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Reporte zur Charge U6395AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 2 MO 1

VAERS 1349697

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6395AA

gering
Staat
PA
Alter
1,3
Geschlecht
F
Eingang
26.05.2021
Impfdatum
07.05.2021
Beginn
07.05.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

An expired Pentacel was given to a 15 month old as a 4th dose, no AE; Initial information was received on 07-May-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves a 15-month-old female patient who was administered 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot: DTAP/ IPV: U6395AA, ActHIB: UJ160AA, expiry date: 24-Apr-2021) via intramuscular route in thigh for prophylactic vaccination on 07-May-2021. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA) for prophylactic vaccination. It was a case of an actual medication error due to Expired product administered (latency same day). At the time of report, 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
PREVNAR 13; PNEUMOVAX; MMR; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1334950

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6395AA

gering
Staat
MO
Alter
0,3
Geschlecht
F
Eingang
20.05.2021
Impfdatum
27.04.2021
Beginn
27.04.2021
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

Symptomtext

The patient was administered expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number-00578878) and transmitted to Sanofi on 27-Apr-2021. This case involves a three month old female patient who was administered a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot Number:U6395AA, Expiration Date: 24-Apr-2021; Lot Number: UJ162AB, Expiration Date : 24-Apr-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 27-Apr-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter stated the expiration date was read incorrectly. The reporter wanted to know if the vaccine was still valid and what needed to be done going forward. Also, the reporter mentioned they came to the health department for the vaccines and this was the only one she has had. At the time of report, 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 943145

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6395AA

gering
Staat
PA
Alter
-
Geschlecht
M
Eingang
14.01.2021
Impfdatum
04.12.2020
Beginn
04.12.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

patient was given only the DTaP/IPV portion of the PENTACEL. so the patient was just given the liquid with no AE; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional. This case involves a 3 months old male patient who received only the dtap/ipv portion of the pentacel, so the patient was just given the liquid (product preparation issue), of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IMMUNOGLOBULIN ANTIHEPATITIS B (HEPATITIS B); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR). On 04-Dec-2020, the patient received 0.5 mL dose once a day via intramuscular route in the left thigh of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: U6395AA and expiry date unknown) for prophylactic vaccination. This was an actual medication error due to inappropriate reconstitution technique (PT: Product preparation issue) (latency was same day). No laboratory data reported. At the time of reporting, no adverse event was reported to the patient. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B [IMMUNOGLOBULIN ANTIHEPATITIS B]; PREVNAR
Allergien
-
Vorherige Impfungen
-