Introduction : Adverse Events Following Immunization (AEFI) range from more frequent minor side effects, such as fever or pain at the injection site, to rare but serious adverse reactions such as anaphylaxis, death, etc. For the children between 6 weeks to 6 years under the AEFI Surveillance Programme, syrup paracetamol (125mg/5ml) is recommended for uniformity and preventing dosing errors. However, AEFI cases due to paracetamol overdoses do occur. This study describes a series of five paracetamol overdose following immunization reported in Tamil Nadu during 2024 and enlists the state level interventions to prevent the occurrence of paracetamol overdose following immunization.
Methods : AEFI cases are reported through the SAFEVAC portal in accordance with the AEFI Surveillance and Response Operational Guidelines (2024) and undergo causality assessment by the State Causality Assessment Committee. In 2024, of 454 cases reported in Tamil Nadu, five were identified as paracetamol overdose and assessed for causality.
RESULTS: Among the five cases, four children recovered, while one child died from severe toxicity leading to acute liver failure. The reasons attributed are incorrect dosing by health workers, repeated administration by caregivers, misinterpretation of prescriptions, and the availability of non-uniform paracetamol formulations. State-level corrective measures included, supply of a uniform paracetamol formulation (125 mg/5 ml syrup with measuring cups) through TNMSC, communication with the National AEFI Secretariat regarding the risks posed by multiple formulations, training of Medical Officers and Health Workers on safe dispensing with supportive supervision, and sensitisation of professional bodies (IMA, IAP) on overdose risks.
CONCLUSION: This case series illustrate how errors in dosage, misinterpretation by caregivers, and the use of multiple formulations can have serious consequences, including death. State level interventions demonstrate that coordinated policy decisions, capacity building, and stakeholder engagement are essential to safeguard child health and prevent recurrence of such adverse events.