Document ID: chunk:federal_register_of_legislation:F2022L00189:clause:1_1
Version: federal_register_of_legislation:F2022L00189
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 3944–6003

1                                                   information about adverse events following immunisation with vaccines that relates to one or more of the following:    the NCIRS          to facilitate appropriate and effective analysis of data relating to safety signals associated with vaccines
                                                      (a) the aggregate numbers of AEMS reports;
                                                      (b) the number of doses administered, as included in the AIR;
                                                      (c) case narratives of individual AEMS reports;
                                                      (d) case-line listed data, including (but not limited to) the:
                                                        (i) number allocated to the adverse event by the TGA;
                                                        (ii) date the adverse event was reported to the TGA;
                                                        (iii) date of the onset of symptoms;
                                                        (iv) sex of the patient;
                                                        (v) age of the patient;
                                                        (vi) reaction outcome;
                                                        (vii) vaccine;
                                                      (e) the TGA's analysis of data provided by NCIRS or drawn from the AEMS and AIR databases;
                                                      (f) methodologies and results of analysis pertaining to risk of adverse events following immunisation with vaccines

Part 2—SAEFVIC

Therapeutic goods information that may be released
Column 1                                            Column 2                                                                        Column 3           Column 4
Item                                                Kinds of information                                                            Persons or bodies  Purposes