Merck Sterile Diluent syringe experienced suction when twisting the needle onto the hub of syringe; causing cap of syringe to pop off; MMRII was administered to a patient that was reconstituted using the defective sterile diluent syringe; caller unsure if patient received full amount of dose as some of the diluent leaked out due to the suction.; unsure if patient received full amount of dose; No additional AE; This spontaneous report was received from a nurse, concerning to a 15-month-old. The patient’s medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the syringe device of the sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (lot # 1973242 has been verified for that product, expiration date reported and confirmed as 17-FEB-2026) experienced suction when twisting the needle into the hub of the syringe (Device malfunction), causing the cap to pop off (Syringe issue). Also, on an unknown date, using that defective syringe device to reconstituted, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA] (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength and route of administration were not provided; lot # Y010046 has been verified to be valid for this vaccine, expiration date reported and confirmed as 29-MAY-2026). (Poor quality device used). The reporter was unsure if the patient received the full dose as some diluent leaked out due to the suction (Device leakage) (Accidental underdose). No symptoms were reporter. No additional adverse event (No adverse event).

No additional AE; initiated the series with GARDASIL approximately 10 years ago. Patient never received the subsequent doses in the series and would like to complete the series with GARDASIL 9; This spontaneous report was received from a nurse practitioner and refers to a currently 24-year-old female. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in 2015 (reported as approximately 10 years ago), the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, (0.5 milliliter, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) administered for prophylaxis. Patient never received the subsequent doses in the series and would like to complete the series with GARDASIL 9 (Inappropriate schedule of vaccine administered). No additional AE/No PQC (No adverse event). Additional information is not expected.

no additional AEs/No other information provided; Caller reports adult formulation of RECOMBIVAX HB was administered to a 18 year old female. No other information provided. No additional AEs/PQC reported. Caller declined AE follow up letter.; This spontaneous report was received from a pharmacist and referred to an 18-year-old female patient. The patient’s concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported. On 15-JAN-2025, the patient was vaccinated adult formulation with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 10 Microgram/1.0 ml intramuscular injection, 1.0 ml, administered intramuscularly for prophylaxis (lot #, anatomical site of administration and expiry date were not provided) (overdose) by Health Professional. No other information provided. No additional adverse events (AEs). Additional Information is not expected.

The next morning after Shingrix injection, the patient stated that four blisters appeared at injection site, left arm. Patient stated that 5 days later the blisters resolved.

Patient was inappropriately given varicella and shingrix vaccines. Patient should not have received both. Patient was informed of the error, given information on what to do in the case of increased symptoms, and provided the clinic number if she had any additional questions or concerns. The patient required a translator and was contacted by a translatory assisted and expressed understanding.

nothing on site, MD did research on administration at this age and then spoke with parents and educated on S/s that they should look for. The Proquad was administered 1in below the Pediarix on the Rt thigh. Pt was alert and crying and observed for 20-30 min after administration before leaving the clinic with mother.

red and some swelling in the right arm

Patient reports she developed severe pain of left shoulder within hours of administration. She reports her immunization was given in an improper location and was given too high. She is still experiencing pain from top of shoulder into neck muscles, and down elbow. She is currently in Physical Therapy. Motrin and heat are not improving pain. Range of motion has been affected. She has difficulty sleeping and dressing. She has been instructed to avoid laying on left side. She is a left side sleeper previous to this event. She has been instructed to ice it daily. She is being evaluated by one of her primary care physicians tomorrow. She will continue with Physical Therapy. She will also be scheduled acute follow up with the clinic who administered her flu vaccine when an appointment is available.

Patient is presenting to our office on 1/27/2025 for left arm soreness that has been present since receiving the Tdap booster on 4/22/24. Patient states that she began having left deltoid muscle soreness 2 days after receiving the vaccine and the pain has not gone away or improved. Pain is described as a 7/10, non-radiating, constant pain that makes it difficult to carry any objects with her left arm. Patient has not been to the hospital or seen a doctor previously for this complaint. She has not tried any medications for pain.

1053 – Patient was given vaccinations and stated she was okay. 1056 – Patient fell off of the bed (3 ft) and hit right side of head on to concrete floor. Patient tensed up, as if she was going to seize, and EMS was called by APRN and school nurse was called to bring emergency bag by RN. Vital signs were started as patient arose to sitting position. She stated she did not know what happened that caused her to be on the floor but had a headache, weakness, and was sweating. Stated last thing she remembered was her vision going fuzzy, having a headache, and feeling weak following the Gardasil vaccination. She said this started after medication was put in to arm. Patient was alert and orientated x3, eyes equal and reactive with no tunneling, felt like she was weak with headache and sweating, paleness noted on assessment. 1059-1101- AP RN attempted to call guardian. 1103 – Guardian called back on patient’s sister’s cell phone. APRN spoke with guardian over situation. Guardian stated she would be on her way to the school now, estimated to arrive in 10 minutes. 1105 – Patient was moved on to bed with the standby assist x3. Wet towel was placed on head and legs were raised. Patient will remain NPO at this time. Stated she last ate at 0730, chicken biscuit and 2 apple juices. 1110 – EMS arrived, report given. 1112 – Orthostatic vital signs and blood glucose check was started by EMS. 1118 – Cardiac monitor was placed on patient by EMS. HR 96, normal sinus rhythm per EMS. 1132 – Guardian arrived and given explanation of what happened from staff, then spoke with EMS workers. 1143 – Patients guardian spoke with EMS and staff, chose to sign EMS paperwork to refuse transportation. Stated that she would take her to Urgent Care for head evaluation after leaving. She was still complaining of headache but weakness and vision had improved. Patient was walking but APRN walked her to car as standby assist. 1150 – Report was given to Urgent Care (RN). 1157 – Supervisor, RN, made aware of the situation. 1221 – Added report given to Urgent Care (RN). 1243 – Spoke with RN, about appropriate reporting.