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Reporte zur Charge UJ567AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
LA 1 TN 1 IN 1 RI 1

VAERS 1279597

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ567AA

mild
Staat
LA
Alter
71,0
Geschlecht
F
Eingang
02.05.2021
Impfdatum
29.12.2020
Beginn
01.01.2021
Tage bis Beginn
3,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Contusion Injection site pain Skin warm

Symptomtext

3 inch by 2 inch oval bruise (red/brown in color) with yellow border located on inner left arm. Warm to touch. Patient reports pain after injection but has since resolved.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NO
Vorgeschichte
NO
Andere Medikamente
ASA, Alprazolam, Temazepam, Calcium, Vitamin E&C, APAP,
Allergien
Hydrocodone/Codiene
Vorherige Impfungen
-

VAERS 1713147

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ567AA

gering
Staat
TN
Alter
80,0
Geschlecht
M
Eingang
18.09.2021
Impfdatum
07.09.2021
Beginn
07.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

80 year old male patient administered expired dose of Fluzone High Dose, with no reported adverse event; Initial information received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health professional via Medical Information (Reference number- 00759809). This case involves 80-year-old male patient who was vaccinated with the expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 07-Sep-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ567AA and expiry date: 30-Jun-2021) (Frequency: Once) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported "they administered expired FLUZONE HIGH DOSE to a patient. what are the proper steps for the patient after this situation?" At 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 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 1178311

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ567AA

gering
Staat
IN
Alter
1,0
Geschlecht
F
Eingang
07.04.2021
Impfdatum
18.03.2021
Beginn
18.03.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

A patient received an expired diluent at the time of vaccination, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00525075) and transmitted to Sanofi on 18-Mar-2021. This case involves an one-year-old female patient who received an expired 0.5 mL dose of diluent of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ567AA and expiry date: 01-Mar-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 18-Mar-2021 (expired product administered). The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to expired product administered (latency same day). 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 978320

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ567AA

gering
Staat
RI
Alter
-
Geschlecht
M
Eingang
27.01.2021
Impfdatum
-
Beginn
12.01.2021
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Memory impairment

Symptomtext

Memory issue; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00428032) and transmitted to Sanofi on 13-Jan-2021 via call-center. This case involves an 81-year-old male patient who experienced memory issue (memory impairment), while he received vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent]. The patient's medical history, past vaccination(s), past medical treatment, concomitant medication and family history were not provided. On an unknown date, the patient received a (one dosage form) dose of suspect influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] (lot number UJ567AA) (0.7 mg) via unknown route at an unknown administration site for prophylactic vaccination. On 12-Jan-2021, the patient developed a non-serious memory issue (memory impairment), following the administration of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent]. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. Outcome of the event was unknown.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Memory impairment
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-