Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
had a reaction after she received the covid vaccine/redness and soreness in arm; had a reaction after she received the covid vaccine/redness and soreness in arm; chills; slept for 12 hours last night; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019548 (Biotech), 2021SA279542 (SANOFI). Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from the patient. This case involves a 70 years old female patient who had a reaction after she received the covid vaccine/ redness and soreness in arm, slight chills, and slept for 12 hours last night while being treated with DUPILUMAB [DUPIXENT] delivered via Dupilumab syringe and COVID-19 VACCINE. And forgot to inject her Dupixent and is z week late on it with no reported adverse event directly linked to product dose omission in error. The patient's past medical history included Personal History of other malignant neoplasm of skin, Insomnia, Gastro-Esophageal Reflux Disease without Esophagitis and Bilateral Acute Atopic Conjunctivitis. 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 Poly osteoarthritis, Chronic Obstructive Asthma, Allergic Rhinitis Due To Pollen and Allergy-Codeine Sulfate, Iodine, Tizanidine HCL (hydrochloride). Concomitant medications included MULTIVITAMIN [VITAMINS NOT OTHERWISE SPECIFIED (NOS)] (MULTIVITAMIN [VITAMINS NOS]); ASCORBIC ACID, BETACAROTENE, COPPER, MANGANESE, NICOTINIC ACID, RIBOFLAVIN, RIBOFLAVIN, SELENIUM, VITAMIN E NOS, XANTOFYL, ZINC (OCUVITE + LUTEIN); CALCIUM CARBONATE (OYSTER SHELL CALCIUM); ELASOMERAN (SPIKEVAX); MONTELUKAST SODIUM (MONTELUKAST SODIUM); AZELASTINE HCL (AZELASTINE HCL); BECLOMETASONE DIPROPIONATE (QVAR REDIHALER); FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE); MOXIFLCXACIN HCL (MOXIFLOXACIN HCL); FLUCONAZOLE (FLUCONAZOLE); AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN CLAVULANIC ACID); ASPIRIN [ACETYLSALICYLIC ACID] (ASPIRIN [ACETYLSALICYLIC ACID]); GUAIFENESIN (MUCINEX); AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (AZELASTINE/FLUTlCASONPROPIONAAT); and FAMOTIDINE (FAMOTIDINE). On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection of strength 300 mg/2 ml at a dose of 300 mg Q O W via subcutaneous route for Refractory extrinsic Asthma. On 11-AUG-2021, the patient developed a non-serious event "forgot to inject her Dupixent and is a week late on it with no reported adverse event" (product dose omission in error) (unknown latency) following the first dose intake (Batch number: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB. On 22-Apr-2025, the patient took COVID-19 VACCINE (unknown formulation, strength, dose, frequency, route of administration and indication). On 22-APR-2025, the patient developed a non-serious event "reaction after she received the covid vaccine/redness and soreness in arm" (vaccination site erythema) (vaccination site pain) (unknown latency) following the first dose intake (Batch number: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB and COVID-19 Vaccine. On 22-APR-2025, the patient developed a non- serious event "slight chills" (chills) (unknown latency) following the first dose intake and (unknown latency) (unknown latency) following the first dose intake (Batch: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB and COVID-19 VACCINE. On 22-APR-2025 the patient developed a non- serious event "slept for 12 hours last night" (hypersomnia) (unknown latency) following the first dose intake and (unknown latency) (unknown latency) following the first dose intake and (unknown latency) (unknown latency) following the first dose intake (Batch: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB and COVID-19 VACCINE. It was reported "Patient stated that she forgot to inject her Dupixent and is a week late on it. I advised patient to inject her dose today and resume the every other week dosing. Patient expressed verbal understanding. She had a reaction after she received the covid vaccine on 22-Apr-2025. She has redness and soreness in arm, slight chills, and slept for 12 hours last night. Reports she gets that every time she gets a covid vaccine. No other details provided." Action taken: With respect to Dupilumab: No action taken for the events vaccination site erythema, vaccination site pain, chills, hypersomnia and unknown for the event product dose omission in error. With respect to Covid-19 Vaccine: Not applicable for all the events. Corrective treatment: Not reported for the events vaccination site erythema, vaccination site pain, chills, hypersomnia. Outcome: Unknown for the events vaccination site erythema, vaccination site pain, chills, hypersomnia. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 23-Apr-2025 from patient: Based on information received new events vaccination site erythema, vaccination site pain, chills, hypersomnia, concomitant medications, co-suspect, medical history were added and text amended accordingly.
Allergic rhinitis due to pollen; Arthrosis multiple; Asthma
Medical History/Concurrent Conditions: Acute atopic conjunctivitis; Gastroesophageal reflux disease; Insomnia; Malignant neoplasm of skin, other; Product dose omission
MULTIVITAMIN [VITAMINS NOS]; OCUVITE + LUTEIN; OYSTER SHELL CALCIUM; SPIKEVAX; MONTELUKAST SODIUM; AZELASTINE HCL; QVAR REDIHALER; FLUTICASONE PROPIONATE; MOXIFLOXACIN HCL; FLUCONAZOLE; AMOXICILLIN CLAVULANIC ACID; ASPIRIN [ACETYLSALICYLIC