Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: Dehydration; Lethargy; Poor feeding; Inadvertently receive a pneumococcal 20 (Prevnar 20), in addition to the Vaxelis and RotaTeq; it did result in an emergency room visit; received this vaccine the wrong time; This is a spontaneous report received from a Physician.  An 18-day-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 11Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 3 days for immunisation; rotavirus vaccine live reassort oral 5v (ROTATEQ), on 11Jul2024 as dose number unknown, single) for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), on 11Jul2024 as dose number unknown, single) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEHYDRATION (medically significant), outcome "recovered"; LETHARGY (medically significant), outcome "recovered"; POOR FEEDING INFANT (medically significant), outcome "recovered", described as "Poor feeding"; WRONG PRODUCT ADMINISTERED (medically significant), outcome "unknown", described as "Inadvertently receive a pneumococcal 20 (Prevnar 20), in addition to the Vaxelis and RotaTeq; it did result in an emergency room visit; received this vaccine the wrong time". The events "dehydration", "lethargy" and "inadvertently receive a pneumococcal 20 (prevnar 20), in addition to the vaxelis and rotateq; it did result in an emergency room visit; received this vaccine the wrong time" required emergency room visit. Clinical course: the reporting physician (pediatrician from an outside facility) stated regarding a patient that was at the time of the initial report was two weeks old. The physician was advised that this baby at three days old was inadvertently given the pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein). In addition, the patient received diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (meningococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid; and rotavirus vaccine live reassort oral 5v. The reporting physician stated, "It was a staffing error. There was another baby that needed it, two months old like apparently in a door or an exam room next to that baby and the staff went into the wrong patient and gave it to the wrong patient." On 12Jul2024, this resulted in an emergency room visit and lab work for dehydration and lethargy, when the baby received the pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) at the wrong time. The physician further stated, "Yes, because that mean that's the only precipitating events, the baby was feeding well, went to the clinic outside facility, received that vaccine addition to VAXELIS and ROTATEQ and then about a half day later baby developed lethargy and poor feeding." The patient received for treatment a bolus of intravenous (IV) fluid. The physician stated the baby recovered.  Regarding the causality, the physician stated, "I am now yes, the baby transferred care to me today. In my opinion probably because the baby was feeding fantastically prior and so you know like two months or four months, we say that feeding could change a little bit when they are get, they get fussy. It does seem like to be corelated."  The patient underwent the following laboratory tests and procedures: Bilirubin conjugated: (13Jul2024) Normal; Blood bilirubin: (13Jul2024) Normal; Blood bilirubin unconjugated: (13Jul2024) Normal; Blood lactic acid: (13Jul2024) Normal; Full blood count: (13Jul2024) Normal; Metabolic function test: (13Jul2024) Normal; Weight: (11Jul2024) Unknown results, notes: the weight of the day of vaccination. Therapeutic measures were taken as a result of dehydration, lethargy, poor feeding infant.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile