VAERS Reports UJ493AAA

VAERS 2523800

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ493AAA

schwer

Staat: FL
Alter: 60,0
Geschlecht: M
Eingang: 06.12.2022
Impfdatum: 21.02.2022
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: ja ER: unbekannt Erholt: nein

Cervical vertebral fracture Fall Paralysis Quadriplegia

Symptomtext

paralyzed/quadriplegic; fractured a cervical vertebrae; fall; Initial information was received on 01-Dec-2022 regarding an unsolicited valid serious case received from a consumer/non-health-care professional. This case involves 60 years old male patient who reported paralyzed/quadriplegic, fractured a cervical vertebrae and fall after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Feb-2022, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UJ493AAA, expiry date: 30-Jun-2021) (strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient had a serious event paralyzed/quadriplegic (Quadriplegia) and fractured a cervical vertebrae (cervical vertebral fracture) (unknown latency) following the administration of influenza quadrival A-B vaccine. On an unknown date the patient had a non-serious event fall (unknown latency) following the administration of influenza quadrival A-B vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events. Seriousness Criteria: Medically significant and disability for event paralyzed/quadriplegic. Medically significant for fractured a cervical vertebrae.; Sender's Comments: Sanofi Company Comment dated 05-Dec-2022: This case involves 60 years old male patient who reported paralyzed/quadriplegic, fractured a cervical vertebrae and fall after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, vaccination history, family history and any relevant medical history of patient, any concurrent conditions and lab investigations precludes comprehensive case assessment.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Paralysis
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1128064

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UJ493AAA

gering

Staat: FL
Alter: 60,0
Geschlecht: M
Eingang: 24.03.2021
Impfdatum: 19.02.2021
Beginn: 01.02.2021
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja

Asthenia Cervical vertebral fracture Fall Hemiplegia Hypoaesthesia Impaired work ability Sensory loss Weight bearing difficulty

Symptomtext

Initial information regarding an unsolicited valid serious case was received from a physician via consumer/non-health care professional via Regulatory Agency (Reference number- 00512481) and transmitted to Sanofi on 10-Mar-2021. This case involves a 60-year-old male patient who had a Guillain Barre syndrome, paralyzed, unable to move his left side at all (hemiplegia), feeling weak (asthenia), unable to hold up the weight of his body, fell (fall), broke C3, loss of sensation on right side, numbness on right side (hypoesthesia) and stroke while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On 19-Feb-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ493AAA, expiry date: 30-Jun-2021) via unknown route in the left arm for vaccination. In Feb-2021, the patient got out of bed and was feeling weak, unable to hold up the weight of his body and because of this, he fell and broke his C3 and was unable to move his left side at all, approximately 12 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 20-Feb-2021, the ambulance came and took him to the Hospital. They ruled out a stroke and Guillain Barre syndrome (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date in 2021, the patient was experiencing numbness and loss of sensation on right side (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Initially he could not move left side, but now he could move. On 02-Mar-2021, the patient was transferred to hospital out of state due to help gain mobility. The events were assessed as medically significant, and patient was hospitalized for the events. The Caller stated that her stepfather took the flu vaccine and within 24 hours he was paralyzed and is still hospitalized. He is unable to work. The Caller and wife of patient were requesting compensation from the adverse events (AE's) that they feel is a result of the Sanofi flu vaccine. No laboratory data was provided. It was not reported if the patient received a corrective treatment. On an unknown date in 2021, the hemiplegia recovered while outcome of other events was unknown. Sender's Comments: This case concerns 60-year-old male patient who had Guillain-Barre syndrome, hemiplegia, asthenia, weight bearing difficulty, fall, cervical vertebral fracture, sensory loss, hypoesthesia and cerebrovascular accident after vaccination with FLUZONE. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Asthenia
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -