Vaccine Safety Flashcards
The MMR vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
A. Live, attenuated
The varicella vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
A. Live, attenuated
The hepatitis A vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
B. Inactivated
The yellow fever vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
A. Live, attenuated
The rotavirus vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
A. Live, attenuated
The polio vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
B. Inactivated
The rabies vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
B. Inactivated
The diphtheria toxoid vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
C. Antigen derived from living or killed cells
The tetanus toxoid vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
C. Antigen derived from living or killed cells
The Hib vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
D. Conjugate
The pneumococcal vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
D. Conjugate
The meningococcal vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
D. Conjugate
The hepatitis B vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
E. Recombinant DNA derived
The HPV vaccine is: A. Live, attenuated B. Inactivated C. Antigen derived from living or killed cells D. Conjugate E. Recombinant DNA derived
E. Recombinant DNA derived
________ is a medical incident that takes place after an immunization, causes concern, and believed to be caused by immunization. It is important to note that describing an event as such does not and must not imply causality, just a belief of causality.
Adverse Event Following Immunization (AEFI)
You get a vaccine at the pharmacy, you walk across the street and you get hit by a car 5 minutes later, is that an adverse event following immunization (AEFI)?
Yes, technically it is. That is why it is important to collect and have large vaccine trials where there is a DSMB (Data Safety Monitoring Board), who is required for associating adverse events with vaccines when correct.
There are multiple major types of Adverse Events Following Immunization (AEFI). \_\_\_\_\_\_\_\_\_ is an event caused or precipitated by the vaccine when given correctly, caused by the inherent properties of the vaccine. A. Vaccine Reaction B. Program Error C. Injection Reaction D. Coincidental E. Unknown
A. Vaccine Reaction
There are multiple major types of Adverse Events Following Immunization (AEFI). \_\_\_\_\_\_\_\_\_ is an event that arises from anxiety about, or pain from, the injection itself rather than the vaccine. A. Vaccine Reaction B. Program Error C. Injection Reaction D. Coincidental E. Unknown
C. Injection Reaction
There are multiple major types of Adverse Events Following Immunization (AEFI). \_\_\_\_\_\_\_\_\_ is an event whose cause cannot be determined. A. Vaccine Reaction B. Program Error C. Injection Reaction D. Coincidental E. Unknown
E. Unknown
There are multiple major types of Adverse Events Following Immunization (AEFI). \_\_\_\_\_\_\_\_\_ is an event caused by an error in vaccine preparation, handling, or administration. A. Vaccine Reaction B. Program Error C. Injection Reaction D. Coincidental E. Unknown
B. Program Error
There are multiple major types of Adverse Events Following Immunization (AEFI). \_\_\_\_\_\_\_\_\_ is an event that happens after immunization but not caused by the vaccine - a chance association. A. Vaccine Reaction B. Program Error C. Injection Reaction D. Coincidental E. Unknown
D. Coincidental
There have been numerous vaccine safety concerns over the years. Some people feared that smallpox vaccine was associated with: A. Multiple maladies B. GBS C. SIDS D. Cow illnesses E. Demyelinating syndromes F. Autism Spectrum Disorder (ASD) G. Inclusion myositis
D. Cow illnesses
There have been numerous vaccine safety concerns over the years. Some people feared that the influenza vaccine was associated with: A. Multiple maladies B. GBS C. SIDS D. Cow illnesses E. Demyelinating syndromes F. Autism Spectrum Disorder (ASD) G. Inclusion myositis
B. GBS
There have been numerous vaccine safety concerns over the years. Some people feared that the pertussis vaccine was associated with: A. Multiple maladies B. GBS C. SIDS D. Cow illnesses E. Demyelinating syndromes F. Autism Spectrum Disorder (ASD) G. Inclusion myositis
C. SIDS
There have been numerous vaccine safety concerns over the years. Some people feared that the hepatitis B vaccine was associated with: A. Multiple maladies B. GBS C. SIDS D. Cow illnesses E. Demyelinating syndromes F. Autism Spectrum Disorder (ASD) G. Inclusion myositis
E. Demyelinating syndromes
There have been numerous vaccine safety concerns over the years. Some people feared that the thimerosal in vaccines was associated with: A. Multiple maladies B. GBS C. SIDS D. Cow illnesses E. Demyelinating syndromes F. Autism Spectrum Disorder (ASD) G. Inclusion myositis
F. Autism Spectrum Disorder (ASD)
__________ is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
Biologics License Application (BLA)
The Vaccine Adverse Event Reporting System (VAERS) is considered:
A. Active Surveillance
B. Passive Surveillance
B. Passive Surveillance
Phase 4 studies conducted by manufacturers and/or government agencies are considered:
A. Active Surveillance
B. Passive Surveillance
A. Active Surveillance
_____________ is a national system for passive surveillance jointly managed by the FDA and CDC that collects reports AE reports received from health care professionals, vaccine manufacturers, and the public.
Vaccine Adverse Event Reporting System (VAERS)
Who can submit data to the Vaccine Safety Datalink (VSD)?
Participating healthcare professionals
___________ is a program run by the CDC that involves 8 health maintenance organizations that participate in large linked database that tracks
vaccination (exposure), outpatient, emergency department, hospital and laboratory data (health outcomes), demographic variables (confounders) and includes approximately 3% of U.S. population.
Vaccine Safety Datalink (VSD)
___________ is a weekly epidemiological digest for the United States published by the Centers for Disease Control and Prevention (CDC). It is the main vehicle for publishing public health information and recommendations that have been received by the CDC from state health departments.
Morbidity and Mortality Weekly Report (MMWR)
The first vaccine for this disease resulted in a high incidence of intussusception (IS).
1st Rotavirus vaccine (called Rotashield)
When the proximal intestine gets pulled into the distal intestine, it is called ______.
Intussusception (IS)
This vaccine was licensed in 1998 for the treatment of rotavirus, but was voluntarily pulled off the market by the manufacturer in 1999 due to a high incidence of intussusception.
Rotashield
With the Rotashield vaccine, it was discovered that the majority of intussusception reports came back following the receiving of the ____ dose of the rotavirus vaccine.
A. First
B. Second
C. Third
A. First
The leading and most common adverse events seen are (there are 4):
Fever
Local Swelling
Redness
Induration (Hard knot in area)
True or False: Passive and active surveillance, including observational studies, after licensure are needed to detect and evaluate vaccine safety concerns.
True
