Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U777688 | OT / RL |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | UNK | Z008265 | OT / RL |
it infiltrated and there was a lump of fluid under the skin; instead of it being admisstered in the muscle it was given subcutaneously; This spontaneous report was received from an office worker and a Nurse Practitioner and refers to a(n) 2-month-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 28-Jul-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (lot #Z008265, expiration date: 21-Jul-2027) (VAXNEUVANCE) administered by Subcutaneous route in Right Thigh and with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS), (lot #U777688, expiration date 10-Jun-2026) administered by Subcutaneous route in Right Thigh (expiration date was not reported) as prophylaxis. Per reporter vaccines were administered incorrectly and instead of it being administered in the muscle it was given subcutaneously (Incorrect route of product administration) so it infiltrated and there was a lump of fluid under the skin where it did not belong and it has not gone away in 3 weeks. Patient now has a "lump on its leg" located "right above the knee, on the side facing away from the body, on the right side". Caller stated the vaccines were "administered lower than it should have" and the HCP believes "as the needle was going in, the medical assistant started pushing in causing the lump to form. At the reporting time, the patient had not recovered from it infiltrated and there was a lump of fluid under the skin. Action taken with suspect vaccines was not reported. Causality was not provided.; Reporter's Comments: Keywords : BP; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02859364-02859338 , CLIC number : , ESTAR number : , IRMS number : 500UW00000jLrkBYAS|21082025230024|1680 , Central date : 2025-08-22 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2321607 , MNSC case number : 02859364 , MNSC interaction number : 02859338 , Integration log UniqueID : 500UW00000jLrkBYAS|21082025230024|1680 , Service cloud CaseID : 500UW00000jLrkBYAS