Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | 1 | T005735 | OT / LL |
patient was administered PEDVAX HIB on 5/27/2025 it was noted that the vaccine had expired on 6/12/2022.; No additional AE details reported; PEDVAX HIB packaging had the following lot and expiration: Y003144 9/11/2026. Could the vial have been labeled in error by the manufacturer? We are puzzled by the expiration date of almost 3 years ago.; This spontaneous report was received from a nurse and refers to a 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 27-May-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), 0.5 mL as prophylaxis, it was noted that the vaccine had expired on 16-Jun-2022 (expired product administered). The packaging had the following lot and expiration: (lot #Y003144, expiration date: 11-Sep-2026), however, the administered vial label had the following lot and expiration: (lot #T005735, expiration date: 12-Jun-2022) and it was enquired if the vial had been labeled in error by the manufacturer (product label issue). It was reported that the carton contained all the same product/lot, and the name was "PEDVAX HIB 0.5ML DOSE 10 SINGLE DOSE VIALS", one vial lot was #T005735, expiration date: 12-Jun-2022 and all other 9 vials were lot #Y003144, expiration date: 11-Sep-2026. The vaccine was administered to patient and a few moments later and then realized the expiration date was years over. This product had been stored in the original carton in the refrigerator, the reporter did not known what date was the carton or tray first opened. The carton was not glue sealed, in addition, multiple people had access to the product and it was checked with all personnel who had access if they could had inadvertently caused the mix. No damage noticed to the shipping carton on arrival to site or noted on the shipping carton's contents on arrival. No adverse event. Follow-up information was received from the nurse on 25-Jun-2025. Patient's identifiers were provided (previously invalid due to unknown patient). This report was regarding a 10-week-old female patient. Her birth weight was 9 lbs 8 oz, number of sibblings:1. No illness at time of vaccine administration. Concomitant medications included Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) Pediarix (Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid), Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)). The patient was in office for a 2-month well child visit. She received 4 vaccines (as previously reported); this was the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) administered to the patient and it was given in a private doctor's office/hospital by a healthcare professional in the left vastus lateralis (lot #T005735, expiration date: 12-Jun-2022). After that, the medical assistance was documenting the vaccines in the electronic medical record system and realized that Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) was expired. She returned to the box the vial came from but the other vaccines were not expired and all other vaccines in the box matched the lot number on the box, the medication error occurred during the administration (as previously reported). No drug treatment was prescribed. The action taken with the vaccine was reported as "pulled box", the box and the sticker were available to be returned. The patient had no reaction, no side effects from vaccine administration.
pediarix; prevnar 20; Rotateq