pfizer covid vaccine package insert

Individuals 12 years of age and older may receive a booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). See Overall Safety Summary (Section 6) for additional information. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 2. and MMWR published EUA fact sheets revised with warning added, June 25 FDA approval of Pfizer BioNTech COVID -19 vaccine on August 23, 2021 CDC issued initial Emergency Use Instructions (EUI) for the Pfizer-BioNTech COVID-19 vaccine on November 17, 2021, and another EUI for the Moderna COVID-19 vaccine on February 11, 2022. . The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. New York, NY: Pfizer Inc.; 2022. Vaccines: COVID-19: DEAR COLLEAGUE LETTERS: 16-year-old Visit: HPV: MenACWY Dose #2: DONATE TO IAC: The observed risk is highest in males 12 through 17 years of age. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Any vaccine remaining in vials must be discarded after 6 hours. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. Do not refreeze. 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 respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Meet the honorees The Crossword Where they . This webpage providers information and materials for historical reference only. The thermal container maintains a temperature range of -90C to -60C (-130F to -76F). This diluent is not packaged with the vaccine and must be sourced separately. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. For general questions, visit the website or call the telephone number provided below. Storage in boxes or bins can help maintain temperature longer, especially if power is lost. The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. Observe patient for 30 minutes following vaccination iii. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? From an independent report (Kamar N, Abravanel F, Marion O, et al. The vial stoppers are not made with natural rubber latex. . Amtrak issued a memo to employees saying that it would allow those who have not been vaccinated against COVID-19 to opt for regular testing. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS): The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods: IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older. WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. When you get your first COVID-19 vaccine, you will get a vaccination card. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart to individuals 12 years of age and older. can be found in the package insert. Thawed vials can be handled in room light conditions. In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. N Engl J Med), Table 5: Study 2 Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 6: Study 2 Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 7: Demographics (population for the primary efficacy endpoint), Table 8: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection, Table 9: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection, Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) Participants Without Evidence of Infection up to 1 Month After Dose 2 Dose 2 Evaluable Immunogenicity Population, This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older. These NDC will not be manufactured. Vials must reach room temperature before dilution. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. No. The vaccine is administered as a 2-dose series, 3 weeks apart. Adverse Reactions Identified in Post Authorization Experience. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Data have not yet been submitted to FDA on administration of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent at the same time with other vaccines. At that time, FDA published a BLA package insert that included the approved new COVID-19 vaccine trade name Comirnaty and listed two new NDCs and images of labels with the new trade name. Covid-19 Vaccine Pfizer, Bivalent package insert / prescribing information for healthcare professionals. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The safety population includes participants 16 years of age and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. J. Novavax monovalent vaccine may be used as a first booster in an adult patient COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. for a COVID-19 vaccine without a COVID- 19 vaccination documented. The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. Do not add more than 1.8 mL of diluent. The vaccine will be an off-white suspension. This Fact Sheet may have been updated. section at the end of this Fact Sheet. For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see www.clinicaltrials.gov. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. Tell the vaccination provider about all of your medical conditions, including if you: The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. The vaccine efficacy information is presented in Table 8. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. 2022 . This product (for ages 12 years and older) is no longer being distributed. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: Some vials also may have a purple label border. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Side effects that have been reported with these vaccines include: These may not be all the possible side effects of these vaccines. This information in the package insert supersedes the storage conditions printed on the vial cartons. On This Page. Talk to your vaccination provider if you have questions. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The safety evaluation in Study 2 is ongoing. 5.2. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). Procedures should be in place to avoid injury from fainting. Please see the, Table 1:Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 3: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, (Kamar N, Abravanel F, Marion O, et al. Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020. From an independent report (Kamar N, Abravanel F, Marion O, et al. Oxford-AstraZeneca COVID-19 vaccines have shown a few cases of blood clotting disorders . After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders is 0.2 mL for individuals 5 through 11 years of age [see Dosage and Administration (2.1)]. Amtrak announced yesterday that it will temporarily halt a COVID-19 jab mandate for employees after issuing a warning about possible service reductions due to labor shortages. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. for Healthcare professionals: PACLITAXEL, Vial U.S. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. Symptoms may appear 2 to 14 days after exposure to the virus. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older9. Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. (package insert). It is predominantly a respiratory illness that can affect other organs. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. The storage, preparation, and administration information in this Fact Sheet apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Perforated bins may allow for better air circulation around the vaccine, thus helping to maintain correct temperature. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, when prepared according to their respective instructions for use, can be used interchangeably. Wyeth/Pfizer: Nov 2021: Bexsero: Meningococcal Group B: GlaxoSmithKline: Jan 2022: Pneumovax 23: Pneumococcal (polysaccharide) Merck: Apr 2021: Prevnar 13: . N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. Last Reviewed: September 28, 2022. See section 3 for vaccine volume and spacing based on age and vaccine formulation. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. . Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. NAME OF THE MEDICINE BNT162b2 [mRNA] 2. or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks (range 12 to 20 weeks) prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of . There may be clinical trials or availability under EUA of other COVID-19 vaccines. Table 7 presents the specific demographic characteristics in the studied population. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). FDA Approval - 6/3/22. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. Package insert / product label Dosage form: injection, suspension. Package Inserts : Additional Immunization Resources : Photos: Adult Vaccination: Screening Checklists: Ask the Experts: Shop IAC: CDC Schedules . For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. N Engl J Med), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. 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 Pfizer-BioNTech COVID-19 Vaccine. The safety evaluation in Study 2 is ongoing. In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. CDC does not have a specific recommendation for brands of containers or bins for storage of vaccine. Some vials also may have a purple label border on the label. Thawed vials can be handled in room light conditions. The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose.

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