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Reporte zur Charge U1C572M

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
WA 2 NJ 2

VAERS 2416752

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge U1C572M

gering
Staat
WA
Alter
-
Geschlecht
M
Eingang
20.08.2022
Impfdatum
19.07.2022
Beginn
19.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

administered IPOL after it exceeded the stability data documented in the local labelling with no reported adverse event; administered IPOL after it exceeded the stability data documented in the local labelling with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who had administered IPV (VERO) [IPOL] after it exceeded the stability data documented in the local labelling with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an 19-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot U1C572M and expiry date: 17-Jun-2023)) via subcutaneous route in the right deltoid for Immunization. On an 19-Jul-2022, the patient developed a non-serious administered ipol after it exceeded the stability data documented in the local labelling with no reported adverse event (poor quality product administered) (latency same day) following the administration of IPV (VERO). On an unknown date, the patient developed a non-serious event of administered ipol after it exceeded the stability data documented in the local labelling with no reported adverse event (product temperature excursion issue)(latency unknown). 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2413278

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge U1C572M

gering
Staat
WA
Alter
12,0
Geschlecht
F
Eingang
17.08.2022
Impfdatum
19.07.2022
Beginn
19.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

patient being administered IPOL after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; patient received the IPOL after it was not suitable for use with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old female patient who was being administered ipol (IPV (VERO) ) after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and patient received the ipol after it was not suitable for use 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 VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 19-Jul-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot U1C572M, expiration date:17-Jun-2023, via subcutaneous route in the right deltoid as Immunization The patient was being administered ipol after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO). On 19-JUL-2022 the patient received the ipol after it was not suitable for use with no reported adverse event (poor quality product administered) same day following the administration of IPV (VERO). Action taken was not applicable. Corrective treatment: None. At time of reporting, the outcome was Unknown for all. 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
VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2356738

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge U1C572M

gering
Staat
NJ
Alter
1,0
Geschlecht
F
Eingang
03.07.2022
Impfdatum
09.05.2022
Beginn
09.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered No adverse event

Symptomtext

IPOL vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event; Initial information received on 15-Jun-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 ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event while receiving vaccine IPV (VERO) [IPOL]. 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 Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation. On 09-May-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (batch lot U1C572M Expiry date :17-Jun-2023 )(unknown strength and formulation)via intramuscular route in right thigh for immunization. On 09-May-2022 (latency :same day)the patient developed a non-serious event of ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event (incorrect dose administered) following the administration of IPV (VERO). 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.; Sender's Comments: 01148369:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS A; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 2322047

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge U1C572M

gering
Staat
NJ
Alter
1,3
Geschlecht
F
Eingang
16.06.2022
Impfdatum
16.06.2022
Beginn
16.06.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered

Symptomtext

Patient received an 11th dose of ipv vaccine. Polio vials come in a 10th dose vials with additional vaccine residual. Per sanofi pasteur vaccine manufacture and CDC guide lines; only the numbers of doses indicated in the manufactures insert package should be drawn. After the maximum number of doses have been withdrawn, the vial should be discarded, even if there is residual vaccine or the expiration date has not been reached. patient parent have been notified and child will be vaccinated, appt scheduled for 07/15/2022. Due to the IPV vaccine incident. Center has implemented changes to prevent this error form happening again. Created a vaccine puncture log, in which every time we draw a dose from a multidose vaccine vial, we are documenting the dose umber on the log. We all are aware to only draw the doses indicated by the manufactures package insert, After the maximum number of doses have been withdrawn, the vial will be discarded, even if there is residual vaccine. The log is attached to each vaccine box. All the personal who administers vaccines have been trained of these changes.

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