Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
hair loss; skin on her hand was so dry and cracked that it hurts; skin on her hand was so dry and cracked that it hurts; bumpy skin; skin on her hand was so dry and cracked that it hurts; huge rash/rash is on her whole-body including face and head/rash got worse/ splotches went from pea sized to baseball size. They tend to be round in nature and look more like a bruise/ blotches; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA284609 (Sanofi), AE-021212 (BioNTech SE). A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), till Apr2025 at single-dose for dermatitis atopic, psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (medically significant) with onset 2022, outcome "not recovered", described as "huge rash/rash is on her whole-body including face and head/rash got worse/ splotches went from pea sized to baseball size. They tend to be round in nature and look more like a bruise/ blotches"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss"; DRY SKIN (non-serious), SKIN FISSURES (non-serious), PAIN OF SKIN (non-serious), outcome "unknown" and all described as "skin on her hand was so dry and cracked that it hurts"; SKIN DISORDER (non-serious), outcome "unknown", described as "bumpy skin". The action taken for dupilumab was dosage permanently withdrawn in Apr2025. Therapeutic measures were taken as a result of rash, dry skin, skin fissures, pain of skin. Clinical course: Patient explained she had developed a huge rash after she had her Covid shot while she was taking Dupixent. Last Covid was 2022 and the Dupixent was on Apr2025. The rash was on her whole-body including face and head (rash) (onset: an unknown date in 2022) (seriousness criteria: medically significant), her hair loss (alopecia). She asked a simple question: what had you learned about the intersectional medical outcomes for patients who both were Dupixent and COVID-19 users. That was when the undiagnosed skin problem began and it was awful. It was ruining her ability to function - the skin on her hand was so dry (dry skin) and cracked (skin fissures) that it hurts (pain of skin) she use Neosporin daily to quiet the pain and the impact on her skin had aged her face and body, much to her chagrin. Doctors had tried typical eczema treatments but they did not work. Now the doctor wanted to experiment with using Dupixent like drugs for psoriasis. She was now skeptical after use of the Dupixent and the COVID shots. She must say that for the few months that she used Dupixent without COVID-19 shots, her skin was beautiful, perfect for the first time in her 64 years of life. Through an administrative error, she lost financial support and so she went about 6 months, she got back on it never cleared her skin the way it had in the 1st usage. At the same time, she had taken 1-2 Covid shots/booster by that time so it was not clear whether the Dupixent did not work as well because of the Covid-19 shot. She called and asked questions of medical team and the pharmacist who provided the medication. She was only told to allow 2-3 days between shots - Dupixent and Covid-19. And nurse told her that sometimes when there was a hiatus in medication use, the medication did not work as effectively. Until the rash got worse about 9 months - 12 months later - the splotches went from pea sized to baseball size. They tend to be round in nature and look more like a bruise. She was regularly asked by family and friends whether she was being abused at home- that was how horrible these blotches look. There was a breakout on her face regularly happening close to the hairline, when the bumpy (skin swelling) part of the rash recedes, She guess it closes the hair follicle and that hair falls out. Where there was no rash, there was no hair loss. This was what she could tell. She didn't think this problem results from any one box of medication. It was acute and pervasive. Corrective treatment: Unknown topical lotions for rash; Neosporin (unspecified) for dry skin, pain of skin, skin fissures and not reported for alopecia, swelling. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. BNT162b2 is under agreement with BIONTECH SE.
DUPIXENT