Adverse Event Reporting Form Step 1/5: Leave this field blank Patient Details: Patient’s Name Country Age/Date of Birth Weight in Kg. Height Sex Male Female Pregnancy Status Date of Adverse Event Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 Seriousness Death Life Threatening Hospitalization- Initial /Prolonged Disability Congenital-anomaly Other Medically Important Required intervention to prevent permanent impairment/ damage Adverse Event Description Adverse Event Outcome Not Recovered Recovering Unknown Recovered with sequelae Recovered Fatal Recovered Date Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 Date of Death Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 Related Tests/ Laboratory data (If available) Other Medical History (Including Pre-existing Condition) Tests/ Laboratory Reports (If any) Choose file Uploading… (0%) Browse A file with this name has already been uploaded. This file type isn’t allowed. This file size is too big. Delete Delete Delete 0/3 Files uploaded Product Name For multiple products, please fill: ProductName1 , ProductName2 Batch/Lot No. For multiple products, please fill: Batch1, Batch2 Mfg. Date For multiple products, please fill: Mfg. Date1 , Mfg. Date2 Exp. Date For multiple products, please fill: Exp.Date1 , Exp.Date2 Dose and Frequency Therpay Start Date Therpay Stopped Date Reason for Use/ Indication Action taken after reaction Drug withdrawn Dose reduced Dose increased Dose continued Reaction abated after use stopped or dose reduced Yes No Not Applicable Reaction reappeared after reintroduction Yes No Not Applicable Product Name (optional) For multiple products, please fill: ProductName1 , ProductName2 Batch/Lot No. (optional) For multiple products, please fill: Batch1, Batch2 Mfg. Date (optional) For multiple products, please fill: Mfg. Date1 , Mfg. Date2 Exp. Date (optional) For multiple products, please fill: Exp.Date1 , Exp.Date2 Dose and Frequency (optional) Therpay Start Date (optional) Therpay Stopped Date (optional) Reason for Use/ Indication (optional) Name Profession Contact No. Country code + Phone number E-mail Address Date of Reporting Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 Continue
