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Reporte zur Charge UT5570BA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
1Bleibende Schaeden
TX 2

VAERS 2675977

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UT5570BA

moderat
Staat
TX
Alter
34,0
Geschlecht
M
Eingang
24.08.2023
Impfdatum
21.10.2016
Beginn
15.11.2016
Tage bis Beginn
25,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: ja ER: ja Erholt: nein
Anal incontinence Autoimmune disorder Blood test normal Cough Dizziness Dyspnoea Gait disturbance Headache Hyperventilation Hypoaesthesia Hypoaesthesia oral Intervertebral disc protrusion Magnetic resonance imaging spinal abnormal Myelitis Paraesthesia oral Pneumonia Pyrexia Streptococcal infection

Symptomtext

fever of 103.5; Autoimmune; bowel incontinence; deep breathing; tingling in the tip of his tongue; pneumonia; Strep URI; face and mouth being numb; disc herniation; difficulty walking; myelitis; cough; trouble breathing; headache; dizziness; Initial information received on 10-Aug-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 34 years old male patient (180 cm and 190 kg) who experienced myelitis, autoimmune, fever of 103.5, bowel incontinence, cough, deep breathing, dizziness, headache, tingling in the tip of his tongue, pneumonia, strep uri, face and mouth being numb, disc herniation, trouble breathing and difficulty walking after receiving influenza quadrival A-B intradermal vaccine[Fluzone]. The patient's past medical history included Weakness, Low back pain, Sexual dysfunction, Bladder incontinence, Anxiety and Spasticity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Chronic fatigue, Depression and Sensory deficit. On 21-Oct-2016, the patient received 0.1 (unspecified units) of suspect influenza quadrival A-B intradermal vaccine lot UT5570BA via intradermal route in the right arm for prophylactic vaccination (strength and expiry date: unknown). On 15-Nov-2016 the patient had myelitis, autoimmune (autoimmune disorder), bowel incontinence (anal incontinence), cough, deep breathing (hyperventilation), dizziness, headache, tingling in the tip of his tongue (paraesthesia oral), pneumonia, strep uri (upper respiratory tract infection), face and mouth being numb (hypoaesthesia), disc herniation (intervertebral disc protrusion), trouble breathing (dyspnoea), difficulty walking (gait disturbance) (latency 25 days). On 03-Dec-2016 the patient had fever of 103.5 (pyrexia) (latency 1 month 13 days). Relevant laboratory test results included: Blood test - On an unknown date: [bloodwork came back negative for viral/bacterial infection] Body temperature - On 03-Dec-2016: [fever of 103.5] Magnetic resonance imaging - On 03-Dec-2016: ; on 31-Mar-2017: [TII-12 minimal disc space is seen with minimal annular type disc bulge producing minimal thecal sac impingement] Streptococcus test - On an unknown date: Positive Reportedly, At L5-S 1 prior left laminectomy was identified with enhancing scar abutting the disc space and left lateral canal and left S 1 nerve root. Considering the enhancement, no specific recunent disc herniation was identified. Some residual disc bulge or broad-based disc herniation was seen within the right lateral canal producing minimal thecal sac impingement. Moderate bilateral mild bilateral neuroforaminal was seen. No malignant bone marrow replacement or cord signal abnormality was seen. A 3 mm focus of contrast enhancement in the right superior cerebellar peduncle was noted on TI postcontrast axial image 8 after further review. This punctate focus of signal intensity seen on a single axial slice was of uncertain etiology or clinical significance. Attention on follow-up imaging was recommended to exclude a true underlying lesion such as a demyelinating plaque or neoplasm. The 3.5 em long low TII high T2-weighted intra-axial lesion within the proximal cervical cord at the C2 and C3 vertebral body levels demonstrates patchy enhancement after contrast administration. This lesion had not enlarged since the recent comparison study, and no other enhancing cord lesions were seen in the lower cervical or upper thoracic cord. No hemorrhage was evident. No enhancing paraspinal soft tissue mass was present. Punctate soft tissue cysts about the nasopharynx do not enhance and are incidental. Vertebral bodies were normal in height. signal, and alignment. No enhancing marrow lesion was present. Discs appear normal without significant herniation. There was no spinal canal stenosis or cord compression Action taken: not applicable. The patient was treated with penicillin v benzathine (penicillin v benzathine) for Hypoaesthesia and unknown for other events. Outcome was Not Recovered / Not Resolved for all the events. Seriousness criteria: Medically significant for myelitis, autoimmune disorder and pneumonia, Disability for all events.; Sender's Comments: Sanofi Company Comment dated 14-Aug-2023: This case involves a 34 years old male patient (180 cm and 190 kg) who experienced myelitis, autoimmune, fever of 103.5, bowel incontinence, cough, deep breathing, dizziness, headache, tingling in the tip of his tongue, pneumonia, strep uri, face and mouth being numb, disc herniation, trouble breathing and difficulty walking after receiving influenza quadrival A-B intradermal vaccine[Fluzone]. Additionally patient's medical history of Weakness, Low back pain, Sexual dysfunction, Bladder incontinence, Anxiety and Spasticity, and ongoing Depression and Sensory deficit condition could be confounding factor for events to occur.Further information regarding previous vaccination, concomitant medication and tolerance, allergic history, 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.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dyspnoea
Hospital-Tage
-
Labordaten
Test Name: bloodwork; Result Unstructured Data: bloodwork came back negative for viral/bacterial infection; Test Date: 20161203; Test Name: body temperature; Result Unstructured Data: fever of 103.5; Test Date: 20170331; Test Name: MRI; Result Unstructured Data: TII-12 minimal disc space is seen with minimal annular type disc bulge producing minimal thecal sac impingement; Test Name: rapid strep test; Test Result: Positive
Aktuelle Erkrankungen
Chronic fatigue; Depression; Sensory deficit
Vorgeschichte
Medical History/Concurrent Conditions: Anxiety; Bladder incontinence; Low back pain; Sexual dysfunction; Spasticity; Weakness
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649696

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UT5570BA

gering
Staat
TX
Alter
40,0
Geschlecht
M
Eingang
27.06.2023
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered No adverse event

Symptomtext

might have been given intradermally around one-tenth of a milliliter, with no reported adverse event; Initial information was received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient). This case involves 40 years old male patient who have been influenza quadrival a-b intradermal vaccine [Fluzone] taken intradermally around one-tenth of a milliliter with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient might have been received a dose around one-tenth of a milliliter suspect influenza quadrival A-B intradermal vaccine Solution for injection in pre-filled syringe (lot number: UT5570BA, strength, administrative site, expiration date: Unknown) via intradermal route for Immunization (immunisation) with no reported adverse event (incorrect dose administered) (latency: same day) No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event might have been given intradermally around one-tenth of a milliliter, with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-