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Reporte zur Charge UJ402AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 1 CA 1

VAERS 1813068

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ402AAA

gering
Staat
FL
Alter
0,2
Geschlecht
M
Eingang
23.10.2021
Impfdatum
11.10.2021
Beginn
11.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

was given expired Pentacel with no reported adverse event; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00811243). This case involves a two-month-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 11-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ402AAA and expiry date: 10-Oct-2021) (frequency: once) via intramuscular route in the right thigh for prophylactic vaccination. It was reported "nurse told him it may not be necessary to re-administer because it is only one day expired, however, to follow-up with manufacturer." It was an actual medication error case due to expired vaccine used (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 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; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 1094034

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ402AAA

gering
Staat
CA
Alter
-
Geschlecht
F
Eingang
12.03.2021
Impfdatum
25.02.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Medication error No adverse event

Symptomtext

received a medication error described as getting a double does of DTap-IPV due to the consumer was, given a dose of Pentacel and Tripedia with no AE; Initial information regarding this unsolicited valid non-serious case from via Medical Information (Reference number- 00496166). This case involves a 15-months old female patient received a medication error described as getting a double dose of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] (batch number: unknown and expiration date: unknown), DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [DTAP-IPV] (batch number: unknown and expiration date: unknown) due to the consumer was, given a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/ HIB(PRP/T) VACCINE [PENTACEL] (batch number: UJ402AAA and expiration date: 09-Oct-2021) at a dose of 0.5 ml via intramuscular route in the right thigh and concomitant medication Tripedia (extra dose administered) for prophylactic vaccination. Medical history, past medical treatments, vaccinations and family history were not provided. It was an actual medication error due to the extra dose administered (latency: unknown). At the time of reporting, the patient had no adverse event. Disclaimer: 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. 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
TRIPEDIA
Allergien
-
Vorherige Impfungen
-