(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 redness; nausea; feeling unwell; swollen
lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
-- These may not be all the possible side effects of the vaccine. Serious
and unexpected side effects may occur. The vaccine is still being studied
in clinical trials. Call the vaccination provider or healthcare provider
about bothersome side effects or side effects that do not go away
There is no information on the use of the vaccine with other vaccines.
Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.globenewswire.com/Tracker?data=xdypPuTxcjAtzMWzjupygR06KoCRJLFZaTYPSRomIdcIUtE6Jt_y5MhWgVwDX4Vk0zcgC_lHD-T47lptcHwKmwCQzXZJzqFrKx9JfmWmVrsBZbf9FTiFNoNhyBykvBsjZ77oraPEodzvNxfijM1uq-18TpeEaSOFz80WfRN3V4Sy41Hw3cqcgJjbpMNxjkyfkOzVFhrtig2d0Z0cX0APRCi3mVYfG0UCWhexvFVIFZO5YfotM-2nBB55JAiPjR4OgqiU_2yQD7SRg1y34QQjHQx3TVj3b8O3Vyc6RIZx8UNym8S8hb1F0ng4INOZgsDI http://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at https://www.globenewswire.com/Tracker?data=DobgjF5UFLwybFyJOjveH4ANGz39pNLU9vo2bKYjFMRhqcUuHBKSxosuLoLGlJTDnqwx6KlOewlTSry9Brl0o-MxfLyi4ls26bY8iYVAQ05Np5f4wNax_W9r9VJh-zWNMU5CbOHv_M2-4Y9mq6xaKala-_Z5B2R0keCL8bIxfSqR_R-eU8xKrazdUw605wGb0VHFmJFw12znm2Yb-_EYH8hJdTZtMdfCI9aP631wtv7m5570rXWTP_q0N4Ho37_USInlg6lGoxXxhPPDF8LDGNH6p_zhPs4Nq4xlfiQy_NLVDIRik1lb8rjCwgMUW6wc2JAWm4ZeNFJmn2sKe1d7Bw== www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please https://www.globenewswire.com/Tracker?data=4AmawpC-6emOuGg_U5ohJo_0SlY_fFoxwxm8FP33z4LIesBQKeDSnDXeMb6qS7fQK4X39HsatK3yKvjhE4jItThVetvaKSH26hdeGkKNsdjJ4H2n3T9IDlbKJLQyo5CrAlwCttxf-TpXzN8l3-EXf89CmjYV7W1vIDepyT1o0Xa610_t9IPSZ4gc7546mAs8c5i_Qkhf5nHShttAHZYRWtBUeE0TG9ZGh1JIWSSIrArw_ljnskSewRIKjNgKTXwMZmwKQUhDQkq2LkX41SN28LVWh-ZWcVAyTFE55W_qSXjJwdzez6FntrqWkbET3ZmRpFhdic7alKERc-iKfqD4Pw== click here for full Prescribing Information (16+ years of age). Please https://www.globenewswire.com/Tracker?data=4AmawpC-6emOuGg_U5ohJrjpP762zjtIV1FSDYtJ2P-ia3gJI4ov06IE_MByy9m0l7zWR3rLhc0msi_Q_Y9fXyqNMzFOY2h1Tr7ubPCOZoQywEs8ooixYzQutWlVsp_PxRG3uK1sOSsIQvf5e_7GB0b7f1pEhj5PiUeItFrTGrKKA_HhZyyNWjgKhraCIWSprC3GGnajU33rQ66_VTOVbsYpX33FBrDKauJJGcFJ4ZeGQzd3ZvMY6f3Mcam3YHqksx8VLsXnQwPaXsl1ssCAgVX9up-dP3ugdIFEvReokMvSNc3jh-VdjzWpPFR6rAvv3chpW9FTRz698YsbJl_jeg== click here for Fact Sheet for Vaccination Providers (12+ years of age).
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at https://www.globenewswire.com/Tracker?data=DobgjF5UFLwybFyJOjveH7l_isO49y5ZxGVdd5pykx23qbQ_vR0NmDG0C7vs6LoAG3r6i12tamK2oZdVabalr-9F4u6AM6JgLkXJIG-j1WttplPz3xIqjk09c8l6uaPC-Xrl1utOwyk8I3hTs0Y1CzwhZfuD_ga4GU4EgMH6PuNp_7Pho0kKSt9QzIcT8kw2HUuZsbRHiQxsohunHGXT8obZf9fyixR-VKm6jsqrBElGccohiZLInyYNHRr8l7iOTiuiwDatTJFLwBELg16FrMQhgZXb258vyRv3O4Ai_4c= www.Pfizer.com. In addition, to learn more, please visit us on https://www.globenewswire.com/Tracker?data=DobgjF5UFLwybFyJOjveH_F-aI2fYhR9c0SZj5_narv48qhXKGmnfytJZrz9oQUvMyqucc8gLnWwLSXBoXBI5XdPHxIBjfexcQaESwJVIjJkr4X9bO4_bd_h99RF4xcax2uqbZrD8UDlQlPTWuKYW-bq1TWzRxskuHuDHVTMj_qipo_Vg44tQ0f-Gl8uaQJdb-NAnwsc8IPcb4CF72RXA24kW4iM1DCtVe9WkfHhAdFJYi_sYP0rU09_0EyWkCaEdIOcN4quq06JmI2wWBoP55V-4EeBMo4hx4uYadzjIaU= www.Pfizer.com and follow us on Twitter at https://www.globenewswire.com/Tracker?data=HmjwpONLv-_K-ZzsE2IXG-jsfhYNCZw4eiSJ1guzdDL4IZa_CnckhKGUxX15T2C7BqwWL1MRbeQLSRzier9UrlKIlTlxrxiMjlelM_XAchE19KurPe0qt4XTsWBCKQ3pqtiKAygxmWjReAQa_bzKD8vMXUKIYZ0rMuf2Loqb3PDazxFSB8o51td6h1Vh0ooP7qXDyvON2zi7VN5sLmX_SXLFII7E9OTv3FJ3yzjVFf3uHLuiPaeuZIAYXnW1E5p1i6JTG2Rq_yYhxJ4S6vzgvQ== @Pfizer and https://www.globenewswire.com/Tracker?data=HmjwpONLv-_K-ZzsE2IXG7nM7LuTQajyQD5hyN_U_v1t-U81rgAMAFtq2bRoDaHVmM6906UpIRLp9axoakXDVY9b0jXX7Wg8gQ9eyARvPEMMXyAgPm-QAanYLl2LHZMHzI4h-8kA0KVbzFqknCEfsAkx_E3L-uTfDbe2ZhqI0hLOjIpcLZV5XDFpEX3dBz4sW13Z0lo3Osw67gUHfzmEZgHeXgVW6FYmP2TBbyce3xuwVEItv7AehHOEaLFrGdcbJn8eKSrYeWaWhiMayxsM8lJE3sAK-uG2XSbZcSAm4Hc= @Pfizer News, https://www.globenewswire.com/Tracker?data=X8_frO7xai-ADFtCyMojnPbt0t65ppGwlAtpc_7tOKRZlQpV1veLd2lzLSCUWrcb67qoqrNw1bdN5xXTSxqcR7vQOZPDwrT1MldVGNh6fnyiCjfkdpOy2P0V-bGfc2tlfUgOr7SRvC0y_oG-_WN0Ht0oKh3qQehPMsk_FwEKO4s-R3PmoBlQc9Oy2XB9sE6PW2F7UlKwtFtZ5l-pg3Jtm06lxJFwYYbbNERQdOunjHcs9JTxYLAY0_C86DozUj2JGCjD3RL4vaGZtVazTmN12yBc6icd_RE4edlWLzc9nys= LinkedIn, https://www.globenewswire.com/Tracker?data=BZ6aOm6hcWVJyMx7m1RnL6XzwoeWFuCn4OvQejzJOForgSWkSQuhI8nOogkCaL8G1Ulkj71ul9xRO8m5HVQA-wTBrULTLS8jNceQSMV96VMJGVCjPI7NNkE_6z82L7KQ8ulZzY9ghZ924PMB27b4HRbQR-ifpdzDBqMHd2fqjIthzur2e7WeKPht49sZ7UWfCYkYbhQb8WXwpEkEyVim8algfFnxtY0clzWLTAbqeRN_rMftabXVyC388LrxSNVWMvRjOXQ_HubdYfE6lT7edCW28cUF-KIDLgpT6DzCAGA= YouTube and like us on Facebook at https://www.globenewswire.com/Tracker?data=8P9XoIgulyJvYsnMIDzHQROaKjhREWekIlZZLNU1rE5nM23FJrWFi6s_6X782Uyq07j9gBhz_wqe-RDaElAl9esZN4KNr6HDCpgb387HtVlDiOGQNyt2Mr5M9m4Ex_bt2JgI7xLJsLld7Kn1zaU5kWv-L6TEs4AaigMQwphlk-TnIppHOm_Y7mgizG6LInEvoyJv2NO9fnpTJPbgAsnlxL9CL_Zw5m5isFHyU413y2BjnGOKkuQWQioclBYaCulBGxuuX60lba_OM1eY6K8KYS3BhKsrV4Sm4Oak_Fj_NtZ_s6XCLZMYvYgVxPd9NsxN Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of September 20, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the potential in children 5 to 11 years of age and a study in children 6 months to 5 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 2/3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; whether and when our Phase 3 clinical trial will demonstrate protection from infection or disease following a booster (third) dose, which is the subject of ongoing study; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when data from BNT162b2 in younger pediatric populations will be submitted to the FDA and other regulatory authorities to request amendments to emergency use or conditional marketing authorizations, whether and when applications for a potential booster (third) dose will be filed in any other jurisdictions and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the potential amendments to request
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September 20, 2021 06:45 ET (10:45 GMT)