Sex: F
Vaccine: COVID19, FLU4, UNK
Symptoms: Crying, Drug ineffective, Dry skin, Haemorrhage, Poor quality sleep
Clinical narrative: bleeding; DISTURBS SLEEP; CRACKED AND DRY EVERYDAY; weeping; SKIN IS ITCHY; NOT SEEN ANY CHANGES YET; Initial information received on 24-Jan-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (non healthcare professional ).  This case involves a 43 years old female patient who reported bleeding, disturbs sleep, cracked and dry everyday, weeping, skin is itchy and not seen any changes yet while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] and while treated with Dupilumab [Dupixent] via prefilled syringe and Covid-19 Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Contact dermatitis, Dermatitis, Eczema, Malignant neoplasm NOS(not otherwise pecified), Insomnia, Allergy to metals and Rubber sensitivity.  Concomitant medications included Vitamins NOS(not otherwise specified) (Multivitamin); and Clobetasol Propionate.  On 12-Jan-2022, the patient started taking Dupilumab at a dose of 300 mg QOW(every other week) via subcutaneous route, strength-300 mg/2mL (with an unknown batch number,formulation) for Dermatitis atopic.  On an unknown date, the patient started taking Covid-19 Vaccine  (with an unknown batch number,formulation,strength,frequency, route, administration site) for Immunisation.  On an unknown date, the patient received a  dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event bleeding (haemorrhage) (unknown latency) and non-serious event disturbs sleep (poor quality sleep),cracked and dry everyday (dry skin),weeping (crying),skin is itchy (pruritus) and not seen any changes yet (drug ineffective)(unknown latency) following the first dose intake  of Dupilumab,Influenza Quadrival A-B Vaccine and of Covid-19 Vaccine.   Patient reported that she has not seen any changes yet. patient says over the last week, skin is itchy, disturbs sleep, bleeding, weeping, cracked and  dry everyday.  Action taken : Not applicable for drug ineffective and unknown for other events  with Dupilumab, Quadrivalent influenza vaccine and Covid-19 Vaccine  was not applicable.  Corrective treatment : No corrective treatment reported for the events.  Event outcome : Unknown for all the events.  Seriousness criteria : This event(haemorrhage) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 02-Feb-2022. This case involves a 43 years old female patient who reported bleeding, disturbs sleep, cracked and dry everyday, weeping, skin is itchy and not seen any changes yet while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] and while treated with Dupilumab [Dupixent] via prefilled syringe and Covid-19 Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.