Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash pruritic, Systemic lupus erythematosus, Urticaria
Clinical narrative: Lupus SLE; This clinical trial case initially received on 07-Jun-2024, was reported by a health professional and concerns an elderly female subject.  Weight: 69.2 kg; Height: 169 cm  The subject was enrolled in the study  Past medical history included right (R) Knee Replacement, Tubal Ligation. At the time of the event the subject had Depression, Anxiety, Post-Menopausal, Body aches. Concomitant medication: Aleve (naproxen sodium) for body aches, Lexapro (escitalopram oxalate) for anxiety and depression.  The subject's historical vaccine included influenza vaccine (brand not specified) received on an unspecified date in Oct-2022, for unreported indication.  Administration of company suspect drug:  On 04-Dec-2023 14:58, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of Influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Left deltoid, Lot number: Not reported. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On 13-Dec-2023, 8 days 9 hours after receiving aQIV c HD vs QIVr vs aQIV, the subject was diagnosed with Lupus SLE ( Outcome: Not recovered / Not resolved). As reported, the subject had rash and was diagnosed with lupus SLE after multiple tests. Alternative cause of event is Lupus  On 13-Dec-2023, the subject noticed upper left arm and shoulder were itchy.  On 14-Dec-2023, the subject woke up with itchy, rough, raised, rash and welts on left arm and left side of chest, contacted the site and started a treatment with Claritin (loratadine) 10 mg daily orally for the treatment of symptoms of lupus SLE (diagnosed later).   On 15-Dec-2023, the subject came to site for evaluation and reported normal temperature but persistent rash and started a treatment with Benadryl (diphenhydramine hydrochloride).  On 02-Jan-2024, the subject went to dermatology, was perscribed mometasone furoate and Zyrtec, and started a treatment with mometasone furoate 1 mg twice a day topical use for the treatment of symptoms of lupus SLE (diagnosed later).   On 03-Jan-2024, the subject started a treatment with Zyrtec (cetirizine hydrochloride) 10 mg daily orally for the treatment of symptoms of lupus SLE (diagnosed later).   On 09-Jan-2024, the subject reported rash had spread to checks, stomach, neck and was still present on chest and arm. The subject was recommended to see primary care practitioner (PCP).  On 15-Feb-2024, the subject was seen by PCP, had blood work done and was referred to rheumatologist and back to dermatologist.  On 08-Mar-2024, a dermatologist biopsied the rash.  On an unspecified date in Mar-2024, the subject started treatment with Plaquenil (hydroxychloroquine sulfate) at a dose of 200 mg orally twice a day (BID), for lupus SLE.  On 09-Apr-2024, laboratory panel for lupus confirmed the diagnosis.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Treatment medication: Benadryl   Reporter's assessment:  The Investigator assessed the event of 'Lupus SLE' as a mild adverse event of special interest (AESI) and non- serious. The event was assessed as not related to the study vaccine and the alternative cause for the event was reported as lupus.  The subject remained blinded in the study.  Follow-up (12-Jun-2024) received from the Investigator: Current condition Lupus SLE' was deleted. The event verbatim was changed from Lupus' to Lupus SLE' and the event was recoded - LLT changed from Systemic lupus erythematosis' to SLE'.  It was confirmed that the event was a non-serious AESI. The indication was updated to Lupus SLE' for Plaquenil treatment medication. The narrative was updated accordingly.  Follow-up (23-Jul-2024) received from the Investigator: 'Rash lupus' was provided as the alternative cause of the event. Indication was changed from Pruritic rash' to Lupus SLE' for concomitant medications Claritin, mometasone furoate, and Zyrtec medications and medications changed to treatment. The event summary description was updated and the narrative was amended accordingly.  Follow up (31-Jul-2024) received from the Investigator: Event description was updated. The narrative was amended accordingly.  Follow up (13-Aug-2024) received from the Investigator: Alternative cause for the event was changed. The reporter's assessment was amended accordingly.  Follow up (20-Aug-2024) received from the physician. Event seriousness, start date updated and treatment medication deleted. Correction was done for reporter state. Reporters state spelling updated.  Follow-up (29-Aug-2024) received from an Investigator: updated alternative cause of event Lupus SLE from other to lupus, added AEID extension, updated narrative accordingly.  Case correction (27-Aug-2024): Upon internal review company causality and case comment updated.; Reporter's Comments: On 14-Dec-2023, 10 days after receiving aQIVc HD vs QIVr vs aQIV, the subject started treatment of symptoms of lupus SLE (diagnosed later). The subject was subsequently diagnosed with Lupus SLE after multiple tests. Since the pathophysiology of autoimmune conditions is complex, and aetiology is unknown, the causal role of the study vaccine cannot be completely excluded. Therefore, the Sponsor's causality is assessed as possibly related for the event of systemic lupus erythematosus, since vaccination may have triggered the autoimmune response. The concomitant medication Aleve (naproxen sodium) is considered a possible confounding factor for the event. Listedness was assessed using IB version 4.