Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
intensive care unit in February due to a brain bleed, caused by low platelet count; intensive care unit in February due to a brain bleed, caused by low platelet count; sent to emergency room for dizziness; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA072402 (Sanofi), AE-019819 (BioNTech). Initial information received on 28Feb2024 regarding an unsolicited valid non-serious case received from patient via specialty pharmacy. The case was updated to serious on 02Jun2025. This case involved a 68-year-old male patient who had been admitted to the intensive care unit in February due to a brain bleed caused by a low platelet count while being treated with dupilumab [Dupixent]delivered via dupilumab single dose prefilled pen and the COVID-19 vaccine. Every couple of injections he has some of the liquid trickle back out of his leg with no reported adverse event directly linked to accidental exposure to product and exposure via skin contact. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Terbinafine and Tirzepatide (Mounjaro). On 16Mar2021, the patient started taking dupilumab Solution for injection (strength-300mg/2ml) at a dosage of 300 mg with frequency of QOW (Every Other Week) via subcutaneous route for Atopic dermatitis. On an unknown date, the patient started taking covid-19 vaccine (with an unknown dosage, strength, frequency and route) for an unknown indication. Reportedly, the patient stated that every couple of injections, some of the liquid had trickled back out of his leg(accidental exposure to product)(exposure via skin contact)(onset date; latency-unknown). He mentioned that he did not have much fatty tissue and experienced difficulty with injections in his abdomen. No additional pertinent information was provided. (Batch number: Lot 3F278A, Expiry date: 31Jul2025). Upon follow up information received, the patient stated that his last dose of DUPIXENT was in Jan2025. He was admitted to the intensive care unit in February due to a brain bleed(cerebral haemorrhage), which was attributed to a low platelet count(platelet count decreased)(onset date-Feb2025)(latency-approximately 3 years 11 months). The patient's doctors believed that DUPIXENT may have contributed to the low platelet levels. He reported that his platelet count had consistently been at the low end of normal or slightly below normal (around 200). The patient was sent to the emergency room for dizziness(Dizziness)(onset date Feb2025)(latency-approximately 3 years 11 months), where he was diagnosed with a brain bleed and received platelet infusions. At the time of reporting, he was no longer taking DUPIXENT, following the advice of his doctors. He had been on DUPIXENT for four years and believed that his platelet levels began to decline after receiving COVID-19 vaccines, although it was unclear whether the two were related. No additional details were provided (batch number- 4F517A; expiration date- 31Aug2026) Action taken- drug withdrawn for Platelet count decreased, Cerebral haemorrhage and Dizziness; not applicable for other events. Corrective treatment- platelet infusions for Platelet count decreased and Cerebral haemorrhage; not reported for other events Outcome- Not Recovered / Not Resolved for Cerebral haemorrhage (its symptoms). Seriousness Criteria-medically significant and Hospitalized for Cerebral haemorrhage(its symptoms). 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 02Jun2025 from the patient. Based on this information, the case initially considered as non-serious was upgraded to serious. New event- Cerebral haemorrhage(Platelet count decreased and Dizziness as symptom) were added. Clinical course updated. Text amended accordingly. Sanofi Company Comment on 05-Jun-2025: This case involved a 68-year-old male patient who was admitted to the intensive care unit in February due to a brain bleed caused by a low platelet count while being treated with dupilumab [Dupixent]delivered via dupilumab single dose prefilled pen. Causal relationship of the suspect drugs cannot be denied however limited information provided regarding this case preclude comprehensive assessment of this case. Case would be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medication. Batch/lot number is not provided, and it cannot be obtained. Comirnaty is under agreement with BIONTECH SE.
Medical History/Concurrent Conditions: Atopic dermatitis
TERBINAFINE; MOUNJARO; DUPIXENT
Test Date: 202502; Test Name: platelet count; Result Unstructured Data: Test Result:200; Comments: around 200; slightly below normal; Test Name: platelet count; Result Unstructured Data: Test Result:consistently been at the low end of normal