Sex: F
Vaccine: COVID19, UNK
Symptoms: Renal impairment, Skin discolouration, Weight, Weight decreased, White blood cell count
Clinical narrative: started experiencing bruises all over her body; base of her cheek turned brown; lost about 30lbs over the course of the month; first dentist she wen to told her all her teeth were dead and had to remove everything, got a 2nd opinion who told her only a few are dead and have to be removed; blames these symptoms on the covid shot she took 3 years ago to which she had an allergic reaction to at that time; labs from last month showed very poor kidney function; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2021SA256995.  Initial information was received on 28Jul2021 regarding an unsolicited valid case received from a patient. The case upgraded to serious on 02Aug2024. This case involves a 69 years old female patient (not pregnant) who reported labs from last month showed very poor kidney function, started experiencing bruises all over her body, base of her cheek turned brown, lost about 30lbs over the course of the month, first dentist she went to told her all her teeth were dead and had to remove everything, got a 2nd opinion who told her only a few are dead and have to be removed and blames these symptoms on the covid shot she took 3 years ago to which she had an allergic reaction to at that time while being treated with Dupilumab [Dupixent] via prefilled pen and Covid-19 vaccine. The patient's past medical history, medical treatment(s), vaccination(s), risk factor and family history were not provided. Concomitant medications included fexofenadine hydrochloride (allegra allergy), trazodone hydrochloride (trazodone hydrochloride), fexofenadine hydrochloride (fexofenadine hydrochloride); tizamdine hydrochloride (tizanidine hydrochloride); tramadol hydrochloride (tramadol hydrochloride); sertraline hydrochloride (sertraline hydrochloride); triamcinolone acetonidc (triamcinolone acctomdc); denosumab (prolia); meloxicam (meloxicam); levothyroxine sodium (levothyroxine sodium); famotidine (famotidine), cyclobcnzaprtne hydrochloride (cyclobenzaprine hydrochloride); mupirocin (mupirocin); medozine hydrochloride (meclizine hcl); gabapentin (gabapentin); oxycodone hydrochloride (oxycodone hydrochloride); pseudoephedrine hydrochloride (sudafed congestion); clonazepam (clonazepam); salbutamol sulfate (albuterol sulfate); bupropion hydrochloride (wellbutnn sr). and cimetidine (tagamet hb).  On an unknown date, the patient started taking dupilumab solution for injection with the dose of 300 mg QO W subcutaneously, strength: 300mg/2ml, (with an unknown batch number and expiry date) for Atopic dermatitis, unspecified. Patient reported 2 missed doses of dupilumab for unknown reason and in May she started experiencing bruises all over her body (contusion) (onset date, latency, batch number, expiry date- unknown) that the base of her cheek turned brown (skin discolouration) (onset date, latency, batch number, expiry date- unknown) and she lost about 30Ibs over the course of the month ( weight decreased) (onset date, latency, batch number, expiry date- unknown) she also said onset date, latency, batch number, expiry date- unknown) The first dentist she went to told her all her teeth were dead and had to remove everything. She got a 2nd opinion who told her only a few ate dead and have to be temoved (pulplcss tooth) (onset date, latency, batch number, expiry date- unknown). The labs from last month showed very poor kidney function (renal impairment) (onset date- Jul2024, latency, batch number, expiry date- unknown). Her doctors still not sure what's going in - her blood isn't actually thin and her wbc (white blood cell) counts are fine so they're not sure if it's cancer or not. Patient hadn't been referred to any specialists yet and was still supposed to get more labs done, she blames these symptoms on the covid shot she took 3 years ago to which she had an allergic reaction to at that time (hypersensitivity) (onset date, latency, batch number, expiry date- unknown). It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. No action taken with dupilumab for all events. Action taken was unknown for Covid-19 vaccine. Corrective treatment was not reported for all events. Outcome was unknown for all events. Seriousness criteria was reported as Medically significant for event renal impairment. Additional information was received on 10Oct2023 from patient: Strength, device were added. Text amended. Additional information was received on 02Aug2024 from patient, Case upgraded to serious. Event of product dose omission issue was added. New events of contusion, skin discolouration, weight decreased, pulpless tooth, renal impairment, hypersensitivity, suspect covid-19 vaccine were added. Text amended accordingly.  Sanofi Company comment dated on 08Aug2024: This case involves a 69 years old female patient who had renal impairment while being treated with dupilumab. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be ruled out. Case will be re-evaluated post further update on the patient's underlying disease conditions, medical history, concomitant drugs and drug history, concurrent illnesses. Case was serious. Case Listedness was Unlisted.   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.