VAERS Reports UJ394AA

VAERS 2507535

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ394AA

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Staat: WI
Alter: 72,0
Geschlecht: F
Eingang: 14.11.2022
Impfdatum: 10.11.2022
Beginn: 10.11.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Extra dose administered

Symptomtext

Patient was given a second flu shot during the same flu season. She received a Flulaval Vaccine on 10/22/2022 from her doctor's office and then received a Fluzone High Dose vaccine on 11/10/2022 from the health department. Nurse received verbal consent from client to do the flu shot on 11/10, but patient must have forgotten that she received the flu shot already. It was discovered during data entry that client had already gotten the flu shot. Nursing facility where patient resides was notified.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: Unknown
Allergien: -
Vorherige Impfungen: -

VAERS 1115361

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ394AA

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Staat: FL
Alter: -
Geschlecht: F
Eingang: 19.03.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Product preparation error

Symptomtext

The medical assistant forgot to mix the liquid with the powdered ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician. This case involves a four-month-old female patient who received only the liquid portion of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension for injection, lot UJ394AA and expiry date not reported) via an intramuscular route in an unknown administration site for prophylactic vaccination on an unknown date (product preparation issue). The medical assistant forgot to mix the liquid with the powdered ACT-HIB. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day). At the time of reporting, 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 holders 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: Product preparation error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ROTAVIRUS VACCINE; PREVNAR 13
Allergien: -
Vorherige Impfungen: -