Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Product administration interrupted, Retching, Underdose
Clinical narrative: The patient crying during the administration; Patient started to gag and almost vomited/gaging; half of the dose was administered/unsure how much was swallowed/mom requested stopping/half of the container was gone; This spontaneous report has been received from a medical assistant concerning to a 6-month female patient.   The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On unspecified dates, the patient received 2 doses of each of the following vaccines: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dosage, vaccination scheme frequency, lot number and expirations date were not reported) as prophylaxis; and also diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 7v (crm197) (PREVENAR) (dosages, vaccination scheme frequencies, routes of administration, anatomical sites of application, indications, lot numbers and expirations dates were not reported).  On 28-JUL-2022, the patient received the third doses of otavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dosage and vaccination scheme frequency were not reported; lot number 1742417 with an expiration date reported and established as 14-OCT-2022) as prophylaxis; and also also diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) administered intramuscularly (IM) on the right thigh (RT) (dosage, vaccination scheme frequency, route of administration, anatomical site of application and indication were not reported; lot number UJ659AA with an expiration date reported as 31-JAN-2023) and  pneumococcal vaccine conj 7v (crm197) (PREVENAR) administered intramuscularly oon the left thigh (LT) (dosage, vaccination scheme frequency, route of administration, anatomical site of application and indication were not reported; lot number FG5300 with an expiration date reported as 31-JAN-2023). On the same date, it was reported that only part of the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient, because shortly after started the administration, the patient started crying, gagged and almost vomited (retching). Therefore, and the parent (also reported as "mom") stopped the remaining administration, about half of the dose was administered (also reported as "half the container was gone") but it was unsure how much was swallowed (incorrect dose administered).   There were no reactions after stopped the rotavirus vaccine, live, oral, pentavalent (ROTATEQ). It was recommended to repeater.  It was added that a call was placed to manufacturer and the medical assistance (MA) was told that since half of the container was administered, it was no recommended to repeater added a dose and the patient's mother was aware and agreed.   The outcome of the event crying, and retching was not provided. The causal relationship between the events and the suspect therapies was unknown.