Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Z013401 | — |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Z015291 | — |
No symptoms reported; HCP calling to report an adverse for RECOMBIVAX HB and VAQTA for a single patient. Caller states an adult patient was inadvertently administered the pediatric dose for both vaccines.; This Spontaneous report was received from Nurse and referred to a/an 20-year-old ( Race Unknown ) ( Ethnicity No Information) Female Adult patient. The patient's medical history included Prior Bone Marrow Transplant Recipient. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 21-May-2026, the patient started therapy with Hepatitis A Vaccine, Inactivated, Pediatric, 25 u/0.5mL Suspension for injection 64457227:4095 (1.00 dosage form) (total) (Batch/Lot Number: Z015291) (Expiration date: 13-Nov-2026) dose form was Suspension for injection. On 21-May-2026, the patient started therapy with Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 (1.00 dosage form) (total) (Batch/Lot Number: Z013401) (Expiration date: 10-Feb-2028) dose form was Suspension for injection. The patient started therapy with Hepatitis A Vaccine, Inactivated, Pediatric, 25 u/0.5mL Suspension for injection 64457227:4095 for the treatment of prophylaxis, The patient started therapy with Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 for the treatment of prophylaxis, On 21-May-2026, the patient experienced HCP calling to report an adverse for RECOMBIVAX HB and VAQTA for a single patient. Caller states an adult patient was inadvertently administered the pediatric dose for both vaccines. (Product administered to patient of inappropriate age). On an unknown date, the patient experienced No symptoms reported (No adverse event). The Outcome of Product administered to patient of inappropriate age was not provided. The Outcome of No adverse event was not provided. The action taken with Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 regarding Product administered to patient of inappropriate age was Not applicable with Not Applicable dechallenge and rechallenge results. The action taken with Hepatitis A Vaccine, Inactivated, Pediatric, 25 u/0.5mL Suspension for injection 64457227:4095 regarding Product administered to patient of inappropriate age was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis A Vaccine, Inactivated, Pediatric, 25 u/0.5mL Suspension for injection 64457227:4095 regarding No adverse event with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 regarding No adverse event with Not Applicable dechallenge and rechallenge results. The Nurse considered the event Product administered to patient of inappropriate age (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093, the event Product administered to patient of inappropriate age (,) to be not assessed to Hepatitis A Vaccine, Inactivated, Pediatric, 25 u/0.5mL Suspension for injection 64457227:4095, the event No adverse event (,) to be not assessed to Hepatitis A Vaccine, Inactivated, Pediatric, 25 u/0.5mL Suspension for injection 64457227:4095, and the event No adverse event (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 The Nurse considered the event Product administered to patient of inappropriate age to be non-serious and the event No adverse event to be non-serious
Medical History/Concurrent Conditions: Bone marrow transplant