Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Product storage error, Vaccination site cellulitis, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: a cellulitic patch around the right deltoid muscle; completely swollen right arm; vaccination site inflammation; irregular red ring shape around the whole deltoid muscle.; Caller also states that the pharmacy representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them; Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via phone call (under Medical Information Inquiry Number: 00761956).  This case is linked to cluster case Id: 2021SA302683.  This case involves a 55-years old female patient who experienced a cellulitic patch around the right deltoid muscle (vaccination site cellulitis), completely swollen right arm (extensive swelling of vaccinated limb), vaccination site inflammation and irregular red ring shape around the whole deltoid muscle. (vaccination site erythema) and Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them (Incorrect product storage) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On 08-Sep-2021, the patient received a first 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number: UT7319LA and expiry: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination.  On 08-Sep-2021, the patient developed a non-serious cellulitic patch around the right deltoid muscle (vaccination site cellulitis), completely swollen right arm (extensive swelling of vaccinated limb), vaccination site inflammation and serious irregular red ring shape around the whole deltoid muscle. (vaccination site erythema) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller stated that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08-Sep-2021 and that 3 co-workers had adverse reactions to the vaccine. She asked if patients were having more site reactions this year and asked if anything was added to the vaccine. She stated that switching from the prefilled syringe to the Multi Dose Vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 co-workers that experienced adverse reactions and stated that she would contact Medical Information when she obtaines information on the third co-worker. Caller stated that she could be contacted by Sanofi Safety if further information was needed and asked for the direct phone number for Medical Information. She also stated that the representatives did not had a cooler for the vaccines and that they appeared out at room temperature when she saw them."  This case was an actual medication error due to Incorrect product storage.  No lab data was provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of events was reported as unknown.  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 the 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.