Sex: F
Vaccine: COVID19
Symptoms: Application site pain, Crying, Erythema, Injection site pain, Product prescribing error
Clinical narrative: burned when applied; 11-year-old female patient was prescribed dupilumab for severe asthma; skin erosion; face rash got worse that was red and raw; face rash got worse that was red and raw; rash erythematous; injection bums midway through; cries a little; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-health care professional) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2019SA116434 (Sanofi).  A 11-years-old female patient received second dose of COVID-19 Vaccine - Manufacturer Unknown, administration date Aug2021 (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DUPILUMAB taken for asthma, start date: Jan2021; EUCRISA taken for rash erythematous, start date: 2021. Vaccination history included: Bnt162b2 (1st dose), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "face broke out rash". The following information was reported: RASH (non-serious), ERYTHEMA (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "face rash got worse that was red and raw"; RASH ERYTHEMATOUS (non-serious) with onset Aug2021, outcome "not recovered", described as "rash erythematous"; APPLICATION SITE PAIN (non-serious), outcome "unknown", described as "burned when applied"; SKIN EROSION (non-serious) with onset Aug2021, outcome "unknown", described as "skin erosion"; INJECTION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "injection bums midway through"; PRODUCT PRESCRIBING ERROR (non-serious), outcome "unknown", described as "11-year-old female patient was prescribed DUPILUMAB for severe asthma"; CRYING (non-serious) with onset 2021, outcome "recovered" (2021), described as "cries a little". Therapeutic measures were taken as a result of rash, erythema, rash erythematous, application site pain, skin erosion, injection site pain, product prescribing error, crying.  Additional Information: Since an unknown date, the patient started taking subcutaneously DUPILUMAB solution for injection (strength: 300mg/2mL) at an initial loading dose of 400 mg once (batch number and expiration date: unknown) followed by a maintenance dose of 200 mg every other week (QOW) from an unknown date (batch number and expiration date: unknown) for Severe Asthma/Moderate persistent asthma, delivered via DUPILUMAB Prefilled Syringe. In the context of COVID-19 crisis, the batch number and expiration date were not requested. Reporter could not confirm if DUPILUMAB was being taken as an add on maintenance, but was also stated that patient started with sample dose. On an unknown date, after unknown latency, a 11-year-old female patient was prescribed DUPILUMAB for severe asthma (product prescribing error). On an unknown date in Aug2021, patient received second dose of COVID-19 vaccine. On her second COVID vaccine on an unknown date in Aug2021, after unknown latency, patient had her face rash got worse that was red and raw (rash erythematous and skin erosion). Patient was being told to make sure DUPILUMAB should not be given one week before the vaccine and should be okay to give 48 hours after the vaccine per doctor recommendation. On an unknown date in 2021, the patient was prescribed CRISABOROLE cream (strength, dosage, route, batch number, expiry: unknown) used for rash erythematous which made the face rash worse and burned when applied (application site pain; latency: unknown). Her doctor stated her on a 5-days pack of oral prednisone, then the face rash cleared but it came back on the eyes, and side of her face on an unknown date in 2021. It was also reported that the mother lets the prefilled syringe sit out 45 minutes before administering the injection and the patient stated that the injection burnt midway through (injection site pain; onset: 2021; latency: unknown). The injections were given on the outer area of triceps and patient cried a little (crying; onset: 2021; latency: unknown) but about an hour after, the burning seemed to be gone away. At the time of the report, DUPILUMAB was ongoing. Action taken was not applicable for product prescribing error; no action taken for rest all events with DUPILUMAB; no action taken for rash erythematous; not applicable for rest all events with COVID-19 vaccine; not applicable for product prescribing error; unknown for rest all events with CRISABOROLE. Corrective treatment: CRISABOROLE cream and PREDNISONE for Rash erythematous; not reported for rest all events. Outcome: not recovered for face broke out in a rash/face rash got worse that was red and raw/face rash cleared up but it came back on the eyes, and side of her face, face rash got worse that was red and raw; recovered for injection burns midway through, patient cries a little; unknown for rest all events. Reporter causality was not reported for all the events. Company causality: overall company causality was reportable for injection site pain and not reportable for rest all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.