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Reporte zur Charge UJ635AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MA 1 TX 1 WA 1 NC 1

VAERS 2615047

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AAA

gering
Staat
MA
Alter
7,0
Geschlecht
M
Eingang
14.04.2023
Impfdatum
21.06.2022
Beginn
21.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

extra dose administered with no reported AE; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA113854. This case involves a 7 years old male patient who was administered an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jun-2022, the patient received 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ635AAA; Expiry date: 30-NOV-2022) (Strength: Standard; Frequency: utr) via intramuscular route in unknown administration site for immunisation. On 21-Jun-2022 the patient was administered an extra dose of HIB (PRP/T) VACCINE with no reported adverse event (extra dose administered) (Latency: same day). It was reported, Nurse has questions on how to proceed. She states the PENTACEL components were all given separately and an extra dose was given by accident. Call transferred. The nurse states that their clinic did not receive the immunization records on a new patient until after extra doses of DAPTACEL, IPOL, and ACTHIB were given in error. Extra dose of ACTHIB given on 21Jun2022. The nurse asks if these are valid doses or should they be reinjected. The HCP asks if the patient will experience any AE's as a result of this Action taken: not applicable. At time of reporting, the outcome was Unknown for the event extra dose administered with no reported ae. 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.

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

VAERS 2529546

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AAA

gering
Staat
TX
Alter
-
Geschlecht
M
Eingang
13.12.2022
Impfdatum
07.12.2022
Beginn
07.12.2022
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 Medication error No adverse event

Symptomtext

received the ACTHIB vaccine that was expired with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 2 years old male patient who received the HIB (PRP/T) VACCINE [ACT-HIB] that was expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE). On 07-Dec-2022, the patient received a dose of 0.5ml of suspect HIB (PRP/T) VACCINE, (frequency: once) (lot: UJ635AAA ; expiry date: 30-Nov-2022) via unknown route in unknown administration site for immunization. It was reported that the patient received the Acthib vaccine that was expired with no reported adverse event (expired product administered) (onset date: 07-Dec-2022; latency: same day). Thee reporter will reschedule the patient to come in to get another dose of the 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
DAPTACEL; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2322981

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AAA

gering
Staat
WA
Alter
1,0
Geschlecht
F
Eingang
17.06.2022
Impfdatum
08.06.2022
Beginn
08.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

given ACTHIB vaccine that was diluted with a different diluent with no reported adverse event; Initial information was received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 12 months old female patient who experienced given acthib vaccine that was diluted with a different diluent 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 08-Jun-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot UJ635AAA, expiry-17-Nov-22) (dose, formulation, and strength: unknown) via intramuscular route in left thigh for immunisation. On 08-Jun-2022, the patient developed a non-serious given acthib vaccine that was diluted with a different diluent with no reported adverse event (product preparation error) (latency same day) following the administration of HIB (PRP/T) vaccine. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event given acthib vaccine that was diluted with a different diluent 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
-

VAERS 2278159

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AAA

gering
Staat
NC
Alter
1,7
Geschlecht
M
Eingang
16.05.2022
Impfdatum
13.05.2022
Beginn
13.05.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered Wrong product administered

Symptomtext

Nurse administering vaccines administered two Dtaps instead of one dtap and one prevnar. Patient's parent notified of incident and voiced no concerns. We offered for them to return same day or reschedule for a different day to receive the vaccine that was missed but they declined and would call back.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
dairy products
Vorherige Impfungen
-