Adverse Event Reporting
Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Interim Authorization
In order to mitigate the risks of using this unapproved product under Interim Authorisation and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this Interim Authorisation is limited to the following (all requirements must be met):
- Pfizer BioNTech COVID 19 Vaccine is authorized for use in individuals 12 years of age and older.
- The vaccination provider must communicate to the individual receiving the Pfizer BioNTech COVID-19 Vaccine or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving Pfizer BioNTech COVID 19 Vaccine.
- The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.
- The vaccination provider is responsible for mandatory reporting of the vaccine adverse event :
- vaccine administration errors whether or not associated with an adverse event,
- serious adverse events* (irrespective of attribution to vaccination),
- cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
- cases of COVID-19 that result in hospitalization or death. Complete and submit reports to website www.pfizersafetyreporting.com or email [email protected] or fax 8001012817 (local toll free) or call +65 64038888. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report.
- The vaccination provider is responsible for responding to HSA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine to recipients.
*Serious adverse events are defined as:
- Death;
- A life-threatening adverse event;
- Inpatient hospitalization or prolongation of existing hospitalization;
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
- A congenital anomaly/birth defect;
- An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
Other Adverse Event Reporting to Pfizer, Inc.
Vaccination providers may report all other adverse events to the extent feasible to Pfizer using the contact information below
Website
www.pfizersafetyreporting.com
Email
[email protected]
Fax number
8001012817 (local toll free)
Telephone number
+65 64038888
Important Safety Information
- Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
- In clinical studies with a data cut-off of March 13, 2021, adverse reactions in participants 16 years of age and older included pain at the injection site (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), injection site redness (9.9%), 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%)
- In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).
- Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials
- Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
- Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
- There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
- Vaccination providers must report Adverse Events in accordance with the Fact Sheet and the reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
- Vaccination providers should review the Fact Sheet for mandatory requirements and Information to Provide to Vaccine Recipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors
- Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com
Ensuring the Authenticity of Pfizer‑BioNTech COVID‑19 Vaccine
- Pfizer is committed to patient safety and ensuring that people have accurate information about the investigational Pfizer‑BioNTech COVID‑19 Vaccine, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate Pfizer‑BioNTech COVID‑19 Vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm
- The Health Sciences Authority (HSA) of Singapore has authorized the interim authorization to permit the emergency use of the unapproved product, Pfizer‑BioNTech COVID‑19 Vaccine, for active immunization to prevent COVID‑19 in individuals 12 years of age and older.
- The Pfizer‑BioNTech COVID‑19 Vaccine is only administered intramuscularly by a health care professional
- The Pfizer‑BioNTech COVID‑19 Vaccine is not taken orally and is not available in a capsule or tablet form
- Authentic Pfizer‑BioNTech COVID‑19 Vaccines, manufactured by Pfizer Inc., will include the Pfizer name and logo on the label and are dispensed in a vial with a purple cap
- The Pfizer‑BioNTech COVID‑19 Vaccine is not sold online
- The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Pfizer
If you suspect the Pfizer‑BioNTech COVID‑19 Vaccine you have purchased may be counterfeit, contact us here.
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Source: Safety Information | CVDVACCINE Singapore | CVD Vaccine Singapore EUA (Version 6.0)