Sex: F
Vaccine: COVID19
Symptoms: Fall, Illness, Vaccination site irritation
Clinical narrative: had a fall after receiving covid shot; she has injection site irritation with this medication and from the covid vaccine; was sick; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2021SA282813 (Sanofi).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 10Jul2020) at 300 mg (300 mg every other week), subcutaneous and second regimen since 13Nov2020) at 300 mg (300 mg qow (every other week)) for asthma. The patient's relevant medical history included: "unspecified asthma/ severe persistent asthma, uncomplicated" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (hospitalization) with onset 2024, outcome "unknown", described as "was sick"; FALL (hospitalization), outcome "unknown", described as "had a fall after receiving covid shot"; VACCINATION SITE IRRITATION (hospitalization), outcome "unknown", described as "she has injection site irritation with this medication and from the covid vaccine". The action taken for dupilumab was temporarily withdrawn. Clinical course: Initial information received on 23Aug2021 regarding an unsolicited valid case received from a Non- Healthcare Professional; this case became serious on 25Mar2024. Patient was in the hospital, was sick, had a fall after receiving covid shot, injection site irritation with dupilumab and from the covid vaccine and it was painful while being treated with dupilumab [Dupixent] via dupilumab prefilled syringe and covid-19 vaccine. On 10Jul2020, the patient started taking dupilumab Solution for injection at a dose of 300 mg every other week subcutaneously (strength: 300 mg/2ml) for unspecified asthma/ severe persistent asthma, uncomplicated. On 13Nov2020 the patient restarted the therapy at dose of 300 mg QO W. On an unknown date, the patient started taking covid-19 vaccine (with an unknown form, dose, frequency, strength, route) for COVID-19 vaccination. Patient had injection site irritation with dupilumab and from the covid vaccine. Patient also had a fall after receiving covid shot; unknown if md (Doctor of Medicine) was aware. Pt (patient) stated that dupixent was painful. Pt was in the hospital (hospitalization) (onset and latency unknown) (unknown batch number and expiry date) and had missed an injection (dupilumab), date unknown. MD was aware. Hospital dates, reason, and duration not provided. Pt would resume dupilumab therapy on an unknown date. Pt was due for dose 01Nov2024, was sick (illness) (onset: 2024), hadn't taken dose all of November 2024. Patient reported missed dupilumab dose on 15Nov2024. Patient took next dupilumab dose on 22Nov2024. No further information given. Unknown if MD was aware. It was unknown if there were lab data/results available.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  BNT162B2 is under agreement with BIONTECH SE.