Age: 31.0
Sex: M
Vaccine: FLUR3
Symptoms: Cough, Dysuria, Electrocardiogram, Fatigue, Food intolerance
Clinical narrative: chest pain/tightness; Difficulty urinating, reports pressure on left and right lower abdomen; coughing; unable to tolerate food/liquid; general weakness/fatigue; chest pain; hypertension; Nausea; unknown fever; patient passed out; profuse sweating; limited movement in the affected arm; vomiting; Insomnia; Initial information received on 26-Aug-2024 regarding an unsolicited valid serious case received from a Patient.  This case involves a 31 years old male patient where patient passed out, profuse sweating, limited movement in the affected arm, vomiting, insomnia, chest pain, hypertension, chest pain/tightness, difficulty urinating, reports pressure on left and right lower abdomen, coughing, unable to tolerate food/liquid, nausea, unknown fever and general weakness/fatigue after receiving vaccine Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history included Injection site pain as he has been taking flu shots for 14-15 years.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 23-Aug-2024, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (strength- standard) (lot- U8432AA and expiry date- 30-APR-2025) via unknown route in Arm NOS (not specified) (dose, formulation: not provided) for Immunisation.  On 23-Aug-2024 the patient developed profuse sweating (hyperhidrosis), limited movement in the affected arm (joint range of motion decreased), vomiting and insomnia (latency- same day).  On 24-Aug-2024 the patient passed out (loss of consciousness) (latency- 1 day). This event was assessed as medically significant.  On 24-Aug-2024 the patient developed chest pain, hypertension, nausea, unknown fever (pyrexia) (latency- 1 day).  On 25-Aug-2024 the patient developed general weakness/fatigue (fatigue) (latency- 2 days).  On 26-Aug-2024 the patient developed chest pain/tightness (chest discomfort), difficulty urinating, reports pressure on left and right lower abdomen (dysuria), coughing (cough), unable to tolerate food/liquid (food intolerance) (latency- 3 days).  Action taken- not applicable.  The patient was treated with Ondansetron every 8 hours as needed for Nausea and Vomiting and 2 bags of IV fluids, EKG, blood work, IV Zofran and an unknown IV medication and prescribed 2 bottles of oral electrolyte solution.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event nausea, hypertension, patient passed out, insomnia, profuse sweating, limited movement in the affected arm, vomiting, general weakness/fatigue, chest pain/tightness, difficulty urinating, reports pressure on left and right lower abdomen, chest pain, coughing and unable to tolerate food/liquid and was Recovered / Resolved on 24-Aug-2024 for the event unknown fever.; Sender's Comments: Sanofi Company Comment dated 28-Aug-2024: This case involves a 31 years old male patient where patient passed out, profuse sweating, limited movement in the affected arm, vomiting, insomnia, chest pain, hypertension, chest pain/tightness, difficulty urinating, reports pressure on left and right lower abdomen, coughing, unable to tolerate food/liquid, nausea, unknown fever and general weakness/fatigue after receiving vaccine Influenza quadrivalent recombinant vaccine [Flublok]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.