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Reporte zur Charge UK007AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 4 NV 1

VAERS 2718865

SANOFI PASTEUR · HIB (ACTHIB) · Charge UK007AB

gering
Staat
NV
Alter
1,0
Geschlecht
F
Eingang
29.11.2023
Impfdatum
15.11.2023
Beginn
15.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

patient was administered with the ACTHIB using sterile water as the diluent instead of the specific ACTHIB diluent with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered with the HIB (PRP/T) VACCINE [ACT-HIB] using sterile water as the diluent instead of the specific ACTHIB diluent 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 Hepatitis A vaccine (Hepatitis A), Measles vaccine, Mumps vaccine, Rubella vaccine (MMR VACCIN), and Pneumococcal vaccine CONJ 20V (CRM197) (Pneumococcal Vaccine CONJ 20V (CRM197)) all for Immunisation. On 15-Nov-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UK007AB via intramuscular route in the left vastus lateralis as prophylactic vaccination(immunization). On 15-Nov-2023, the patient was administered with the HIB (PRP/T) vaccine using sterile water as the diluent instead of the specific ACTHIB diluent with no reported adverse event (product preparation error) (latency: same day). No lab data 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 and Regulatory Authority 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
HEPATITIS A; MMR VACCIN; PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)
Allergien
-
Vorherige Impfungen
-

VAERS 2714298

SANOFI PASTEUR · HIB (ACTHIB) · Charge UK007AB

gering
Staat
IL
Alter
1,3
Geschlecht
F
Eingang
15.11.2023
Impfdatum
27.10.2023
Beginn
27.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

only received the diluent and not the lyophilized powder portion (with no reported adverse event); Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2023SA343804, 2023SA343809 and 2023SA343771. This case involves a 15-months-old female patient who only received the diluent and not the lyophilized powder portion for 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. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); hepatitis A vaccine (Hepatitis A); and Influenza Vaccine for Prophylactic vaccination. On 27-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection at a dose of 0.5 ml total (lot: UK007AB, expiry date: 31-Dec-2024) via intramuscular route in the right thigh for Immunization; only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (same day latency). Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment. 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
DAPTACEL; HEPATITIS A; INFLUENZA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2713957

SANOFI PASTEUR · HIB (ACTHIB) · Charge UK007AB

gering
Staat
IL
Alter
1,3
Geschlecht
M
Eingang
14.11.2023
Impfdatum
30.10.2023
Beginn
30.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Single component of a two-component product administered

Symptomtext

only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received from country on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2023SA343804, 2023SA343771 and 2023SA345528. This case involves 16 months old male patient who only received the diluent and not the lyophilized powder portion for 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. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation; Hepatitis A Vaccine for Immunisation; and influenza vaccine (Flu [influenza vaccine]) for Immunisation. On 30-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UK007AB, expiry date- 31-DEC-2024) via intramuscular route in the left thigh for Immunization. On 30-OCT-2023 the patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day) following the administration of HIB (PRP/T) vaccine. Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment. 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 and Module of the 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
DAPTACEL; HEPATITIS A VACCINE; FLU [INFLUENZA VACCINE]
Allergien
-
Vorherige Impfungen
-

VAERS 2713956

SANOFI PASTEUR · HIB (ACTHIB) · Charge UK007AB

gering
Staat
IL
Alter
1,0
Geschlecht
M
Eingang
14.11.2023
Impfdatum
30.10.2023
Beginn
30.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Single component of a two-component product administered

Symptomtext

patients received a dose of acthib. however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received from country on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2023SA343771, 2023SA345528 and 2023SA343809 . This case involves a 1 years old male patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] however, one patient only received the diluent and not the lyophilized powder portion 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); HEPATITIS A VACCINE (HEPATITIS A); and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination (Immunization). On 30-Oct-2023, the patient received a 0.5 mL dose 4 of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (Frequency = once), (Strength = standard) (lot UK007AB and expiry date: 31-Dec-2024) via intramuscular route in the right thigh for Immunization. On 30-Oct-2023, the patient received a dose of acthib. however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE. It was reported that "Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering?". 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 and Module of the 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
DAPTACEL; HEPATITIS A; INFLUENZA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2713955

SANOFI PASTEUR · HIB (ACTHIB) · Charge UK007AB

gering
Staat
IL
Alter
1,3
Geschlecht
F
Eingang
14.11.2023
Impfdatum
26.10.2023
Beginn
26.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error Single component of a two-component product administered

Symptomtext

only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2023SA343804, 2023SA343809 and 2023SA345528. This case involves 15 months old male patient who only received the diluent and not the lyophilized powder portion for 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. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation and Hepatitis A Vaccine (Hepatitis A) for Immunisation. On 26-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UK007AB, expiry date- 31-DEC-2024) via intramuscular route in the right thigh for Immunization. On 26-Oct-2023, the patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day) following the administration of HIB (PRP/T) vaccine. Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment. 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
HEPATITIS A; DAPTACEL
Allergien
-
Vorherige Impfungen
-