Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Z011258 | OT / RA |
No additional AE; Was the dose administered? Yes, but it was an incomplete dose; Identify when the issue occurred: While Performing the Injection Into The Patient; Syringe did not break- the staff attempted to administer two different syringes and they were unable to administer or push the plunger to administer the dose due to what appeared to be pressure in the syringe; This Spontaneous report was received from Nurse and referred to a/an patient of unknown age and gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 13-Feb-2026, the patient started therapy with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 (GARDASIL 9) (0.50 mL) (total) (Batch/Lot Number: Z011258) (Expiration date: 07-Aug-2027) dose form was Suspension for injection (Dose Text: incomplete dose). The patient started therapy with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 for the treatment of prophylaxis. On 13-Feb-2026, the patient experienced Identify when the issue occurred: While Performing the Injection Into The Patient (Poor quality device used). On 13-Feb-2026, the patient experienced Was the dose administered? Yes, but it was an incomplete dose (Accidental underdose). On 13-Feb-2026, the patient experienced Syringe did not break- the staff attempted to administer two different syringes and they were unable to administer or push the plunger to administer the dose due to what appeared to be pressure in the syringe (Syringe issue). The Outcome of Accidental underdose was not provided. The Outcome of Poor quality device used was not provided. The Outcome of Syringe issue was not provided. The action taken with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 regarding Accidental underdose was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 regarding Poor quality device used with Not Applicable dechallenge and rechallenge results. Case Assessments: Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 regarding Syringe issue with Not Applicable dechallenge and rechallenge results. The Nurse considered the event Poor quality device used (,) to be not assessed to Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121, the event Accidental underdose (,) to be not assessed to Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121, and the event Syringe issue (,) to be not assessed to Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 The Nurse considered the event Poor quality device used to be non-serious, the event Accidental underdose to be non-serious, and the event Syringe issue to be non-serious This is an invalid case due to Unknown Patient. Follow up information was received from the Nurse on 17-Feb-2026. This Spontaneous report referred to a 14 -year-old Male patient. The patient's concurrent conditions included Mild persistent asthma, Eczema, Food allergy, Allergy to influenza vaccine, Cholesteatoma Right middle ear, and Conductive earing loss of right ear. The patient's concomitant medication included Singulair (Montelukast sodium), Proair HFA (Salbutamol sulfate), Cetrizine (Cetirizine hydrochloride), and Triamcinolone (Triamcinolone acetonide). On 13-Feb-2026, the patient was vaccinated with the second dose of Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) (GARDASIL 9) 0.5 mL, total, intramuscularly (IM) in the Right Deltoid (total) (Batch/Lot Number: Z011258, Expiration date reported as 27-Aug-2027, but upon internal validation established as 07-Aug-2027); but it was reported that the plunger of the syringe seemed to be defective, as it was pushed hard regardless of whether or not a needle was on it. Two different doses with different needles were attempted and neither would be injected into the patient. After second attempt, the patient and his parents did not want any further attempts made. No additional adverse event was reported. This case was previously invalid but after follow-up information became valid as patient's identifiers were provided.
Allergy to vaccine; Asthma; Cholesteatoma of middle ear; Conductive hearing loss (Normal hearing on left ear.); Eczema; Food allergy (Dairy, egg, peanut, tree nut, sesame)
Singulair; Proair HFA; Cetrizine; Triamcinolone acetonide