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Reporte zur Charge U7045DA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 2

VAERS 1035627

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge U7045DA

mild
Staat
CA
Alter
32,0
Geschlecht
M
Eingang
17.02.2021
Impfdatum
01.12.2020
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Arthralgia Asthenia Magnetic resonance imaging normal Pain

Symptomtext

right shoulder pain/ patient complaining of scapular pain; patchy weakness and pain in the upper body; patchy weakness and pain in the upper body; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via Agency (under reference number US-SANOFI-00457309). This case involves a 32 years old male patient who experienced right shoulder pain/ complaining of scapular pain (arthralgia) and patchy weakness and pain in the upper body (pain) (asthenia), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date in December 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot U7045DA and expiration date not reported) via intramuscular route in the right deltoid for prophylactic vaccination. On an unknown date, the patient reported at the neurology office having right shoulder pain/ complaining of scapular pain (arthralgia) and patchy weakness and pain in the upper body (pain) (asthenia), 2-3 weeks after administration. Patient has had an MRI (Magnetic resonance imaging) on an unknown date which was unremarkable. Treatment included OT and PT (Physical and Occupational Therapy). At the time of reporting the patient did not recovered from any of the events.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Arthralgia
Hospital-Tage
-
Labordaten
Test Name: MRI; Result Unstructured Data: MRI which was unremarkable
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1774874

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge U7045DA

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
09.10.2021
Impfdatum
01.10.2021
Beginn
01.10.2021
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 Medication error

Symptomtext

received FLUZONE QIV NP vaccinations from single-dose vials that had expired with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under the reference 00798634). This case involves ten patients (unknown age and gender) who had received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from single-dose vials that had expired (expired product administered). The patients' past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 01-Oct-2021, the patients received a dose of suspect INFLUENZA QUADRIVAL (0.5 ml, single dose vial, lot U7045DA and expiration date: 30-Jun-2021) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine administered (same day latency). It was reported "Caller states that ten employees at her facility received FLUZONE QIV NP vaccinations on 01OCT2021 from single-dose vials that had expired on 30JUN2021. Caller asked whether or not those doses counted or if the employees should be revaccinated." 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.

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