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Reporte zur Charge UJ452AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 2

VAERS 1020164

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UJ452AB

gering
Staat
TX
Alter
4,0
Geschlecht
F
Eingang
10.02.2021
Impfdatum
12.12.2020
Beginn
12.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

a patient received a dose of FLUZONE which was stored at 0.7 Celsius for 25 hours and 24 minutes/ No AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant) via Medical Information (Reference number: 00444786). This case involves a 4 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was stored at 0.7 Celsius for 25 hours and 24 minutes lot UJ452AB, Expiry date: 30-Jun-2021 via intramuscular route in unknown administration site on 12-Dec-2020 for prophylactic vaccination. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to incorrect product storage (latency: same day). Description: Call received from medical assistant (MA) reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT Multi Dose Vials (MDVs) AND PREFILLED SYRINGES, MENACTRA, ADACEL and DAPTACEL at 0.7 Celsius for 25 hours and 24 minutes. Caller reported opened IPOL MDVs and opened Fluzone Quadrivalent MDVs. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone Quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines. At the time of reporting, 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 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1019177

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UJ452AB

gering
Staat
TX
Alter
-
Geschlecht
F
Eingang
10.02.2021
Impfdatum
01.12.2020
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

temperature excursion of unknown cause at 0.7C for 25 hours and 24 minutes /no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 year old female patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL] (batch number and expiry date not provided) via an unknown route at an unknown administration site for prophylactic vaccination and and INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] (batch number: UJ452AB and expiry date: 30-Jun-2021]) via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination]. Reporter reported a temperature excursion of unknown cause. PENTACEL, IPOL, FLUZONE QUADRIVALENT MDV AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened Ipol MDVs and opened Fluzone quadrivalent MDVs. See related cases. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone quadrivalent MDVs were administered post excursion. See related cases. Caller with question on viability of administered vaccines. Additional Description of event Adverse events :MA reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT MDV AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened Ipol MDVs and opened Fluzone quadrivalent MDVs. See related cases. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone quadrivalent MDVs were administered post excursion 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 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-