VAERS Reports UJ476AA

VAERS 924577

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ476AA

schwer

Staat: WA
Alter: 9,0
Geschlecht: M
Eingang: 06.01.2021
Impfdatum: 24.09.2000
Beginn: 04.11.2020
Tage bis Beginn: 7.346,0
Dosis: N/A
Route/Site: IM / LA

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

Acute disseminated encephalomyelitis Bacterial tracheitis Biopsy brain CSF test Central nervous system inflammation Critical illness Cytogenetic analysis Electroencephalogram Encephalomyelitis Encephalopathy Endotracheal intubation Immunoglobulin therapy Intensive care Lumbar puncture Magnetic resonance imaging Optic neuritis Paroxysmal sympathetic hyperactivity Plasmapheresis

Symptomtext

Patient was admitted to the hospital, critically ill and intubated in the ICU with encephalomyelitis consistent with acute disseminated encephalomyelitis (ADEM) associated with MOG-IgG positivity (or MOGAD). Course complicated by respiratory failure, paroxysmal sympathetic hyperactivity, optic neuritis, staph aureus tracheitis requiring antibiotics and ongoing encephalopathy. - underwent thorough infectious work up, multiple MRIs, lumbar puncture and brain biopsy - underwent several days of electroencephalogram (EEG) - Received 5 days IV methyl prednisone followed by a slow taper - Received 6 days of plasma exchange or PLEX - Received IVIg 2mg/kg (and will received monthly IVIg for 6 months)

Weitere VAERSDATA-Felder

Praegender Schweregrund: Intensive care
Hospital-Tage: -
Labordaten: MRI, lumbar puncture, brain biopsy, CSF infectious studies including autoimmune panels, infectious metagenomic panel, genetic testing.
Aktuelle Erkrankungen: none.
Vorgeschichte: none.
Andere Medikamente: -
Allergien: No known allergies
Vorherige Impfungen: -

VAERS 976983

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ476AA

gering

Staat: TX
Alter: 57,0
Geschlecht: F
Eingang: 27.01.2021
Impfdatum: 02.10.2020
Beginn: 07.01.2021
Tage bis Beginn: 97,0
Dosis: 2
Route/Site: OT / RA

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

Extra dose administered No adverse event

Symptomtext

patient that had received two Fluzone Quad vaccinations during this flu season. The first one was administered on 10/2/2020 and the second one on 01/17/2021/no AE; Initial information received on 08-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involved a 57 year old female patient who received 0.5 ml of two INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ506AB and expiry date: 30-Jun-2021) via unknown route in right deltoid for prophylactic vaccination during this flu season. The first one was administered on 02-Oct-2020 and the second one on 07- Jan-2021 (Extra dose administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to extra dose administered (latency 3 months 5 days post the first dose). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 976980

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ476AA

gering

Staat: CA
Alter: -
Geschlecht: M
Eingang: 27.01.2021
Impfdatum: 09.11.2020
Beginn: 09.11.2020
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Extra dose administered No adverse event

Symptomtext

given a double dose of the Fluzone Quadrivalent, first dose given on 09Nov2020 and second dose given 06Jan2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from other health professional (Nurse) via call center. This case involved a 71 year old male patient who received a 0.5 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number- UJ476AA and expiry date- 30-Jun-2021), via unknown route at unknown administration site, on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error given a double dose of the Fluzone Quadrivalent, first dose given on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered).. At the time of reporting, the patient had no 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 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -