Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Product storage error
Clinical narrative: the temperature at 5:30 and it was 20 degrees Celsius due to dusting behind the refrigerator and knocked the switch off; redness and sweling at the injection site; redness and sweling at the injection site; redness and sweling at the injection site; Based on information received on 01-Oct-2019, the report previously considered as non-valid became valid: [patient detail and event details were reported].  Based on additional information received on 01-Oct-2019, this case becomes medically confirmed.  Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked with 2019SA284746 (same reporter).  This case involves a 22 year old patient (gender not reported) who experienced redness and sweling at the injection site (Vaccination site inflammation) (Vaccination site erythema) (Vaccination site swelling), while he/she received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5660AA and expiry date: 06-Aug-2021) via intramuscular route in the left deltoid. On 20-Aug-2019, the patient received a dose of suspect VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)] not produced by Sanofi Pasteur lot S015402 via subcutaneous route in the left arm.  On 27-AUG-2019, the patient developed a non-serious redness and sweling at the injection site (vaccination site inflammation) (vaccination site swelling) and (vaccination site erythema) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)].  It was also a case of actual medication error due to incorrect product storage. It was reported that the temperature at 5:30 was 20 degrees celsius due to dusting behind the refrigerator and knocked the switch off.  Final diagnosis was redness and sweling at the injection site.  The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]).  The patient was recovering from all the events (reported as improved condition).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Follow up information received from a other healthcare professional on 01-Oct-2019.  Case became valid and new events were reported. Event description updated.  List of documents held by sender: none.