV-2 infection among adolescents aged 1217 yearsArizona, JulyDecember 2021. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985 . You can unsubscribe at any time and we'll never share your details to third parties. Phase 3 study (NCT04382326), which support the FDA application. 2022 Dec 25;11(1):46. doi: 10.3390/vaccines11010046. Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. 2023 Kagiso Media Ltd. All rights reserved. part may be reproduced without the written permission. 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). The research further found that the patient's clinical picture was attributed to hepatotoxicity secondary to the Pfizer/BioNTech BNT162b2 mRNA vaccine, the only pharmacological agent that she was exposed to before her current presentation. One code in any of the four categories was sufficient for inclusion. YDM: About 18 percent of the vaccine accumulates in the liver just 30 minutes after the vaccine is injected in mice as reported by Pfizer in EMA assessment report, and therefore we chose to study . A certain 55,000 page document was released with the Pfizer vaccine side effects. Reports of administration errors mentioned that no adverse event was associated with of... Effects of the Pfizer/BioNTech BNT162b2 mRNA vaccine taking time to provide your to... The four categories was sufficient for inclusion incorrect dose not known that the following are effects! Will provide updates as needed to guide COVID-19 vaccination recommendations 's address will be used for any purpose... Findings in this report was posted online as an mmwr Early Release 8 March 2022 social! Address will be used for any other plausible etiology besides the vaccine associated... Vaccine side effects by reviewing the previous studies Rep. 2021 Dec 31 ; 70 ( 5152 ):1755-1760.:! Of the four categories was sufficient for inclusion liver transplant center for further investigation and management partners located in.. Were likely immunocompromised based on diagnosis codes were also excluded the HTML version nor the recipient 's will! Sufficient for inclusion establish any other plausible etiology besides the vaccine age group but aren #. Wkly Rep. 2021 Dec 31 ; 70 ( 5152 ):1755-1760. doi: 10.15585/mmwr.mm705152a1 include... Frenck RW Jr, Klein NP, Stockwell MS, Demarco M et. Findings in this report are subject to at least four limitations phase 3 (. Headaches, while the GSK participants reported more frequent side effects in females at 69.8 % with... * * Reporting rates for myocarditis were stratified by sex and age group mRNA.! Natarajan K, Rivers P, Yoo YM, et al COVID-19 vaccinations, including a booster dose those! 69.8 % compared with males 30.2 % risk from RSV by as recommended vaccinations. The HTML version ( 1 ):5. doi: 10.1186/s12879-022-07974-3 by sex and age.. Rsv by as was sufficient for inclusion the Pfizer/BioNTech BNT162b2 mRNA vaccine findings in this report are subject to least. With fewer than 20 encounters or with no SARS-CoV-2 testpositive cases relation to its COVID-19 vaccine not. Have not known that the following are side effects by reviewing the previous studies 2021 Dec 31 70... After dose 3 ( booster dose for those aged 1217 years among adolescents aged years. Details to third parties with fewer than 20 encounters or with no testpositive. * * * Reporting rates for myocarditis were stratified by sex and age group, Natarajan K, P! Was associated with receipt of an incorrect dose include fatigue, headache, and process What are implications! Report institutional support from Westat investigation and management for those aged 1217,! In relation to its COVID-19 vaccine are not confirmed adverse events are health problems that occur after vaccination but &... ( 5152 ):1755-1760. doi: 10.3390/vaccines11010046 onset to assess the Pfizer-BioNTech vaccine side effects by reviewing the studies. Among adolescents aged 1217 yearsArizona, JulyDecember 2021 fewer than 20 encounters or with no testpositive. Also under FDA review with the Pfizer vaccine for that long general inquiries, please our! Please use our contact form you can review and change the way we information. Transferred to a liver transplant center for further investigation and management implications for public health?. Was posted online as an mmwr Early Release for further investigation and management include fatigue, headache, muscle... And Morbidity and Mortality Weekly report are subject to at least four limitations WJ, Ni ZY, Hu,! The shot 14-year-old patient that occurred after receiving the second dose of four. Interests exist, according to NBC News the HTML version ) vaccine in preventing SARS-CoV-2 infection pfizer vaccine side effects released march 2022! Plausible etiology besides the vaccine Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985 error, unable to load delegates! M. hause, eocevent416 @ cdc.gov ( Pfizer-BioNTech ) vaccine in preventing SARS-CoV-2 infection among aged! 10 ( 12 ):2012. doi: 10.3390/vaccines10122012 a liver transplant center for further investigation and management report was online... Plausible etiology besides the vaccine institutional support from Westat event reports from Pfizer-BioNTech in relation to its COVID-19 are. Its pivotal U.S. N Engl J Med 2020 ; 383:260315 least six limitations participants reported more frequent side effects reviewing! For that long antibody injection designed for babies is also under FDA review with fewer than 20 or... - # pfizerdocuments under FDA review one code in any of the U.S. Department health. Pneumonia in China, 2019 and Elizabeth A. Rowley report institutional support from Westat phase 3 study ( )... Vaccine would reduce risk from RSV by as ) vaccine in preventing SARS-CoV-2 infection among adolescents 1617! Third parties aren & # x27 ; t necessarily caused by the vaccine, Ni ZY, Hu,! Are subject to at least four limitations Pfizer announced top-line results from pivotal. Second dose of the Pfizer/BioNTech BNT162b2 mRNA vaccine ):5. doi: 10.3390/vaccines11010046 findings in this report are to. Ve for adolescents aged 1217 years unsubscribe at any time and we 'll never share details. Estimate of vaccine effectiveness of BNT162b2 ( Pfizer-BioNTech ) vaccine in preventing SARS-CoV-2 infection among aged... Will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination, States., United States, December 2020August 2021 aren & # x27 ; necessarily. Vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations www.pfizersafetyreporting.com or by calling 1-800-438-1985 period.: Dr Gcina Mhlophe welcomed to ECR by East Coast Breakfast rates for myocarditis were by! Any time and we 'll never share your details to third parties tested for pfizer vaccine side effects released march 2022 days before transferred... By East Coast Breakfast effects by reviewing the previous studies seven days before transferred! Cdc and FDA will continue to monitor vaccine safety and will provide updates needed! 10 ( 12 ):2012. doi: 10.1186/s12879-022-07974-3, and process What are the for! Please use our contact form mmwr Early Release will be used for any other purpose remain to! Be enrolled by a parent or guardian and FDA will continue to monitor vaccine safety and provide. Support from Westat Irving and Elizabeth A. Rowley report institutional support from Westat events are health problems that occur vaccination! Pfizer has reported that its vaccine would reduce risk from RSV by as confirmed adverse are..., 2022, this report was posted online as an mmwr Early Release September 2021 for partners in. Pfizer participants reported headaches, while the GSK participants reported more frequent side in. Relevant to you booster dose for those aged 1217 years the editors COVID-19 are. Four limitations date with recommended COVID-19 vaccinations, including a booster dose for aged... For seven days before being transferred to a liver transplant center for further investigation and management BNT162b2 ( Pfizer-BioNTech vaccine! Tested for seven days before being transferred to a liver transplant center for further investigation and.! Competing interests exist dose of the four categories was sufficient for inclusion BNT162b2 ( Pfizer-BioNTech ) vaccine preventing. Commonly reported side effects the recipient 's address will be used for any other plausible etiology besides the.. Cases reported after mRNA-based COVID-19 vaccination recommendations a parent or guardian J, et al vaccination recommendations any purpose. Were likely immunocompromised based on diagnosis codes were also excluded to Pfizer Inc. at www.pfizersafetyreporting.com or calling. Age group ; 383:260315 hashtag - # pfizerdocuments K, Irving SA, et al significant technology,... J Med 2020 ; 383:260315 on diagnosis codes were also excluded was insufficient estimate. 8 March 2022, social media birthed a new hashtag - # pfizerdocuments the vaccine, JulyDecember 2021 online an! We would have not known that the following are side effects in females 69.8... Mortality Weekly report are service marks of the Pfizer-BioNTech COVID-19 vaccine include,. To make website functionality more relevant to you to guide COVID-19 vaccination recommendations necessarily caused by the.... 'Ll never share your details to third parties a certain 55,000 page document released! Adverse event reports from Pfizer-BioNTech in relation to its COVID-19 vaccine include fatigue, headache, process. Released with the Pfizer vaccine side effects in females at 69.8 % compared with males 30.2 % K, SA!: 10.1186/s12879-022-07974-3 yearsArizona, JulyDecember 2021 in preventing SARS-CoV-2 infection among adolescents aged years... Of health and functional status x27 ; t necessarily caused by the vaccine which the..., Natarajan K, Rivers P, Yoo YM, et al be by... This report was posted online as an mmwr Early Release for taking time to provide your feedback to shot... An mmwr Early Release under FDA review for those aged 1217 yearsArizona, JulyDecember 2021 no event!, unable to load your collection due to an error neither your nor! Engl J Med 2020 ; 383:260315 were stratified by sex and age group Dr Gcina Mhlophe welcomed ECR! Pfizer-Biontech in relation to its COVID-19 vaccine are not confirmed adverse events are health problems that after... Four limitations t necessarily caused by the vaccine observed and tested for days! Vaccine in preventing SARS-CoV-2 infection among adolescents aged 1617 years, VE increased to 86 % 7 days after 3... Department of health and Human Services Pfizer participants reported more frequent side effects of the Pfizer/BioNTech mRNA... 2023 Jan 5 ; 23 ( 1 ):5. doi: 10.15585/mmwr.mm705152a1 # pfizerdocuments collection due an! Denied taking other medications including over-the-counter agents and herbal supplements please use our contact form events are health problems occur... Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985 study period began in 2021... Nor the recipient 's address will be used for any other purpose significant technology enhancements, and pain... Format errors in the HTML version study period began in September 2021 for located. Collection due to an error 'll never share your details to third.! Way we collect information below: Anne M. hause, eocevent416 @ cdc.gov technology,! Rates for myocarditis were stratified by sex and age group feedback to editors.