Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report vaccines were administered after experiencing a temperature excursion.; This spontaneous report was received from a Licensed vocational nurse (LVN) (also reported as nurse), referring to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical histories, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.   On 23-JUL-2024, the patients were vaccinated with improperly store hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot # X020849 which has been verified to be valid, expiration date reported and established as 26-DEC-2024; and lot # X026666 which has been verified to be valid, expiration date reported and established as 29-MAY-2025 (strength, dose number, dose quantity, route and anatomical location of administration and vaccination scheme frequency were not provided); also with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot# W028535 which has been verified to be valid, expiration date reported and established as 10-MAY-2025; and lot# X022980 which has been verified to be valid, expiration date reported and established as 18-MAY-2026 (strength, dose number, dose quantity, route and anatomical location of administration and vaccination scheme frequency were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # number 20332351 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported as 11-JUN-2025; and lot # 1989398, which has been verified to be valid, expiration date reported and established as 25-NOV-2024, administered orally (strength, dose number, dose quantity, and vaccination scheme frequency were not provided) all previous mentioned vaccines administered as prophylaxis; and additionally with  diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS), injection, lot# U7623AA, which has been verified to be valid, expiration date reported and established as 08-DEC-2025, administered for prophylaxis  (strength, dose number, dose quantity, route and anatomical location of administration and vaccination scheme frequency were not provided). All vaccines were administered after a temperature excursion of 8.8.1 degree Celsius (C) during a time frame of 4 minutes and 45 seconds (product storage error). No previous temperature excursion was reported.  No additional adverse event (AE) was reported (no adverse event).  This case is non-valid due to no patients' identifiers and no exact patient number.  Follow up information was received from a Licensed vocational nurse (LVN) (also reported as nurse) on 10-SEP-2024.  The reporter provided the lot# 2032351 for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), which has been verified to be a valid lot#, with an expiration date reported and established as 06-OCT-2024. Previously, the lot# was reported as 20332351 (which was an invalid lot#).  Follow-up information was received from two physicians on 01-OCT-2024, pertaining a 15-month-old female patient. On unspecified dates, the patient was vaccinated with the first and second doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, as prophylaxis (strengths, doses, lot numbers, expiry dates, anatomical locations, and routes of administration were not provided). On 23-JUL-2024, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot#X022980, expiry date: 18-MAY-2026, administered intramuscularly as prophylaxis (strength and dose were not reported), that as previously mentioned had gone trough a temperature excursion.   This case was no longer considered non-valid as patient identifiers were updated.   Lot# is being requested and would be provided upon received.; Sender's Comments:  US-009507513-2410USA001686: US-009507513-2410USA001694: US-009507513-2410USA001631:Oiginal case