Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Pelvic pain, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: flushing of the face and chest; Rash; Extreme weakness; Fast heart beat; Blood pressure 180/80; Severe headache; Pelvic pain; Tired/fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 73-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number A555J, expiry date 10-JUN-2025) for prophylaxis.   On 28-SEP-2024 17:00, the patient received FluLaval 2024-2025 season. On 29-SEP-2024, 1 days after receiving FluLaval 2024-2025 season, the patient experienced headache (Verbatim: Severe headache), pelvic pain (Verbatim: Pelvic pain) and tiredness (Verbatim: Tired/fatigue). On 02-OCT-2024, the patient experienced flushing (Verbatim: flushing of the face and chest), rash (Verbatim: Rash), weakness (Verbatim: Extreme weakness) and heartbeats increased (Verbatim: Fast heart beat). In OCT-2024, the patient experienced increased blood pressure (Verbatim: Blood pressure 180/80). On 07-OCT-2024, the outcome of the headache, pelvic pain and tiredness were resolved (duration 8 days) and the outcome of the flushing, rash, weakness and heartbeats increased were resolved (duration 5 days). The outcome of the increased blood pressure was resolved.   It was unknown if the reporter considered the headache, pelvic pain, tiredness, flushing, rash, weakness, heartbeats increased and increased blood pressure to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the headache, pelvic pain, tiredness, flushing, rash, weakness, heartbeats increased and increased blood pressure to be related to FluLaval 2024-2025 season and Flulaval 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 Information: GSK Receipt Date: 07-OCT-2024 The reporter was the patient.  The patient received a dose of FluLaval vaccine on Saturday. The next two days (Sunday and Monday) the patient experienced a severe headache, pelvic pain, and fatigue. On Tuesday 01-OCT-2024, the patient felt better but was just tired. On Wednesday afternoon (02-OCT-2024), the patient had a sudden onset of extreme weakness, rash and flushing of the face and chest, and a fast heart beat.  The patient went to urgent care for treatment. While at urgent care, her urine was tested and was negative, and she was tested for COVID which was also negative. The patient's temperature was normal and pulse rate was 80 (her pulse was usually 55-60). Her blood pressure was 180/80. Her heart and lungs were clear. Time to onset of flushing, rash, weakness, heartbeats increased was 4 days and increased blood pressure was less than 2 weeks with FluLaval vaccine. The doctor believed what she was experiencing was from the vaccine. On Thursday 03-OCT-2024, the patient felt better but was tired. The patient was about 98 percent better on Sunday 06-OCT-2024 and was filling fine at the time of the reporting.