| Methods |
Retrospective cohort study assessing the safety of pandemic H1N1 vaccination |
| Participants |
Danish women who were pregnant during the time interval between November 2009 and September 2010 (n = 58,585). Of these, 7062 received influenza vaccine. |
| Interventions |
Monovalent, inactivated, AS03‐adjuvanted split‐virion influenza A (H1N1) pdm09 vaccine (Pandemrix, Glaxosmithkline Biologicals) |
| Outcomes |
Abortion cases (retained or spontaneous) |
| Notes |
Government funded |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| PCS/RCS ‐ selection exposed cohort
All outcomes |
Low risk |
|
| PCS/RCS ‐ selection non‐exposed cohort
All outcomes |
Low risk |
|
| PCS/RCS ‐ comparability
All outcomes |
High risk |
|
| PCS/RCS ‐ assessment of outcome
All outcomes |
Low risk |
|
| Summary assessment |
Unclear risk |
Unclear |
