Age: 0.17
Sex: M
Vaccine: HPV9, HIBV, HPV9, RV5
Symptoms: Fatigue, Hypophagia, Injection site swelling, Irritability, Product administered to patient of inappropriate age
Clinical narrative: Caller stated after her son received his vaccinations on 7/15/2021, he appeared to be "more clingy, unsettled, and developed a low fever of 99 .1 °F."; Caller stated after her son received his vaccinations on 7/15/2021, he appeared to be "more clingy, unsettled, and developed a low fever of 99 .1 F."; fussiness; Caller stated after her son received his vaccinations on 7/15/2021, he appeared to be "more clingy, unsettled, and developed a low fever of 99 .1 °F."; Caller reported her son (age: 2 months old) was mistakenly administered GARDASIL 9 instead of PNEUMOVAX 23 on 7/15/2021; Caller reported her son (age: 2 months old) was mistakenly administered GARDASIL 9 instead of PNEUMOVAX 23 on 7/15/2021.; seeming tired/poor feeding; seeming tired/poor feeding; family reported local swelling at vaccine site; This spontaneous report has been received from the physician and also from the patient's mother, referring to a 2-months-old male patient. It was stated that the patient had none pertinent medical history, concomitant medications, and past drug reactions or allergies. It was reported by the physician that patient was a well child.  On 15-JUL-2021, the patient was mistakenly vaccinated with once dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular injection as part of his routine vaccinations (prophylaxis) (lot number S028737, has been verified to be valid lot number, expiration date reported and established as 03-APR-2022) (dose, vaccination scheme frequency, dose number and anatomical site of administration were not provided) instead of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (wrong product administered). It was reported that on that same date, the patient also received two additional vaccines Rotavirus Vaccine, Live, Oral, Pentavalent (reported as "Rotavirus") (manufacturer unknown) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (reported as "HIv") (manufacturer unknown) also as part of his routine vaccinations (prophylaxis) (doses, vaccination scheme frequencies, dose numbers, anatomical sites , lot numbers and expiration dates of administration were not provided). It was reported by the physician, that they realized of the error on the dispensing process, less than an hour (reported as "less than an hour") after vaccination and immediately alerted the patient's family and monitoring precautions were discussed (product dispensing issue).  On the same date (15-JUL-2021), after the patient vaccination, the patient appeared to be more clingy (dependent personality disorder), unsettled (restlessness) and developed a low fever of 99.1 degrees Fahrenheit (99.1 F )(pyrexia) for which he received acetaminophen (TYLENOL). Additionally, he experienced fussiness that night (irritability). On an unspecified date in July 2021, he also experienced local swelling at vaccine site (vaccination site swelling), seemed tired (fatigue) and had poor feeding (feeding disorder) for seven days.  It was reported by the physician that no drug treatment was prescribed for the events of vaccination site swelling, irritability, fatigue and feeding disorder.   On 19-JUL-2021, the patient recovered from the pyrexia, dependent personality disorder and restlessness events.   On an unknown date in July 2021, the physician stated all events (also reported as "symptoms") were resolved. The patient was doing well without symptoms (events).  The causality assessment between the events and the suspect vaccines was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability