Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Obsessive-compulsive symptom, Orthostatic hypotension, Temperature intolerance, Tic
Clinical narrative: Began to hit herself with her arms uncontrollably/abnormal body movements and neurological problems; Anxiety; OCD symptoms; Motor and vocal tics; Orthostatic hypotension; Intolerance to cold; Hallucination; Having problems holding her phone and couldn't pick up food; This spontaneous case was received on 12-Aug-2021 from physician via Agency (reference number: SEQW21-01593) and concerned a 15-year old female patient.   The patient had no relevant medical history and was not taking any concomitant medications. The patient was healthy and never had any problems before and had always stayed up to date on her vaccines. The patient's historical vaccine included Gardasil vaccine (HPV vaccine VLP rL1 4v (yeast)).  On 17-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for an influenza prophylaxis. The batch number reported was 279827 and expiration date was 18-Jun-2021.  On 19-Oct-2020, two days after receiving Flucelvax Quadrivalent, the patient started having problems holding her phone and could not pick up food.   On an unknown date, the patient began to hit herself with her arms uncontrollably and a vest was purchased to prevent that. The patient also experienced severe anxiety, obsessive-compulsive disorder (OCD) symptoms, motor and vocal tics (reported as ticks), hallucinations, orthostatic hypotension and intolerance to cold. The patient saw her pediatrician, pediatric neurologist, five different neurologists and was seeing her rheumatologist, however further details were not provided.  On an unknown date, the patient started treatment with guanfacine for tics and with unspecified selective serotonin reuptake inhibitors (SSRI) for anxiety.   At the time of initial reporting on 12-Aug-2021, the patient had not recovered from the events.   The reporter assessed the events as related to Flucelvax Quadrivalent. It was reported that a reporter's daughter received Flucelvax Quadrivalent last year and had an adverse reaction.   The event of hallucination was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 15-year old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. After two days patient experienced decreased mobility. An unknown amount of time after vaccination the patient experienced anxiety, symptoms of obsessive-compulsive disorder, ticks, hallucinations, orthostatic hypotension and intolerance to cold. Information regarding related diagnostic findings have not been provided, although patient visited paediatricians and neurologist. Insufficient information provided precludes a proper causality assessment.; Reporter's Comments: Reporter's daughter received Flucelvax Quadrivalent last year and had an adverse reaction.; Sender's Comments: A 15-year old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. After two days patient experienced decreased mobility. An unknown amount of time after vaccination the patient experienced anxiety, symptoms of obsessive-compulsive disorder, ticks, hallucinations, orthostatic hypotension and intolerance to cold. Information regarding related diagnostic findings have not been provided, although patient visited paediatricians and neurologist. Insufficient information provided precludes a proper causality assessment.