Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysphonia, Eczema, Epistaxis, Eyelid contusion
Clinical narrative: neuropathy has increasingly gotten worse/neuropathy in hands; neuropathy has increasingly gotten worse/neuropathy in hands; reaction from Covid vaccine; muscle pain in her pelvis area; fever chills; fuzzy in the head; voice was funny; itching; hairy though; bleeding on the biidged of her nose; black and blue on top of her left eye lids; flare ups are not going away; DUPIXENT MY WAY  This is a solicited report form a contactable consumer (patient), based on the information received by Pfizer (MFR Control No.2019SA243843).   A 79-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Aug2021 (at the age of 79-years-old) as dose 3 (booster), single for COVID-19 immunisation; and dupilumab, subcutaneous from 10Jun2019 (Batch/Lot Number: 9LOO5A; Expiration Date: 31Dec2020) and ongoing, at 600 mg, 1x/day, and via an unspecified route of administration from 31Aug2021 (Batch/Lot number was not reported) to 31Aug2021, at unspecified dose for eczema. Previously the patient received the first dose of bnt162b2 in Feb2021, and the second dose on an unspecified date. Medical history included small fiber neuropathy from Oct2017 and ongoing, atopic dermatitis from an unknown date and unknown if ongoing. Concomitant medications included hydrocortisone, acetic acid, pimecrolimus and triamcinolone acetonide, all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, the patient experienced small fiber neuropathy has increasingly gotten worse/neuropathy in hands, reaction from covid vaccine, muscle pain in her pelvis area, fever chills, fuzzy in the head, voice was funny, itching, hairy though, bleeding on the biidged of her nose, black and blue on top of her left eye lids and flare ups are not going away. It was reported that patient had neuropathy in her hands a reaction from covid vaccine, muscle pain in her pelvis area, fever chills. felt fuzzy in the head, her voice was funny small fiber neuropathy has increasingly gotten worse, itch-ing is much better, hairy thouch, lot number is 91, it is hard to read not sure if the next digits are o's or d's, think they are o's, bleed-ing on the bridged of her nose, black and blue on top of her left eye lids, flare ups are not going away. On an unknown date (latency unknown for all the events), the patient's small fiber neuropathy had increasingly gotten worse (small fiber neuropathy, condition aggravated), itching was much better (pruritus), hairy though (hypertrichosis), lot number was 91, it was hard to read, she was not sure if the next digits were o's or d's, she thought they were o's (visual impairment), bleeding on the bridged of her nose (Epistaxis), black and blue on top of her left eye lids (eyelid contusion). and flare-ups are not going away (eczema). Upon follow, patient reported neuropathy in her hands (neuropathy peripheral) (stan date, latency. unknown) and off label use (start date, latency: unknown) Patient reported that she found the needle cover very hard to remove for the syringe because it was very tiny and tight, and she had neuropathy in her hands. Upon follow up, patient advised she had neuropathy in hands and struggles with taking off the needle covers. Patient advised was almost like the needle cover was vacuumed. patient advised needle cover was also small, making it more difficult for her to take off the needle cover. Patient was reporting a reaction from Covid vaccine in Feb2021 (vaccination complication) and she had muscle pain in her pelvis area for 36hrs (myalgia) (un-known latency) and on Tuesday 31Aug2021 she had a booster vaccine and she had fever chills (pyrexia), her voice was funny (dysphonia) she felt fuzzy in the head for a day and a half (feeling abnormal) (latency: 2 years 2 months 21 days). No treatment and consumer reports she is doing better. She had also had Dupixent injection 30Aug2021 a-day before her shot. The action taken with dupiluman in response to events was dose not changed. Neuropathy and hairy though were not resolved, myalgia was resolved, the outcome of events bleeding on the biidged of her nose, black and blue on top of her left eye lids and eczema aggravated was unknown, and the other events were resolving.   Reporter causality: Not reported for all events.  Company causality; reportable for vaccination complication, myalgia, pyrexia, dysphonia, feeling abnormal and not reportable for all other events.   The reporter's assessment of the causal relationship of the reported 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-  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: As per the information in the case provided, the causal association between the events Neuropathy peripheral, Condition aggravated,Vaccination adverse reaction, Myalgia, Pyrexia, Feeling abnormal, Dysphonia, Pruritus, Hypertrichosis, Epistaxis, Eyelid contusion, Eczema and the suspect drug bnt162b2 cannot be excluded. 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.