Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | — | — |
not eating very well; potential dehydration.; meant to receive VAXELIS but received VAQTA; Inconsolable the night after the administration; HCP called to report a 2-month-old patient was administered a VAQTA vaccine and experienced a fever and was inconsolable the night after the administration. HCP states the patient was meant to receive VAXELIS but received VAQTA instead and is now pre; Fever; Slightly sunken fontanelle; This spontaneous report was received from a physician and refers to a 2-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 28-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) at a dose of 0.5 mL, administered intramuscularly for vaccination (lot number and expiration date were not reported), instead of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate], and Hepatitis B [Recombinant] Vaccine (VAXELIS) (dose, indication, lot number, and expiration date were not reported). (Wrong product administered, Product administered to patient of inappropriate age). On 28-May-2025, the patient experienced fever (pyrexia) and was inconsolable the night after the administration (emotional distress). On 29-May-2025 (reported as a day later), the patient went to the emergency room, afebrile (conflicting information, fever was also reported as not recovered), not eating very well (decreased appetite), and with a slightly sunken fontanelle (fontanelle depressed) that indicated potential dehydration. At the time of the report, the patient had not recovered from the events. The causal relationship between the events and Hepatitis A Vaccine, Inactivated was not provided.; Reporter's Comments