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Reporte zur Charge UJ531AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 2 AZ 1

VAERS 2309780

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj531aaa

gering
Staat
PA
Alter
0,2
Geschlecht
M
Eingang
06.06.2022
Impfdatum
06.05.2022
Beginn
06.05.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect product formulation administered No adverse event

Symptomtext

medication error due to a patient being administered only the DTAP-IPV liquid component of the PENTACEL vaccine, with no reported adverse event; Initial information on 19-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 2 months old male patient who had medication error due to a patient being administered only the dtap-ipv liquid component of the pentacel 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); Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar); And Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) all for prophylactic vaccination. On 06-May-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine, frequency: once, dose number 1st (route, strength, formulation: unknown) lot uj531aaa, expiry date: 22-Jul-2022 via intramuscular route in the thigh nos for prophylactic vaccination. On 06-MAY-2022 the patient developed a non-serious event medication error due to a patient being administered only the dtap-ipv liquid component of the pentacel vaccine, with no reported adverse event (Incorrect product formulation administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. Action taken with was not applicable. It was not reported if the patient received a corrective treatment for the event (Incorrect product formulation administered). At time of reporting, the outcome was Unknown for the event Incorrect product formulation 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.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B VACCINE; PREVNAR; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 2294294

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ531AAA

gering
Staat
PA
Alter
0,2
Geschlecht
M
Eingang
25.05.2022
Impfdatum
06.05.2022
Beginn
06.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

administered the liquid component of the Pentacel to a patient without diluting the lyophilized component (with no reported adverse event); Initial information received 19-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 weeks old male patient who experienced administered the liquid component of the pentacel to a patient without diluting the lyophilized component (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 for prophylactic vaccination, pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination and rotavirus vaccine for Prophylactic vaccination. On 06-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (strength, formulation: unknown) (lot UJ531AAA; expiry date: 22-Jul-202) via intramuscular route in right thigh for prophylactic vaccination. On 06-May-2022 (latency: same day) the patient experienced administered the liquid component of the pentacel to a patient without diluting the lyophilized component (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; 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B VACCINE; PREVNAR 13; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1908656

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ531AAA

gering
Staat
AZ
Alter
0,3
Geschlecht
F
Eingang
30.11.2021
Impfdatum
15.11.2021
Beginn
15.11.2021
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

PENTACEL reconstituted with sterile water with no reported adverse event; Initial information was received on 15-Nov-2021 regarding an unsolicited valid non-serious case received from other health professional and non-healthcare professional via Medical information (MI) under reference number - 00858573) This case involves a 4-months old female patient who was vaccinated with suspect vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] while preparing vaccine reconstituted with sterile water with no adverse event (product preparation error). The patient's past medical treatments, concomitant medication and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination. On 15-Nov-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] (lot number UJ531AAA and expiry date 22-Jul-2022 was reported) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day). At the time of report, no adverse event reported. Event 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 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
PREVNAR 13; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-