No additional AE; FBE called on behalf of nurse to report an expired dose of GARDASIL 9 was administered to 1 patient. Per FBE, nurse stated dose expired on 1/8/2025 and was administered on 1/22/2025. FBE stated the nurse did not report any patient symptoms or provide; This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient’s historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 22-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number W029724, expiration date 08-JAN-20225 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.

No symptomatic adverse events were reported. No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a Temperature Excursion.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient’s pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 17-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter, lot # Y006522; which has been verified to be valid lot # for varicella virus vaccine live (Oka/Merck), expiration date: 25-MAR-2026, administered as prophylaxis (strength, dose number, route, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error) after a temperature excursion (TE) occurred at a temperature of -11.6 C degrees Celsius during a time frame of 3 hours 5 minutes and 0 seconds. Previous temperature excursions could not be confirmed. No additional adverse event (AE) was reported (no adverse event). This is one of several reports received from the same reporter.; Sender’s Comments: US-009507513-2501USA008877: US-009507513-2501USA009045: US-009507513-2501USA008880: US-009507513-2501USA008882:02740767 US-009507513-2501USA007446: US-009507513-2501USA008935: US-009507513-2501USA007047: US-009507513-2501USA008861:

HCP called to report a T/E and reports improperly stored PROQUAD was given to 2 patients on 1/17/2025. No symptoms or side effects reported. Related AE case filed in 02738574. No additional AE/no PQC. ? Names of vaccines involved (including lot; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient’s pertinent medical history, drug reactions or allergies, or concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number wheter Y014306 or Y015990 has been verified to be a valid lot number, with expiration date 18-FEB-2026 and 23-MAR-2026, respectively) administered as prophylaxis (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at -13.4 °C (-14 °C up to 10 °C ) for 4 hours 30 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported. This is one of two reports received from the same reporter.; Sender’s Comments: US-009507513-2501USA006018:

PATIENT HAD 2 VACCINES ON 01/15/25, SPIKEVAX AND CAPVAXIVE, SINCE THEN PT HAS REPORTED OF RED AND ICTCHING ON THE INJECTION SITE, PT CALLED TODAY AND REPORTED OF THE SYMPTOMS THAT STARTED ON 1/15/25 EVENING AND LAST UNTIL NOW.

PATIENT CALLED THE PHARMACY WANTING TO TELL THE PHARMACY THAT SHE THINKS THE NOVAVAX VACCINE WAS ADMINISTERED INCORRECTLY. SHE STATES THAT THE VACCINATOR PINCHED HER SKIN WHILE INJECTING, AND THAT SHE DID NOT FEEL THE NEEDLE. SHE ALSO STATES THAT SHE DID NOT HAVE TYPICAL VACCINE SIDE EFFECTS FOR 2 DAYS, INSTEAD OF 1 DAY THAT SHE IS USED TO. PHARMACIST TRIED TO RATIONALIZE WITH PATIENT THAT WE USE THE APPROPRIATE NEEDLES FOR IM INJECTION (1 INCH ) AND THE SIDE EFFECTS DOES NOT SOUND ATYPICAL. THE PATIENT WAS ADAMENT THAT SHE THOUGHT IT WAS ADMINISTERED SUBCUTANEOUSLY AND THAT THIS IS REPORTED TO MAKE SURE EVERYONE IS AWARE.

Patient states that she received covid19 vaccine on November 18, 2023 and in December 2023 she was diagnosed with breast cancer. She had surgery in 1/2024 and radiation. She states she is currently fine

COVID19 vaccine and flu vaccine given concurrently. Patient has received these vaccines in the past but not given concurrently. Developed fluid retention/swelling after vaccinations, and was hospitalized in 1/2025 for fluid retention, swelling, low protein, low iron, low vitamin D.

Patient had a rash develop the day after vaccines on the right thigh. No leg pain, but parents reported patient had been scratching at leg. Parents gave a singular dose of Benadryl but no apparent improvement. Patient was brought in to the office to be seen by his pediatrician. on 1/29/2025

Pt called ~4pm in Wednesday 1/29/25 asking about what to do with swelling, redness and heat of upper right arm. Recommended going to Walk-in care, trying cold compress for swelling (about 4 inches in diameter) as well as taking some ibuprofen (not to exceed 32oomg/day). She mentioned a similar reaction when receiving the first Shingrix but not as expansive in area.

pt says her arm was little sore the day of the vaccine but the next day she was running errands she bacame weak and her walking became slower. Her gait was getting worse. She became thirsty and felt like she was going to pass out. She was at a store and needed to drive home but was worried about getting home. Once she got home she had to climb stairs to get into her room. She wanted to email her son to let him know she was not feeling well but was so weak she could not type. Her entire body was hurting. She passed out and slept for hours but stayed in the bed for 5 days total. She only got out of the bed to urinate. She could hear the phone ringing but couldn’t answer it. Her stomach was so inflammed she had to stay laying down. She had headach with the stomach ache. After the 5th day she was able to start functioning more normally. By the 6th day she felt normal. She contacted the pharmacy to let them know. She saw her PCP on Dec 24th and notated her reactions.