Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Suicidal ideation
Clinical narrative: she felt suicidal; tingling; itchiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Jun2021 (Lot number: 2F156A, Expiration Date: 31Oct2024) at 300 mg (300 mg every other week (strength: 300mg/2ml)) for asthma, eczema, dermatitis atopic. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "spongiotic dermatitis" (unspecified if ongoing); "dermatitis atopic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "she felt suicidal"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling"; PRURITUS (non-serious), outcome "unknown", described as "itchiness". The action taken for dupilumab was unknown.  Clinical information: The Dupixent single dose prefilled pen component of the combination product Dupixent (Single entity for initial use) has been identified with a device issue, it is unknown if the product was stored or used properly. The device was operated by the Patient. It was reported the patient took a dose of Dupixent 300 mg and her pen misfired and the medication ran out of pen onto the patient abdomen and onto the floor. The patient did not have a loading dose. The patient did notice a small bubble under her skin and complained of a great deal of pain with the injection which hurt more than normal. The patient stated she started to have symptoms after she received her second Pfizer Covid injection and never had this problem before. She stated the itchiness, tingling was so severe she felt suicidal. The patient is requesting a replacement pen and has the pen available. To be evaluated by PV. The patient injected Dupixent by herself. Patient had received auto-injector training prior to use in Office. Patient applied the injection in Stomach. The auto-injector remain in the product cartoon during storage. Patient received Partial dose of Dupixent. There was no delay from time of cap removal until injection, patient holding the Auto-injector at a 90-degree angle while injecting, patient depress the yellow safety cover completely on skin and hear initial click, the plunger (yellow window) moved, the viewing window turn partially or completely yellow after pulling off skin. The patient had experience with Auto-injector other than Dupixent. Patient felt pain while it was injecting. The batch 2F156A gave no indication of problems during assembly/packaging and the final control of the unpacked Dupixent. The pain at injection site described, following the injection, might be related to the application practice. For example, if a blood vessel was hit, this might have caused the irritation of the skin. Is the pain at injection site is observed again, the physical should be informed. Hence, these skin effects are not considered to be an AE but they are result of the pressure applied on the injection button by the complainant on his body. The leakage event is related to a device issue/complaint to a leakage from the syringe. Therefore, no leakage investigation is necessary. The itchiness experienced by the patient (a lack of effect) is related to the device malfunction and the missed dose. Other influences related to the therapy and/or interactions with other medications have to be considered. The final investigation was completed on 16Feb2023 with summarized conclusions as no faults detectable. Company Agent causal reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.