Age: 24.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Muscle spasms
Clinical narrative: Unresponsive to stimuli; Syncope; Immediate post-injection reaction; Muscle spasms; Muscle twitching; Musculoskeletal stiffness; Skin warm; Hyperhidrosis; Dizziness; Initial information received on 19-Nov-2024 regarding an unsolicited valid  serious courtesy case received from a consumer/non-healthcare professional.  This case involves a 24 years old female patient who was unresponsive to stimuli, had syncope, hyperhidrosis, immediate post-injection reaction, muscle spasms, muscle twitching, musculoskeletal stiffness, skin warm and dizziness after receiving Novavax COVID-19 Vaccine and influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Sep-2024, the patient received an unknown dose of Novavax COVID-19 vaccine not produced by Sanofi Pasteur (strength, formulation, expiry date- unknown, lot 6024MF013) via intramuscular route in unknown administration site as COVID-19 Immunization (Immunization) and received an unknown dose of influenza trivalent recombinant vaccine Solution for injection (strength, expiry date- unknown and lot U8432AA) via intramuscular route in unknown administration site as prophylactic vaccination (Immunization).  On 24-SEP-2024 the patient developed unresponsive to stimuli, syncope, hyperhidrosis, immediate post-injection reaction, muscle spasms, muscle twitching, musculoskeletal stiffness, dizziness and skin warm  (latency- same day) following the administration of influenza trivalent recombinant vaccine and Novavax COVID-19 Vaccine.  Reportedly, Patient immediately reported dizziness after vaccination. She became hot to the touch and sweaty. She fainted. She opened her eyes but was unaware of her surroundings. She had extremity muscle spasm/twitching. The patient's body was stiff. She was unaware for around 5 minutes. She she did wake up and was applied cold compresses to the back of her neck and chest. Blood pressure several times. It was low but increased over several minutes.   Relevant laboratory test results included: Blood pressure measurement - On 24-Sep-2024:  [low]  Action taken was not applicable for both.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for all the events.  Seriousness criteria: The events (unresponsive to stimuli, syncope) were assessed as medically significant; Sender's Comments: Sanofi company comment dated 25-Nov-2024: This case involves a 24 years old female patient who was unresponsive to stimuli, had syncope, hyperhidrosis, immediate post-injection reaction, muscle spasms, muscle twitching, musculoskeletal stiffness, skin warm and dizziness after receiving Novavax COVID-19 Vaccine and influenza trivalent recombinant vaccine [Flublok TIV]. Further information regarding concurrent condition during 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