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Reporte zur Charge UJ575AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 2455736

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AAA

gering
Staat
TX
Alter
3,0
Geschlecht
M
Eingang
23.09.2022
Impfdatum
09.08.2022
Beginn
09.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

No adverse eventreceived both a pentacel dose and a dose of acthib, on the same day with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) both for Prophylactic vaccination. On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation. On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine. Action taken: Not applicable. 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 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.; Sender's Comments: 01275067:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2450466

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AAA

gering
Staat
TX
Alter
3,0
Geschlecht
M
Eingang
17.09.2022
Impfdatum
09.08.2022
Beginn
09.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

receiving both a Pentacel dose and a dose of ACTHIB, on the same day with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) both for Prophylactic vaccination. On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation. On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine. Action taken: Not applicable. 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS A; MMRVAXPRO
Allergien
-
Vorherige Impfungen
-

VAERS 2091403

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AAA

gering
Staat
ME
Alter
-
Geschlecht
U
Eingang
05.02.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

one of three patients received an ACTHIB vaccine that was not diluted with the 0.4% Sodium Chloride with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ575AAA expiration date 07-Oct-2022 via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event, "one of three patients received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event" (product preparation error) (unknown latency) following the administration of HIB (PRP/T) VACCINE. It was reported, "Caller stated that during inventory she noticed that there was an extra diluent in the box of ACTHIB. Caller stated that someone must have reconstituted a dose of ACTHIB with the incorrect diluent. Caller unsure of which patient would have received incorrect diluent. Caller asking what recommendations are and if they should revaccinate all potential patients who received this vaccine." Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. It was not reported if the patient received a corrective treatment for the event (one of three patients received an ACTHIB vaccine that was not diluted with the 0.4% Sodium Chloride with no reported adverse event). At time of reporting, the outcome was Unknown for the event one of three patients received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-