Did narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada? A review of post-marketing safety surveillance data
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
A vaccine safety signal and association between new onset of narcolepsy and AS03-adjuvanted pandemic influenza A(H1N1) vaccine (Pandemrix, GlaxoSmithKline) in children and young adults has been reported in several European countries. In Ontario, Canada, AS03-adjuvanted pandemic A(H1N1) vaccine (Arepanrix, GlaxoSmithKline) was the primary vaccine administered in 2009/10, with 4.8 million doses distributed. We assessed post-marketing safety surveillance data by extracting adverse events following immunisation (AEFIs) associated with this vaccine from the integrated Public Health Information System. Reports were screened for key terms related to narcolepsy and further limited to children and young adults four to 29 years of age. Of 1,604 AEFIs reported in Ontario, 53 reports met the search criteria. Individual assessment by a nurse consultant for additional context suggestive of narcolepsy yielded five reports for secondary medical review. None of the five reports proved consistent with a possible narcolepsy diagnosis based on the available information. We present the first post-marketing assessment from Canada of narcolepsy reports following receipt of Arepanix. Continued investigation of differences between Arepanrix and Pandemrix and subsequent risk of narcolepsy is indicated. In light of the limitations of passive surveillance to detect a signal in this instance, validation using other data sources is prudent.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.023 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it