Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic diathesis, Head discomfort, Hypoaesthesia, Insomnia, Lacrimation increased
Clinical narrative: she has to keep a long sleeve shirt on because if she bumps into something sharp it bleed; blood spots on her arms starting 1.5 weeks ago; eyes they hurt; blood blisters on her arms; low-grade fever; numbness in her arms and legs; trouble sleeping; pressure in her head; feeling very tired; retaining water; gain back 8 to 10 pounds; wakes up every 1 to 2 hours at night and feels like she has to pee; nose is runing; her eye are water; eyes they hurt; sores on her skin; itching on her arms; DUPIXENT MY WAY  This is a solicited report received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier: 2022SA426189. A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), from 01Sep2022 (Batch/Lot number: unknown) to 01Sep2022 at 300 mg (300 mg (every other week)), subcutaneous for dermatitis. The patient's relevant medical history included: "Lost 50 pounds" (unspecified if ongoing), notes: intentionally; "skin ulcers" (unspecified if ongoing); "bruises " (ongoing), notes: bruises easily; "skin is very thin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMORRHAGIC DIATHESIS (medically significant), outcome "not recovered", described as "she has to keep a long sleeve shirt on because if she bumps into something sharp it bleed"; SKIN HAEMORRHAGE (non-serious), outcome "recovering", described as "blood spots on her arms starting 1.5 weeks ago"; EYE PAIN (non-serious), EYE PAIN (non-serious), outcome "not recovered" and all described as "eyes they hurt"; BLOOD BLISTER (non-serious), outcome "recovering", described as "blood blisters on her arms"; PYREXIA (non-serious), outcome "not recovered", described as "low-grade fever"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness in her arms and legs"; INSOMNIA (non-serious), outcome "not recovered", described as "trouble sleeping"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "pressure in her head"; FATIGUE (non-serious), outcome "not recovered", described as "feeling very tired"; FLUID RETENTION (non-serious), outcome "not recovered", described as "retaining water"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "gain back 8 to 10 pounds"; NOCTURIA (non-serious), outcome "not recovered", described as "wakes up every 1 to 2 hours at night and feels like she has to pee"; RHINORRHOEA (non-serious), outcome "not recovered", described as "nose is runing"; LACRIMATION INCREASED (non-serious), outcome "not recovered", described as "her eye are water"; SKIN LESION (non-serious), outcome "recovered", described as "sores on her skin"; PRURITUS (non-serious), outcome "not recovered", described as "itching on her arms". The patient underwent the following laboratory tests and procedures: Body temperature: 98 to 99, notes: Low grade fever; 97.6, notes: Normal; Weight: gained 8 to 9; Lost 50. The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of blood blister [salicylic acid (Eucerin)], insomnia [melatonin every night 10mg], pruritus [over the counter cream (unspecified)]. Clinical course: On an unknown date (latency, unknown), the patient had "blood spots on her arms starting" 1.5 weeks ago, itching. Patient stated that dupixent is not working (drug ineffective) and stated that she wants to stop taking dupixent. Patient stated that she is having trouble sleeping, she has pressure in her head and is feeling very tired, she has a low-grade fever, it is 98 to 99 and her normal is 97.6. She stated that she still has itching on her arms. She is having numbness in her arms and legs and has joint pain. She says that she has been retaining water, if she wears high socks, it leaves an imprint on her leg. She stated that she has gained back 8 to 10 pounds. She stated that she bruises easily. She mentioned that the sores on her skin are gone. She stated that she has wakes up every 1 to 2 hours at night and feels like she has to pee. She stated that her nose is running, her eyes are water and they hurt. She stated that she has to keep a long sleeve shirt on because if she bumps in something sharp it bleeds. She stated that her skin is very thin but that was not new are ongoing. Since starting dupixent, she stated that she has gained 8 to 9 pounds. The nurse reported that the consumer lost 50 pounds intentionally but has gained back 8 to 10 pounds since starting dupixent.  ~ The reporter's assessment of the causal relationship of the events with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Reporter comment: local evaluator comment: 03Nov2022; 15Nov2022  Company comment: Evaluation in light of similar events in the past. The case serious and company agent causal was no. Case listedness was unlisted and case outcome was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter's Comments: local evaluator comment: 03Nov2022; 15Nov2022; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate