Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Fatigue, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: Flu-like symptoms; Delirious; Numb hands and face; Bacterial infection; Chest pain; Dizzy; This is a spontaneous case, initially received from consumer via Med Communication (reference number: SEQ19-03036) on 23-Sep-2019, concerning a 42-year-old, female patient.   The patient's relevant medical history, drug reactions or allergies and concomitant medications were not reported.  On 09-Sep-2019 at 11:30 in the morning, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number and expiration date: not reported] for prevention of influenza. On the same day, after vaccination, the patient started to feel tired and got a headache. It was reported that the patient developed body aches by the end of the day.  On 10-Sep-2019, the patient took Advil (ibuprofen) for the headache.  On 11-Sep-2019 and 12-Sep-2019, the patient felt fine.  On 13-Sep-2019, four days after vaccination, the patient woke up with a severe sore throat/burning, with many more symptoms and side effects. The patient had come down with flu like symptoms and other side effects such as fever, vomiting, headache, chills, body aches, tired, weakness, numb hands and face, dizzy, congestion, runny nose, sneezing, chest pain, heavier period, delirious and nauseous.  On 16-Sep-2019 in the morning, the patient visited her physician. The physician said some people would experience flu like symptoms. The patient was given an antibiotic shot because the physician felt the patient had a bacterial infection at this point. In addition, the physician advised the patient to return within three days if she still was not feeling better. The patient was prescribed amoxicillin and methylprednisolone.  On 23-Sep-2019, the patient woke up still feeling queasy and tired, having a lot of mucus and pressure in her head and the feelings in her hands were not 100 % back. The patient also reported that she missed 3 days of work and many days being sick. The patient stated that she truly believed that this was the cause of the flu shot.  At the time of initial reporting, the patient did not recover from flu-like symptoms, bacterial infection, numb hands and face, chest pain, dizzy and delirious.  The reporter assessed the case as non-serious and related to Afluria.  Company Comment: The patient experienced delirium, hypoaesthesia, influenza like illness, bacterial infection, dizziness and chest pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal relationship between the suspect product and the events is assessed as related.; Reporter's Comments: The patient experienced delirium, hypoaesthesia, influenza like illness, bacterial infection, dizziness and chest pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal relationship between the suspect product and the events is assessed as related.