Table 3.

Age-, Sex-, and Site-Comparable Event Rates and Risk of Adverse Events for Recipients of Recombinant Zoster Vaccine Versus Recipients of Zoster Vaccine Live in a Vaccine Safety Datalink Study Cohort (Final Primary Sequential Analysis Results)^a

Adverse Event Group	Observed No. of Events	Observed Rate per 10,000 Doses of RZV	Expected No. of Events b	Relative Risk
Acute myocardial infarctionc	320	4.94	379.83	0.84
Strokec	287	4.43	376.19	0.76
Nonhemorrhagic	267	4.12	321.04	0.83
Hemorrhagic	41	0.63	77.21	0.53
Supraventricular tachycardia	151	2.33	125.45	1.20
Polymyalgia rheumatica	134	2.07	152.68	0.88
Convulsion-associated terms excluding epilepsy	112	1.73	123.56	0.91
Bell’s palsyd	86	1.33	95.72	0.90
Optic ischemic neuropathye	37	0.57	52.61	0.70
Giant cell arteritise	35	0.54	49.20	0.71
Anaphylaxise	20	0.31	15.15	1.32
GBSd,f	6	0.09	4.83	1.24

Abbreviations: GBS, Guillain-Barré syndrome; RZV, recombinant zoster vaccine; ZVL, zoster vaccine live.

^a January 2018–December 2019 for the RZV group and January 2013–December 2017 for the historical ZVL group.

^b The expected number of events following receipt of RZV was estimated from historical data on ZVL recipients, adjusting for site, age group, and sex.

^c Results for acute myocardial infarction and stroke were also adjusted for diabetes and hypertension during the year prior to RZV or ZVL vaccination.

^d In analysis 5, a preliminary safety signal was observed for Bell’s palsy (36 cases vs. 24 expected; RR = 1.51, adjusted P = 0.03), indicating a potentially elevated risk for RZV recipients versus historical ZVL recipients. In analysis 2, a preliminary safety signal was observed for GBS (3 cases vs. 0.6 expected; RR = 5.25, adjusted P = 0.02).

^e Results for optic ischemic neuropathy, giant cell arteritis, and anaphylaxis were adjusted for site and age group (60–64, 65–74, or ≥75 years) only.

^f GBS results were unadjusted.