Table 2.
Details of 25 girls reporting adverse reactions to the quadrivalent human papillomavirus vaccine
| Vaccine category, dose, and concomitant vaccines | Suspected hypersensitivity reaction | Onset of reaction (min) | Skin prick test result | Intradermal test result | Vaccine challenge | Challenge reaction | Notes |
|---|---|---|---|---|---|---|---|
| Probable hypersensitivity (median 17.5 minutes): | |||||||
| Third dose | Urticaria, angio-oedema, laryngeal oedema, tachypnoea, palpitations | 390 | Negative | Negative | NA | NA | Anaphylaxis after third dose |
| First (and second) dose | Urticaria (urticaria, angio-oedema, hoarse voice, laryngeal oedema) | 20 (15) | Negative | Positive | NA | NA | Anaphylaxis after second dose |
| First dose | Urticaria | 15 | Negative | Negative | Quadrivalent HPV vaccine | Reported limited urticaria four hours later | |
| Possible hypersensitivity (median 16 hours): | |||||||
| Second dose | Urticaria | 960 | Negative | Negative | Elected not to proceed with challenge before evaluation | Elected not to proceed with challenge before evaluation | Hyperventilating after intradermal test. Reported non-specific limited rash several hours after intradermal test |
| Unlikely hypersensitivity (median 19 hours): | |||||||
| First dose plus H-B-Vax II | Generalised rash, angio-oedema | 2 | Negative | Negative | Bivalent HPV vaccine | None | Hypersensitivity unlikely as did not receive quadrivalent vaccine |
| First dose plus H-B-Vax II | Generalised rash | 120 | Negative | Negative | Bivalent HPV vaccine | None | Hypersensitivity unlikely as did not receive quadrivalent vaccine |
| First dose | Generalised rash | 2160 | Negative | Negative | Quadrivalent HPV vaccine | Reported nausea, vomiting, and lethargy two days later | Hypersensitivity unlikely as reaction was different to previous reaction |
| First dose plus H-B-Vax II | Urticaria, angio-oedema | 2880 | Negative | Negative | Bivalent HPV vaccine | None | Hypersensitivity unlikely as did not receive quadrivalent vaccine |
| Not hypersensitivity (median 90 minutes): | |||||||
| First dose plus Varilrix plus tetanus | Generalised rash | 1440 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose plus H-B-Vax II | Generalised rash (eczema) | 1440 | NA | NA | Quadrivalent HPV vaccine | None | Skin testing deemed unnecessary |
| First dose | Generalised rash | 1080 | NA | NA | Quadrivalent HPV vaccine | None | Skin testing deemed unnecessary |
| First dose | Generalised rash | 1080 | NA | NA | Quadrivalent HPV vaccine | None | Declined skin testing |
| First dose | Generalised rash | 180 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose plus Boostrix | Generalised rash | 720 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose | Urticaria | 2880 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose | Angio-oedema | 5 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose | Generalised rash | 90 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose | Generalised rash | 1440 | NA | NA | Quadrivalent HPV vaccine | None | Declined skin testing |
| First dose | Angio-oedema | 1440 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First dose | Urticaria | 15 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First (and second) dose | Urticaria (urticaria) | 30 (20) | Negative | Negative | Quadrivalent HPV vaccine | None | Twin of schoolgirl |
| Third dose | Urticaria | 10 | Negative | Negative | NA | NA | Twin of schoolgirl |
| First dose | Generalised rash, tachypnoea | 20 | Negative | Negative | Quadrivalent HPV vaccine | None | Thought to hyperventilate after first dose |
| First dose | Generalised rash | 30 | Negative | Negative | Quadrivalent HPV vaccine | None | |
| First (and second) dose | Urticaria (urticaria) | 10 (10) | Negative | Negative | Quadrivalent HPV vaccine | None |
HPV=human papillomavirus; NA=not applicable; H-B-Vax II=vaccine against hepatitis B (Merck); Varilix=vaccine against varicella (GlaxoSmithKline); Boostrix=vaccine against diphtheria, tetanus, and pertussis (GlaxoSmithKline).