Sex: U
Vaccine: FLU4, UNK
Symptoms: Injection site discomfort, Injection site nodule, Pain in extremity, Product storage error
Clinical narrative: sore arm; knots underneath the injection site; had some discomfort after injection; Fluzone Quad 0.5, Fluzone quad .25, and menactra where temperatures reached a low of 34.2 and a high of 35.2 for a cumulative time of about 60 hours due to the door not being completely shut; Based on information previously received, the following information [events were coded, new suspect was added, Menactra was removed] have been amended.  Initial information received on 07-Oct-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  This case involves an adult patient who experienced knots underneath the injection site (vaccination site mass), sore arm (pain in extremity) and had some discomfort after injection (vaccination site discomfort), while he/she received vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route and unknown administration site.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious knots underneath the injection site (vaccination site mass), sore arm (pain in extremity) and had some discomfort after injection (vaccination site discomfort) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was also a case of product storage error. It was reported that Fluzone quad 0.5, fluzone quad .25, and menactra reached temperatures a low of 34.2 and a high of 35.2 for a cumulative time of about 60 hours due to the door not being completely shut.  The reported lot: numbers were Fluzone 0.5 Lot: UJ212AA, expiry date: 20-Jun-2020; Fluzone 0.25 lot: U6653BD expiry date: 30-Jun-2020; Menactra lot: U5869AD expiry date: 05-Aug-2020 lot: U6522AB ,expiry date: 29-Jan-2021.  Final diagnosis was had some discomfort after injection, sore arm, knots underneath the injection site and Not Applicable fluzone quad 0.5, fluzone quad .25, and menactra where temperatures reached a low of 34.2 and a high of 35.2 for a cumulative time of about 60 hours due to the door not being completely shut.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown for all events and not applicable for product storage error.  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.  Addendum 22-Jan-2020  Based on the information received on 30-Oct-2019, a significant amendment was done to code events and suspect products (as patient details and adverse events were reported).