Programmatic pharmacovigilance process:

• • Case investigations of all severe, serious and non-serious AEFI, clusters and AEFIs of concern are conducted by the Department of Health.
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• • Case investigation is done by a multi-disciplinary team from the district or the province preferably within 48 hours of reporting.
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• • Once all the information about the case is available, Causality assessment is conducted by the National Immunisation Safety Expert Committee (NISEC).
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• • NISEC is an independent ministerial advisory committee meeting on a weekly basis, and providing scientific advice and recommendations to the NDoH and SAHPRA.


• • Once causality assessments are completed, the NISEC assessments are shared with SAHPRA and the NDoH.

All severe, serious and non-serious cases will be assessed for causality by the NISEC.

• • An AEFI is considered a serious event if it
• o results in death;
• o is life-threatening;
• o requires inpatient hospitalisation or prolongs an existing hospitalisation;
• o results in persistent or significant disability/incapacity
• o causes a congenital anomaly/birth defect; or
• o is a medically significant event or reaction


• • Non-serious AEFIs usually resolve within a few days without any prolonged or persistent negative outcomes.


• • Events occurring above the expected rate or of unusual severity


• • Signals generated as a result of individual or clustered cases as these could signify a potential for large public health impact.
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  Information on a new or known adverse event that may be caused by the vaccine and requires further investigation. Safety signals can be detected from a wide range of sources such as individual case safety reports, clinical studies and scientific literature.

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The selection of cases for Causality assessment focuses on:

• • Case investigation completed
• Case investigation completed, with both the Case Reporting and Case Investigation Forms.


• • Specific diagnosis
• There must be a specific ‘diagnosis’ (e.g. clinical sign, abnormal laboratory finding, symptom and/or disease) for the case, which is being investigated for a possible association with the vaccine.


• • Details and evidence
• All details of the case should be available at the time of assessment, including supporting documentation (e.g. clinical notes, laboratory results, post-mortem report).

Report the AEFI as soon as possible after identification, ideally within 24 hours. Provide as much details as possible about the case, including the following:

• • Details of the vaccine recipient (Name, Surname, ID number, contact details, home address, gender, province)
• • Name of the vaccine administered
• • AEFI experienced (provide as much detail as possible, what happened, when, how, etc.).
• • Co-existing medical conditions
• • Other medicines taken by the vaccine recipient (including traditional medicines)
• • Laboratory results
• • Post mortem investigation in the event of death occurring after vaccination

• A. Consistent with causal association to immunisation
• • Vaccine product-related reaction: Caused / precipitated by a vaccine due to one/more of the inherent properties of the vaccine product, even when the vaccine has been prepared, handled and administered correctly
• • Vaccine quality defect related: Caused / precipitated by a vaccine, due to one / more quality defects of the product, including its administration device, provided by manufacturer
• • Immunisation error-related reaction: Caused by inappropriate vaccine handling, prescribing or administration
• • Immunisation anxiety-related reaction: Arising from anxiety about the immunisation and fear of an injection

• B. Indeterminate
• • Temporal (Time) relationship is consistent but there is insufficient definitive evidence for vaccine causing event (may be new vaccine-linked event). Potential signal and maybe considered for investigation.
• • Qualifying factors result in conflicting trends of consistency and inconsistency with causal association to immunisation

• C. Inconsistent with causal association to immunisation
• • Coincidental event: An event that happens after vaccination but is not caused by the vaccine or vaccination process, because there are underlying or emerging condition(s), or a condition(s) caused by exposure to something other than vaccine.

• D. Unclassifiable
• • The case cannot be classified because the information available about the case is inadequate and additional information is required for classification.