Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Exostosis, Fall, Fatigue
Clinical narrative: total knee replacement surgeryon her right knee; small outbreak of eczema on right thumb that is being stubborn/breakthrough eczema on her thumb; bone spurs as well that has gotten worse; Condition aggravated; fallen several times; tore meniscus on right knee; Pneumonia; right eye macular degeneration; glaucoma; had a reactions to the covid vaccine, she stated she had a rash for 4-5 days, and it itched for a few days longer than that; had aches ad pains and felt tired for 48 hours after; felt tired for 48 hours after; DUPIXENT MY WAY  This is a solicited report and received from Consumer or other non HCPs from License Party. Other Case identifier(s): 2021SA091274 (SANOFI), AE-018669 (BioNTech).  This case involves a 75-years-old female patient who had total knee replacement surgery on her right knee, glaucoma, had a reaction to the covid vaccine, she stated she had a rash for 4-5 days and it itched for a few days longer than that, had aches, and pains and felt tired for 48 hours after and felt tired for 48 hours after and small outbreak of eczema on right thumb that is being stubborn/breakthrough eczema on her thumb, bone spurs as well that has gotten worse, fallen several times, tore meniscus on right knee and while on dupilumab, COPD (chronic obstructive pulmonary disease) has improved and passed away due to pneumonia while she was treated with dupilumab (Dupixent) delivered via dupilumab prefilled syringe and covid-19 vaccine. The patient's past medical history included fall. The patient's past medical treatment (s) and family history were not provided. At the time of the event, the patient had ongoing osteoarthritis, exostosis, asthma and chronic obstructive pulmonary disease. Concomitant medications included: Probiotics nos, gabapentin, Levothyroxine sodium, Ascorbic acid, Betacarotene, Cupric oxide, Tocopheryl acetate, Zinc oxide (Preservision areds); Pramipexole dihydrochloride monohydrate (Mirapex), Rosuvastatin; Escitalopram oxalate (Lexapro); Latanoprost; Calcium citrate, Colecalciferol (Citracal + D3); Omeprazole, Vitamin d, Vitamins nos (multivitamin); Calcium; Fluticasone Furoate, Vilanterol trifenatate (Breo ellipta); Allopurinol and Flonase. On 04Nov2019, the patient started taking dupliumab solution for injection with strength 300mg/2mL at 600 mg as loading dose followed by 300 mg QOW subcutaneously in 2019 for atopic dermatitis unspecified and flexural eczema. First time product used: No.  On an unknown date in 2021, the patient started taking covid-19 vaccine (with an unknown batch number, strength, form, dose route) for prophylactic vaccination. Patient stated she had a reaction to the COVID vaccine she had a rash for 4-5 days, and it itched for a few days longer than that (rash pruritic, start date:2021 and latency. few years approximately). She had aches and pains (pain. start date:2021, latency: few years approximately) and felt tired for 48 hours after (fatigue. start date:2021. latency: few years approximately). On an unknown date the patient experienced small outbreak of eczema on right thumb that was being stubborn (eczema) (latency few years approximately). In the last 6 months, she has developed glaucoma (onset: 2021, latency: approximately 2 years). And she also has right eye macular degeneration since unknown date (onset latency: unknown). She did not admit of having the family history and told that these may be age-related. Since unknown date for years, the consumer has osteoarthritis on her right knee, her right knee was then bone on bone and has bone spurs as well that has gotten worse (exostosis / Condition aggravated; unknown onset and latency). Before and after dupilumab, she had fallen several times (fall; unknown onset and latency). This last summer (unknown date), she fell and tore her meniscus on her right knee (meniscus Injury; unknown onset and latency). While being on dupilumab, her asthma and COPD (Chronic obstructive pulmonary disease) had Improved as well (therapeutic response unexpected; unknown onset and latency). She would have a right knee replacement surgery on 13Dec2021 and she is also on Prolia, she had osteoarthritis on her right knee, her right knee was now bone on bone and had bone spurs as well that had gotten worse: she had fallen several times: and she fell and tore her meniscus on her right knee. She had total knee replacement surgery on her right knee (Knee arthroplasty) on13Dec2021 (latency 2 years 1 month 9 days) she was admitted to the hospital because of this surgery. She had been discharged from the hospital on unknown date and was currently in rehab. The nurse received the information from her husband today. 23Dec2021. Patient eczema was 99 percent improved. Patients husband stated that his wife had passed away due to pneumonia (pneumonia) (event onset and unknown latency) (unknown batch number and expiry date for all events).  Information on batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken: unknown for glaucoma, not applicable for therapeutic response unexpected and pneumonia No action taken for rest all the events associated with dupilumab and not applicable for all the events associated with covid-19 vaccine. Corrective treatment-Not reported for glaucoma, pneumonia, eczema, exostosis, fall, meniscus injury, rash pruritic, pain and fatigue. Outcome-unknown for glaucoma, fall, meniscus injury, not recovered/not resolved for exostosis, recovering/resolving for knee arthroplasty, eczema, rash pruritic, pain and fatigue and fatal for pneumonia.  Reporter causality: unassessable for eczema: not related to knee arthroplasty, rash pruritic, pain, fatigue, not reported for rest of the events. Company causality: reportable for eczema: not reported for the other events. Seriousness criteria: hospitalization for knee arthroplasty, medical significant for glaucoma, macular degeneration and pneumonia and fatal for pneumonia. Additional information was received on 30Sep2021: company suspect drug therapy start date updated and a new event (eczema) added. Narrative amended accordingly. Additional information was received on 18Oct2021 from patient, based on this information case was updated as serious case due to addition of event glaucoma which is considered as medially significant text amended. Additional information was received on 21Oct2021 from patient. Outcome for event along with verbatim small outbreak of eczema on right thumb that is being stubborn/breakthrough eczema on her thumb was updated to recovering. Text amended. Additional information was received from patient via call center in 27Oct2021: medical history added, drug start date and clinical course updated new events (fall, meniscus injury, therapeutic response unexpected and exostosis) were added. Text amended accordingly. Additional information was received from patient's husband via call center on 23Dec2021. Event knee arthroplasty added. Clinical course updated. Text amended accordingly. Additional information was received on 06Mar2025 from patient's husband-added event-pneumonia, strength and formulation was added text amended accordingly.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: A causal attribution between the vaccination with BNT162B2 and the development of rash pruritus, pain and fatigue cannot be completely excluded, considering the known adverse event profile of the suspect vaccine and known adverse events profile.  Other events including pneumonia, fall, arthroplasty, bone spurs, eczema, glaucoma and macular degeneration are intercurrent medical conditions or underlying diseases associated with predisposing factors such as old age, ongoing osteoarthritis, atopic dermatitis, asthma and chronic obstructive pulmonary disease.; Reported Cause(s) of Death: Pneumonia