Received Feb 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
she was concerned that she had covid (covid-19); arem still visible red swollen knot (peripheral swelling); Her arm still had a visible red swollen knot (peripheral swelling) (erythema); she has allergic rhinitis; Pneumonia; her sinuses and throat were burning; her sinuses and throat were burning; feeling really sick; This is a spontaneous report and received from Consumer or other non HCPs from License Party. Other Case identifier(s): 2026SA017797 (Sanofi), AE-022659 (Biontech). A 36-year-old female patient (unknown if pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Jan2026 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), on 01Dec2025 as 300 mg, weekly, Expiration Date: 31Jan2028) subcutaneous for oesophagitis. The patient's relevant medical history included: "Food allergies: banana (cross sensitivity to latex). cherry, eggplant, papaya, potato, tomato, tree nut," (ongoing); "Eosinophil esophagitis" (unspecified if ongoing). Concomitant medication(s) included: RIBOFLAVIN; THIAMINE HCL; TYLENOL; PEPCID [FAMOTIDINE]; ZUMANDIMINE; FLUTICASONE PROPIONATE; B-100 COMPLEX; CLARITIN [LORATADINE]. Past drug history included: Unasyn, reaction(s): "Drug allergies: unasyn". The following information was reported: MALAISE (non-serious) with onset 12Jan2026, outcome "unknown", described as "feeling really sick"; PNEUMONIA (medically significant) with onset 13Jan2026, outcome "unknown"; THROAT IRRITATION (non-serious) with onset 13Jan2026, outcome "unknown", SINUS DISORDER (non-serious) with onset 13Jan2026, outcome "unknown" and all described as "her sinuses and throat were burning"; COVID-19 (non-serious), outcome "unknown", described as "she was concerned that she had covid (covid-19)"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "arem still visible red swollen knot (peripheral swelling)"; ERYTHEMA (non-serious), outcome "not recovered", described as "Her arm still had a visible red swollen knot (peripheral swelling) (erythema)"; RHINITIS ALLERGIC (non-serious), outcome "unknown", described as "she has allergic rhinitis". The patient underwent the following laboratory tests and procedures: Biopsy: her eczema were high on her biopsies prescriber, notes: her eczema were high on her biopsies prescriber was not aware (Eosinophil count Increased); Eosinophil count: high. The action taken for dupilumab was unknown. Clinical course: patient who was now feeling ill like she may be coming down with covid or pneumonia, she woke up and her sinuses and throat were burning, she concerned that she had covid: feeling really sick. It Just hurts, the actual injection stings since starting on dupixent stinging with injection. Joints all popping/the crackling In her knuckles and other joints. broke out In a rash on her shins of red dots In circle patches/had a rash on her legs over the weekend/ it was red dots in circle patches, states already gone away, her primary doctor diagnosis It as eczema, her arm still had a visible red swollen knot, she has allergic rhinitis and her eosinophil levels were high on her biopsy while being treated with Dupilumab [dupixent] delivered via Dupixent single dose pre-filled pen and COVID-19 vaccine. At the time of the event, the patient had ongoing Drug allergies: unasyn, Food allergies: banana (cross sensitivity to latex). cherry, eggplant, papaya, potato, tomato, tree nut. On 01Dec2025, the patient started taking DUPIXENT (DUPILUMAB) Solution for Injection of strength 300 mg/2ml at a dose of 300 mg QW (Once a week) subcutaneously for Eosinophil esophagitis. On 12Jan2026, the patient started taking COVID-I9 vaccine of unknown formulation, dosing, frequency, route of administration and Indication. Patient stated with the Duplxent injections, it Just hurts, the actual injection stings, since starting on duplxent her Joints all popping (injection site pain) (onset 01Dec2025, latency-same day). She heard the crackling in her knuckles and other joints, denies pain (joint noise) (onset 01Dec2025, latency-same day) (Batch number5F734A, expiry date on 31Jan2028) mild sting with injection joint popping unsure if medication was working for her, states that It was hard to tell If It was working because she was not having symptom prior to taking dupixent. her Eosinophil levels were high on her biopsies prescriber was not aware (Eosinophil count Increased) (unknown onset and latency) (Batch number-5F734A, expiry date on 31Jan2028). On 10Jan2026, she broke out in a rash on her shins of red dots In circle patches, her primary doctor diagnosed It as eczema, patent stated it has resolved. patient stated worried because she gave herself the dupixent on monday. Patient had a rash on her legs over the weekend, she went to primary care medical doctors office and diagnosed the rash as eczema (eczema) (rash) (onset- 10Jan2026, latency 1 month on 10 days, (Batch number-5F734A, expiry date on 31Jan2028).she stated that it was red dot in circle patches, states already gone away. she received the covid vaccine during the visit. she received the covid vaccine on 12Jan2026, the next morning she woke up her sinuses and throat were burning. She was concerned that she had covid-19 (throat irritation) (sinus disorder) (onset-13Jan2026,latency-l month 13 days) and was wondering if she needed to separate the dupixent injection which was also administered on 12Jan2026 and the covid vaccine sickness following covid vaccine (illness) (onset- 12Jan2026, latency month 12 days) (Batch number-5F734A. expiry date on 31Jan2028). patient stated feeling really sick. stated she was now feeling ill like she may be coming down with covid or pneumonia (pneumonia) (onset 13Jan2026, latency-1 month 13 days) , feeling unwell (malaise) (onset-12Jan2025, latency I month 12 days) following the same day administration of dupixent and covid shot, unsure If the symptoms were due to receiving both Injections on the same day. Her arm still had a visible red swollen knot (peripheral swelling) (erythema) (unknown onset and latency) (Batch number-5F734A, expiry date on 31Jan2028). Patient stated that she has allergic rhinitis (Rhinitis allergic ) (unknown onset and latency) (Batch number 5F73dA, expiry date on 31Jan2028). Corrective treatment: Not reported for all events. Sanofi comment dated 21Jan2026: This case involves a 35 years old female patient who was now feeling Ill like she may be coming down with covid or pneumonia while being treated with Dupilumab [Duplxentl delivered via Dupixent single dose pre-filled pen. The causal role cannot be excluded but covid vaccine can also be a confounding factor, however, lack of information regarding relevant medical history, concurrent conditions, underlying disease, therapy details, event details, pre-existing risk factors , Iprsonal and lifestyle history precludes comprehensive case assessment. The case will be reassessed based on followup information that will be received. COMIRNATY is under agreement with BIONTECH SE.
Food allergy
Medical History/Concurrent Conditions: Eosinophilic esophagitis
RIBOFLAVIN; THIAMINE HCL; TYLENOL; PEPCID [FAMOTIDINE]; ZUMANDIMINE; FLUTICASONE PROPIONATE; B-100 COMPLEX; CLARITIN [LORATADINE]; DUPIXENT
Test Name: biopsy; Result Unstructured Data: Test Result:her eczema were high on her biopsies prescriber; Comments: her eczema were high on her biopsies prescriber was not aware (Eosinophil count Increased); Test Name: eosinophil levels; Result Unstructured Data: Test Result:high