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Reporte zur Charge U J748AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

14Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 3 TX 2 NC 2 KS 2 GA 1 TN 1 FL 1 KY 1

VAERS 1868488

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

moderat
Staat
TX
Alter
90,0
Geschlecht
M
Eingang
14.11.2021
Impfdatum
11.11.2021
Beginn
11.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Gait disturbance Movement disorder Tremor

Symptomtext

Information provided by the son. The patient experienced shaking of the hands, sitting in a chair and stomping his feet, slow to walk, both shoulders were hurting, and put both arms up around his neck. The son stated they called the family physician and he recommended to take tylenol. The patient took the tylenol and is doing much better as reported by the son.

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

VAERS 1756947

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

moderat
Staat
GA
Alter
65,0
Geschlecht
F
Eingang
02.10.2021
Impfdatum
22.09.2021
Beginn
23.09.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Neuralgia Paraesthesia

Symptomtext

Tingling down left arm that patient determines is nerve pain that goes from left shoulder to fingertips

Weitere VAERSDATA-Felder
Praegender Schweregrund
Paraesthesia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
Hydrochlorothiazide 12.5mg, enalapril 20mg pop
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1925868

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

mild
Staat
TN
Alter
68,0
Geschlecht
F
Eingang
06.12.2021
Impfdatum
01.12.2021
Beginn
02.12.2021
Tage bis Beginn
1,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Injection site erythema Injection site swelling

Symptomtext

Erythema and swelling below injection site

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

VAERS 1836813

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

mild
Staat
TX
Alter
74,0
Geschlecht
M
Eingang
02.11.2021
Impfdatum
31.10.2021
Beginn
31.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Back pain Impaired driving ability Pain

Symptomtext

After the vaccine, about 10 minutes, my lower back experienced an intense throbbing pain, so much that I could not drive. I waited about 10 minutes until pain subsided. I drove home and the pain is gone, but my lower back is still sore.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Back pain
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
NoneBa
Vorgeschichte
None
Andere Medikamente
Prescriptions: Levothyroxine; Omeprazole; Clonazepam; Buspirone; and Tamsulosin HCL Dietary Supplements: Fish Oil; Cranberry w/Vitamin C' Milk Thistle; Melatonin;; Multivitamin
Allergien
Medications: Tetanus Vaccine Food and Others: Melons; Bananas; Raw Bananas; Raw Nuts; Avacados; Dust; Bermuda Grass
Vorherige Impfungen
Tetanus Vaccine 17 years old

VAERS 1776720

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

mild
Staat
-
Alter
71,0
Geschlecht
F
Eingang
11.10.2021
Impfdatum
08.10.2021
Beginn
09.10.2021
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Local reaction Pain in extremity Peripheral swelling Skin warm

Symptomtext

Patient came in Friday 10/8/21 at around 1030 for her yearly influenza vaccine. She had minimal arm soreness on Friday evening. On Saturday she noted that her arm was quite red, warm, and painful and was swollen "the size of a baseball". She did take a Benadryl that evening at the advice of her daughter which did help her sleep. On Sunday morning, her arm was still warm and red with some swelling but the swelling was improved. On Monday, her arm is still slightly red and slightly warm but overall much better. Patient never had systemic reaction just localized reaction. She will call if symptoms worsen or do not resolve.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain in extremity
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1768590

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge U J748AA

mild
Staat
FL
Alter
66,0
Geschlecht
F
Eingang
07.10.2021
Impfdatum
29.09.2021
Beginn
29.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Back pain Chills

Symptomtext

Severe chills 8:15, sharp mid- back pain 8:45

Weitere VAERSDATA-Felder
Praegender Schweregrund
Back pain
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
Diabetes, depression, insomnia, hypertension
Andere Medikamente
Metformin, amlodipine, bupropion, citalopram, trazadone, levothyroxine Calcium, vit D, vit A, fish oil, B complex, iron
Allergien
Sulfa
Vorherige Impfungen
-

VAERS 2483754

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
CA
Alter
65,0
Geschlecht
F
Eingang
20.10.2022
Impfdatum
06.10.2022
Beginn
06.10.2022
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 Medication error No adverse event

Symptomtext

accidental administration of expired FLUZONE HIGH DOSE vaccine by an HCP with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2022SA419905(CLUSTER) and 2022SA420369(CLUSTER). This case involves a 65 years old female patient who had accidental administration of expired fluzone high dose vaccine by an health care professional(hcp) with no reported adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Oct-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( lot UJ748AA and expiration date: 30-Jun-2022) at a dose of 0.7ml once via intramuscular route in the left deltoid for immunization. On 06-Oct-2022(latency: same day), the patient had accidental administration of expired fluzone high dose vaccine by an hcp with no reported adverse event (expired product administered) . Action taken :not applicable. It was not reported if the patient received a corrective treatment for the event. Outcome: 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 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 2482596

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
CA
Alter
-
Geschlecht
F
Eingang
19.10.2022
Impfdatum
06.10.2022
Beginn
06.10.2022
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

accidentally administered expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022 with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2022SA417918(CLUSTER), 2022SA419905(CLUSTER) and 2022SA419905(CLUSTER). This case involves an unknown age female patient who accidentally received last year's expired dose of fluzone high dose with no reported adverse event. (Influenza quadrival A-B high dose HV vaccine) [Fluzone high-dose quadrivalent]. The patient's past medical history, medical treatment(s) and family history were not provided. On 06-Oct-2022, the patient accidentally received last year's expired dose of influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (0.7 ml 1X)(lot number: UJ748AA; expiry date : 30-Jun-2022: strength, formulation unknown) via unknown route in left deltoid for immunization, with no reported adverse event (expired product administered) (latency : same day). It was reported Pharmacist reporting that 3 patients accidentally received last year's expired dose of FLUZONE HIGH DOSE and requesting revaccination recommendations regarding dosing and timing of administration. A nurse practitioner (same as prescriber) accidentally administered 3 expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022. The pharmacist identified the administration of expired products today, 10OCT2022, stating that she did not know "why last year's formulation was in the fridge." Pharmacist inquired what the recommendations are for the timing and need for revaccination with current FLUZONE HIGH DOSE QIV. SRDs emailed to requestor. Pharmacist denied any untoward effects from the administration of the expired vaccines at this time and advised that the patients would be revaccinated with current FLUZONE HIGH DOSE QIV Action taken with was not applicable. 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
-

VAERS 2479464

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
CA
Alter
-
Geschlecht
F
Eingang
15.10.2022
Impfdatum
06.10.2022
Beginn
06.10.2022
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 Incorrect product formulation administered No adverse event Product storage error

Symptomtext

accidentally received last year's expired dose of fluzone high dose with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2022SA417918(Cluster) and 2022SA420369(Cluster). This case involves an unknown age female patient who accidentally received last year's expired dose of fluzone high dose with no reported adverse event. (Influenza quadrival A-B high dose HV vaccine) [Fluzone high-dose quadrivalent. The patient's past medical history, medical treatment(s) and family history were not provided. On 06-Oct-2022, the patient accidentally received last year's expired dose of influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (0.7 ml 1X)(lot number: UJ748AA; expiry date : 30-Jun-2022: strength, formulation unknown) via unknown route in left deltoid for immunization, with no reported adverse event (expired product administered)(latency : same day). It was reported Pharmacist reporting that 3 patients accidentally received last year's expired dose of FLUZONE HIGH DOSE and requesting revaccination recommendations regarding dosing and timing of administration. A nurse practitioner (same as prescriber) accidentally administered 3 expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022. The pharmacist identified the administration of expired products today, 10OCT2022, stating that she did not know "why last year's formulation was in the fridge." Pharmacist inquired what the recommendations are for the timing and need for revaccination with current FLUZONE HIGH DOSE QIV. SRDs emailed to requestor. Pharmacist denied any untoward effects from the administration of the expired vaccines at this time and advised that the patients would be revaccinated with current FLUZONE HIGH DOSE QIV Action taken with was not applicable. 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
-

VAERS 1887861

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
NC
Alter
79,0
Geschlecht
F
Eingang
20.11.2021
Impfdatum
05.11.2021
Beginn
05.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product storage error

Symptomtext

FLUZONE HIGH DOSE was administered to one patient post-excursion and temperature excursion was negative 3 degree Celsius for 14 hours, no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via consumer/non-health care professional via Medical Information (Reference number- 00852572) and transmitted to Sanofi on 10-Nov-2021. This case involves a 79 years 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 excursion of negative 3 degree Celsius (C) for 14 hours (Product storage error) The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On 05-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection) produced by Sanofi Pasteur (lot number: UJ748AA and expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to product storage error temperature too low (latency same day). It was reported "Director of nursing reports a temperature excursion for FLUZONE HIGH DOSE; temperature excursion was negative 3C; total time of excursion was 14 hours; temperature excursion caused because there was a heating outage in the building and they were experiencing a cold front in their area. Director of nursing asks for stability information. Director of nursing states FLUZONE HIGH DOSE was administered to 1 patient post-excursion; asks if the patient needs to be re-vaccinated. Treatment. Director of nursing states the patient had no reaction post administration and did not require treatment. director of nursing states that patient was not pregnant at time of FLUZONE HIGH DOSE administration" 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1851038

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
NC
Alter
79,0
Geschlecht
F
Eingang
08.11.2021
Impfdatum
05.11.2021
Beginn
05.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product storage error

Symptomtext

Patient received vaccine that was involved with a Temperature excursion and was not deemed viable by manufacturer to use.

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

VAERS 1808035

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
KS
Alter
64,0
Geschlecht
F
Eingang
22.10.2021
Impfdatum
13.10.2021
Beginn
13.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Patient got a High Dose Flu Vaccine and should of received a regular dose due to only being 64 years old.

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

VAERS 1793451

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
KY
Alter
69,0
Geschlecht
M
Eingang
16.10.2021
Impfdatum
27.09.2021
Beginn
27.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administration error

Symptomtext

received a vaccination of fluzone high-dose quadrivalent after the physician was informed that it was no longer suitable for use/ no AE; Initial information was received on 01-OCT-2021 regarding an unsolicited valid non-serious case received from a Physician (Reference number- 00794512) and transmitted to Sanofi on 01-OCT-2021. This case involves a 69-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after the physician was informed that it was no longer suitable for use with no adverse event (Product administration error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 27-Sep-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ748AA and expiry date 30-Jun-2022] via unknown route in unknown administration site for prophylactic vaccination. It was reported "Caller states that a patient received a vaccination of FLUZONE HIGH-DOSE QUADRIVALENT on 27SEP2021 after the physician was informed that it was no longer suitable for use." It was a case of actual medication error due to Drug administration error (latency was on same day). At the time of reporting, patient had no adverse 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 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1779372

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ748AA

gering
Staat
KS
Alter
60,0
Geschlecht
F
Eingang
12.10.2021
Impfdatum
05.10.2021
Beginn
05.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Product administered to patient of inappropriate age

Symptomtext

Client received the Fluzone High Dose Quadrivalent instead of the regular Fluzone Quadrivalent which should of been administered due to her being under 65 years of age. No adverse reactions noted from client at this time.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-