Received May 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Z003748 | — |
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y003145 | — |
infant wiggled during vaccination and led to a small scratch; HEP A (VAQTA) leaked out, the mom is convinced the infant did not receive the full vaccination; Picture sent of thigh showing scratch due to infant moving during injection, erythremia.; HEP A (VAQTA) leaked out, the mom is convinced the infant did not receive the full vaccination; infant wiggled during vaccination and led to a small scratch; This spontaneous report was received from a Nurse and refers to a 12-month-old infant patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 06-May-2026, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB-LIQUID), suspension for injection, 0.5 milliliters (mL), administered as prophylaxis (Lot No. Y003145 has been verified to be a valid lot number for [haemophilus b conjugate vaccine (meningococcal protein conjugate], expiration date reported, and upon internal validation established as 12-Sep-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); also with hepatitis a vaccine, inactivated injection (VAQTA) suspension for injection, 0.5 milliliters (mL), administered as prophylaxis (Lot No. Z003748 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated injection], expiration date reported and upon internal validation established as 08-Jul-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided). On the same date (06-May-2026), it was stated that the infant wiggled during vaccination and led to a small scratch (scratch) (injury associated with device) and some hepatitis a vaccine, inactivated injection (VAQTA) leaked out, the patient's mom was convinced the infant did not receive the full vaccination (accidental underdose) (injection site discharge). Additionally, picture was sent of thigh showing scratch due to infant moving during injection, erythremia (vaccination site erythema). At the reporting time, the outcome of the events of scratch, injection site discharge, injury associated with device and vaccination site erythema was not reported. The causal relationship between the events of scratch, injection site discharge, injury associated with device and vaccination site erythema was not provided.