VAERS 2371884
SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge UIA451M
- Staat
- CO
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
Temperature excursion of Unopened IPOL at 24.4 F for 13 hours with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01180402 This case involves report of temperature excursion of unopened IPV (VERO) [IPOL] at 24.4 f for 13 hours with no reported adverse event while receiving vaccine. This case is linked to case 2022SA271987(Tenivac). On an unknown date, temperature excursion of unopened: ipol (lot UIA451M and expiry date: 28-FEB-2023) at 24.4 f for 13 hours with no reported adverse event (product storage error). It was reported that Caller was reporting a temperature excursion. The cause of the temperature excursion was unknown. Caller is requesting stability information on these products. Confirmed with caller that products were not administered to any patients post temperature excursion This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data the cause of the excursion was unknown. 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 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
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- Labordaten
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- Aktuelle Erkrankungen
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- Vorgeschichte
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- Andere Medikamente
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- Allergien
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- Vorherige Impfungen
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