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Reporte zur Charge UJ522AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NY 2 AL 2 WA 1 IN 1

VAERS 2440256

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ522AA

gering
Staat
WA
Alter
-
Geschlecht
U
Eingang
12.09.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

ACT-HIB vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient and reported a product preparation error (received Act-Hib vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event ), for the 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 an unknown dose of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength , ( lot: UJ522AA ; expiry date: 06-Aug-2022) for immunization. The reporter stated that approximately 6 patients received the ACT-HIB vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event (product preparation error) (latency: same day) 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.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2413293

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ522AA

gering
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
17.08.2022
Impfdatum
08.08.2022
Beginn
08.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired vaccine administered with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who administered expired vaccine 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. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunization; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunization. On 08-Aug-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE( lot UJ522AA and expiration date: 06-Aug-2022) at a dose of 0.50 ml via intramuscular route in the left thigh for immunization. On 08-Aug-2022 (Latency: same day),the patient developed a non-serious event of expired vaccine administered with no reported adverse event (expired product administered) following the administration of 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
HEPATITIS A; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2413276

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ522AA

gering
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
17.08.2022
Impfdatum
08.08.2022
Beginn
08.08.2022
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

Symptomtext

set of twins to receive ACT-HIB 2-days past the expiration date with no reported adverse events; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who experienced set of twins to receive act-hib 2-days past the expiration date with no reported adverse events 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. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation. On 08-AUG-2022 , the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE once (lot UJ522AA; expiry date: 06-aug-2022) via intramuscular route in the right thigh for immunization. On 08-AUG-2022 the patient reported set of twins to receive act-hib 2-days past the expiration date with no reported adverse events (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE. Action taken: not applicable. It time of reporting, the outcome was Unknown for the event expired product administered. 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.; Sender's Comments: 01227624:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS A VACCINE; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2195947

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ522AA

gering
Staat
IN
Alter
0,3
Geschlecht
F
Eingang
24.03.2022
Impfdatum
16.03.2022
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

added a different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 3 months old female patient who experienced different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, 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. Concomitant medications included Diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (Yeast), Pertussis vaccine acellular 3-component, Polio vaccine Inact 3V (VERO), Tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination; and Pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination. On 16-Mar-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine unknown formulation, (batch lot UJ522AA expiry date unknown) via intramuscular route for immunization. On an unknown date the patient developed a non-serious event added a different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event (product preparation error) (unknown latency) following the administration of HIB (PRP/T) Vaccine. Action taken: not applicable. At time of reporting, the outcome was Unknown for the 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PEDIARIX; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 1860453

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ522AA

gering
Staat
AL
Alter
0,5
Geschlecht
U
Eingang
11.11.2021
Impfdatum
01.11.2021
Beginn
01.11.2021
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

Symptomtext

patient had administred Pentacel and ACT Hib on same time with no adverse event; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from an Other Health Professional via Media Information (under reference 00837120). This case involves a 6-months-old and unknown gender patient who was administered with HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], which was double dose of the HIB vaccine (extra dose administered). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination. Medical history,medical treatment, vaccination and family history were not provided. On 01-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ494AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination. On 01-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ522AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to extra dose administered (latency on same day). It was reported that ''a child was administered ACTHIB and PENTACEL on the same date. Are there any side effects that they need to look out for?'' 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 1834229

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ522AA

gering
Staat
AL
Alter
0,5
Geschlecht
M
Eingang
01.11.2021
Impfdatum
01.11.2021
Beginn
01.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Crying Feeling abnormal

Symptomtext

Increased fussiness/crying.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Crying
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
No
Allergien
None
Vorherige Impfungen
-