VAERS Reports UT7108KA

VAERS 1856899

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7108KA

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Staat: VA
Alter: 48,0
Geschlecht: F
Eingang: 10.11.2021
Impfdatum: 29.10.2021
Beginn: 29.10.2021
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

patient received an expired dose, with no reported adverse event; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via consumer via phone call (under Medical Information Inquiry Number: 00834434) in a specific country. This case involves a 48 years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event (expired product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On 29-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled) (lot number: UT7108KA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency: same day). It was reported "How do we handle it; health care professional (HCP) reporting a patient who received an expired dose of FLUZONE QUADRIVALENT (prefilled); caller would like counselling on revaccination process and adverse effects to look out for." 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 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 943567

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7108KA

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Staat: -
Alter: -
Geschlecht: U
Eingang: 14.01.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Axillary mass

Symptomtext

incredible allergic reaction causing plum sized lump in lymph glands in the armpit; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves patient who experienced incredible allergic reaction causing plum sized lump in lymph glands in the armpit (axillary mass), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE 2020-2021 (lot UT7108KA and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious incredible allergic reaction causing plum sized lump in lymph glands in the armpit (axillary mass) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the reports, the outcome was not reported for the event axillary mass.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Axillary mass
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -