Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Along with allergic recation to Moderna covid-19 booster; Temporary paralysis; Weight loss; Upper respiratory tract infection off and on; Battling an illness; Got covid-19 2 years ago; This spontaneous case was reported by a patient and describes the occurrence of DRUG HYPERSENSITIVITY (Along with allergic recation to Moderna covid-19 booster), PARALYSIS (Temporary paralysis) and WEIGHT DECREASED (Weight loss) in an 87-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Dupilumab solution for injection for Atopic dermatitis. Concurrent medical conditions included Atopic dermatitis. On 07-Jun-2023, the patient started Dupilumab (Subcutaneous use) 300 milligram every two weeks. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced COVID-19 (Got covid-19 2 years ago). In March 2024, the patient experienced ILLNESS (Battling an illness). On an unknown date, the patient experienced DRUG HYPERSENSITIVITY (Along with allergic recation to Moderna covid-19 booster) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection off and on). an unknown date, the patient experienced PARALYSIS (Temporary paralysis) (seriousness criterion medically significant) and WEIGHT DECREASED (Weight loss) (seriousness criterion medically significant). At the time of the report, DRUG HYPERSENSITIVITY (Along with allergic recation to Moderna covid-19 booster), PARALYSIS (Temporary paralysis), WEIGHT DECREASED (Weight loss), COVID-19 (Got covid-19 2 years ago) and UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection off and on) outcome was unknown and ILLNESS (Battling an illness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. The patient had no medical history, concomitant disease or risk factor. There was no Lab data results available. On In unknown date, the patient took Moderna Covid-19 vaccine (Elasomeran) With unknown dose, formulation, strength, route, frequency for prophylactic vaccination (immunization). Patient stated that he was battling an illness (illness) for the last 2 months Onset Mar-2024 and latency 9 months approximately with unknown batch and expiry date and he had not been using his dupilumab. The patient had medication on hand and will request a shipment when needed. The patient got covid-19 two years ago, with an onset date of 15-Jun-2023, and a latency period of eight days. Since then, he had experienced intermittent upper respiratory infections, although the onset and latency of these infections were not known. Additionally, the patient had an allergic reaction to the Moderna covid-19 booster, which resulted in temporary neck paralysis and weight loss, with the specifics of onset and latency remaining unclear. The batch and expiry date of the vaccine were also unknown. During the period of temporary paralysis, the patient was unable to took Dupixent and could not recall the exact dates of these events. Action taken includes the withdrawal of a drug in 2024 due to an unspecified illness, another withdrawal for paralysis on an undetermined date, and an unknown case related to drug hypersensitivity. Additionally, there was a noted weight decrease with no action taken for other events associated with dupilumab, while all events related to elasomeran remain unspecified. Reporter causality was unassessable for all events.; Reporter's Comments: Company comment: Treatment with dupilumab remains as a confounder. The benefit-risk relationship of product is not affected by this report.
Atopic dermatitis
Dupilumab
Test Name: weight; Result Unstructured Data: loss