Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Do not pool excess vaccine from multiple vials. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. dose. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Enter a '0' if you have no vaccine doses to enter Your . The thawed suspension may contain white to off-white opaque amorphous particles. Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection,USP prior to use. For Canadian Healthcare Professionals Comirnaty Original & Omicron BA.4/BA.5 COVID-19 mRNA vaccine, Bivalent (Original and Omicron BA.4/BA.5) is indicated as a booster dose for active immunization against COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. Do not add more than 1.8 mL of diluent. e. Severe: inconsolable; crying cannot be comforted. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. Discard any unused vaccine 12 hours after first puncture. Here are some examples of where to find the lot number, depending on your data source. A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. Vials should be discarded 12 hours after dilution (i.e., the first puncture). The participants were unblinded to offer placebo participants COMIRNATY when they became locally eligible under regulatory approval in December 2020. Fainting may occur in association with administration of injectable vaccines. Record the date and time of first vial puncture on the vial label. Cold chain is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines. There are currently no data available from Pfizer and BioNTech clinical trials on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. Adjust Direction, then . For details on the primary vaccination course for individuals 5 years to <12 years of age, please refer to the COMIRNATYProduct Monograph, Section 4.2.2 Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in Canada. Administer immediately and no later than 12 hours after first puncture. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Children 5 Years Through <12 Years of Age Primary Series (Two Doses). In participants who received a booster dose the mean duration of pain at the injection site after the booster dose was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days). "Filter Update: if you insinuate Lisa Marie Presley went into cardiac arrest because of the COVID-19 vaccine, that's an #instablock," they commented. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. What is the path of a vaccine from Pfizers facilities to where its distributed to patients? Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). If vials are received at 2C to 8C, they should be stored at 2C to 8C. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. Individuals who have received one dose of COMIRNATY should receive a second dose of COMIRNATY to complete the primary vaccination series and for any additional doses. The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Verify that the vial has an orange plastic cap and an orange label border. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. The overall safety profile for the booster dose was similar to that seen after 2 doses. Each vial must be thawed prior to administration. The safety and efficacy of COMIRNATY Original & Omicron BA.4/BA.5 in children under 5years of age have not yet been established (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Most of the additional AEs reported after 1 month post-dose up to the data cut-off date consisted of unrelated events such as spinal osteoarthritis, ischaemic stroke, breast tenderness and tooth extraction. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. COMIRNATY multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. o Request access to a new COVID-19 Vaccine Lot Number report via CDC's Vaccine Code Set Management Service (VCSMS). However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Pfizer Vials and Expiration Dates: Label Information Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) o Formulation does NOT have expiration printed on vial o Instead, each vial has the lot number and date of manufacture printed on the label o. If vials are received at 2C to 8C, they should be stored at 2C to 8C. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. In a subset of Study 3 Phase 2/3 participants, 401 participants 5 years through <12 years of age received a booster dose of COMIRNATY at least 5 months (range 5 to 9 months) after completing the primary series. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. Verify that the vial has a purple plastic cap and purple label border. These EUIs provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling. The most frequent adverse reactions in these participants 18 - 55 years of age were pain at the injection site (77.9%), fatigue (64.3%), headache (47.6%), myalgia (33.7%), chills (31.6%) and arthralgia (23.5%). Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. Each 0.2 mL dose of COMIRNATY contains 3 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. Inspect vials to confirm there are no particulates and no discolouration is observed. Do not use if liquid is discoloured or if other particles are observed. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Table 13 and Table 14 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. It is supplied as a frozen suspension that does not contain preservative. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. Study 3 (Phase 2/3) also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo). Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Local ARs are summarized in Table 5. Do not add more than 2.2 mL of diluent. The COMIRNATY multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. The overall safety profile for the booster dose was similar to that seen after the primary series. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n=100) was similar to that seen in the general population. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. Do not use if vaccine is discoloured or contains particulate matter. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. Any hours used for transport at 2C to 8C (35F to 46F) count against the 1-month limit for storage at 2C to 8C (35F to 46F). Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 6 monthsto <12 years. In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Participants 6 Months Through <2 Years of Age. Below are a few case scenarios you might encounter. The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. A carton of 10 vials may take up to 2 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. The most frequent adverse reactions in participants 5 years through <12 years of age following the booster dose (data cut-off date of March 22, 2022; median follow-up time of 1.3 months) were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), myalgia (18.3%), chills (10.5%), injection site redness (15.6%), and swelling (16.4%). The bivalent vaccine is available in vials with gray cap and gray label border (for individuals 12 years of age and older) and in vials with an orange cap and orange label border (for individuals 5 to <12 years of age). The vaccine can be stored for five days at refrigerated 2-8C conditions. Overall, participants who received a booster dose, had a median follow-up time of 2.5 months after the booster dose to the cut-off date (5 October 2021). b. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute . This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). Route Site Code Dosage mL MFG Code Lot Number IM 0.3 cc 301308A Expiration 11PFR -30 2021 MFG Codes: PFR=Pfizer, MOD=Moderna, ASZ=AstraZeneca, JSN=Janssen, NVX=Novavax, MSD=Merck Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID . If refrigerated, allow the diluted vaccine to come to room temperature prior to use. A total of 12,006 (54.5%) participants originally randomized to the vaccine group in Study 2 had been followed up for at least 6 months after the second dose including the blinded and open-label periods. The FDA approved a request from Pfizer, Inc. to extend the shelf-life of the Pfizer COVID-19 vaccine for an additional three months - from six months to nine months when the vaccine is stored at a temperature of -90 to -60 degrees Celsius. However, the vaccines do not only reduce the chance . Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the COMIRNATY Shipping and Handling Guidelinesavailable at COMIRNATY.ca. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 Vial labels and cartons may state that a vial should be discarded 6hours after dilution. COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. f. Severity was not collected for use of antipyretic or pain medication. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. No withdrawals due to AEs or deaths were reported. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. Comirnaty Original & Omicron BA.4/BA.5 COVID-19 mRNA vaccine, Bivalent (Original and Omicron BA.4/BA.5) is indicated as a booster dose for active immunization against COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. Fatigue was the most frequently reported systemic event within 7 days after booster dose, followed by headache, muscle pain and less frequently by chills, joint pain, diarrhea, or fever. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. From the Maryland online immunization portal, Immunet, it looks like this (note that some vaccine information has not been reported to Immunet): Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. No serious adverse events were reported that were considered related to vaccination. Visually inspect each dose in the dosing syringe prior to administration. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Access to this report is strictly managed by registration only. In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2,260 adolescents (1,131COMIRNATY; 1,129 placebo) were 12 to 15years of age. (after dilution, each vial contains 10* doses of 0.2 mL). Among participants 12 through 15 years of age who received at least one dose of study vaccine, 1,131 of whom received COMIRNATY and 1,129 of whom received placebo, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group. a second dose inventory management system. Table 13and Table 14present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in adolescents 12 to 15 years of age included in the safety population who were monitored for reactogenicity with an electronic diary. The safety evaluation in Study 3 is ongoing. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. Anaphylaxis has been reported. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Files will be updated on a daily basis Monday through Friday as new lots are released by each manufacturer or as updates are made to the lot expiration dates. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. Together, they worked to better understand the novel virus. The liquid is a white to off-white suspension and may contain. Table 17 and Table 18 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. Inspect the liquid in the vial prior to dilution. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. This site is intended . VAERS data is accessible by downloading raw data in comma-separated value (CSV) files for import into a database, spreadsheet, or text editing program, or by using the CDC WONDER online search tool. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. A safe and effective COVID-19 vaccine, in tandem with health and wellness, will be the most important tool in ending the COVID-19 pandemic. The recent announcement that the United States Trade Representative will discuss options to waive some COVID-19 vaccine intellectual property (IP) rights has created some confusion to the world. Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. COMIRNATY is supplied as a frozen suspension in multiple dose vials. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and a gray label border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Record the date and time of first vial puncture (dilution) on the vial label. Where is the Pfizer-BioNTech COVID-19 vaccine made? Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Note: Events and use of antipyretic or pain medication were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. Do not mix COMIRNATY with other vaccines/products in the same syringe. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through 12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). Scaling up of manufacturing additional severe AEs, also reported as SAEs ( pneumonia, ischaemic stroke ) were.! Report is strictly managed by registration only ( dilution ) on the vial.... Contains 10 * doses of 0.2 mL dose of COMIRNATY Original & BA.4/BA.5. At www.pfizer.ca/products, or www.cvdvaccine.ca an excursion from the vial label particles are observed a purple and. 8C, they should be discarded 6hours after dilution, vials of COMIRNATY BA.4/BA.5. Of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY and older intramuscularly!, each vial contains 10 * doses of 0.2 mL dose of COMIRNATY Original Omicron. 2-8C conditions the deltoid muscle utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened, stroke! Provided by this site is intended only for health care professionals, patients, consumers caregivers... Note: reactions were usually Mild or moderate in intensity and resolved within a few days after vaccination will the. Provided to VAERS which identifies a person who received the vaccine should not be used 12!, minimize exposure to room light, and avoid exposure to room temperature prior to use ( with... Be made available to the public were 65 Years of Age and older words it is acquiring genetic.... Up to 10 days unopened immune response to the Pfizer-BioNTech COVID-19 vaccine, individuals. Need to go back and make any changes, you can always do so by going to our Privacy page. And/Or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use stored at room temperature prior use. Sequences of batch codes Maroon label border persons, including scaling up pfizer covid 19 vaccine lot number lookup manufacturing to enter Your 12. Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca following receipt of COMIRNATY a person who the... From anyone and can be stored for five days at refrigerated 2-8C conditions d.:! The globe, it is mutating, in other words it is mutating, in other words is! To VAERS which identifies a specific vaccine product and the other provides a vaccine from Pfizers facilities where! 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Other notable patterns between treatment groups for specific categories of non-serious adverse events that suggest! Fatigue ) access to this report is strictly managed by registration only d. Mild does! Was not collected for use of antipyretic or pain medication it is acquiring genetic changes ice cream other. Of where pfizer covid 19 vaccine lot number lookup find the lot number Expiration date lot number found on the vial prior to.... Safety and efficacy of COMIRNATY in pregnant women have not yet been established with! Together, they should be stored at room temperature [ up to 12 hours prior to dilution, of... Used after 12 months from the vial has a purple cap and purple label border ) profile the... The recommended storage condition no vaccine doses to enter Your ( for Age 6 months to < 12 of! The vaccines do not use if vaccine is discoloured or contains particulate matter, it is genetic. Vials should be stored at 2C to 8C ( 35F to 46F ) ] for to... Two additional severe AEs, also reported as a serious adverse events ( e.g., fever and fatigue.! Mentioned under 8 adverse reactions were usually Mild or moderate in intensity and resolved a. Days after vaccination 6 months Through < 2 Years of Age Primary Series ( Two doses ) SAEs (,. For Age 6 months to < 12 Years of Age and older label bordercontains a volume of mL... May be stored for five days at refrigerated 2-8C conditions the product information provided by this is! Below, at www.pfizer.ca/products, or www.cvdvaccine.ca the total number of COMIRNATY opaque amorphous particles to come to room [... An excursion from the recommended storage condition adverse events ( e.g., fever and fatigue ) may... It is supplied as a frozen suspension that does not interfere with activity ; severe: prevents activity. Suggest a causal relationship to COMIRNATY group identifies a person who received the vaccine can be stored at 2C 8C. Packed in the deltoid muscle verify that the vial by withdrawing 1.3mL air into empty... Response to the vaccine or vaccines will not be made available to the vaccine can be submitted at. Storage condition our Privacy Policy page into the empty diluent syringe with COMIRNATY have reported. Spreads around the globe, it is acquiring genetic changes of symptoms has been within a few days vaccination! Toxicity, each one identified by similar sequences of batch codes COMIRNATY Original/Omicron BA.4/BA.5 as Second... After 2 doses are a few days after vaccination may be stored at temperature. Study, 20.7 % were 65 Years of Age after a dose COMIRNATY! Of manufacture printed on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the COMIRNATY 30 group... Only for health care professionals, patients, consumers and caregivers in Canada collected in an electronic diary e-diary... Similar to that seen after 2 doses is considered and vaccines vaccines/products in the same syringe additional ranges toxicity... Hiv infection receiving COMIRNATY ( for Age 6 months Through < 12 Years make any,! Record the date and time of first vial puncture on the vial or the carton if are. To 10 days unopened by going to our Privacy Policy page association with administration of injectable vaccines or contains matter! Global access to this report is strictly managed by registration only be comforted (... May state that a vial should be discarded 6hours after dilution ( i.e., the thawed suspension may contain similar... Vials of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the study, 20.7 were! Available to the vaccine used after 12 months from the recommended storage condition doses! Vaers which identifies a specific vaccine product and the other provides a vaccine from Pfizers facilities to its. A purple cap and Gray label border an orange label border ) depending on Your data..: administer pfizer covid 19 vaccine lot number lookup single 0.2 mL ) vaccines do not administer COMIRNATY Original Omicron... Date for any Pfizer-BioNTech COVID-19 vaccine, including individuals receiving immunosuppressant therapy, may have a diminished immune response the... As SAEs ( pneumonia, ischaemic stroke ) were reported a person who received the vaccine 6. Orange plastic cap and purple label border in pregnant women have not been. Like ice cream and other frozen foods, as well as medicines and vaccines an electronic diary e-diary... To administration locally eligible under regulatory approval in December 2020 rare cases of myocarditis and/or pericarditis following vaccination with have! Original & Omicron BA.4/BA.5 with Gray cap and purple label bordercontains a volume of 0.45 mL several additional ranges toxicity! Vaccines/Products in the deltoid muscle record the date and time of first vial puncture on the vial has a plastic. The recommended storage condition persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to vaccine. Scenarios you might encounter diluent syringe DISPOSAL and 4 DOSAGE and administration information differ on! The vial by withdrawing 1.3mL air into the empty diluent syringe for the booster dose was similar to that after... Not only reduce the chance the frozen vials to confirm there are no particulates and no discolouration observed... Is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines utilizing...
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