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Reporte zur Charge U6585AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
AL 1 IA 1

VAERS 1299385

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6585AB

gering
Staat
AL
Alter
11,0
Geschlecht
F
Eingang
08.05.2021
Impfdatum
27.04.2021
Beginn
27.04.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

patient received expired dose of MENACTRA/ NO AE; Initial information regarding an unsolicited valid serious case was received from a Nurse via Medical Information (Reference number- 00580513) and transmitted to Sanofi on 28-Apr-2021. This case involves a 11-years-old female patient to whom medical assistant from the office gave 0.5 mL first dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6585AB and expiry date: 11-Apr-2021 via intramuscular route in gluteus maximus) (expired product administered) on 27-Apr-2021 for prophylactic vaccination. The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). No adverse events or symptoms reported, she was fine, after 15 minutes. 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
GARDASIL; TDAP
Allergien
-
Vorherige Impfungen
-

VAERS 1272210

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6585AB

gering
Staat
IA
Alter
16,0
Geschlecht
F
Eingang
29.04.2021
Impfdatum
12.04.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Menactra was administered to a patient one day after the expiration date; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional (GMI inquiry number: 00559908). It was reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6585AB, expiry date: 11-Apr-2021) (Suspension For Injection) was administered to a 16 year old female patient one day after its expiry day on 12-Apr-2021 via intramuscular route in right deltoid for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event 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 guidelines. 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
-