ANALYSIS OF ADVERSE EVENTS REPORTED FOLLOWING SINGLE DOSE MONOVALENT H1N1 (SWINE FLU) VACCINE

Objective: To identify the adverse events reported following monovalent single dose intramuscular Swine Flu Vaccine within a period of 6 weeks after vaccination. Methodology: This descriptive study was conducted from November 2010 to January 2011 in Lady Reading Hospital Peshawar, a 1400 bedded, tertiary care hospital, where single dose monovalent swine flu vaccine was available free of cost. Recipients were all healthy hospital employees, above 18 years of age. A printed proforma was designed, in which adverse events were recorded (either by telephone or personal appearance) after 24 hours, 1 week and then after 6 weeks. Informed consent was taken before vaccine administration. The study was approved by the ethical review committee of the institution.Results: Seven hundred and ninety two individuals were included in the study with mean age of 27.67 (SD=10.7). Males were 52.3% while the rest were female. Two hundred and fifty (31.6%) were students, 214 (27%) were paramedical staff, 153 (19.3%) were doctors, 139 (17.6%) were nursing staff, while 19(2.4%) were senior teaching staff. After 24 hours of vaccination, redness at injection site was found in 36(4.5%), soreness in 29 (3.7%), and itching in 23 (2.9%), headache in 66 (8.3%), nausea in 35 (4.4%),fever in 21 (2.7%), dizziness in 6 (0.8%), and muscle aches in 1 (0.1%). After 7 days, only 3 (0.4%)individuals had soreness and tenderness at injection site, 2 (0.3%) had fatigue, 4 (0.5%) had fever and 2(0.3%) had dizziness. After 6 weeks, no local or systemic adverse events were noted.Conclusion: swine flu vaccine causes minor local or systemic side-effects in the form of pain, headache,fever, and fatigue in the first 24 hours of administration, and is free of short term and serious adverse events