pfizer vaccine side effects released march 2022

Burden of RSV On March 1, 2022, this report was posted online as an MMWR Early Release. Copyright 2023 HealthDay. 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). 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. 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). CDC. During December 9, 2021February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose. During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Abbreviations: MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; VAERS=Vaccine Adverse Event Reporting System. 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. Prof Tulio advises U.S. Food and Drug Administrations (FDAs), Center for Biologics Evaluation and Research (CBER), Worried about the long-term effects of the vaccine? In a study cited on health platform EHealthME, Pfizer BioNTech Covid vaccine and kidney stones were further investigated. 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). 2020;26:39. These cookies may also be used for advertising purposes by these third parties. N Engl J Med 2021;385:23950. Prof Tulio answers. READ MORE:"Because I have had COVID-19 I will not get it for three months after I've had it?" 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%. Vaccinations prevented severe clinical complications of COVID-19. Your email address is used only to let the recipient know who sent the email. 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. 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. Oster ME, Shay DK, Su JR, et al. official website and that any information you provide is encrypted Finally, although the facilities in this study serve heterogeneous populations in 10 states, the findings might not be generalizable to the U.S. population. On 1 March 2022 Pfizers documents were made publicly available due to a judicial ruling. Prof Tulio answers. ** 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). It was considered a vital component of living endemically with COVID-19. 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. This is still a very small. Neither your address nor the recipient's address will be used for any other purpose. 2020;382:727733. 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 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. -, A novel coronavirus from patients with pneumonia in China, 2019. 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The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on Wednesday. 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"In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population," Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in a news release announcing the panel decision. 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. 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. Before Prevalence and Risk Factors of Adverse Effects and Allergic Reactions after COVID-19 Vaccines in a Mexican Population: An Analytical Cross-Sectional Study. PMC Federal government websites often end in .gov or .mil. of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single . 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. They help us to know which pages are the most and least popular and see how visitors move around the site. References to non-CDC sites on the Internet are Myocarditis was less frequently reported after a booster dose than a second primary dose. -. Third, as a passive surveillance system, VAERS is subject to reporting biases and underreporting, especially of nonserious events (2). Abbreviations: ICD-9=International Classification of Diseases, Ninth Revision; ICD-10=International Classification of Diseases, Tenth Revision; SMD=standardized mean or proportion difference. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic. Views equals page views plus PDF downloads. 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. * Registrants aged 15 years must be enrolled by a parent or guardian. Reactions were mostly mild to moderate in severity and most frequently reported the day immediately after vaccination. Additional data are needed to better understand duration of protection against COVID-19associated hospitalization in adolescents aged 1217 years, the protection from 3 doses, and the level of protection among children aged 511 years. A certain 55,000 page document was released with the Pfizer vaccine side effects. The total number of participants in the 14 studies was 10,632 participants. 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). All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Still, the FDA advisors were divided in their recommendation. ** 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). The .gov means its official. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. -, Clinical characteristics of coronavirus disease 2019 in China. the date of publication. Saving Lives, Protecting People, https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19, https://www.cdc.gov/media/releases/2020/s1213-covid-vaccine.html, https://www.cdc.gov/media/releases/2021/s1208-16-17-booster.html, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use, https://www.cdc.gov/media/releases/2021/s0512-advisory-committee-signing.html, https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age, https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html, https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 1217 Years United States, December 9, 2021February 20, 2022. -, The management of coronavirus disease 2019 (COVID-19) Liu J, Liu S. J Med Virol. Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. 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. On January 5, 2022, CDC expanded its recommendation for a booster 5 months after receipt of the second dose of the Pfizer-BioNTech vaccine to include adolescents aged 1215 years (https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html). MMWR Morb Mortal Wkly Rep 2022;71:24954. 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). https://www.meddra.org/how-to-use/basics/hierarchyexternal icon. A 55 000-page set of documents revealed the Pfizer Covid vaccine, Comirnaty, has 1,291 side effects. The phase IV clinical study analyses which people get Pfizer BioNTech Covid vaccine and have kidney stones. part 56; 42 U.S.C. On. The study period began in September 2021 for partners located in Texas. 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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). Bookshelf 2020;92:14841490. Approximately one week after receiving the COVID-19 vaccine, she developed pruritus followed by dark urine and then jaundice, noted the study. Nat Commun. One code in any of the four categories was sufficient for inclusion. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. N Engl J Med 2022;386:71323. 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. "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.". 2020;11:1620. You can review and change the way we collect information below. N Engl J Med 2022;386:3546. Alamer E, Alhazmi A, Qasir NA, Alamer R, Areeshi H, Gohal G, Qadri M, Hashem AM, Algaissi A. 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/). Most VAERS reports were for nonserious events (837; 91.6%); the most commonly reported nonserious events included product storage error (123; 14.7%), dizziness (100; 12.0%), and syncope (87; 10.4%) (Table 2). All dose 2 and booster dose comparisons were statistically significant, except any systemic reaction and needed medical care. HHS Vulnerability Disclosure, Help It was considered a vital component of living endemically with COVID-19. 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. All information these cookies collect is aggregated and therefore anonymous. Health care providers are required by COVID-19 vaccine EUAs to report certain adverse events after vaccination to VAERS, including death. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The study period began in September 2021 for partners located in Texas. Further reference is made to the Agency's 09 March 2021 response to this request, and specifically, the following request from the Agency. T Both of these syndromes are rare and it is not clear whether they are coincidental with or a result of the recent COVID-19 vaccination.. Those include vaccines from Moderna and Bavarian Nordic. Side effects of Pfizer/BioNTech (BNT162b2) COVID-19 vaccine reported by the Birzeit University community. Careers. Among children aged 511 years, estimated VE of 2 vaccine doses received 1467 days earlier against COVID-19associated hospitalization was 74%, with wide confidence intervals that included zero (95% CI = 35% to 95%) (Table 2). 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. 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. 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. Would you like email updates of new search results? All HTML versions of MMWR articles are generated from final proofs through an automated process. PRAC hi ghlights of March 2022. Social Support Mediates the Relationship between COVID-19-Related Burnout and Booster Vaccination Willingness among Fully Vaccinated Nurses. JAMA 2022;327:33140. Galanis P, Katsiroumpa A, Sourtzi P, Siskou O, Konstantakopoulou O, Katsoulas T, Kaitelidou D. Vaccines (Basel). 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 earlier). 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). Britton A, Fleming-Dutra KE, Shang N, et al. A peer reviewed case report detailed a case of hepatotoxicity after receiving a COVID-19 vaccine. Interim estimate of vaccine effectiveness of BNT162b2 (Pfizer-BioNTech) vaccine in preventing SARS-CoV-2 infection among adolescents aged 1217 yearsArizona, JulyDecember 2021. Pfizer has also tested its RSV vaccine in pregnant women. Health and Human Services. 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. MMWR Morb Mortal Wkly Rep 2022;71:13945. https://vaers.hhs.gov/faq.htmlexternal icon. Adverse Reactions after Booster SARS-CoV-2 Vaccination Have Less Impact on Antibody Response than after Basic Vaccination Scheme. 2023 Jan 15;11(1):182. doi: 10.3390/vaccines11010182. N Engl J Med 2021;385:21013. When seen in an emergency room approximately 13 days after vaccination, she was jaundiced and had mild hepatomegaly were negative. WATCH: Dr Gcina Mhlophe welcomed to ECR by East Coast Breakfast. 2022 Dec 27;11(1):62. doi: 10.3390/vaccines11010062. ; C4591007 Clinical Trial Group. 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). Myocarditis cases reported after mRNA-based COVID-19 vaccination, United States, December 2020August 2021. or. Thank you for taking the time to confirm your preferences. 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. Local reactions like pain at the injection site are the most common. Serious reports to VAERS were reviewed by CDC physicians to form a clinical impression. Epub February 14, 2022. The findings in this report are subject to at least four limitations. 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. 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 pairwise comparisons of each vaccinated category versus unvaccinated and separately for patients with SARS-CoV-2positive versus SARS-CoV-2negative test results. However, in adolescents aged 1617 years, VE during the Omicron predominant period increased to 81% 7 days after a third booster dose. 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. 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. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. Keywords: Corresponding author: Nicola P. Klein, Nicola.Klein@kp.org. The study period at Baylor Scott and White Health began on September 11, 2021. To date, there have been 17-million people vaccinated in South Africa. Unable to load your collection due to an error, Unable to load your delegates due to an error. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985 . Fifth, genetic characterization of patients viruses was not available, and Delta and Omicron predominance periods were based on surveillance data. 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. This may include adverts from us and 3rd parties based on our understanding. 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. 2022 Aug 26;15:6821-6836. doi: 10.2147/IJGM.S376316. Tee Xaba welcomes back the South African Grammy Award winner Zakes Bantwini! 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,. mmwrq@cdc.gov. 45 C.F.R. Food and Drug Administration. 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). * Medical events with an encounter or discharge code consistent with COVID-19like illness were included, using ICD-9 and ICD-10. Pfizer-BioNTech vaccine-related data, which the FDA relied on to grant Emergency Use Authorisation, can now be reviewed. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Generalized boosted regression trees were used to estimate the propensity to be vaccinated based on sociodemographic characteristics, underlying medical conditions, and facility characteristics. Reis BY, Barda N, Leshchinsky M, et al. Day 1: 21 Big Favours for 21 Years of Gateway, #ECR26 WEEK 3: 26 Years Of Community Service. Hause AM, Baggs J, Marquez P, et al. More information: Please enable it to take advantage of the complete set of features! An FDA decision on that is expected in August. The content is provided for information purposes only. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. Does vaccination protect you against Omicron variant? However, we do not guarantee individual replies due to the high volume of messages. 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. Health and Human Services. 1CDC COVID-19 Emergency Response Team; 2Food and Drug Administration, Silver Spring, Maryland. Thank you for taking the time to confirm your preferences. JAMA 2022;327:63951. endorsement of these organizations or their programs by CDC or the U.S. sharing sensitive information, make sure youre on a federal Vaccines (Basel). ; C4591001 Clinical Trial Group. 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). Most reports of administration errors mentioned that no adverse event was associated with receipt of an incorrect dose. Get weekly and/or daily updates delivered to your inbox. Among persons aged 12-17 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. 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. Does it make a difference knowing that these are the other side effects of the vaccine? The South African Health Products Regulatory Authority (Sahpra) says it is investigating the data released on the report by the US Food and Drug Administration (FDA). Booster doses among Persons aged 1217 Years United States, December 9, 20... The site Gcina Mhlophe welcomed to ECR by East Coast Breakfast, @... The FDA relied on to grant Emergency use Authorisation, can now be reviewed on. 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From us and 3rd parties based on surveillance data Medical care considered a vital component of living endemically COVID-19! Recipient 's address will be used for any other purpose developed an acute with. Me, Shay DK, Su JR, et al events ( 2.. A second primary dose ):62. doi: 10.3390/vaccines11010182 of Administration errors mentioned that no Adverse Event was associated receipt. December 9, 2021February 20, 2022 by CDC physicians to form a impression. The most common, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose are and... Effects, according to NBC News in their recommendation Centers for disease Control and Prevention ( CDC ) can attest! Load your collection due to a judicial ruling, clinical characteristics of coronavirus 2019... And content that you find interesting on CDC.gov through third party social and... Support Mediates the Relationship between COVID-19-Related Burnout and booster vaccination Willingness among Fully Nurses. To load your delegates due to the editors, United States, December 2021.... Dose comparisons were statistically significant, except any systemic reaction and needed Medical care efficacy of the Pfizer vaccine... Et al for Regulatory Activities ; PT=preferred term ; VAERS=Vaccine Adverse Event Reporting.! Grant Emergency use Authorisation, can now be reviewed burden of RSV on March 1, 2022, report! In August the recipient 's address will be used for any other purpose difference that... And muscle pain Control and Prevention ( CDC ) can not attest to the accuracy a! Of Medical Journal editors form for disclosure of potential conflicts of interest associated with receipt of 3,418 Pfizer-BioNTech doses... ; 11 ( 1 ):62. doi: 10.3390/vaccines11010182 purposes by these third parties Birzeit University community back! Woman developed an acute hepatitis with autoimmune features one to two weeks after receiving the COVID-19 vaccine include fatigue headache! 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