Received Jul 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 4 | Z015658 | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | — | — |
She did not show immunity, and previously received HEPB 3 doses; pediatric patient was given 1.0ML instead of 0.5ML 17 years 10 months patient, given adult dose of RECOMBIVAXHB; previously received HEPB 3 doses/ given adult dose of RECOMBIVAXHB; received HEPB 3 doses on 8/72008, 10/8/2008; This Spontaneous report was received from Physician Assistant and referred to a/an 17-years-old Female Adolescent 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 10-Jun-2026, the patient started therapy with Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 (1.00 mL) (total) (Batch/Lot Number: Z015658) (Expiration date: 14-Jul-2028). On 07-Aug-2008, the patient started therapy with hepatitis b vaccine (recombinant) suspension for injectionAsked But Unknown Batch/Lot Number., On 08-Oct-2008, the patient started therapy with hepatitis b vaccine (recombinant) suspension for injectionAsked But Unknown Batch/Lot Number., and On 11-Feb-2009, the patient started therapy with hepatitis b vaccine (recombinant) suspension for injectionAsked But Unknown Batch/Lot Number. The patient started therapy with Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 for the treatment of Prophylaxis, The patient started therapy with hepatitis b vaccine (recombinant) suspension for injection for the treatment of Prophylaxis, On 08-Oct-2008, the patient experienced received HEPB 3 doses on 8/72008, 10/8/2008 (Inappropriate schedule of product administration). On 10-Jun-2026, the patient experienced pediatric patient was given 1.0ML instead of 0.5ML 17 years 10 months patient, given adult dose of RECOMBIVAXHB (Overdose). On 10-Jun-2026, the patient experienced previously received HEPB 3 doses/ given adult dose of RECOMBIVAXHB (Extra dose administered). On an unknown date, the patient experienced She did not show immunity, and previously received HEPB 3 doses (Hepatitis B antibody negative). The Outcome of Hepatitis B antibody negative was not provided. The Outcome of Overdose was not provided. The Outcome of Extra dose administered was not provided. The Outcome of Inappropriate schedule of product administration was not provided. The action taken with Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 regarding Hepatitis B antibody negative was Not applicable with Not Applicable dechallenge and rechallenge results. The action taken with hepatitis b vaccine (recombinant) suspension for injection regarding Hepatitis B antibody negative was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 regarding Extra dose administered with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 regarding Overdose with Not Applicable dechallenge and rechallenge results. Case Assessments: hepatitis b vaccine (recombinant) suspension for injection regarding Extra dose administered with Not Applicable dechallenge and rechallenge results. Case Assessments: hepatitis b vaccine (recombinant) suspension for injection regarding Overdose with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 regarding Inappropriate schedule of product administration with Not Applicable dechallenge and rechallenge results. Case Assessments: hepatitis b vaccine (recombinant) suspension for injection regarding Inappropriate schedule of product administration with Not Applicable dechallenge and rechallenge results. The Physician Assistant considered the event Extra dose administered (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094, the event Overdose (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094, the event Extra dose administered (,) to be not assessed to hepatitis b vaccine (recombinant) suspension for injection, the event Overdose (,) to be not assessed to hepatitis b vaccine (recombinant) suspension for injection, the event Inappropriate schedule of product administration (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094, and the event Inappropriate schedule of product administration (,) to be not assessed to hepatitis b vaccine (recombinant) suspension for injection the causality for the event Hepatitis B antibody negative to Hepatitis B Vaccine (Recombinant), 10 mcg/mL Suspension for injection 64457236:4094 was not reported, and the causality for the event Hepatitis B antibody negative to hepatitis b vaccine (recombinant) suspension for injection was not reported, The Physician Assistant considered the event Overdose to be an overdose event, the event Hepatitis B antibody negative to be non-serious, the event Extra dose administered to be non-serious, and the event Inappropriate schedule of product administration to be non-serious