Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician and nurse. This case involves a 10 years old male patient who experienced tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected, pain, redness and swelling at the injection site, while he received vaccines ADACEL and FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. It was also a case of an actual medication error due to Wrong injection technique as Patient received both ADACEL and FLUZONE QUADRIVALENT, both given in the left deltoid. On 15-Nov-2018, the patient received a 0.5ml dose of suspect FLUZONE QUADRIVALENT lot UJ034AD, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On 15-Nov-2018, the patient received injection of suspect ADACEL lot number, expiry date not reported via unknown route in the left deltoid. On 15-Nov-2018, the patient developed a non-serious tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected (paraesthesia) Within 20 minutes following the administration of FLUZONE QUADRIVALENT and following the administration of ADACEL. On 15-Nov-2018, the patient developed a non-serious tingling and numbness from his elbow down to fingers. the 5th, 4th and 3rd fingers were particularly affected (hypoaesthesia) Within 20 minutes following the administration of FLUZONE QUADRIVALENT and following the administration of ADACEL. On unknown date, the patient developed a non-serious pain, redness and swelling at the injection site (vaccination site inflammation) with unknown latency following the administration of FLUZONE QUADRIVALENT and following the administration of ADACEL. On 16-Nov-2018the symptoms continued and patient was evaluated by a physician. Physician reports that his Strength is good and is able to squeeze hands equally. ROM fair. Final diagnosis was tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected and pain, redness and swelling at the injection site. As a corrective treatment physician recommended ibuprofen and cool compress. Patient will be monitored by his HCP. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected, as Unknown for pain, redness and swelling at the injection site. 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 and Module VI of the 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.