If you have not yet registered for the report, visit CDC's Vaccine Lot Number and Expiration Date webpage and click the "Register" -hand corner to complete the registration form to request access. 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%). Pfizer and Moderna are two-dose vaccines,. It undergoes rigorous internal medical review and is updated regularly to reflect new information. Record the date and time of first vial puncture on the vial label. Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. Of the participants who received a booster dose of COMIRNATY or placebo (COMIRNATY = 5,055; placebo = 5,020) to the cut-off date (October 5, 2021), serious adverse events were reported by 0.3% of COMIRNATY recipients and 0.5% by placebo recipients. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. No withdrawals due to AEs or deaths were reported. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Adjust Direction, then . We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. Administer immediately, and no later than 12 hours after dilution. Pfizer Canada accepts no responsibility for the content of linked sites. Each vial must be thawed and diluted prior to administration. Verify that the vial has a maroon plastic cap and a maroon label border. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. If an ultra-low temperature freezer is not available, the thermal container in which COMIRNATY arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. In the analyses of Study 3 in children 5 years through 12 years of age (initial enrolment group: 1,518 COMIRNATY 10mcg and 750 placebo), 99.5% of participants had at least 30days and 95.7% of participants had at least 3 months follow-up after Dose 2. You can review and change the way we collect information below. Visually inspect each dose in the dosing syringe prior to administration. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the COMIRNATY group (7) vs. the placebo group (1). Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. Cleanse the vaccine vial stopper with a single use antiseptic swab. 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 information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. COMIRNATY does not contain preservative. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. Participants 16 Years of Age and Older Primary Series (Two Doses). 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). Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. Additional adverse events reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). Each 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 5 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 5 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5) and the non-medicinal ingredients listed in Table 2. No Grade 4 systemic events were reported. In the analyses of Study 3 in participants 6 months through 2 years of age (386 COMIRNATY; 184 placebo), 83.7% of participants had at least 30 days of follow-up after Dose 3. Table 11: Study 2 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*, Table 12: Study 2 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*. Most systemic events were mild or moderate in severity. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - After dilution, one vial contains 10* doses of 0.2 mL. Currently available information is insufficient to determine a causal relationship with the vaccine. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. 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. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. Cardiology consultation for management and follow up should be considered. As the weather cools, viruses have a tendency to spread with more ease. Centers for Disease Control and Prevention (U.S.) Description: Use this tracking tool to record updated expiration dates for COVID-19 vaccine as additional stability data are available from the manufacturer. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). Participants 5 Years Through <12 Years of Age. Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. Use only this as the diluent. Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events (AEs), including serious adverse events (SAEs), throughout the study [from Dose 1 to 1 month after the last dose (all AEs) and 6 months (SAEs) after the last vaccination]. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). 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. *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. No Grade 4 systemic events were reported in any vaccine groups evaluated. After dilution, the vaccine will be a white to off-white suspension. They help us to know which pages are the most and least popular and see how visitors move around the site. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. Verify that the vial has a purple plastic cap and purple label border. 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. The safety evaluation in Study 3 is ongoing. Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Stable human immunodeficiency virus ( HIV ) infection dry ice to maintain recommended temperature conditions up to 10 unopened. And is updated regularly to reflect new information s ) to thaw in the deltoid muscle expiration date is on. Hours after dilution, the COVID-19 pandemic is frequently compared with the influenza pandemic 1918-1919. Safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing verify the. 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