Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Abnormal behaviour, Agitation, Aphasia, Communication disorder, Contusion
Clinical narrative: Neurological reaction; Agitation; Not sleep for next 51 hours; Stopped eating and drinking; Stopped talking / Not talking to anybody; Screaming; Slamming his body to the floor or the couch; Tremors/ shacking; Spasms; Twitching; Bruises from banging and hitting himself; Bang his head; Arms up in the air, very stiff; Inability to stand up on is own and walk; Constant stare with no focusing; Having body movements like tremors; This spontaneous case was received on 15-Nov-2023 from other non-healthcare professional (consumer's mother) (reference number: SEQW23-04294) and concerned a 10-year-old, male patient.   The patient's concurrent conditions included autistic disorder. The patient's concomitant medications included trazodone and clonidine, both used for unreported indications. The patient's historical vaccine included influenza vaccine (brand not specified), on an unspecified date for an unspecified indication, after which the patient did not had a reaction.   On 04-Nov-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 944493 and the expiry date was 30-Jun-2024.  On the same date, by noon, after receiving Flucelvax Quadrivalent, the patient had a severe neurological reaction and showed signs of agitation. On the same evening, six hours later, the reporter started seeing that something was not right, the patient did not sleep for the next 51 hours. At night, the patient would take medication for sleep, but it did not work.   On an unspecified date in Nov-2023, the patient stopped eating, drinking, and talking, so they ended up going to the emergency department (ED). The patient was screaming and having body movements like tremors, spasms, and twitching, movements that did not make any sense. The patient was slamming his body to the floor or the couch and trying to bang his head.  On 06-Nov-2023 at 2:30 a.m., the patient was admitted to the Hospital. The hospital considered that this was a severe adverse reaction to the vaccine. The patient received IV fluids and underwent several labs including X-ray and urine analyses, however, results were not provided. The patient gradually and very slowly started coming around.    On the same date, around 10:30-11:00 a.m., the patient was discharged from the hospital and was told to follow up with his Primary Care Physician within 48 hours.   On an unspecified date in Nov-2023, the patient's Primary Care Physician was able to observe the shaking, inability to stand up and walk on his own, constant stare with no focusing, and not talking to anybody. The patient also had some bruises from banging and hitting himself.   On an unspecified date in Nov-2023, reported as all this time, the patient had his arms up in the air, shaking them, very stiffly.  On 11-Nov-2023, the patient started, very slowly, coming around. The patient's mother reported that she started seeing some improvements. The patient started talking more, eating better, and drinking fluids, and finally put his arms down.   At the time of initial reporting, the patient was recovering from all events. As reported, the patient was probably about 95% of where he should be, but he was still not completely there. It took a week plus to get him back and it was a horrific event to go through.  The reporter assessed all events as related to Flucelvax Quadrivalent. As reported, the hospital considered that this was a severe adverse reaction to receiving a vaccine.  All events were assessed as serious due to the seriousness criterion of medical significance.  Company comment: A 10-year-old, male patient was vaccinated with Flucelvax Quadrivalent. A few hours following vaccination, patient experienced neurological symptom and agitation. On the same night following vaccination, patient experienced insomnia, which lasted the next 51 hours. These events were followed by eating and communication disorder (reported as stopped eating, drinking and talking), screaming, self-destructive behaviour, head banging, as well as events which were reported as movements that did not make any sense: tremors, muscle spasm, and muscle twitching. Two days following vaccination, the patient was hospitalized. Reportedly, the hospital assessed these events as a severe reaction to vaccination. The patient received IV fluids, gradually felt better and was discharged. However, in the next 5 days, patient experienced musculoskeletal stiffness and tremor (reported as all this time he had his arms up in the air, shaking them, very stiff), was staring without being able to focus, was unable to stand up and walk on his on, and had contusions as a result of banging and hitting his head. One week following vaccination, patient's mother reported that the patient was feeling better. The patient's concurrent conditions included autistic disorder. Causality for neurological symptom and agitation is assessed as possibly related, based on chronological plausibility. Insomnia is assessed as not related and considered a manifestation of agitation and autistic disorder. Screaming, self-destructive behaviour, head banging, and staring are assessed as not related, based on biological implausibility and confounding concurrent condition. Causality for musculoskeletal stiffness, tremor (shaking), tremor (tremor), muscle spasm, muscle twitching, gait inability, eating and communication disorder is assessed as not related to the suspect role and these events are seen as a manifestation of autistic disorder. Causality for contusion is assessed as not related and is seen as a consequence of head-banging and self-destructive disorder.; Reporter's Comments: As reported, the hospital considered that this was a severe adverse reaction to receiving a vaccine.; Sender's Comments: A 10-year-old, male patient was vaccinated with Flucelvax Quadrivalent. A few hours following vaccination, patient experienced neurological symptom and agitation. On the same night following vaccination, patient experienced insomnia, which lasted the next 51 hours. These events were followed by eating and communication disorder (reported as stopped eating, drinking and talking), screaming, self-destructive behaviour, head banging, as well as events which were reported as movements that did not make any sense: tremors, muscle spasm, and muscle twitching. Two days following vaccination, the patient was hospitalized. Reportedly, the hospital assessed these events as a severe reaction to vaccination. The patient received IV fluids, gradually felt better and was discharged. However, in the next 5 days, patient experienced musculoskeletal stiffness and tremor (reported as all this time he had his arms up in the air, shaking them, very stiff), was staring without being able to focus, was unable to stand up and walk on his on, and had contusions as a result of banging and hitting his head. One week following vaccination, patient's mother reported that the patient was feeling better. The patient's concurrent conditions included autistic disorder. Causality for neurological symptom and agitation is assessed as possibly related, based on chronological plausibility. Insomnia is assessed as not related and considered a manifestation of agitation and autistic disorder. Screaming, self-destructive behaviour, head banging, and staring are assessed as not related, based on biological implausibility and confounding concurrent condition. Causality for musculoskeletal stiffness, tremor (shaking), tremor (tremor), muscle spasm, muscle twitching, gait inability, eating and communication disorder is assessed as not related to the suspect role and these events are seen as a manifestation of autistic disorder. Causality for contusion is assessed as not related and is seen as a consequence of head-banging and self-destructive disorder.