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Reporte zur Charge UJ512AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IA 2 NY 1 MI 1 WV 1

VAERS 918771

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ512AB

mild
Staat
NY
Alter
-
Geschlecht
M
Eingang
02.01.2021
Impfdatum
26.10.2020
Beginn
26.10.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Chills Pyrexia Vaccination complication

Symptomtext

Severe reaction to influenza vaccine (FLU *20-21 FLUZONE HD) Lot UJ512AB. Administered 10/26/2020. Five hours after receiving the vaccine sudden onset of very high fever (up to 103.6) and violent shivers. Fever still high after 24 hours.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chills
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
None
Andere Medikamente
Synthroid 175 mcg, Tamsulosin 0.4 mg, Fosamax
Allergien
None
Vorherige Impfungen
-

VAERS 1897847

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ512AB

gering
Staat
IA
Alter
68,0
Geschlecht
F
Eingang
24.11.2021
Impfdatum
16.11.2021
Beginn
16.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Patient was given Fluzone HD PF 2020-2021. Expired vaccine from last influenza season. Expired 6-30-2021

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

VAERS 1897834

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ512AB

gering
Staat
IA
Alter
65,0
Geschlecht
M
Eingang
24.11.2021
Impfdatum
16.11.2021
Beginn
16.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product storage error

Symptomtext

Patient was given Fluzone HD PF 2020-2021. Expired vaccine from last influenza season. Expired 6-30-2021

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1756440

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ512AB

gering
Staat
MI
Alter
67,0
Geschlecht
F
Eingang
02.10.2021
Impfdatum
27.09.2021
Beginn
27.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

nurse administered an expired dose of FLUZONE QUADRIVALENT HIGH DOSE with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00787284) and transmitted to Sanofi on 27-Sep-2021. This case involves a 67 year old female patient to whom a nurse administered an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (lot number and expiry date: not reported) for prophylactic vaccination. On 27-Sep-2021, the patient received a dose (0.7ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ512AB; expiry date: 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination. It was the case of actual medication error due to expired vaccine used (latency: same day). It was reported "Pharmacist states that a nurse administered an expired dose of FLUZONE QUADRIVALENT HIGH DOSE to a patient on 27SEP2021; caller would like to know how soon the vaccine can be re-administered and any adverse effects to look out for" Also, the reporter mentioned, the patient was given the dose from the last year's supply. No adverse events were reported at the time of this report. The outcome of the event was reported as unknown. 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1756420

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ512AB

gering
Staat
WV
Alter
72,0
Geschlecht
M
Eingang
02.10.2021
Impfdatum
23.09.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

nurse accidentally gave an expired fluzone high dose quadrivalent with no reported adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other-health care professional and consumer via Agency - 00782322]. This case involves 72 years old male patient who was accidentally vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered). The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ512AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid, for prophylactic vaccination. It was reported "Nurse Manager states that the last year's stock of FLUZONE HIGH DOSE QUADRIVALENT did not get pulled and as a result a nurse accidentally gave an expired FLUZONE HIGH DOSE QUADRIVALENT to a patient in error. She asks if the dose was valid or if it needs to be readministered". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Outcome of event was unknown. 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-