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Reporte zur Charge UJ569ABA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 CO 2

VAERS 2161869

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ569ABA

gering
Staat
MI
Alter
0,3
Geschlecht
M
Eingang
05.03.2022
Impfdatum
21.02.2022
Beginn
21.02.2022
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

administered the DTAP-IPV portion of PENTACEL without first reconstituting with the HIB portion, with no reported adverse event; Initial information received on 23-Feb-2022 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a 4 months old male patient who was administered the dtap-ipv portion of pentacel without first reconstituting with the hib portion, 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. Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination. On 21-Feb-2022, the patient received one Dosage form of 0.5 ml, once a day of suspect Pentacel Vaccine (lot UJ569ABA, expiry date: 11-Sep-2022) via intramuscular route in the left thigh for immunization. On 21-FEB-2022 the patient was administered the dtap-ipv portion of pentacel without first reconstituting with the hib portion, with no reported adverse event (product preparation error) (latency: same day) following the administration of Pentacel Vaccine. Action taken was not applicable. Outcome was 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 2134711

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ569ABA

gering
Staat
MI
Alter
0,3
Geschlecht
M
Eingang
23.02.2022
Impfdatum
21.02.2022
Beginn
23.02.2022
Tage bis Beginn
2,0
Dosis
2
Route/Site
SYR / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product dose omission issue

Symptomtext

It was noted on 2/23/22 that there was only a single dose of Hib left in the Pentacel box. We reviewed all patients that received this lot # and were able to narrow it down to this patient being the one that did not receive Hib. A safety report has been filed with the manufacturer. The Owner/Physician of our practice has been notified and will be reaching out to the family to schedule the dose of hib. Sanofi is shipping a pack of hib diluent so we can administer the remaining vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product dose omission issue
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2037698

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ569ABA

gering
Staat
CO
Alter
-
Geschlecht
M
Eingang
15.01.2022
Impfdatum
15.12.2021
Beginn
15.12.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

one of the children did not receive the ACT-HIB portion of the vaccine, with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious case was received from the health professional. This case involves a 5 months old male patient who did not receive the act-hib portion of the 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), and family history were not provided. Concomitant medications included rotavirus vaccine (Rotavirus Vaccine) for prophylactic vaccination; and hepatitis b vaccine (Hepatitis B Vaccine) for prophylactic vaccination. On 15-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Strength : 0.5 ML; form, dosage: unknown; lot/batch number: UJ569ABA) via intramuscular route in unknown administration site for immunization. On 15-DEC-2021 the patient developed a non-serious event 'one of the children did not receive the act-hib portion of the vaccine, with no reported adverse event' (product preparation error) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It is reported 'Caller reporting that two children received the PENTACEL vaccine on 15Dec2021 but one of the children did not receive the ACT-HIB portion of the vaccine. Caller stated they do not know which one of the patient did not receive the ACT-HIB portion. Caller is wanting to find out what to do'. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event one of the children did not receive the act-hib portion of the vaccine, 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
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2020337

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ569ABA

gering
Staat
CO
Alter
-
Geschlecht
F
Eingang
10.01.2022
Impfdatum
15.12.2021
Beginn
15.12.2021
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 error

Symptomtext

did not receive the ACT-HIB portion of the vaccine with no reported adverse event; Initial information was received on 04-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old female patient who did not receive the act-hib portion of the 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. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 15-Dec-2021, the patient received a dose (0.5 ml total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with strength 0.5 ml, lot number UJ569ABA with expiration date 11-Sep-2022 (ACT-HIB lot number- UJ569AB; Expiration date- 11-Sep-2022) via intramuscular route in the right thigh as immunization. On 15-DEC-2021 the patient developed a non-serious event "did not receive the act-hib portion of the vaccine with no reported adverse event"? (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (did not receive the ACT-HIB portion of the vaccine with no reported adverse event). At time of reporting, the outcome was Unknown for the event did not receive the act-hib portion of the vaccine 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
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B VACCINE; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-