AEFI reporting MCQs With Answer

Introduction: This quiz collection on AEFI reporting MCQs With Answer is designed for M.Pharm students specializing in Clinical Pharmacy Practice. It focuses on adverse events following immunization (AEFI), covering definitions, classification, reporting pathways, causality assessment, signal detection and key aspects of vaccine safety monitoring. The questions emphasize practical knowledge required to identify, document and report AEFIs accurately, interpret causality frameworks and understand roles of healthcare professionals in immunization safety. These MCQs will help students reinforce regulatory expectations, clinical decision-making in suspected vaccine reactions, and the pharmacist’s responsibility in strengthening pharmacovigilance systems within immunization programs.

Q1. What is the most appropriate definition of an Adverse Event Following Immunization (AEFI)?

• An adverse reaction proven to be caused by the vaccine
• Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine
• A predictable local injection site reaction occurring within minutes of vaccination
• An event only related to vaccine manufacturing defects

Correct Answer: Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine

Q2. Which of the following is NOT one of the standard WHO categories of AEFI based on causality?

• Vaccine product-related reaction
• Program error-related reaction
• Injection technique-related anxiety
• Coincidental event

Correct Answer: Injection technique-related anxiety

Q3. Which of the following events is classified as a “serious” AEFI?

• Mild local pain at the injection site
• Fever of 38°C resolving within 24 hours
• Hospitalization or prolongation of existing hospitalization
• Transient appetite loss not requiring treatment

Correct Answer: Hospitalization or prolongation of existing hospitalization

Q4. Which database is the WHO’s global repository for suspected adverse reactions to medicines and vaccines reported by countries?

• VAERS
• VigiBase
• MedWatch
• Yellow Card Scheme

Correct Answer: VigiBase

Q5. In causality assessment of AEFI, which of the following elements is LEAST relevant?

• Temporal relationship between vaccination and event
• Biological plausibility and known vaccine adverse effect profile
• Coincidental illnesses or alternative explanations
• Manufacturer’s profit margin for the vaccine

Correct Answer: Manufacturer’s profit margin for the vaccine

Q6. The Brighton Collaboration primarily provides which resource for AEFI evaluation?

• Vaccine pricing guidelines
• Standardized case definitions and levels of diagnostic certainty for adverse events
• Cold chain equipment specifications
• Advertising standards for vaccines

Correct Answer: Standardized case definitions and levels of diagnostic certainty for adverse events

Q7. Which of the following best describes a “program error-related reaction”?

• An adverse event caused by contamination during manufacturing
• An event caused by incorrect vaccine administration, such as wrong route or dose
• An adverse reaction due to vaccine adjuvant contents
• A coincidental illness unrelated to vaccination

Correct Answer: An event caused by incorrect vaccine administration, such as wrong route or dose

Q8. Who among the following should report suspected AEFIs in a healthcare setting?

• Only the treating physician
• Pharmacists, nurses, physicians and any healthcare worker who observes or is informed of the event
• Only the vaccine manufacturer
• Only public health officers at national level

Correct Answer: Pharmacists, nurses, physicians and any healthcare worker who observes or is informed of the event

Q9. Which timeframe is most critical for immediate reporting of a severe AEFI such as anaphylaxis in most immunization programmes?

• Within 24 hours to the appropriate public health authority
• Within 6 months during annual review
• Only if the event becomes chronic after one month
• No reporting is required for anaphylaxis

Correct Answer: Within 24 hours to the appropriate public health authority

Q10. Which of the following best characterizes an immunization anxiety-related reaction?

• An event due to a contaminated vaccine batch
• A psychogenic response such as fainting or hyperventilation associated with fear of injection
• Anaphylaxis due to vaccine component allergy
• Severe local abscess from improper injection technique

Correct Answer: A psychogenic response such as fainting or hyperventilation associated with fear of injection

Q11. During causality assessment, the term “dechallenge” refers to which action?

• Reviewing the patient’s diet
• Withdrawal of the suspect vaccine/exposure and observation for resolution of event
• Administering an antidote to the vaccine
• Re-administering the vaccine immediately to confirm the reaction

Correct Answer: Withdrawal of the suspect vaccine/exposure and observation for resolution of event

Q12. Which vaccine safety concept involves identifying higher-than-expected reporting rates of specific events to prompt further investigation?

• Signal detection
• Cold chain monitoring
• Vaccine efficacy study
• Batch release testing

Correct Answer: Signal detection

Q13. AEFIs that occur due to a defect in the vaccine’s quality (e.g., contamination) are classified as:

• Vaccine product-related reaction
• Vaccine quality defect-related reaction
• Program error-related reaction
• Coincidental event

Correct Answer: Vaccine quality defect-related reaction

Q14. Which is the most appropriate first-line treatment for acute anaphylaxis following vaccination?

• Oral antihistamine only
• Intramuscular epinephrine, airway support and emergency measures
• Topical steroid at injection site
• Observation without intervention

Correct Answer: Intramuscular epinephrine, airway support and emergency measures

Q15. In a causality assessment algorithm, an event is classified as “coincidental” when:

• There is evidence that the vaccine directly caused the event
• Alternative causes are more likely and temporal relationship is inconsistent with known vaccine effects
• The event is prevented by the vaccine
• There is no temporal relationship because the event occurred prior to vaccination

Correct Answer: Alternative causes are more likely and temporal relationship is inconsistent with known vaccine effects

Q16. Which of the following is a key role of clinical pharmacists in AEFI surveillance?

• Designing vaccine manufacturing plants
• Identifying, documenting and reporting suspected AEFIs; counselling on vaccine safety; assisting in causality assessment
• Approving marketing authorization for vaccines
• Handling only medication errors unrelated to vaccines

Correct Answer: Identifying, documenting and reporting suspected AEFIs; counselling on vaccine safety; assisting in causality assessment

Q17. Which of the following best describes a “vaccine product-related reaction”?

• An adverse event due to stress prior to immunization
• An event caused by the inherent properties of the vaccine or its components (e.g., known reactogenicity)
• An event due to incorrect storage temperature in the cold chain
• A coincidental unrelated medical condition

Correct Answer: An event caused by the inherent properties of the vaccine or its components (e.g., known reactogenicity)

Q18. What is the importance of documenting batch and vial numbers when reporting an AEFI?

• It is unnecessary and rarely used
• To facilitate traceability, detect batch-specific problems and enable targeted investigations or recalls
• To calculate vaccine profit margins
• Only for record-keeping in pharmacies, not for safety

Correct Answer: To facilitate traceability, detect batch-specific problems and enable targeted investigations or recalls

Q19. Which element is essential for a high-quality AEFI report submitted to a surveillance system?

• Complete patient identifiers, detailed clinical description, timing related to vaccination and vaccine details
• Only the vaccine name without clinical detail
• Only the reporter’s opinion without clinical data
• Only the patient’s opinion without vaccination information

Correct Answer: Complete patient identifiers, detailed clinical description, timing related to vaccination and vaccine details

Q20. After an AEFI signal is detected at the national level, which is the most appropriate next step?

• Immediate global recall of all vaccine lots without investigation
• Conducting a rapid assessment, detailed investigation, causality analysis and appropriate risk communication
• Ignoring it until multiple countries report the same issue
• Stopping all immunization programs permanently

Correct Answer: Conducting a rapid assessment, detailed investigation, causality analysis and appropriate risk communication

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