Vaccine Safety
Common Adverse Events
Vaccines are considered to be safe and effective with most common adverse events being mild and are signs that the body is developing immunity:
- Pain, swelling, or redness where the shot was given
- Mild fever
- Chills
- Feeling tired
- Headache
- Muscle and joint aches
Serious Adverse Events
More serious side effects are rare but can occur. Some examples are:
- Anaphylaxis (0.65 cases/1 million vaccinations)
- Thrombocytopenia from Rubella vaccine (1 case/40,000 vaccinations)
- Orchitis from Mumps vaccine (0.3 cases/1 million vaccinations)
- Intussusception from Rotavirus vaccine (1 case/100,000 vaccinations)
- Guillain-Barre from flu vaccine (1 case/1.25 million vaccinations; association is stronger with flu infection than the vaccine)
Why Report a Vaccine Adverse Event
- It helps to improve patient safety through careful monitoring and pharmacovigilance.
- It is required by IHS policy in Chapter 7 of the Indian Health Manual
- Adverse reactions to vaccines will be reported online using Form VAERS-1, Vaccine Adverse Event Reporting System . A copy of each report will be filed in the pharmacy with a copy sent to the Pharmacy and Therapeutics Committee.
- Healthcare providers may be required by law to report under certain conditions:
- Any adverse event listed in the VAERS Table of Reportable Events following Vaccination that occurs within the specified time period after vaccinations.
- An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.
