Age: 6.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Anxiety, Confusional state, Hallucination, Headache, Mydriasis
Clinical narrative: hallucination-like symptoms; confusion; dilated eyes; felt like he was "going to die", worried parents might hurt him,; vomiting; head pain, booboo inside his head; fever; night terrors; This case was reported by a other health professional via call center representative and described the occurrence of hallucination in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and ondansetron (Zofran) for product used for unknown indication.   On 8th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Zofran at an unknown dose and frequency. On 8th November 2021, 3 hrs after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced vomiting, headache, fever and night terrors. On 10th November 2021, the patient experienced hallucination (serious criteria GSK medically significant), confusion, pupils dilated and impending doom. The patient was treated with paracetamol (Tylenol) and ibuprofen. The action taken with Zofran was unknown. On 8th November 2021, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the hallucination, night terrors, confusion, pupils dilated and impending doom were unknown and the outcome of the vomiting was recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the hallucination, vomiting, headache, fever, night terrors, confusion, pupils dilated and impending doom to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 8th November 2021, the patient received Flulaval and experienced vomiting, head pain, fever 3 hours after the vaccination.  The patient went to the emergency room on same night and received Zofran. On 8th November 2021, less than a day after receiving Flulaval and Zofran, the patient experienced night terrors. On 10th November 2021, 2 days after receiving Flulaval and Zofran, the patient experienced confusion, hallucination like symptoms, and dilated eyes. The patient stated that he felt like he was going to die, and was worried that his parents might hurt him and there was a booboo inside his head. On 11th November 2021, the patient experienced another fever (100.6 degree F). The patient was altering between Tylenol and Ibuprofen as a treatment for fever. The reporter stated that, emergency room visit was required. No additional information was provided. It was unknown if the reporter considered the hallucination, fever, night terrors, confusion, pupils dilated and impending doom to be related to Zofran. The reporter consented to follow up.