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Rol Organization Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, FDA Bhavan, ITO, Kotla Road, New Delhi -110002 www.cdsco.nic.in Worldwide Unique no. A. Patient information 1. Patient initials 12. Relevant tests/ laboratory data with dates 2. Age at time of Event or date of birth 3. Sex: M F 4.Weight: Kgs B. Suspected Adverse Reaction 13. Other relevant history, including pre-existing medical conditions (e.g., allergies, race, pre.

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