Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 96295 | OT |
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y018677 | OT |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4432 | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3734K | OT |
zero patients who received the affected administered doses reported any adverse issues or side effects; TE for PEDVAX HIB and GARDASIL 9 with multiple excursion that occurred over a month ago and were inadvertently administered to an unknown number of patients; Spontaneous report was received from Nurse concerning multiple patients 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. In Nov-2025, the patient started therapy with PEDVAX HIB (Batch/Lot Number: Y018677) (Expiration date: 10-Apr-2027). In Nov-2025, the patient started therapy with GARDASIL 9 (Batch/Lot Number: Y015179) (Expiration date: 28-Jan-2027). The patient started therapy with PEDVAX HIB for the treatment of Prophylaxis, The patient started therapy with GARDASIL 9 for the treatment of Prophylaxis, In Nov-2025, the patient experienced TE for PEDVAX HIB and GARDASIL 9 with multiple excursion that occurred over a month ago and were inadvertently administered to an unknown number of patients. On an unknown date, the patient experienced zero patients who received the affected administered doses reported any adverse issues or side effects. Laboratory tests were not reported. The Outcome of TE for PEDVAX HIB and GARDASIL 9 with multiple excursion that occurred over a month ago and were inadvertently administered to an unknown number of patients was not provided. The Outcome of zero patients who received the affected administered doses reported any adverse issues or side effects 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 TE for PEDVAX HIB and GARDASIL 9 with multiple excursion that occurred over a month ago and were inadvertently administered to an unknown number of patients was Not applicable with Not Applicable dechallenge and rechallenge results. The action taken with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Suspension for injection regarding TE for PEDVAX HIB and GARDASIL 9 with multiple excursion that occurred over a month ago and were inadvertently administered to an unknown number of patients was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Suspension for injection regarding zero patients who received the affected administered doses reported any adverse issues or side effects 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 zero patients who received the affected administered doses reported any adverse issues or side effects with Not Applicable dechallenge and rechallenge results. The Nurse considered the event Improper storage of product in use (,) 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 No adverse event (,) to be not assessed to Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Suspension for injection, the event Improper storage of product in use (,) to be not assessed to Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Suspension for injection, and the event No adverse event (,) 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 TE for PEDVAX HIB and GARDASIL 9 with multiple excursion that occurred over a month ago and were inadvertently administered to an unknown number of patients to be non-serious and the event zero patients who received the affected administered doses reported any adverse issues or side effects to be non-serious The following updates were made to the case on 03-Dec-2025: Details of the adverse event Improper storage of product in use were updated, including onset (normalized), event (reported), and event (llt). Details of suspect product PEDVAX HIB were updated, including first administration (normalized) and last administration (normalized). Details of suspect product GARDASIL 9 were updated, including first administration (normalized) and last administration (normalized). This is an invalid case due lack of multiple patients identifiers. Follow-up information was received on 16-Dec-2025. The patient was a 4-month-old female patient. From 02-Sep-2025 to 31-Oct-2025, a temperature excursion happened. On 07-Oct-2025, the patient was vaccinated with a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Suspension for injection (LIQUID PEDVAX HIB) administered intramuscularly (site reported as left); with a dose of Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX) administered intramuscularly (site reported as right); with a dose of Rotavirus vaccine live oral 1v (ROTARIX) administered orally; and with a dose of Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) administered intramuscularly (site reported as right). On an unspecified date in November 2025, the vaccines were moved to back up location. The case was no longer considered to be invalid.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-12-17 , MNSC number : 02902189 , CLIC number : , ESTAR number : , IRMS number : Central date : 2025-12-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :