pfizer covid 19 vaccine lot number lookup

The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. Each dose must contain 0.2 mL of vaccine. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. 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. Table 7: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 8: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 9: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Table 10: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Study 2 also included 200 participants with confirmed stable human immunodeficiency virus. In the analysis of Study 2 of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, in adolescents 12 to 15 years of age (N=2260; 1,131 COMIRNATY group vs. 1,129 placebo group), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (9 (0.8%) vs. 2 (0.2%)), and nausea (5 (0.4%) vs. 1 (0.1%)). Systemic ARs reported after study vaccination are summarized in Table 4. 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). Search Search . b. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for booster doses. 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. 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). 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 12 Years of Age and OlderCOMIRNATY is a suspension for intramuscular injection. 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. Do not add more than 1.8 mL of diluent. Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. 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. 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 (1,131 COMIRNATY; 1,129 placebo) were 12 to 15 years of age. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. d. Severe: requires intravenous hydration. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 12 years of age and older. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through <12 years of age. Minimum Pfizer order will now be 1,170 doses. Vials should be discarded 12 hours after dilution. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus(HIV) infection. * Randomized participants who received at least 1 dose of the study intervention. As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ fetal development, parturition, or post-natal development (see 16 NON-CLINICAL TOXICOLOGY). Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. COMIRNATY is supplied as a frozen suspension in multiple dose vials. COMIRNATY Original & Omicron BA.4/BA.5 is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. 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 . Before ordering, please check the Vaccine Advertisement page in the WAIIS to see if other providers in your area have vaccine available. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Vials should be discarded 12hours after first puncture. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 is also based on: Safety data accrued with the COMIRNATY Original/Omicron BA.1 vaccine and with COMIRNATY are relevant to the COMIRNATY Original & Omicron BA.4/BA.5 vaccine because these vaccines are manufactured using the same process. The most frequent adverse reactions in participants >55 years of age were pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), myalgia (22.3%), chills (13.0%) and arthralgia (11.3%). Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with an orange cap and an orange label border. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. In order to provide you with relevant and meaningful content we need to know more about you. Undiluted vials may be stored at room temperature for no more than 2 hours. ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate). COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. Severe systemic events were reported infrequently in both vaccine groups. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. Enter a '0' if you have no vaccine doses to enter Your . No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. Vaccine Information Statement (VIS) Lookup Table CDC has added two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements (VIS). COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. Shortly after, the novel virus was identified as SARS-CoV-2. Not all pack sizes may be available. Cleanse the vaccine vial stopper with a singleuse antiseptic swab. 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. 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. Using a combination of surveys and qualitative . For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. In the analyses of Study 3 in children 5 years through <12 years of age (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo), 99.5% of participants had at least 30 days and 95.7% of participants had at least 3 months follow-up after Dose 2. 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. After dilution, one vial contains 10* doses of 0.2 mL. If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90C to -60C (-130F to -76F); full cartons or individual unpunctured vials may also be transported at 2C to 8C (35F to 46F). These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. Do not store vials at 25C to 15C (-13F to 5F). There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Sorry, you need to enable JavaScript to visit this website. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. Study C4591044 is an ongoing study to evaluate the safety, tolerability, and immunogenicity of new bivalent vaccines including COMIRNATY Original & Omicron BA.4/BA.5. Do not store vials at 25C to 15C (-13F to 5F). Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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. A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. Multiple Dose Vial (for 12 years of age and older: DILUTE BEFORE USE), Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, Multiple Dose Vial (for 12 years of age and older: DO NOT DILUTE), COMIRNATY* 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, 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Do not store vials at 25C to 15C (-13F to 5F). You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect. 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. Overall, among participants who received a booster dose in a subset from Study C4591001 (Study 2), the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through 12 years of age. 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: individuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine) ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. You will be subject to the destination website's privacy policy when you follow the link. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. Each vial must be thawed and diluted prior to administration. Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group. Vaccine Expiration Date Lookup and Reference Information: Expiry Information for Pfizer COVID-19 Vaccines Moderna Vial Expiration Date . Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose. Vials must reach room temperature before dilution. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. Children who will turn from 4 to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the childs age at the start of the vaccination series. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. How Do Viruses Mutate and What it Means for a Vaccine? Each dose must contain 0.2mL of vaccine. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. The participant was treated and recovered. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. post marketing safety data with COMIRNATY. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. Two formulations of COMIRNATY are available for individuals 12 years of age and older. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Do not use if liquid is discoloured or if other particles are observed. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. e. Severe: 6 or more loose stools in 24 hours. Each vial must be thawed prior to administration. Vials should be discarded 12 hours after first puncture. DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), Multiple dose vial(after dilution, each vial contains 6doses of 0.3 mL), DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), Multiple dose vial(each vial contains 6 doses of 0.3 mL), For Age 5 Years to < 12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). Vials of COMIRNATY intended for 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 6 months to <5 years with a maroon cap/maroon label border cannot be used to prepare doses for individuals aged 5 years to <12 years. The participant was treated and recovered. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . A subset from Study C4591001 (Study 2) Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. 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. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Before dilution, allow the thawed vial to come to room temperature. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Visually inspect each dose in the dosing syringe prior to administration. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. There is no information on the co-administration of COMIRNATY with other vaccines. Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. No Grade 4 local reactions were reported. A booster dose of COMIRNATY (0.3 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 16 years of age or older. If the vaccine is frozen, it must be discarded. Download the Seasonal Influenza Crosswalk table. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. Obtain sterile 0.9% Sodium Chloride Injection, USP. It undergoes rigorous internal medical review and is updated regularly to reflect new information. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. Thank you for taking the time to confirm your preferences. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C ( 130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. Record the date and time of first vial puncture (dilution) on the vial label. These codes incorporate the specialized tracking needs of the Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) by identifying two code groups. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. The nucleoside-modified messenger RNA in tozinameran encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes the viral spike of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. If received at 2C to 8C, they should be stored at 2C to 8C. Centers for Disease Control and Prevention. If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C (130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). The safety evaluation in Study 3 is ongoing. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). We have experience working with customers in all markets to ensure success. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. Gently invert the vial containing COMIRNATY 10 times to mix. . Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Non-serious adverse events from Dose 1 through up to 30 days after Dose 3, in ongoing follow up were reported by 18.5% of COMIRNATY recipients and by 18.5% of placebo recipients. b. n = Number of participants with the specified reaction. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Thaw vial(s) of COMIRNATY Original & Omicron BA.4/BA.5 before use either by: Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. Date on the label is NOT the expiration date Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). 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. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. The vial stoppers are not made with natural rubber latex. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). COMIRNATY multiple dose vials (with purple cap and purple label border) are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. 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. 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 discard vaccine without ensuring the expiration date has passed. Inspect the liquid in the vial prior to dilution. 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. A risk to the newborns/infants cannot be excluded. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). A total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period in Study 2. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, Centers for Disease Control and Prevention. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10mcg group vs. 1 (0.1%) in the placebo group. Refrigeration units that are commonly available in hospitals. Additional AEs 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%). Pfizer: Vials stored in an utlracold storage unit can be used until the last day of the month printed on the tray and each vial. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). 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%). Thank you for taking the time to confirm your preferences refrigerated, allow the thawed vaccine may contain to. Vials may be stored at 2C to 8C 562 million Moderna, Pfizer, and Johnson & ;... Distribution is built on a flexible just-in-time system which will ship the vials! Number of participants reporting at least 1 yes or no response for the specified dose no reports of myocarditis/pericarditis anaphylaxis. Vaccines should not be used after 18months from the vial by withdrawing 1.8 mL air into the empty diluent.. 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