Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Mental status changes, Nervous system disorder, Speech disorder
Clinical narrative: Delirium; Dystonic reaction; Agitation; Altered mental status; Electrolyte imbalance; CNS effects; Involuntary body jerks/dyskinesia; Dragging her leg, could not walk straight; Could not talk (mumbled words); Labs were off; This spontaneous case was received on 08-Jun-2022 from other non-healthcare professional (patient's mother) via the regulatory authority (reference number: SEQW22-01578) with four additional documents received on 09-Jun-2022, 10-Jun-2022, 13-Jun-2022 and 17-Jun-2022 (being processed together) and concerned a 6-year-old, female patient.  The patient's concurrent condition included tick, falling and she had signs and symptoms of mercury exposure, prior to receiving vaccine as reported. The patient's concomitant medications were not reported.  On 24-Jan-2017, at 10:39 a.m., the patient was vaccinated with Afluria (TIV) (Influenza vaccine inact split 3v; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left thigh) for flu vaccination. The batch number reported was 14249221A.   The patient's mother believed the nurse switched patient's vaccine (smaller dose) with the father's vaccine (larger dose) (see case 202202594) and, also that the vaccine records did not match what she actually got. The patient's mother considered she received a dose from multi dose vial (MDV) instead of prefilled syringe (PFS). She was looking for confirmation of what vaccine her daughter got and believed the doctor was covering up the mistake they made. The mother stated that hospital had not followed the directions of the manufacturer therefore the hospital was at fault for not following protocol and administering the wrong vaccine into a small child. As reported, Afluria IIV3 multi dose vial for nine years to adult flu vaccine was intended for children nine years of age to adults, and it contained mercury and was not a prefilled syringe but a multidose vial that was not intended for small children. The reporter considered her daughter received a dose higher than her paediatrician put in for her order. Her paediatrician put in an order for a three-year-old prefilled syringe split dose but that was not a lot she received. She received the nine years old to adult influenza multidose vial.   On the same date, immediately after receiving Afluria (TIV), the patient had a severe reaction. She experienced neurological problems, involuntary body jerks, dyskinesia, she was dragging her leg, could not walk straight and could not talk (mumbled words). All of her laboratories were off, as reported.   On an unspecified date in 2017, the patient was placed on clonidine for Tourette's symptoms, but it did not help.   On an unspecified date, the patient also experienced central nervous system (CNS) effects, agitation, altered mental status, delirium, dystonic reaction and electrolyte imbalance.   At the time of initial reporting on 08-Jun-2022, the patient had not recovered from all events as the patient still had symptoms and suffered in silence for years. It was reported that the patient was now okay but would never be the same.  The reporter assessed all events as related to Afluria (TIV). The patient had a severe reaction to vaccine and patient's mother believed the nurse switched patient's vaccine (smaller dose) with the father's vaccine (larger dose) and, also that the vaccine records did not match what she actually got. The patient's mother stated she received vaccine from multi dose vial (MDV) instead of prefilled syringe (PFS).  The reporter considered all events as serious due to medical significance.   This case is linked with case 202202594 (the same reporter, patient's father case).  Company comment: A 6-year-old, female patient was vaccinated with the suspect product Afluria (TIV). As reported the nurse switched patient's vaccine (smaller dose) with the father's vaccine (larger dose). However, as per current  adult dose can be administered to patients 36 months and older. Immediately after vaccination the patient developed unspecified central nervous system effects, dyskinesia, gait disturbance and speech disorder. As reported patients laboratories were abnormal. On an unspecified date, the patient also experienced agitation, altered mental status, delirium, dystonic reaction and electrolyte imbalance. Information regarding the related diagnostic findings was not provided. As reported patient's concurrent condition included signs and symptoms of mercury exposure, however it was not confirmed by laboratory tests. Due to limited information provided, causality is unassessable for all reported events.; Reporter's Comments: The patient had a severe reaction to vaccine and patient's mother believed the nurse switched patient's vaccine (smaller dose) with the father's vaccine (larger dose) and, also that the vaccine records did not match what she actually got. The patient's mother stated she received vaccine from multi dose vial (MDV) instead of prefilled syringe (PFS).; Sender's Comments: A 6-year-old, female patient was vaccinated with the suspect product Afluria (TIV). As reported the nurse switched patient's vaccine (smaller dose) with the father's vaccine (larger dose). However, as per current adult dose can be administered to patients 36 months and older. Immediately after vaccination the patient developed unspecified central nervous system effects, dyskinesia, gait disturbance and speech disorder. As reported patients laboratories were abnormal. On an unspecified date, the patient also experienced agitation, altered mental status, delirium, dystonic reaction and electrolyte imbalance. Information regarding the related diagnostic findings was not provided. As reported patient's concurrent condition included signs and symptoms of mercury exposure, however it was not confirmed by laboratory tests. Due to limited information provided, causality is unassessable for all reported events.