Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | UNK | Y005248 | LL |
no adverse event; Improper storage of product in use; This spontaneous report was received from an Other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2096656, expiration date: 19-Apr-2026) 2 mL. On an unknown date, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection (lot #Y005248, expiration date: 17-Sep-2026) 0.5 mL. The patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), for the treatment of Prophylaxis. The patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), for the treatment of Prophylaxis. On an unknown date, the patient experienced no additional AE. On an unknown date, the patient experienced PEDVAX HIB and ROTATEQ which underwent a temperature excursion were administered. At the reporting time, the outcome of no additional AE and PEDVAX HIB and ROTATEQ which underwent a temperature excursion were administered. was unknown. The action taken with Rotavirus Vaccine, Live, Oral, Pentavalent and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) was reported as not applicable. The case is considered as invalid due to lack of patient's identifiers. Follow up information was received from Other health professional and referred to an 11 months Female patient. 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-Nov-2025, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) PEDVAXHIB INJ Suspension for injection (0.50 mL) (total) (Batch/Lot Number: Y005248) (Expiration date: 17-Sep-2026) dose form was Injection (Anatomical Site:Left Thigh). The patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Suspension for injection for the treatment of Prophylaxis. The vaccine underwent temperature excursion (9.1C for 47 minutes). There was no previous temperature excursions. No adverse event was reported. The suspect product ROTATEQ was removed from the case. The report was no longer considered as invalid.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-12-29 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-12-29 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :