No Additional AE; a patient received their initial dose of ROTATEQ at 5 months old.; This spontaneous report was received from an Other Health Professional and refers to a 5-month-old male patient. The patient’s medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On an unknown date in 2024, at the age of 5 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 ml, lot #y003754 has been verified to be a valid lot number, expiration date not reported but upon internal validation established as 25-OCT-2025) orally for prophylaxis (strength was not provided) (inappropriate schedule of product administration). No additional doses have been given at this time. No additional adverse event (no adverse event) was reported.

the patient had experienced any adverse issues or side effects from the administrations; a patient (15-month-old boy) who is otherwise healthy was inadvertently administered a dose of PROQUAD and VARIVAX by his medical assistant (MA) instead of a dose of MMR II and VARIVAX that was ordered and prescribed by the HCP on 01/15/2025.; a patient (15-month-old boy) who is otherwise healthy was inadvertently administered a dose of PROQUAD and VARIVAX by his medical assistant (MA) instead of a dose of MMR II and VARIVAX that was ordered and prescribed by the HCP on 01/15/2025.; This spontaneous report was received from a nurse practitioner referring to a 15-month-old male patient. The patient’s medical history and concurrent conditions were not reported. On 15-JAN-2025, the patient who was otherwise healthy was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml / once, lot #Y012594, expiration date: 14-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml / once, lot #Y011017, expiration date: 18-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided); along with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, lot #1973283, expiration date: 08-OCT-2026 (strength, dose, route of administration, and indication were not provided) by his medical assistant (MA) (operator of device: health professional) instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (administered for prophylaxis, dose, strength, lot #, expiry date, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) that was ordered and prescribed by the health care professional (HCP) (Wrong product administered and Accidental overdose). The HCP stated he called to check on the patient on the evening on that day after the administration who was “doing well” and the parents did not report the patient had experienced any adverse issues or side effects from the administrations (No adverse event). No other information provided during the call.

No additional AEs were reported; Pharmacist reported that a patient received first dose of GARDASIL 9 about 5 years ago and second dose on 1/14/2025; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient’s medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On an unknown date in 2020 (reported as “about 5 years ago”), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. On 14-JAN-2025, the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Inappropriate schedule of product administration). Both doses were administered as prophylaxis and exact dosage, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided. No additional adverse events (AEs) were reported and no further information was provided. Lot # is being requested and will be submitted if received.

Mom gives history that about 10 minutes after the vaccine was given, child complained of being hot , nauseous, got up the exam table and then fell down on the floor. Mother started screaming and medical assistant and myself rushed into the room, Child was on the floor, looked drowsy but was able to answer all questions. EMS was called before I went in , paramedics came and assessed. No recommendations were made to take her to ER by them. BP was normal- 109/75, Heart rate 99, o2 sat was 99. Child was observed for 30 minutes, water was given. Then discharged home. Child has had Flu shots before in another state from where had moved in August 2024 and never had any reaction to any vaccines

Small lump above collarbone on left side

Patient received a Tdap vaccine 1/21/25, but was found to have recently received a Tdap vaccine on 1/15/25 at a different clinic. Follow-up call with the patient the next day 1/22/25 and patient reports injection site discomfort of both arms, but worse on left.

Patient had a spell starting at about 14:30pm on the day of vaccination. He was very limp and still and mom thought he was sleeping at first, but then his color started leaving. His lips became white. His eyes rolled back in his head and then seemed unfocused. His eyes did dilate when his parents checked them. He laid very still for about 10-15 minutes and then his color and movement started to return, and he returned to his normal self. The doctor’s office was contacted after the incident and parent’s were instructed continue watching him.

10 hours after vaccination, patient went limp, eyes rolled back in his head and his color left him, even his lips were white. His eyes seemed unfocused at this time. He laid very still for about 10 minutes. After 10-15 minutes his color slowly returned and he returned to his “normal self.” Parents contacted the doctor’s office to report the adverse event after it was over.

No reported adverse events per patient, patient received a third dose of this vaccine.

itching, headache, nausea