Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: vaccines were exposed to temperature excursion as refridgerator was out of range; patient received deteriorated products; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient who received vaccines HEPATITIS B VACCINE, ROTAVIRUS VACCINE, PREVENAR 13 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] those were exposed to temperature excursion as refrigerator was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: Family Medical History Relevant to AE(s): mom has borderline diabetes, brain aneurysm and seizures, was in coma during pregnancy.   On 05-Dec-2018, the patient received a 0.5 ml dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot T78675 and expiry 31 Mar 2020 via intramuscular route in the right thigh (age of the patient was 2 months).  On 05-Dec-2018 (age of the patient was 2 months) and on 05-Feb-2019 (age of the patient was 4 months), the patient received a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot R002059 and expiry 03 Jun 2019 via oral route. On the same days, the patient also received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot G9H24 and expiry 03 Jul 2019 via intramuscular route in the right thigh and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5506AA and expiry 05 Sep 2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to incorrect product storage and poor quality product administered.  multiple dates for the excursion to provide as listed below: 01 Dec 2018- It was for 2 hours and 20 minutes with the lowest temperature at 34.2 Fahrenheit. 02 Dec 2018- It was for 20 minutes with the lowest temperature at 33.3 Fahrenheit. 03 Dec 2018- It was for 1 hour with the lowest temperature of 34.3 Fahrenheit. 20 Jan 2019- It was for 10 minutes at 35.4 degrees Fahrenheit. 22 Jan 2019- It was for 10 minutes at 34.5 degrees Fahrenheit 25 Jan 2019- It was for 10 minutes at 35.6 degrees Fahrenheit. 28 Jan 2019- It was for 30 minutes at 34.9 degrees Fahrenheit. 31 Jan 2019- It was for 10 minutes at 32.9 degrees Fahrenheit 09 Feb 2019- It was for 10 minutes at 34.0 degrees Fahrenheit.  It was not reported if the patient had any adverse event.  Other relevant tests included On 05-Feb-2019, Hemoglobin (fingerstick) was 11.6 (result was in normal range).  The patient did not have any problems or complaints from the vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.