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Reporte zur Charge UJ759AD

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 KY 1 NJ 1 TN 1 PA 1

VAERS 1850866

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge uj759ad

moderat
Staat
KY
Alter
76,0
Geschlecht
F
Eingang
08.11.2021
Impfdatum
06.11.2021
Beginn
07.11.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Fall Hypotension Lethargy

Symptomtext

Pt called 11-8-21 reporting of hypotensive event on 11-7-21 to the point of being lathargic. She reported falling from her chair and needed help back up. No other events were reported on the phone call following these events listed. I recommended patient get checkied out physicians office ASAP to address possible underlying conditions or adverse reaction.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Hypotension
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None reported
Vorgeschichte
None reported
Andere Medikamente
None listed
Allergien
-
Vorherige Impfungen
-

VAERS 1825693

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ759AD

moderat
Staat
MI
Alter
85,0
Geschlecht
M
Eingang
28.10.2021
Impfdatum
15.10.2021
Beginn
23.10.2021
Tage bis Beginn
8,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injected limb mobility decreased Pain Pain in extremity

Symptomtext

Pt states right arm pain started about 5 day ago. Explained his pain as soreness when lifting his arm, limiting his mobility of the right arm. Skin on the right deltoid area does not show any redness or swelling. Bandaid from vaccine injection site was still present and measures 4 fingers below the shoulder joint. I did lift the bandaid to inspect the injection site, again no redness, swelling, or drainage is noted. States he has been taking tylenol to treat the pain and feels the pain is increasing. He was advised to contact PCP for further evaluation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injected limb mobility decreased
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1804726

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ759AD

mild
Staat
MI
Alter
74,0
Geschlecht
F
Eingang
21.10.2021
Impfdatum
20.10.2021
Beginn
20.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site pain

Symptomtext

Patient reports mild soreness to right upper arm at the injection site on 10/20/2021 at 7:15 pm. On 10/21/2021 at 2:45 pm, there was no obvious warmth or swelling noted on exam. There was positive point tenderness of right upper arm soreness on exam.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
None needed
Aktuelle Erkrankungen
None
Vorgeschichte
Coronary Artery Disease Left Eye Glaucoma Sarcoidosis History of Hepatitis C and Cocaine Abuse
Andere Medikamente
Crestor Plavix Toprol XL
Allergien
NKA
Vorherige Impfungen
-

VAERS 2000404

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ759AD

gering
Staat
NJ
Alter
-
Geschlecht
U
Eingang
03.01.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event; Initial information received on 27-Dec-2021 regarding an unsolicited valid non-serious case received from a patient. This case involves an unknown demographics patient who experienced (product temperature excursion issue), temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event while receiving vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and while treated with TUBERCULIN TEST [TUBERSOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) (dose, formulation and strength not reported via unknown route in unknown administration site; lot - C5804AA, expiry: 03-Feb-2023, 17-Mar-2023) for Tuberculin test. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot UJ724AA, expiry: 30-Jun-2022 and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ759AD, expiry: 30-Jun-2022 via unknown route in unknown administration site (dose, formulation and strength not reported) as prophylactic vaccination. On an unknown date the patient developed a non-serious event "temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event" (product temperature excursion issue) (unknown latency) following the first dose intake of TUBERCULIN TEST, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "Caller states that a temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged. The highest temperature reached was 70.0F(Fahrenheit). The products involved were unopened: FLUBLOK QUADRIVALENT, TUBERSOL, and FLUZONE HIGH-DOSE QUADRIVALENT. Caller asked for stability information for these products." Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV), TUBERCULIN TEST (TUBERSOL) and QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. It was not reported if the patient received a corrective treatment for the event (temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event). At time of reporting, the outcome was Unknown for the event temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
TUBERSOL
Allergien
-
Vorherige Impfungen
-

VAERS 1876138

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ759AD

gering
Staat
TN
Alter
38,0
Geschlecht
F
Eingang
17.11.2021
Impfdatum
06.11.2021
Beginn
06.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Overdose Product administered to patient of inappropriate age Wrong product administered

Symptomtext

38 year old patient received fluzone high dose quadrivalent vaccine instead of flublok quadrivalent with no reported adverse event; 38 year old patient received fluzone high dose quadrivalent vaccine with no reported adverse event; 38 year old patient received fluzone high dose quadrivalent vaccine with no reported adverse event; Initial information was received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-health care professional via Agency (under reference number - 00847903). This case involves a 38-years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the flublok quadrivalent with no adverse event (Wrong product administered, Product administered to patient of inappropriate age and Overdose). The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On 06-Nov-2021, the patient received 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ759AD and expiry date 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and Overdose (latency was on same day). There were no laboratory data/results available. At the time of report, no adverse event reported. Event outcome was unknown. 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1824749

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ759AD

gering
Staat
PA
Alter
64,0
Geschlecht
M
Eingang
28.10.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via Medical Information (Reference number: 00812383) and transmitted to Sanofi on 19-Oct-2021 in the . This case involved a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided. On 18-Oct-2021, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ759AD, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose. It was reporter " Doctor calling to find out what side effects could occur from the FLUZONE HIGH DOSE QUADRIVALENT. Caller stated that he accidentally gave the vaccine to a patient that was 64 years old. Caller wanting to know comparison of flu vaccines as well." No other vaccines. At the time of this report the patient was fine and had no adverse events after the vaccination. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-