Received Jan 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
has a mark on their ankle that has not disappear for 2 months that looks like teeth bite mark; having redness in front of their ear, under their eyebrows; spider vein; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP from License Party. Other Case identifier(s): AE-022071 (BioNTech), 2025SA214115 (Sanofi). A 27-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Oct2023 at 300 mg weekly (300 mg qw), subcutaneous for eosinophilic oesophagitis; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dupixent for Eosinophilic oesophagitis, reaction(s): "pain with every dupxient injection/ pain while getting his injection"; Dupixent for Eosinophilic oesophagitis, reaction(s): "tissue is swollen at the injection site after each injection/ has a very small swelling". The following information was reported: SCAR (non-serious), 5 days after the suspect product(s) administration, outcome "not recovered", described as "has a mark on their ankle that has not disappear for 2 months that looks like teeth bite mark"; ERYTHEMA (non-serious), 5 days after the suspect product(s) administration, outcome "unknown", described as "having redness in front of their ear, under their eyebrows"; SPIDER VEIN (non-serious), outcome "recovering". The events "has a mark on their ankle that has not disappear for 2 months that looks like teeth bite mark", "having redness in front of their ear, under their eyebrows" and "spider vein" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dupilumab was unknown. Additional information: It was reported, "pain with every dupxient injection (dates unknown) since start of therapy (dec-2024, estimated). Pain duration is the duration of each injection. Patient reports the tissue is swollen at the injection site after each injection (dates unknown) since start of therapy. The swelling resolves a few hours after each injection is administered (dates unknown) md (medical doctor) is not aware. encouraged patients mother to notify the MD. No further information/details provided. Patients mother reported on Saturday, 48 hours post dupixent injection she noticed patient had what appeared to be spider veins the size of a quarter inside of both ankles. One side had broken spider veins and the other side had small spider veins in the shape of the circle. Patient did go into the ER (emergency room) but patient's mother states she was not able to go with patient. They did doppler scan to check for deep vein thrombosis and no blood clots were found. They checked complete blood count and labs were normal. MD is not aware and spider veins have gotten better, barely noticeable. Patient's mother also reported patient reports pain while getting his injection. Pt (patient) mom reported pt had flu shot and covid vaccine and 5 days later, pt started having redness in front of their ear, under their eyebrows, a small part of the temple, and their ears are red (unknown when pt got the vaccines). Pt skipped last Wednesday dupixent injection as instructed by their md and a pharmacist. Pt does not have rash, no trouble breathing, no swelling in tongue, throat, or lips. Pt mom stated that the injection site of Dupixent, has a very small swelling. Pt mom also stated that pt has a mark on their ankle that has not disappeared for 2 months that looks like teeth bite mark. Primary md is aware and is not concerned. No further information." Batch/lot number is not provided, and it cannot be obtained.
DUPIXENT
Test Name: complete blood count; Result Unstructured Data: Test Result: labs were normal; Test Name: doppler scan; Result Unstructured Data: Test Result: no blood clots were found