Report #2882069

Overview

Sex

Male

Age

Age unknown

State

NJ

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

A1c elevated; Arms are sore; This spontaneous case initially received on 10-Dec-2025, was reported by a non-health professional and concerns an adult male patient. Weight: 92.27 kg; Height: 172.7 cm Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for immunization, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available, and will be requested upon follow up. Non-company suspect drugs: On an unknown date, the patient received COVID-19 vaccine (COVID-19 vaccine) for immunization, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available. On an unknown date, the patient had received Kevzara (Sarilumab) for illness, Dose regimen: 200 mg Every other week, Route of administration: Subcutaneous, Lot number: No batch number available. On an unknown date, the patient had received Pneumovax 23 (Pneumococcal vaccine polysacch 23v), Indication: immunization, Dose regimen: 25 mcg, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available. On an unknown date, the patient had Shingrix (Varicella zoster vaccine rgE (CHO)), for immunization, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available. Adverse reactions/events and outcomes: On an unknown date, the patient had Arms are sore (outcome: Unknown), A1c elevated (outcome Unknown). On an unknown date, the patient's arm sore and a1c elevated after receiving first intake Covid-19 Vaccine, varicella zoster vaccine rgE (CHO) [Shingrix], influenza vaccine inact sAg 3v [Fluad] and pneumococcal vaccine polysacch 23v [Pneumovax 23] and while treated with Sarilumab [Kevzara] delivered via prefilled pen. Treatment measures associated with event: Unknown Fluad (TIV) action taken: Not Applicable Reporter assessment: The reporter did not provide seriousness and causality assessment for all events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, both the events are considered related for reporting purposes. Considering implied temporal association (after receiving first intake). Concomitant administration of non-company suspects COVID-19 vaccine, Kevzara (Sarilumab), Pneumovax 23 (Pneumococcal vaccine polysacch 23v), and Shingrix (Varicella zoster vaccine rgE (CHO)), and concomitant drug prednisone are considered confounders. Of note there is insufficient information to perform an in-depth analysis (anatomical location, relevant medical history, concomitant medications, investigations and treatment details, etc.).

Other medications

Methotrexate; Tamsulosin HCL; Chantix; Prednisone; Vitamin d3; Vitamins nos