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Reporte zur Charge UJ504AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 2 TX 1

VAERS 2404194

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ504AAA

gering
Staat
TX
Alter
0,3
Geschlecht
U
Eingang
08.08.2022
Impfdatum
26.07.2022
Beginn
26.07.2022
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 No adverse event

Symptomtext

administerd an expired pentacel vaccine with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old of an unknown gender patient who was administerd an expired pentacel vaccine with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jul-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ504AAA and expiration date: 29-May-2022) at a dose of 0.5ml via unknown route in unknown administration site for immunization. On 26-Jul-2022 (latency: same day), the patient developed a non-serious events of administerd an expired pentacel vaccine with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken :not applicable It was not reported if the patient received a corrective treatment for the event. Outcome: Unknown 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 1931699

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ504AAA

gering
Staat
FL
Alter
0,2
Geschlecht
F
Eingang
08.12.2021
Impfdatum
19.11.2021
Beginn
19.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

This case is linked to case 2021SA394804 (same reporter). This case involves a two-month-old female patient who accidentally received only part of a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and not the HiB portion (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID ACPERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5ml, lot UJ504AAA, expiry date: 29-May-2022) via an unknown route at an unknown administration site for prophylactic vaccination. It was a potential medication error due to Inappropriate reconstitution technique (latency: same day). It was reported "Caller says that a nurse accidentally gave only part of a dose of Pentacel and not the Hib portion. Caller wants to know about next steps and side effects to look for." 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1912318

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ504AAA

gering
Staat
FL
Alter
0,2
Geschlecht
F
Eingang
01.12.2021
Impfdatum
19.11.2021
Beginn
19.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

nurse administered PENTACEL to a patient without mixing the powder form (HIB) with no adverse event; Initial information received on 22-Nov-2021 regarding an unsolicited valid non-serious case from nurse and physician via The Regulatory Authority (under reference 00867952). This case is linked to case 2021SA393946 (Cluster). This case involves a 2 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the powder form (hib) [product preparation issue]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) [lot number and expiration date were not reported] via unknown route in an unknown administration site for Prophylactic vaccination. On 19-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (TOTAL, lot UJ504AAA and expiration date: 29-May-2022) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate reconstitution technique (same day latency). It was reported "The caller stated that a nurse administered PENTACEL to a patient without mixing the powder form (HIB). The caller would like to know how to care for the patient. The caller stated that she was reading online that Sanofi will send them a diluent to mix with the other portion to administer to the patient." At time of reporting, 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 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-