TGA safety signals from FOI 4032 document 9.xlsx

	A	B	C	D	E	F	G
1	Reaction	Cases (In-period)	Cases (Total)	Sole-Suspect (Total)	Sole-Suspect (In-period)	PRR	PRR LCI
2	Vaccine breakthrough infection	14	110	2	44	19.06	9.66
3	Carditis	3	133	3	133	17.28	9.57
4	Immunisation	3	10	2	9	15.59	2.00
5	COVID-19	87	375	15	165	14.99	10.78
6	Gastrointestinal disorder	1	5	0	3	14.75	5.99
7	SARS-CoV-2 test positive	3	9	0	3	12.47	6.43
8	Breakthrough COVID-19	4	6	4	6	11.03	4.28
9	Mitral valve incompetence	2	7	2	7	10.92	1.34
10	Eye disorder	2	3	2	3	10.46	3.29
11	COVID-19	6	13	0	1	9.93	5.75
12	Thrombocytopenia	1	679	1	649	9.71	8.36
13	Immunodeficiency	1	6	1	6	9.36	1.13
14	Polymenorrhoea	5	166	5	156	9.25	6.20
15	Troponin I	1	59	1	57	9.20	4.71
16	Brain injury	1	3	1	3	9.19	2.49
17	Chillblains	1	53	1	50	9.18	4.53
18	Chest X-ray abnormal	2	17	2	15	8.84	2.59
19	Pulmonary embolism	3	1137	2	1090	8.80	7.88
20	Fracture	1	5	1	5	8.62	3.16
21	Blue toe syndrome	1	11	1	11	8.58	1.90
22	Fibrin D dimer increased	1	1219	1	1167	8.45	7.60
23	Pericarditis	56	3024	52	2913	8.44	7.71
24	Sinus rhythm	1	16	1	15	8.32	2.42
25	Blood potassium decreased	1	3	1	3	8.28	2.28
26	Incorrect dose administered	6	53	6	53	8.26	6.08
27	Cardiac tamponade	2	10	2	10	7.80	1.71
28	Amenorrhoea	1	5	1	5	7.62	3.13
29	Costochondritis	4	244	2	237	7.61	5.61
30	Menstruation delayed	2	170	1	165	7.57	5.27
31	Underdose	2	67	2	65	7.46	4.20
32	Hemiplegic migraine	1	19	0	18	7.41	2.52
33	Myocarditis	36	1066	34	1027	7.26	6.30
34	Electrocardiogram T wave inversion					7.21	3.36
35	Echocardiogram abnormal		106			7.19	4.58
36	Multisystem inflammatory syndrome in children					7.02	1.52
37	Electrocardiogram abnormal		544			6.95	5.72
38	Appendicitis		207			6.87	5.00
39	Magnetic resonance imaging heart		43			6.71	3.37
40	Ovarian cyst					6.68	2.94
41	Post-acute COVI D-19 syndrome					6.63	2.23
42	Urinary tract infection					6.60	3.12
43	SARS-CoV-2 test positive		186			6.59	4.75
44	Electrocardiogram ST segment depression					6.55	2.47
45	Intervertebral disc protrusion					6.55	2.47
46	Dementia					6.52	1.96
47	Exercise tolerance decreased					6.43	2.65
48	Proctalgia					6.37	1.81
49	Miliaria					6.37	1.81
50	Electrocardiogram ST segment elevation		168			6.24	4.45
51	Sinus tachycardia		100			6.24	4.02
52	Alopecia areata					6.24	2.09
53	krteriogram coronary abnormal					6.24	0.70
54	Spinal osteoarthritis					6.24	0.70
55	Menstrual disorder		2127			6.04	5.50
56	Menstruation irregular		656			6.02	5.08
57	Mastitis		42			5.95	3.07
58	Dysmenorrhoea		380			5.81	4.67
59	Cardiac disorder		231			5.72	4.33
60	Intermenstrual bleeding		285			5.63	4.39
61	Costochondritis					5.61	2.66
62	Ear discomfort					5.58	2.07
63	Burning sensation					5.46	3.34
64	Maternal exposure during pregnancy					5.46	1.13
65	Computerised tomogram abnormal					5.46	1.13
66	Adenomyosis					5.46	1.13
67	Toothache					5.45	3.19
68	Myopericarditis		362			5.43	4.37
69	Dropharyngeal discomfort		289			5.43	4.25
70	Pericardial effusion		223			5.43	4.12
71	Adverse event following immunisation					5.40	3.41
72	Vasculitic rash					5.33	2.52
73	Cardiac flutter		170			5.30	3.87
74	Supraventricular extrasystoles					5.30	1.96
75	Nephrolithiasis		114			5.23	3.57
76	Vertebrobasilar artery dissection					5.20	1.43
77	Haemorrhage in pregnancy					5.20	1.43
78	Appendicectomy					5.20	1.43
79	Shoulder injury related to vaccine administration					5.17	3.63
80	Product administered to patient of inappropriate age					5.14	2.84
81	Heavy menstrual bleeding		849			5.13	4.47
82	Disorientation					5.13	2.66
83	Breast swelling		88			5.08	3.30
84	Neuralgia					5.02	2.91
85	Expired product administered		389			4.97	4.06
86	Extrasystoles		141			4.89	3.49
87	Kidney infection		40			4.80	2.57
88	Painful respiration					4.80	2.27
89	Myopericarditis		69			4.79	3.72
90	Breast swelling					4.79	2.86
91	Palpitations		5186			4.78	4.53
92	Blood thyroid stimulating hormone increased					4.68	1.27
93	Electrocardiogram QT prolonged					4.68	1.27
94	Blood lactate dehydrogenase increased					4.68	0.94
95	Joint lock					4.68	0.94
96	Overdose					4.68	0.49
97	Blood testosterone decreased					4.68	0.49
98	Vitamin D deficiency					4.68	0.49
99	Vein rupture					4.68	0.49
100	Thrombosis		296			4.62	3.87