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Reporte zur Charge UJ432AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 1 MD 1

VAERS 1299390

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ432AA

mild
Staat
CA
Alter
-
Geschlecht
M
Eingang
08.05.2021
Impfdatum
01.08.2020
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site mass

Symptomtext

a small lump on at injection site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00580956). This case involves a 45-year-old male patient who had a small lump on at injection site (vaccination site mass) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. In August 2020 (date not reported), the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AA and expiry date: 30-Jun-2021) via an intramuscular route in the arm for prophylactic vaccination. On an unknown date, the patient developed a non-serious a small lump on at injection site (vaccination site mass) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient recently presented to pharmacy with a small lump on his right upper arm. He stated that this bump developed at the FLUZONE injection site and has not gone away for 8 months. When providing template information, pharmacist stated that their documentation indicates that patient received vaccine in his left arm. Pharmacist states that he may have switched arms after the information was keyed into the computer. Pharmacist reported that bump was about as small as "the circle part" of a ball-point pen- definitely smaller than a dime. It was hard and painless and feels like scar tissue. The details of laboratory data were not reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the patient had not recovered from the event.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site mass
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1832488

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ432AA

gering
Staat
MD
Alter
65,0
Geschlecht
M
Eingang
01.11.2021
Impfdatum
21.10.2021
Beginn
21.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

accidently administered a dose from last year Fluzone quadrivalent that expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information (Reference number- 00822705) and transmitted to Sanofi on 21-Oct-2021 in a specific country. This case involves a 65-year-old male patient who was accidentally vaccinated with a 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from last year (lot UJ432AA and expiry date 30-Jun-2021) via intramuscular route in the right deltoid on 21-Oct-2021 for prophylactic vaccination (expired product administered). Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to expired vaccine used (latency was on same day). It was reported "Pharmacist wants to know is there anything she should warn the patient about side effect wise and do we have any recommendation as far as revaccination? Caller states that after a patient left she realized that and the patient is not experiencing any side effects." At the time of report, no adverse event 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
-