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Reporte zur Charge UJ469AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
KS 1 MD 1 WA 1

VAERS 947344

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ469AA

mild
Staat
KS
Alter
75,0
Geschlecht
M
Eingang
15.01.2021
Impfdatum
15.09.2020
Beginn
17.09.2020
Tage bis Beginn
2,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Abdominal pain Diarrhoea Gastrointestinal disorder Pyrexia

Symptomtext

9/17/2020- Fever 9/18/2020- Intense watery diarrhea, abdominal pain, fever 9/19/2020- Called ER and reported continued symptoms above. Nurse in ER advises an antidiarrheal be taken. Patient follows instructions with no relief. 09/20/2020- Symptoms continue and patient goes to ER in the morning. Dr. evaluates and tells patient he does not believe the symptoms are vaccine related. Gives IV fluids for dehydration and prescribes oral medication for gastro symptoms. 09/22/2020- Patient feels fully recovered from illness.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Abdominal pain
Hospital-Tage
-
Labordaten
unknown
Aktuelle Erkrankungen
None
Vorgeschichte
Lupus
Andere Medikamente
prilosec 20mg daily losarten 100-25 daily DC Zinc MV Vit D Cosamin Iron Ocuvit "lots of vitamins"
Allergien
unknown antibiotic
Vorherige Impfungen
-

VAERS 1793493

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ469AA

gering
Staat
MD
Alter
74,0
Geschlecht
M
Eingang
16.10.2021
Impfdatum
08.10.2021
Beginn
08.10.2021
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

Patient was administered an expired vaccine with no reported A/E; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician via consumer (Regulatory authority Inquiry Number: 00807266). This case involves a 74- years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] 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 08-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ469AA and expiry date: 2021 via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "There are no side effects but since it's a different formulation, do we advise to give the 21-22 version. How long should we wait. The nurse who administered the vaccine wrote the expiration down and put expired next to it, and then proceeded to administer the vaccine. The physician stated that her facility would be documenting the event as an incident report. The patient is fine." 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 976976

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ469AA

gering
Staat
WA
Alter
86,0
Geschlecht
F
Eingang
27.01.2021
Impfdatum
05.01.2021
Beginn
05.01.2020
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

products were exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of 76 hours due to malfunction of refrigerator with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center from The Agency on 06-Jan-2021. This case involved a 86-year old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of 76 hours due to malfunction of refrigerator with no adverse event (Product storage error). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 05-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE 0.7 mL pre-filled syringe (lot number: UJ469AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. On 05-Jan-2021, it was reported that the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of 76 hours due to malfunction of refrigerator with no adverse event (Product storage error). It was an actual medication error due to product storage error. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-