Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Off label use, Pyrexia, Steroid dependence
Clinical narrative: taking dupixent chronic eosinophilic pneumonia with no reported adverse event; Attributed this to prednisone dependency; She started feeling sick; She started feeling sick with headache with pain in the back of the head; Fever; Trouble breathing; Joint pain; Chills; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA143366.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; dupilumab (DUPIXENT), since Mar2020 (Batch/Lot number: unknown) at 300 mg cyclic (300 mg, cyclic; (every two weeks)), subcutaneous for eosinophilic pneumonia chronic; prednisone (PREDNISONE), first regimen since 1992 (Batch/Lot number: unknown) at 5 mg and second regimen since Feb2022 (ongoing) (Batch/Lot number: unknown) at 2.5 mg. The patient's relevant medical history included: "Asthma" (ongoing); "Eosinophilic pneumonia syndrome" (ongoing); "Age-related osteoporosis" (ongoing); "Rhinitis" (ongoing); "Allergy: bleach" (unspecified if ongoing); "Allergy: caffeine" (unspecified if ongoing); "Allergy: cigarette smoke" (unspecified if ongoing); "Allergy:echinacea" (unspecified if ongoing); "Allergy: alpha. Gal" (unspecified if ongoing); "Allergy: Ginseng" (unspecified if ongoing); "Allergy: Turkey" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; SALBUTAMOL SULFATE; CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC (GLUCONATE); MELATONIN; VITAMIN D 3; TURMERIC CURCUMIN; CETIRIZINE HYDROCHLORIDE; VITAMIN E NOS. Past drug history included: Cortisone, reaction(s): "Allergy:cortisone"; Aspirin, reaction(s): "Allergy: aspirin"; Hydrogen peroxide, reaction(s): "Allergy: Hydrogen Peroxide"; Ibandronate sodium, reaction(s): "Allergy: Ibandronate Sodium"; Icy hot, reaction(s): "Allergy: Icy Hot"; Naproxen, reaction(s): "Allergy: Naproxen"; Voltaren, reaction(s): "Allergy: Voltaren". The following information was reported: CHILLS (non-serious) with onset 09Mar2021, outcome "recovered"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Mar2021, outcome "recovered", described as "Flu like symptoms"; OFF LABEL USE (non-serious), outcome "unknown", described as "taking dupixent chronic eosinophilic pneumonia with no reported adverse event"; STEROID DEPENDENCE (non-serious), outcome "recovered", described as "Attributed this to prednisone dependency"; MALAISE (non-serious), outcome "recovered", described as "She started feeling sick"; HEADACHE (non-serious), outcome "recovered", described as "She started feeling sick with headache with pain in the back of the head"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; DYSPNOEA (non-serious), outcome "recovered", described as "Trouble breathing"; ARTHRALGIA (non-serious), outcome "recovered", described as "Joint pain". The action taken for dupilumab was unknown; for prednisone was dosage reduced.  Additional information: This case involves a 59-year-old female who attributed to prednisone dependency, chills, flu like symptoms, she started feeling Sick with headache with pain in the back of the head, fever. trouble breathing, joint pain, taking dupixenl for chronic eosinophilic pneumonia with no reported adverse event while being treated with DUPILU M R (DUPIXFNT) via prefilled syringe, PFIZER BIONTECH COVID-19 V ACCINE and PREDNISONE. In 1992, the patient started taking PREDNISONE, at a dose of 5 mg which was decreased to 2.5 mg in Feb2022 (with an unknown formulation, frequency, route. batch and expiry date) for allergic conditions. In Mar2020, the patient started taking Dupilumab via pre-filled syringe solution for injection, strength 150mg/ml at a dose 300mg every two weeks subcutaneously (with an unknown batch number and expiry date). The past drug history included Nitrate Analogues and Salicylates. On 09Mar2021, (latency' 1 year approximately) the patient had chills and flu like symptoms (influenza like illness) that staled the new day after vaccine that last 48 hours. On an unknown date in 2022, with a latency or approximately patient report's that she has been on prednisone since 1992 due to her allergic conditions and doctor has been tapering down the dose, went down from 5 mg to 2.5 mg Feb2022 and after a couple of weeks she started feeling sick (malaise) with headache, with pain in the back of the head (headache). joint pain (arthralgia), fever (pyrexia). chills and trouble breathing (dyspnoea). reports that this lasted for a few months and that her body adjusted to the new dose, and she is feeling better now, doctor aware and attributed to prednisone dependency (steroid dependence). On an unknown date the patient stalled taking dupixent for chronic cosinophilie pneumonia with no reported adverse event (product use in unapproved indication) (unknown latency) following the first dose intake of Dcpiloma B, Prednisone and Pfizer BioNTech Covid-19 Vaccine. It was reported received delivery today, the cooler was scaled hut the Dupixent, package was open, reporting lop of Dupixent box opened. Patient wanted to speak to pharmacist make sure the medication was safe to use. The pharmacist advised had been reported before and could happen during transit but assured her was inspected by a pharmacist before. It was unknown if the patient experienced any additional symptoms/event. The patient stayed ice pack was cool upon opening and no other Issues to report. She put medication in the fridge and was ok with using it. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively ensure the authorization holder's compliance with the requirements set out in the Detective 2001/83/EC and Module VI of Good practices, The classification as a medical error is in no way intended, not should it be interpreted or construed as an allegation or clam made by the marketing authorization holder that any third party has contributed to or co be held liable for the occurrence of this medication error. Additional Information was received on 16Sep2022 from patient: Added prednisone as suspect, added medical history, concomitant medications and event headache. arthralgia, pyrexia, dyspnea, steroid dependence, Txt am ended accordingly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.