» Contact your immunization program and/or vaccine manufacturer(s) for guidance per your standard operating procedures (SOPs). SSL Certificate. a temperature excursion and the vaccine may need to be identified as waste. Improperly stored vaccines result in wasted vaccine, and in some cases, suspension of providers from the VFC Program. • Set the COVID-19 vaccine ultra-low temperature freezer at a 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. number of patients when preparing for daily clinics to help reduce over-thawing and transport (when necessary) of vaccine. Dosage: 0.3 mL. 850-922-4195. 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 . • 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). Vaccines exposed to temperature excursions must be labeled "Do Not Use" until more information is gathered by the Immunization Program. •Vaccine is shipped in a container that includes dry ice and digital data logger to monitor temperature. Updated January 2022 Pfizer Customer Service . • 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. Reference number: ☐ Pfizer 1-800-438 . If there is a temperature excursion, please contact Pfizer Customer Support at 1-833-VAX-COVI (1-833 -829-2684) 2. Immunization Section. A: Yes. Vaccines. PRIVACY POLICY. Pfizer ancillary kit has a problem . Temperature excursion questions . JnJ: 1-800-565-4008 . Contact the vaccine manufacturer to evaluate any temperature excursion before continued use of the vaccine. Confirm whether any Pfizer vaccines were affected, if yes, provide the number of 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. • Moderna COVID-19 Vaccine • Pfizer-BioNTech COVID-19 Vaccine . Vaccine Viability - Temperature Excursions during shipment for McKesson Specialty Distributed . (vaccine appointment registration webpage and a phone number that directs callers to staff accepting appointment registrations) to . Pfizer-BioNTech and Moderna COVID-19 vaccines to allow specific individuals . 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 . Pfizer COVID-19 vaccine for children 6 months through 4 years of age. Temperature excursions within the clinic or site Phone: 800-666-7248 Email: cvgovernment@pfizer.com number of patients when preparing for daily clinics to help reduce over-thawing and transport (when necessary) of vaccine. Each thermal shipper has a reusable GPS enabled temperature monitoring device which will be enabled when the shipper is packed. Refrain from making assumptions about the vaccine viability 2. Pfizer COVID-19 Vaccine - Thermal Shipper •Vaccine is shipped directly from Pfizer. Temperature Excursion Refrigerator Power Outage Mechanical Failure (Unit Failure) Unexplained Other: . 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. Upon receiving the Pfizer -BioNTech Covid-19 Vaccine, Points of Distribution (POD) must check vaccine temperature and store vaccines at recommended temperatures immediately. Login . If you experienced a temperature excursion, contact the Immunization Program PRODUCT INFORMATION. Pack the appropriate number of normal saline diluent . 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. 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. 4052 Bald Cypress Way, Bin A11. a temperature display, with min/max/current. Important Contact Information Pfizer Customer Service: (800) 666-7248 or . Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with an orange cap and a label with an orange border. • Set the COVID-19 vaccine storage freezer at a temperature between -58°F and +5°F (- 50°C and -15°C). 1. New: Updated COVID-19 Interval Guidance. Temperature readings outside of the recommended temperature ranges are considered excursions. 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 Contact the ODH COVID-19 Provider Call Center immediately at 1-844-963 . ☐Please check if additional excursion data is attached. Pediatric Pfizer vaccine can be ordered from the COVID19 - Pfizer order set. potential risk for a temperature excursion due to a storage unit or thermal packaging system . email address, phone number, change of delivery . Pediatric Pfizer vaccine can be ordered from the COVID19 - Pfizer order set. Pfizer Inc. 235 East 42nd Street. 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. On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. DPH Helpdesk Vaccine Manufacturer's Quality Control Phone Numbers Sanofi Pasteur 800‐822‐2463 ActHib® Adacel® Daptacel® Medical Information. . If yes, provide the brand, lot numbers, and number of doses of the affected vaccines during the temperature excursion. March 2022 DOH 348-840 . Ultra-low Temperature Freezer Pfizer's COVID-19 vaccine requires ultra-low temperature storage. breaker number along with contact name and phone number . The smaller packaging (450 doses vs 1170 doses) requires more shipper boxes and Controlant temperature monitors to deliver the same number of doses. Schedule for Primary Series and Booster Dose. COVID-19, vaccine, temperature excursion, report Created Date: 4/13/2021 3:23:29 PM . To report a temperature excursion, submit completed report and .pdf document of data logger temperatures to: . Pfizer MDV Pfizer case #/Person contacted: Moderna (866- . Important Contact Information Pfizer Customer Service: (800) 666-7248 or . 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. Medical Director Name Title Phone Number Email Address . 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 . Q: We have ordered in 30-dose increments at a time. 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. Password. In the event of a temperature excursion, contact the vaccine manufacturers, complete this form and submit it to the . 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. 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 . Proper storage and handling begins with an effective vaccine cold chain. . Gather temperature excursion information. Vaccine Temperature Excursion Guide Author: Washington State Department of . Florida Department of Health. For questions, call the NYSDOH COVID-19 hotline 1-888-364-3065. Be prepared to provide documentation and data . back to base alarm and automated temperature . (Refer to . Fax. including the name and phone number of the individual working to determine the viability of the vaccine. Primary Series: 2-dose series separated by at least 3-8 weeks *. 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 . Pfizer COVID-19 . Temperature Monitoring. . Log in. This vaccine is repackaged by the ODH RSS Warehouse. All shipments will be tracked via the onboard GPC monitoring device to ensure end to end distribution within required temperatures 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 . Phone Number Hours Celsius Fahrenheit Minutes Vaccine Coordinator Name . receive a single COVID-19 booster vaccine (Pfizer - BioNTech, Moderna or Janssen) at least 2 months (8 weeks) after receiving their initial Janssen primary . This applies to . Email: cvgovernment@pfizer.com . Beginning the fall of 2020, there were 153 institutes, including Ventavia, that assisted . 7. For clinical questions on the following specific COVID-19 vaccines, see: Janssen COVID-19 Vaccine (Johnson & Johnson) FAQs Pay. Temperature Excursion Reporting • All COVID Vaccine Temperature Excursions require immediate action and must be reported to DPH • A reporting mechanism via the DPH Helpdesk. Moderna:1-866-663-3762. 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 . excursions@modernatx.com Pfizer ; 1-800-505-4426 Sars-COV-2 (Pfizer BioNtech) www.pfizer.com . Manufacturer Contact Information. This applies to . . 1. The provider and patient fact sheets for the Pfizer vaccine are now available for: (New 12/17/2020) Pfizer 1-800-505-4426 www.pfizer.com • Pneumococcal 13-valent (Prevnar 13 TM) Confirm whether any other publicly funded vaccines were involved in the temperature excursion. Each vial carries a limited number of doses. Search for a department and find out what the government is doing 2. Q: We have ordered in 30-dose increments at a time. COVID-19, vaccine, temperature excursion, report Created Date: 4/13/2021 3:23:29 PM . Phone Number: Email: Step 5: Submit the Temperature Excursion Report and attach relevant documents. • Inventory of affected vaccines, including (1) lot #s and (2) whether purchased with public (for example, VFC) or private . POD that de-consolidate vaccine trays are responsible for: USA. The answer to your question may be just a click away. Email: SNSSupport@McKesson.com . Vaccines for School Age Children. 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. VFC Vaccines, Manufacturer, Lot Number(s) & doses affected due to temperature excursion: . Vaccine Coordinator Title Phone Number Email Address . • Follow the Vaccine Temperature Excursion Guide and contact vaccine manufacturers to determine whether the vaccines are viable. 1. people vaccinated annually with Sanofi's vaccines . -80 to -60 C [-112º to -76ºF] for ultra-cold freezer (may be used for Pfizer COVID-19 vaccine). Temperature Excursions for Pfizer-BioNTech In the event of a temperature excursion, contact Pfizer-BioNTech: 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. Deaf or hard of hearing customers, please call 711 (Washington Relay) or email civil.rights@doh.wa.gov. 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. c to -1s0c* -90 . View press release and media call. 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. 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