Surveillance of Adverse Events Following Immunization (AEFI) with Human Papillomavirus (HPV) Vaccine in Canada (Sep. 2006 – Dec. 2007)
Bibliographic record
Abstract
Background: The Quadrivalent HP Recombinant Vaccine, Gardasil™ was approved in Canada in July 2006 and has been in use since September 2006. Gardasil is offered to females between 9 and 26 years of age. The aim of this vaccine is to prevent the diseases associated with HPV types 6, 11, 16, 18 (cervical cancer and anogenital warts). Some jurisdictions have already included this vaccine in their school based immunization program. Methods: All Adverse Event Following Immunization reports received by the Public Health Agency of Canada through passive and active surveillance programs were reviewed and included in the analysis. Results: A total of 148 reports of AEFI was received by the Agency between September 2006 and December 2007, with a reporting rate estimated at 38/100,000 doses distributed. In majority of cases (97.4%) HPV vaccine was the only vaccine given. The age ranged from 10 to 45 years old with median at 18.0 and StD 5.8 years. The most commonly reported AEFIs were injection site pain (20%), other injection site reactions (8%), nausea (8%); dizziness, headache, rash and vomiting (each 7.5%), urticaria (7%); and diarrhea, fever, rash and syncope (each 6%). There were two reports of serious AEFIs - one anaphylactic reaction and one encephalopathy. Medical attention was sought by 51 cases (35%), including 4 hospitalizations, 10 emergency room visits and 37 outpatient visits. The outcome was reported in 58 reports (40%), of which 41 reported full recovery, 10 recovering, and 7 reported some residual effect at the time of reporting. Conclusion: Gardasil is considered a safe vaccine in Canada. AEFIs reported following this vaccine were mainly minor injection site reactions and mild systemic events. AEFI data collected through the Canadian active and passive surveillance programs have been consistent with the data obtained from the pre-licensure clinical trials.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".