Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | 2 | Y015910 | IM / RL |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | 2 | Y015910 | — |
the needle of the syringe to scrape the patient's leg; remaining volume of the VAQTA dose was then "squirted out of the syringe and landed on the mother's clothes; This spontaneous report was received from a Medical Assistant and refers to a 1-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-APR-2025, the patient received the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #Y015910, expiration date: 06-Feb-2026) (0.5 mL / single or two dose series), intramuscularly, for the treatment of Hepatitis A vaccination. The Medical Assistant stated that during the vaccination, the patient moved their leg during the attempt to administer the product, causing the needle of the syringe to scrape the patient's leg (Skin abrasion) and the remaining volume of the vaccine dose was then "squirted out of the syringe and landed on the mother's clothes" (Accidental underdose). Medical Assistant confirmed there have been no medical concerns or reactions reported regarding this event. The patient did not seek medical attention. As treatment for the event the patient received a bandage. The patient recovered from the event of the needle of the syringe to scrape the patient's leg on an unspecified date. At the reporting time, the outcome of remaining volume of the VAQTA dose was then squirted out of the syringe and landed on the mother's clothes was unknown. The action taken with Hepatitis A Vaccine, Inactivated was reported as not applicable. The causal relationship between the event of the needle of the syringe to scrape the patient's leg and Hepatitis A Vaccine, Inactivated was not provided.