Contact the ODH COVID-19 Provider Call Center immediately at 1-844-963 . Scenario: Temperature Excursion onsite in site's unit . In addition, please report the incident to COVID19.provider@doh.nj.gov For Janssen or Moderna vaccines: Phone: (833) 343‐2708 Monday - Friday, 8 a.m. ‐ 8 p.m. Customer Service and Product Inquiries: 1-800-879-3477 Monday through Friday 9:00 a.m. to 7:00 p.m. EST. Age Indications. Login . • Follow the Vaccine Temperature Excursion Guide and contact vaccine manufacturers to determine whether the vaccines are viable. • Submit this report to vaccinetempexcursion@health.ny.gov and include any supporting documentation such as data logger summary report (or section showing excursions), vaccine transport log, temperature log, etc. Dosage: 0.3 mL. -80 to -60 C [-112º to -76ºF] for ultra-cold freezer (may be used for Pfizer COVID-19 vaccine). Pfizer COVID-19 vaccine for children 6 months through 4 years of age. This is the ability to take the liquid vaccine and put it into vials that can be distributed. COVID-19 Pfizer Vaccine Order Requests - This order form is for placing a pediatric Pfizer dose order in a . 1-800-666-7248. Store vaccines that have had a potential temperature excursion per manufacture r's recommendations until steps 2 -4 have been . PRODUCT INFORMATION. The answer to your question may be just a click away. Important Contact Information Pfizer Customer Service: (800) 666-7248 or . • identify temperature excursions, • contact vaccine manufacturers to determine vaccine . If you are considering long term storage of this Pfizer vaccine, look for a unit with these specifications: • Digital temperature display • Microprocessor Control • Audible alarms • Ability to hold ultra-low (-80 to -60oC) temps Search for a department and find out what the government is doing Instructions and information will be provided through the program. 1. Moderna. A temperature excursion is any temperature outside the recommended temperature range for a vaccine. A: The smallest quantity of Pfizer Tris Sucrose vaccine that can be ordered is 60 doses. Temperature Excursions. Each thermal shipper has a reusable GPS enabled temperature monitoring device which will be enabled when the shipper is packed. Fax. Moderna:1-866-663-3762. Contact the Immunization Program to report the incident, and complete this worksheet for ALL temperature excursions. •Vaccine is shipped in a container that includes dry ice and digital data logger to monitor temperature. Register For Prime. NYC providers with enrollment questions may contact NYC DOHMH at nycimmunize@health.nyc.gov or COVID-19: Vaccines. To report a temperature excursion, submit completed report and .pdf document of data logger temperatures to: . number of patients when preparing for daily clinics to help reduce over-thawing and transport (when necessary) of vaccine. Vaccines exposed to storage temperatures outside the manufacturer determined ranges may have reduced potency, creating limited protection and resulting in the re-vaccination of patients, loss of public confidence in vaccines and thousands of dollars in wasted vaccine. people vaccinated annually with Sanofi's vaccines . NEW YORK and MAINZ, GERMANY, February 19, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. Immunization Requirements on CHIRP. This vaccine is repackaged by the ODH RSS Warehouse. New York . 7. Another limitation is freezer capacity. back to base alarm and automated temperature . JnJ: 1-800-565-4008 . • Inventory of affected vaccines, including (1) lot #s and (2) whether purchased with public (for example, VFC) or private . March 2022 DOH 348-840 . Pfizer-BioNTech COVID-19 Vaccine (30 mcg / 0.3 mL) IM suspension Facility name and phone number: Quantity of syringes: Date & Time to discard (6 hours after dilution): receive a single COVID-19 booster vaccine (Pfizer - BioNTech, Moderna or Janssen) at least 2 months (8 weeks) after receiving their initial Janssen primary . A: Yes. Temperature requirements call for different distribution plans. NY 10017 . As with all vaccines, if COVID-19 vaccines are exposed to temperature excursions at any time, the temperature excursion . Pfizer Customer Service . Medical Director Name Title Phone Number Email Address . the vaccine experienced an out-of-range temperature. This vaccine is repackaged by the ODH RSS Warehouse. Refrain from making assumptions about the vaccine viability 2. Pfizer COVID-19 . FDA Medwatch You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or . contact the hildhood Vaccine Program at WAhildhoodVaccines@doh.wa.gov . a temperature display, with min/max/current. . • Set the COVID-19 vaccine storage freezer at a temperature between -58°F and +5°F (- 50°C and -15°C). Pfizer: 1-800- 666-7248. . Important Contact Information Pfizer Customer Service: (800) 666-7248 or . Below are answers to commonly asked clinical questions that apply to all authorized COVID-19 vaccines. All shipments will be tracked via the onboard GPC monitoring device to ensure end to end distribution within required temperatures Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. Temperature excursions within the clinic or site Phone: 800-666-7248 Email: cvgovernment@pfizer.com Manufacturer ontact Numbers Merck 1-800-672-6372 Sanofi Pasteur 1-800-822-2463 GlaxoSmithKline 1-888-825-5249 Pfizer 1-800-438-1985 Seqirus 1-855-358-8966 AstraZeneca (Medimmune) 1-800-236-9933 . 1. Phone: 800-565-4008. • COVID-19 Vaccine Temperature Excursion Guide (PDF) • CDC Storage and Handling Toolkit (PDF) • CDC Identification, Disposal, and Reporting of COVID-19 Vaccine Wastage (PDF) Phone #: (800) 666-7248 . Contact Manufacturer Check (X) manufacturers contacted and complete representative(s) name and reference number assigned to call. • Set the COVID-19 vaccine ultra-low temperature freezer at a Order. Fewer number of vials will thaw in less time; Unopened vials: viable up to 12 hours; Punctured vial: viable up to 12 hours after once punctured ; Thawed vaccine CANNOT be refrozen. Primary Series: 2-dose series separated by at least 3-8 weeks *. The TOTAL amount of time a vaccine is stored at an out of range temperature affects the viability of the vaccine. including the name and phone number of the individual working to determine the viability of the vaccine. email address, phone number, change of delivery . mRNA COVID-19 vaccines are preferred over Janssen COVID-19 Vaccine for primary series and booster doses. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of May 2021 through February 2022 printed on the label may remain in use for 3months beyond the printed date, as long as approved storage conditions between -90ºC to -60ºC have been maintained. temperature excursion information, and accountability records. a temperature excursion and the vaccine may need to be identified as waste. Vaccine Viability - Temperature Excursions during shipment for McKesson Specialty Distributed . Vaccine Cold Chain. Updated January 2022 . Per the CDC, specifically for the Pfizer vaccine, the ancillary kit is designed to include 3 low dead-volume syringes (that permit an extra dose to be drawn) and 3 normal (non-low dead-volume) syringes with each vial. • Moderna COVID-19 Vaccine • Pfizer-BioNTech COVID-19 Vaccine . VFC Vaccines, Manufacturer, Lot Number(s) & doses affected due to temperature excursion: . On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. As of Dec. 30, almost 680,000 doses of the Pfizer and Moderna vaccines have been shipped to providers in Texas, according to the state dashboard. c to -1s0c* -90 . 4052 Bald Cypress Way, Bin A11. breaker number along with contact name and phone number . Pfizer . PFIZER CUSTOMER SERVICE. . A: Yes. Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with an orange cap and a label with an orange border. Vaccines. » Contact your immunization program and/or vaccine manufacturer(s) for guidance per your standard operating procedures (SOPs). Terms of Sale. Over half a billion. . Gather temperature excursion information. Vaccine Temperature Excursion Guide Author: Washington State Department of . Contact the ODH COVID-19 Provider Call Center immediately at 1-844-963-4829 (844-9ODHVAX). Log in. -80 to -60 C [-112º to -76ºF] for ultra-cold freezer (may be used for Pfizer COVID-19 vaccine). Pfizer COVID-19 Vaccine - Thermal Shipper •Vaccine is shipped directly from Pfizer. Immunization Section. This applies to . 5. Vaccine Manufacturer Pfizer 800-438-1985 Vaccine Manufacturer Janssen 800-565-4008 . Email. Phone Number: Email: Step 5: Submit the Temperature Excursion Report and attach relevant documents. Vaccine Manufacturer's Quality Control Phone Numbers Sanofi Pasteur 800‐822‐2463 ActHib® Adacel® Daptacel® Recommended storage temperature is -70 o C. • Pediatric Pfizer-BioNTech vaccine: The internal temperature of the unit should be stabilized between -90 o C to -60 o C (-130 o F to -76 o A non-response will be escalated to CDPH to ensure vaccine cold chain is protected. Medical Information. Pfizer Inc. (800) 505-4426 Sanofi Pasteur (800) 822-2463 Sequiris (855) 358-8966 Pay. Temperature Excursion Refrigerator Power Outage Mechanical Failure (Unit Failure) Unexplained Other: . Q: We have ordered in 30-dose increments at a time. Janssen . For clinical questions on the following specific COVID-19 vaccines, see: Janssen COVID-19 Vaccine (Johnson & Johnson) FAQs The toolkit also contains troubleshooting guides to assist with vaccine storage unit . PROVIDER NUMBER: FACILITY NAME: CONTACT PERSON: PHONE NUMBER: 1) Refer to SOUTH DAKOTA IMMUNIZATION PROGRAM POLICY #04 - VFC Vaccine Exposed to Abnormal Temperatures. 4. Temperature Monitoring. 800.666.7248 Option 8 Email: CDC publishes and routinely updates a comprehensive Vaccine Storage and Handling Toolkit covering topics such as vaccine storage units, temperature monitoring devices, and inventory management, vaccine transport and emergency vaccine storage and handling. (fridge/freezer/Ultracold Freezer). • Model number • Serial number • Date of calibration On Nov. 2, 2021 British Medical Journal (BMJ) published an article that revealed three big issues in Pfizer's vaccine trial based on interview with a whistleblower.The whistle blower, Brook Jackson, was a regional director of one of Pfizer's vaccine trial companies, Ventavia Research Group in Texas. PFIZER.COM. Contact the vaccine manufacturer to evaluate any temperature excursion before continued use of the vaccine. Vaccines for School Age Children. 15 ¾ in x 15 ¾ in x 22in). If you experienced a temperature excursion, contact the Immunization Program Deaf or hard of hearing customers, please call 711 (Washington Relay) or email civil.rights@doh.wa.gov. . Tallahassee, FL 32399-1719. Right now, Pfizer says its vaccine needs to be kept at minus 70 degrees Celsius and can last in a specialty freezer for up to six . • Inventory of affected vaccines, including (1) lot #s and (2) whether purchased with public (for example, VFC) or private . Password. 1. Phone #: 833-272-6634 . number of patients when preparing for daily clinics to help reduce over-thawing and transport (when necessary) of vaccine. McKesson Customer Service . Preparing for Pfizer vaccine for children under 5 years; Do not miss an opportunity to vaccinate; Pfizer 5-11-year-old (orange cap) COVID-19 vaccine available via redistribution . . Track. . Pfizer (Wyeth Vaccines) Merck & Co., Inc. Seqirus Vaccines Moderna GlaxoSmithKline (GSK) MedImmune, Inc Beginning the fall of 2020, there were 153 institutes, including Ventavia, that assisted . In the event of a temperature excursion, contact the vaccine manufacturers, complete this form and submit it to the . a temperature excursion and the vaccine may need to be identified as waste. Call the phone number indicated in the instructions if there are damaged vials. Multidose vial: Up to 6 doses per vial. Pediatric Pfizer vaccine can be ordered from the COVID19 - Pfizer order set. In the event of a temperature excursion, contact the vaccine manufacturers, complete and submit this form . If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985. If you have questions about the expiration date for your Moderna vaccine, please contact the manufacturer by phone at 866-663-3762 or by email at . . 12 years of age and older. 850-922-4195. When stored frozen at -90 °C to -60 °C, 195 vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes. The information from the Fact Sheet supersedes the number of hours printed on vial labels and cartons. SSL Certificate. potential risk for a temperature excursion due to a storage unit or thermal packaging system . Temperature Excursions If the vaccine experiences an out-of-range temperature, immediately contact the Immunization Program at 1-802-863-7638. Improperly stored vaccines result in wasted vaccine, and in some cases, suspension of providers from the VFC Program. Temperature excursion related . Schedule for Primary Series and Booster Dose. Pfizer 1-800-505-4426 www.pfizer.com • Pneumococcal 13-valent (Prevnar 13 TM) FDA Medwatch You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or . Pack the appropriate number of normal saline diluent . Mailing Address. Email: SNSSupport@McKesson.com . Forgot Password? Each vial carries a limited number of doses. Pfizer MDV Pfizer case #/Person contacted: Moderna (866- . USA. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be . Florida Department of Health. ET . (ie. Contact manufacturers to determine vaccine viability o Nonviable vaccine: remove from unit (quarantine to prevent usage); reconcile inventory; return/discard appropriately . 5. iv All temperature excursions identified during shipping must be reported to Pfizer and McKesson the same day as delivery. If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985. The provider and patient fact sheets for the Pfizer vaccine are now available for: (New 12/17/2020) Phone Number Hours Celsius Fahrenheit Minutes Vaccine Coordinator Name . Vaccines exposed to temperature excursions must be labeled "Do Not Use" until more information is gathered by the Immunization Program. If yes, provide the brand, lot numbers, and number of doses of the affected vaccines during the temperature excursion. 800-666-7248 cvgovernment@pfizer.com. Considerations for Planning School-Located Vaccination Clinics. COVID-19 Vaccines for People with Disabilities. Vaccines, Manufacturer & Lot Number(s) affected due to temperature excursion: Vaccine 800-565-4008 jsccovidtempexcursion@its.jnj.com. Sign In. PRIVACY POLICY. Confirm whether any other publicly funded vaccines were involved in the temperature excursion. Effective storage of vaccines in ultra-cold temperatures requires: a freezer which has been assessed as appropriate for the storage of vaccines at ultra-cold temperatures, this includes evidence that the freezer has been serviced in the last 12 months. 2. The smaller packaging (450 doses vs 1170 doses) requires more shipper boxes and Controlant temperature monitors to deliver the same number of doses. Pfizer Shipping Pfizer is running short of COVID-19 vaccine shipper boxes and Controlant temperature monitors because of two factors: 1. 3. A: The smallest quantity of Pfizer Tris Sucrose vaccine that can be ordered is 60 doses. New: Updated COVID-19 Interval Guidance. 866-663-3762 Email not available. • Set the COVID-19 vaccine storage refrigerator at a temperature between 36°F and 46°F (2°C and 8°C), with an ideal average temperature of 40°F (5°C). Temperature Excursion Reporting • All COVID Vaccine Temperature Excursions require immediate action and must be reported to DPH • A reporting mechanism via the DPH Helpdesk. Quarantine your vaccine in an appropriate storage unit. Temperature readings outside of the recommended temperature ranges are considered excursions. Data logger report (summary or section showing excursions), temperature log . Pediatric Pfizer vaccine can be ordered from the COVID19 - Pfizer order set. If there is a temperature excursion, Controlant will send an email and a text, and call if no one responds. COVID-19 Vaccine Indications for Patients Who Are Immunocompromised. COVID-19 Pfizer (COMIRNATY™) vaccine images Ultra-low temperature thermal shipper. Providers should report all COVID-19 vaccine wastage and vaccine storage unit temperature excursions to: https://www.marylandvfc . Phone: 877-829-2619: Pfizer vaccine shipment has a problem: Pfizer Customer Service Phone: 800-666-7248 Email: cvgovernment@pfizer.com: Pfizer ancillary kit has a problem: Contact McKesson MedSurg to report Email: snssupport@mckesson.com. For questions, call the NYSDOH COVID-19 hotline 1-888-364-3065. record the current temperature a minimum of 2 times (at the start and end of the workday) Record: • Min/max temperature (current temperature if no min/max temperature) • Date • Time • Name/initials of person checking and recording temperature • Any actions taken if a temperature excursion occurred If a reading is missed, leave log . Related Articles Phase 1B: What you need to know . Manufacturer Contact Information. Pfizer-BioNTech vaccine: The internal temperature of the unit should be stabilized between -90 o C to -60 o C (-130 o F to -76 o F) prior to stocking vaccine. (vaccine appointment registration webpage and a phone number that directs callers to staff accepting appointment registrations) to . Pfizer: 1-800-438-1985: Sanofi Pasteur: 1-800-822-2463: Seqirus: 1-855- 358-8966: Contact Pfizer MDV Pfizer case #/Person contacted: Moderna (866- . Is the smallest dose available now 100? TERMS OF USE. If your vaccine storage units experience temperatures that are outside of the recommended temperature ranges indicated for vaccines take the following steps: Quarantine your vaccine in an appropriate storage unit. COVID-19 Pfizer Pediatric Vaccine - Pfizer Pediatric Redistribution Guidelines Current as of Jan 31, 2022 . COVID-19, vaccine, temperature excursion, report Created Date: 4/13/2021 3:23:29 PM . Monitoring Vaccine Temperature and Equipment Power Supply Organizing and Storing Vaccine Regular Maintenance of Equipment Section Four: Pfizer/BioNTech COVID-19 Vaccine Storage 10-13 Section Five: Moderna COVID-19 Vaccine Storage 14 Section Six: Janssen COVID-19 Vaccine 15 Section Seven: Temperature Excursions (TEs) 15-16 Proper storage and handling begins with an effective vaccine cold chain. COVID-19 Vaccine Temperature Excursion Policy - This document provides the requirement for all enrolled providers to report any excursions or storage and handling incidents . Upon receiving the Pfizer -BioNTech Covid-19 Vaccine, Points of Distribution (POD) must check vaccine temperature and store vaccines at recommended temperatures immediately. ET •Thermal shipping container dimensions -400mm x 400mm x 560mm (approx. Contact manufacturers to determine vaccine viability o Nonviable vaccine: remove from unit (quarantine to prevent usage); reconcile inventory; return/discard appropriately . Confirm whether any Pfizer vaccines were affected, if yes, provide the number of doses. Handling a Temperature Excursion in Your Vaccine Storage Unit . To report an adverse drug reaction (or suspected side effect) experienced with a Pfizer medication (prescription or a vaccine), please contact us at 1 866 723-7111 or by fax at 1 855 242-5652. Transfers should be limited, especially when being moved at 2oC to 8oC, to decrease likelihood of temperature excursions and disruption to physical stability of vaccine. When a temperature in a vaccine storage unit is discovered outside of the recommended ranges, it is vital to contact the vaccine manufacturers to determine the viability of the vaccines. Temperature excursion related questions: Email: excursions@modernatx.com. Temperature excursions; Green Moderna vials; View press release and media call. (Refer to . COVID-19 Vaccine Temperature Excursion Guide Notify the primary or backup vaccine coordinator immediately if you discover a . Do not move the vaccine. Temperature Excursion Protocol is available. Q: We have ordered in 30-dose increments at a time. excursions@modernatx.com Pfizer ; 1-800-505-4426 Sars-COV-2 (Pfizer BioNtech) www.pfizer.com . Is the smallest dose available now 100? Elicker announced Friday that there had been a "temperature excursion" of Pfizer-BioNTech vaccines and 650 doses had been given out at the Health Department's clinic at 54 Meadow St. between . Please be advised that the Pfizer Prime site will be down Friday, May 6, 7:30p.m. Back-up Vaccine Coordinator Title Phone Number Email Address . The call center is hours are: If your excursion is discovered outside of these hours, please call first thing the next day. New MIIC spreadsheet with race/ethnicity fields and phone number; . Pfizer Inc. 235 East 42nd Street. Reference number: ☐ Pfizer 1-800-438 . COVID-19, vaccine, temperature excursion, report Created Date: 4/13/2021 3:23:29 PM . For questions please contact the North Dakota Immunization Program at . . Store vaccines that have had a potential temperature excursion per manufacturer's recommendations until . So, you may want to take a look at our most frequently asked questions and answers before contacting us. Temperature excursion questions . Be prepared to provide documentation and data . Temperature Excursions for Pfizer-BioNTech In the event of a temperature excursion, contact Pfizer-BioNTech: Phone . POD that de-consolidate vaccine trays are responsible for: ☐Please check if additional excursion data is attached. Temperature Excursions for Pfizer-BioNTech In the event of a temperature excursion, contact Pfizer-BioNTech: While the Pfizer vaccine needs to be stored in a freezer at -94 degrees, most freezers are not designed for that level of cold - most are designed for -20 degrees. Ultra-low Temperature Freezer Pfizer's COVID-19 vaccine requires ultra-low temperature storage. 4. DPH Helpdesk If there is a temperature excursion, please contact Pfizer Customer Support at 1-833-VAX-COVI (1-833 -829-2684) 2. Include details on the sequestered vaccine about the potential excursion, including the name and phone number of the individual working to determine the viability of the vac cine. Email: cvgovernment@pfizer.com . Health care providers interested in learning more about the COVID-19 Vaccine Program may contact the NYSDOH at covid19vaccine@health.ny.gov. To request this document in another format, call 1-800-525-0127. Moderna vaccine shipment has a problem . Pfizer Vaccines Stored in Thermal Shippers . 3. Vaccine Coordinator Title Phone Number Email Address . If you would like to report an adverse event related to Pfizer's COVID-19 vaccine, . 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