No additional adverse event was reported; Nurse calling with a report of an adverse event regarding an expired administration of GARDASIL 9. Nurse stated that a dose of GARDASIL 9 with a labeled expiration date of 1/2/2025 was inadvertently administered to a patient today, 1/27/2025. Nurse; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On 27-JAN-2025, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml / two or three dose series, lot #X005044, expiration date: 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.

No additional AE/PQC; HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with the diluent for HIBRIX (0.9% NaCl) instead of the Merck diluent provided and administered to the same patient on the same day. No symptoms reported. No further inform; This spontaneous report was received from a other health professional referred to a patient of unknown age and gender. No patient’s pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported. On 27-JAN-2025, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1, 0.5 milliliter, intramuscular (strength, anatomical location, vaccination scheme, lot number and expiration date were not reported), for prophylaxis. On the same date, the patient was vaccinated with her/his first dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, intramuscular (strength, anatomical location, vaccination scheme, lot number and expiration date were not reported), for prophylaxis. Both vaccines were inadvertently reconstituted with sodium chloride (Manufacture Unknown) diluent for Haemophilus influenzae type b. (HIBERIX) (also reported as “HIBRIX” conflicting information), (product preparation error). No adverse event was reported. Lot number is being requested and will be submitted if received.

Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was received from a Physician via medical records (MR) regarding a case in litigation and refers to a 16-month-old female patient. The patient’s medical history, concurrent conditions, concomitant therapies were not reported. On 26-AUG-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); which could either be measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection or measles vaccine live (schwartz), mumps vaccine live (rit 4385), rubella vaccine live (wistar ra 27/3) (PRIORIX) (Product origin unknown). On 30-JUN-2009, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); and the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown). On 21-JUL-2009, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Inappropriate schedule of product administration). This is one of the 3 cases referred to the same patient.; Sender’s Comments: US-009507513-2412USA007989: US-009507513-2501USA009376: US-009507513-2412USA007989:

Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was received from a Physician via medical records (MR) regarding a case in litigation and refers to a 9-month-old female patient. The patient’s medical history, concurrent conditions, concomitant therapies were not reported. On 11-JAN-2005, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufactured unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The vaccine could either be hepatitis b vaccine (recombinant) (RECOMBIVAX HB) or hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (Product origin unknown). On 25-APR-2005, the patient received the second dose of hepatitis b vaccine (recombinant) (manufactured unknown) (Inappropriate schedule of product administration). On 26-AUG-2005, the patient received the third dose of hepatitis b vaccine (recombinant) (manufactured unknown) (Inappropriate schedule of product administration). This is one of the 3 cases referred to the same patient.; Sender’s Comments: US-009507513-2412USA007989: US-009507513-2501USA009383:

No symptomatic adverse events were reported; temperature excursion vaccine; This spontaneous report was received from a nurse and refer to a patient of unknown age and gender. There was no information about patient’s concomitant medications, concurrent conditions or pertinent medical history On 18-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # Y004553, expiration date not reported but upon internal validation established as 20-FEB-2026 which was exposed to temperature excursion with the sterile diluent(MERCK STERILE DILUENT), (dose, route, anatomical location were not reported) for prophylaxis. No symptomatic adverse events were reported. This is one of several reports from the same source.; Sender’s Comments: US-009507513-2501USA008885:

No symptomatic adverse events were reported; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROQUAD was inadvertently administered after suffering from a Te; This spontaneous report as received from a registered nurse and refers to a patient of unknown age or gender. The patient’s medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown). On 02-DEC-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # Y013574, expiration date not provided but upon internal validation established as 03-FEB-2026, albumin status rHA) (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature that reached -11.6 degrees Celsius (C) for 3 hours and 5 minutes (product storage error). Previous excursions could not be confirmed neither if product was still supported. No symptomatic adverse events were reported. This is one of several cases reported by the same reporter.; Sender’s Comments: US-009507513-2501USA008885: US-009507513-2501USA008877:

No symptomatic adverse events were reported; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROPQUAD was inadvertently administered after suffering from a T; This spontaneous report as received from a registered nurse and refers to a patient of unknown age or gender. The patient’s medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown). On 14-JAN-2025, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # Y010050, expiration date: 25-NOV-2025, albumin status validated as rHA) (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature that reached -11.6 degrees Celsius (C) for 3 hours and 5 minutes (product storage error). Previous excursions could not be confirmed neither if product was still supported. No symptomatic adverse events were reported. This is one of several cases reported by the same reporter.; Sender’s Comments: US-009507513-2501USA008885: US-009507513-2501USA008877:

No additional AE/no PQC reported.; CRT agent transferred nurse who called to report a 4th dose of GARDASIL 9 was inadvertently administered to a patient. Caller stated patient received doses of GARDASIL 9 on 12/29/2023, 3/15/2024, 7/18/2024, and then received 4th dose on 11/1/2024. Ca; This spontaneous report was received from nurse and refers to a 23-year-old patient of unknown gender. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On 29-DEC-2023, 15-MAR-2023 and 18-JUL-2024 the patient was vaccinated with first, second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact doses, lot #, expiry dates, and anatomical routes of administration were not provided). In addition, on 01-NOV-2024, the patient received 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y013469 (who had been verified to be a valid number, expiration date reported as 10-OCT-2026) (Extra dose administered). No additional adverse event.

No adverse event; HCP called and reported administration of PROQUAD to a patient while on a possible immunosuppressant. A 4-year-old patient is on Dupixent and received a dose of PROQUAD on 17JAN2025. No additional information was known by reporter. No additional AE/P; This spontaneous report was received from nurse concerns to a 4-year-old patient of unknown gender. The patient’s medical history was not reported. The patient’s concurrent conditions included immunosuppression. Concomitant medications included dupilumab (DUPIXENT). On 17-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and anatomical route of administration were not provided) to patient while on a possible immunosuppressant (contraindicated product administered). No additional adverse event. Additional information is not expected.

After 24 hours she passed out and when we could get her awake she started throwing up and was hyperventilating