Disclaimer: This guide provides general information about Adverse Event Following Immunisation (AEFI) and Adverse Drug Reaction (ADR) reporting in South Africa for educational purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment guidance. If you or someone in your care experiences severe or rapidly worsening medical symptoms, seek immediate emergency medical care or consult a registered healthcare professional before making any decisions regarding your treatment.
If you suspect that you, a family member, or a patient has experienced an untoward medical event following a vaccination or medication, you can document and submit an official report in South Africa. Reporting an Adverse Event Following Immunisation (AEFI) or an Adverse Drug Reaction (ADR) helps public health authorities continuously monitor health product safety across the country.
Quick answer: when and how to report a suspected side effect
An Adverse Event Following Immunisation (AEFI) refers to any untoward medical occurrence that happens after receiving a vaccine, regardless of whether there is a proven causal relationship with the vaccine itself. In South Africa, you should report any reaction that is unexpected, severe, persistent, or troubling.
You do not need to wait for a doctor to confirm that a vaccine or medicine definitively caused the issue before submitting a report. Reporting can be completed directly through the official SAHPRA / South African Reporting hub using the Med Safety App, the official SAHPRA e-reporting portal, or by submitting a paper/PDF form via email. You can also report the event directly to your prescribing doctor, clinic nurse, or local pharmacist, who can assist in filing the formal submission.
What information to record
When an unexpected health event occurs after vaccination or taking medication, write down the exact details as soon as possible:
- Product Details: The full trade name of the vaccine or medicine, batch/lot number (if recorded on your vaccination card or prescription label), and dose administered.
- Timeline: The exact date and time the dose was received, as well as the time when symptoms first appeared.
- Symptom Log: Specific descriptions of physical signs (e.g., local swelling, fever temperature, rash distribution) and how symptoms progressed.
Where reporting fits into medicine safety
Submitting a side-effect report contributes to national post-market surveillance—also known as pharmacovigilance. Pharmacovigilance is the science of collecting, assessing, and monitoring data on therapeutic health products to detect previously unknown side effects or rare safety signals. Every report filed in South Africa is evaluated to protect the broader public and update patient safety guidelines.
Who can report a side effect or adverse drug reaction?
In South Africa, AEFI and ADR reporting is open to everyone. The health regulatory system relies on dual reporting from both healthcare providers and the public to maintain a accurate safety profile of registered health products.
- Patients, Consumers, and Caregivers: Any individual who experiences a suspected side effect—or a parent/caregiver reporting on behalf of a minor or dependant—can report directly to health authorities.
- Healthcare Professionals: Doctors, nurses, pharmacists, dentists, and community health workers have a professional obligation under Regulation 40 of the Medicines and Related Substances Act (Act 101 of 1965) to report suspected adverse reactions and product quality issues.
What information to record
Whether you are reporting for yourself or assisting someone else, make sure to collect:
- The reporter’s contact details (name, email address, phone number) so regulators can follow up if necessary.
- The patient’s basic demographic identifiers (initials, age or date of birth, biological sex) without disclosing unnecessary personal information.
- Any prior medical conditions, known allergies, or concurrent medications being taken at the time of vaccination.
Where reporting fits into medicine safety
Direct consumer reporting empowers patients to participate in national health oversight. While clinicians provide clinical observations, patient reports offer insights into how side effects impact daily functioning and quality of life. Together, consumer and professional reports form a comprehensive picture of real-world drug safety. For broader context on how treatments interact in the body, consult our related parent guide and our general guide on medication side effects.
What information should you collect before reporting?
To ensure your report can be properly evaluated by regulatory medical scientists, collect as much factual information as possible before starting your submission. However, if certain non-critical details are missing, do not delay filing a report for serious events.
| Category | Information to Gather | Why It Matters |
| Patient Identifiers | Initials, age, sex, weight, province/location | Distinguishes individual cases without breaching full name privacy. |
| Product Information | Brand name, manufacturer, lot/batch number, expiry date | Identifies whether the reaction is isolated to a specific batch or manufacturing run. |
| Administration Details | Date, time, dose strength, route/site (e.g., left upper arm) | Establishes the exact timeframe between administration and reaction onset. |
| Event Details | Specific symptoms, onset date, duration, severity, outcome | Details the exact nature and progression of the adverse reaction. |
| Medical History | Pre-existing health conditions, concomitant medications, allergies | Helps reviewers evaluate alternative explanations or drug interactions. |
What information to record
To meet the official minimum regulatory criteria for a valid report, SAHPRA requires four basic core elements:
- An identifiable patient (initials, age, or sex).
- An identifiable suspected product (brand name preferred).
- A description of the suspected adverse event or symptom.
- An identifiable reporter with contact details.
Where reporting fits into medicine safety
Detailed record-keeping helps clinical assessors differentiate between expected minor reactions (such as transient low-grade fever or mild injection-site soreness) and genuine safety signals. Accurate batch numbers are vital if an investigation into a specific vaccine lot or supply chain thermal variation is required.
How to report through SAHPRA, Med Safety or the ADR form
The South African Health Products Regulatory Authority (SAHPRA) provides three main reporting pathways for adverse events:
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[ Med Safety App ] [ SAHPRA e-Portal ] [ Email ADR/AEFI Form ]
Download for iOS / Online web form via Download form and email
Android (Select SA) SAHPRA website to [email protected]
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[ Pharmacovigilance Centre ]
Data assessment & risk review
- The Med Safety Mobile Application:
- Available for download on the Apple App Store and Google Play Store.
- After installation, select South Africa as your country.
- Allows you to report offline, save draft submissions, receive official safety news alerts, and track update notifications.
- SAHPRA Online e-Reporting Portal:
- Accessible via the official SAHPRA website under the Health Products Vigilance section.
- Designed for direct browser submission on mobile devices or desktop computers.
- Paper/PDF Form via Email:
- Download the official Adverse Drug Reactions and Quality Reporting Form or the specific AEFI Case Reporting Form (CRF).
- Complete the form with your recorded details and email it directly to
[email protected].
What information to record
When filling out the digital fields or PDF forms:
- Select whether the submission is for a routine medicine reaction (ADR) or a vaccine reaction (AEFI).
- Attach or type all specific symptom timelines and lot details clearly.
- Ensure your phone number and email address are typed correctly so SAHPRA staff can reach you if additional clinical information is needed.
Where reporting fits into medicine safety
Providing multiple reporting channels ensures that every resident in South Africa—whether using a smartphone, desktop computer, or healthcare practitioner—can seamlessly contribute to national safety monitoring.
What counts as a serious or unexpected side effect?
Most post-vaccination symptoms are mild, localized, and short-lived—such as temporary soreness at the injection site, mild fatigue, or a low-grade fever. However, regulatory authorities prioritize serious and unexpected adverse events.
An event is categorized as serious if it:
- Results in death or is life-threatening.
- Requires inpatient hospitalization or prolongs an existing hospital stay.
- Causes persistent or significant disability or incapacitation.
- Results in a congenital anomaly or birth defect.
An event is categorized as unexpected if the specific symptom or severity is not listed in the approved South African Professional Information (PI) or Patient Information Leaflet (PIL).
Red-flag symptoms
Seek immediate emergency medical care if you or anyone else experiences any of the following critical red-flag signs:
- Difficulty breathing, severe shortness of breath, or persistent wheezing.
- Swelling of the face, lips, tongue, or throat (signs of anaphylaxis/severe allergic reaction).
- Sudden chest pain, pressure, or irregular heart palpitations.
- Unexplained fainting, loss of consciousness, or severe dizziness.
- Seizures or convulsions.
- Severe, widespread rash, blistering skin, or sudden facial swelling.
- Unexplained or unusually severe bleeding or bruising.
When to contact a doctor, pharmacist, or emergency service
- Emergency: Call emergency services (e.g., 112 or local private ambulance services) or go to the nearest hospital casualty department immediately for red-flag symptoms.
- Non-Emergency Consult: Contact your general practitioner (GP), clinic nurse, or local pharmacist if mild symptoms persist for more than a few days, worsen over time, or cause significant distress. Never stop or adjust prescribed medications without clinician guidance.
What happens after a report is submitted?
Once an AEFI or ADR report is submitted through the Med Safety App, e-portal, or email, it enters the official national pharmacovigilance framework.
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[ SAHPRA Pharmacovigilance Unit ] ---> Acknowledgment sent to reporter
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[ Clinical Triage & Causality Review ]
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[ Global Safety Databases (e.g., WHO VigiBase) ]
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[ Regulatory Action ] (Updates to safety leaflets, safety alerts, or recall if required)
- Acknowledgment: An automated or written receipt confirmation is sent to the reporter.
- Clinical Evaluation: Pharmacovigilance experts analyze the report details to assess clinical plausibility and verify data completeness.
- Causality Assessment: For serious AEFI clusters, expert advisory committees evaluate whether the event was linked to vaccine administration, immunisation anxiety, program errors, or coincidental underlying illness.
- Data Aggregation: De-identified data is uploaded to national databases and integrated with global monitoring networks, such as the WHO VigiBase database.
- Regulatory Actions: If a definitive safety risk or trend is identified, SAHPRA may issue public safety alerts, update product warning labels, or order product recalls.
What information to record
Keep a personal copy of your submitted report or draft, along with your submission confirmation number, for your own health records. If a SAHPRA officer or healthcare worker contacts you for follow-up details, you can reference this confirmation number easily.
Where reporting fits into medicine safety
Post-market reporting is the primary mechanism for identifying rare adverse effects that may not appear during clinical trials. By taking a few minutes to report a suspected side effect, you directly strengthen the safety and efficacy of health products across South Africa.
Frequently Asked Questions
Can patients report side effects directly in South Africa?
Yes. Patients, consumers, and caregivers can report suspected side effects directly through the SAHPRA Med Safety App, the official online e-reporting portal, or by emailing an ADR/AEFI form to [email protected]. You do not need a healthcare provider’s permission to submit a report.
Do I need proof that the vaccine or medicine caused my reaction?
No. You do not need medical proof or confirmed causality. A temporal relationship—meaning the event happened after taking the medication or receiving the vaccine—is sufficient reason to submit a report for regulatory evaluation.
Can my pharmacist help me file a report?
Yes. Pharmacists, clinic nurses, and doctors can assist you in logging the reaction details and submitting the formal AEFI or ADR report on your behalf.
What are the most important details to include in a report?
At a minimum, include patient age/initials, product brand name, a description of the symptoms experienced, and your contact details so regulatory officers can follow up if needed.