Reporte zur Charge UH454AC

Symptomtext

could barely get up; swelling about the size of an egg on the right side of her neck (the opposite side of the body from the injection site of the left deltoid); redness had spread across her chest, down the other arm, and up to her neck; within 2 minutes of the nurse administering the vaccine, her left arm starting itching on the inside and she had to scratch it; the left arm was red;Initial information regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Medical Information (Reference number- 00634722) and transmitted to Sanofi on 09-Jun-2021. This case involved a female patient who could barely get up (dysstasia), swelling about the size of an egg on the right side of her neck (the opposite side of the body from the injection site of the left deltoid) (swelling), redness had spread across her chest, down the other arm, and up to her neck (erythema), within 2 minutes of the nurse administering the vaccine, her left arm starting itching on the inside and she had to scratch it (vaccination site pruritus) and the left arm was red (vaccination site erythema), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. Medical history included latex allergy and allergy to vaccine. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 11-Nov-2011, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UH454AC and expiration date: 30-Jun-2012) via intramuscular route in the left deltoid for prophylactic vaccination. On 11-Nov-2011, the patient developed a non-serious, swelling about the size of an egg on the right side of her neck (the opposite side of the body from the injection site of the left deltoid) (swelling), redness had spread across her chest, down the other arm, and up to her neck (erythema), within 2 minutes of the nurse administering the vaccine, her left arm starting itching on the inside and she had to scratch it (vaccination site pruritus) and the left arm was red (vaccination site erythema), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious, could barely get up (dysstasia), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient stated that she was latex-sensitive, so that if she received a formulation that had latex she might have reacted to that. Because the patient experienced a bad reaction to a previous vaccine, she has been told she needs to confirm that certain ingredients in the Covid (corona virus disease)-19 vaccine she is planning to get were not present in the Sanofi flu vaccine she got back in 2011. This is on a Covid-19 checklist as something that must be done before she can receive the Covid-19 vaccine. No relevant laboratory tests were reported. It was not reported if the patient received a corrective treatment. Event outcome was reported as unknown for the event difficulty in standing and rest of the events were resolved on an unknown date.