VAERS Reports R1B251N

VAERS 1235847

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge R1B251N

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Staat: CA
Alter: 5,0
Geschlecht: F
Eingang: 21.04.2021
Impfdatum: 31.03.2021
Beginn: 31.03.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

expired dose of Ipol was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (GMI) (Reference number- 00544923) and transmitted to Sanofi on 01-Apr-2021. This case involves a 5-year-old female patient who administered expired dose of IPV (VERO) [IPOL] (Expired product administered). The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided. On 31-Mar-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) [lot R1B251N, expiry date: 13-Mar-2021] via an intramuscular route at a left arm for prophylactic vaccination. It was a case actual medication error due expired product administered. [Latency: at the same time of vaccination]. It was reported that, a clinic was want guidance after an expired dose of Ipol was administered. Product used : Used Still using product : No. At the time of report, 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 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. There will be no information available on the batch number for this case.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1227289

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge R1B251N

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Staat: OR
Alter: 9,0
Geschlecht: F
Eingang: 18.04.2021
Impfdatum: 30.03.2021
Beginn: 30.03.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered Product storage error

Symptomtext

expired dose of Ipol was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional (Reference number- 00541462) and transmitted to Sanofi on 30-Mar-2021. This case involves a 9-year-old female patient who received expired dose of POLIOMYELITIS VACCINE (INACTIVATED) (ipol)) [lot R1B251N and expiry date:13-Mar-2021] via an unknown route at an unknown administration site for prophylactic vaccination on 30-Mar-2021. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to expired vaccine used (Latency: on the same day). At the time of report, 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 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. There will be no information available on the batch number for this case.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -