Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Product distribution issue
Clinical narrative: shipping issue; The child did have a red, swollen, hard lump after vaccines; The healthcare worker is reporting that 10 patients received possibly improperly stored vaccines; This non-valid spontaneous report was received from a healthcare professional and refers to 10 unspecified patients.  The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The vaccines were supposed to be received by the office on 02-MAR-2024 but they were received on 08-MAR-2024 due to shipping issue (product distribution issue). On unknown dates in 2024, the patients received possibly improperly stored doses (incorrect product storage) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot #X023876, expiration date: 27-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). No previous temperature excursion was reported.  No additional adverse events were reported, no further information was provided.  This case is non-valid due to lack of patients' identifiers.  Follow-up was received from the Vaccine Provider on 07-MAY-2024: The primary reporter was described as a Healthcare Worker. The patient was updated to a 4-year-old male. The patient's medical history, concurrent conditions were not provided.   On 19-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot #X023876, expiration date: 27-MAR-2025, administered subcutaneously in the right thigh (exact dose was not provided); and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (manufacturer: Sanofi), lot # was reported as: U7908AA, administered intramuscularly in the left thigh (formulation, expiration date, exact dose were not provided) for prophylaxis.  The product was ordered on 28-FEB-2024. Product was/should have been delivered on or before 02-MAR-2024. Shipment was delayed during transit for an additional 6 days. Received in clinic on 08-MAR-2024 (product distribution issue). Unable to confirm temperature of vaccine for those additional days. The product was inadvertently put into clinic stock for use and 10 doses were administered. The temperature excursion was discovered during an inventory (product storage error). The patients were notified and scheduled for a repeat dose as per recommendations after contacting the manufacturer.  On 19-MAR-2024, the patient experienced vaccination site lump. Upon notification, this patient's father said that child did have a red, swollen, hard lump after vaccines on this date. He was unsure of the site left or right. It was since completely resolved. The vaccine involved was confirmed to be varicella (oka-merck) virus vaccine live (PROQUAD). Staff was educated on cold chain, storage, and vaccines handling.  The causality assessment was not provided.; Sender's Comments:  US-009507513-2405USA003519: