Table 1.
Characteristics of large-scale controlled surveillance studies on the association between BNT162b2 and rare adverse events identified via literature search.
| Author | Database | Sample Size | Design | Follow-Up Time |
|---|---|---|---|---|
| Andrews, et al. [24] | National Immunization Management System, UK | 1.7 and 15.1 million person-time years in vaccinated and unvaccinated group, respectively |
Controlled cohort | Within 28 days after receiving either first or second dose |
| Barda, et al. [25] | Calit Health Services, Israel | 0.88 million people in each vaccinated and unvaccinated group |
Controlled cohort | Within 21 days after receiving either first or second dose |
| Birabaharan, et al. [26] | TriNetX Analytics Network, USA | 0.36 million people in each vaccinated and unvaccinated group |
Controlled cohort | Within 28 days after receiving either first or second dose |
| Hippisley-Cox, et al. [27] | National Immunization Management System, UK | 9.5 million people | Self-controlled case series | Within 8–28 days of receiving the first dose |
| Husby, et al. [28] | Danish Vaccination Register and National Patient Register, Denmark | 3.5 million vaccinated and 0.21 million unvaccinated people |
Self-controlled case series and controlled cohort |
Within 28 days after receiving either first or second dose |
| Hviid, et al. [29] | Danish Vaccination Register and National Patient Register, Denmark | 0.10 million vaccinated and 0.13 million unvaccinated people | Controlled cohort | Within 28 days after receiving either first or second dose |
| Jabagi, et al. [30] | National Health Data System, France |
3.9 million people (aged ≥75 years only) | Self-controlled case series | Within 14 days after receiving either first or second dose |
| Karlstad, et al. [31] | Nationwide Health Registers from Denmark, Finland, Norway, and Sweden | 15 million vaccinated and 4.3 million unvaccinated people | Controlled cohort | Within 28 days after receiving either first or second dose |
| Kerr, et al. [32] | National Health Service, UK | 12.6 million people | Self-controlled case series | Within 28 days after receiving the first dose |
| Klein, et al. [33] | Vaccine Safety Database, USA | 6.2 million people | Self-controlled case series | Within 21 days after receiving either first or second dose |
| Lai, et al. [34] | Hospital Authority, Hong Kong | 0.15 million vaccinated and 0.55 million unvaccinated people | Controlled cohort | Within 28 days after receiving the first dose |
| Li, et al. [35] | Clinical Practice Research Datalink Aurum, UK, and Information System for Research in Primary Care, Spain |
3.6 million people | Self-controlled case series | Within 21 days of the first dose |
| McKeigue, et al. [36] | National Health Service, Scotland | 2.7 million doses | Case-crossover | Within 14 days after receiving either first or second dose |
| Mevorach, et al. [37] | Ministry of Health, Israel | 5 million vaccinated and 9.9 million unvaccinated people | Controlled cohort | Within 30 days after receiving the second dose |
| Patone, et al. [38] | National Immunization Management System, UK | 12.1 million people | Self-controlled case series | Within 28 days after receiving the first dose |
| National Health Service, Scotland | 1.1 million people | Self-controlled case series | Within 28 days after receiving the first dose |
|
| Patone, et al. [39] | National Immunization Management System, UK | 17 million people | Self-controlled case series | Within 28 days after receiving the first dose |
| Shasha, et al. [40] | Meuhedet Health Maintenance Organization, Israel |
0.23 million in each vaccinated and unvaccinated group |
Controlled cohort | Within an average of 22 and 32 days after receiving the first and second dose, respectively |
| Simpson, et al. [41] | National Health Service, Scotland | 0.82 million | Self-controlled case series | Within 28 days after receiving the first dose |
| Wan, et al. [42] | Hospital Authority, Hong Kong | 0.54 million | Nested case-control | Within 42 days after receiving either first or second dose |
| Wan, et al. [43] | Hospital Authority, Hong Kong | 1.96 million | Nested case-control and self-controlled case series | Within 28 days after receiving either first or second dose |
| Whiteley, et al. [44] | National Health Service, UK | 8.7 million vaccinated and 25 million unvaccinated people |
Controlled cohort and self-controlled case series | Within 28 days after receiving the first dose |