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Reporte zur Charge UJ919AD

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

23Reporte angezeigt
0Todesfaelle
3Hospitalisiert
1Lebensbedrohlich
3Bleibende Schaeden
CA 5 OR 3 MT 2 MN 2 AZ 1 AK 1 WA 1 TN 1 IN 1 IA 1 OK 1 MA 1

VAERS 2505891

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

schwer
Staat
AZ
Alter
70,0
Geschlecht
M
Eingang
11.11.2022
Impfdatum
19.10.2022
Beginn
24.10.2022
Tage bis Beginn
5,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: ja ER: ja Erholt: nein
Asthenia Balance disorder Endotracheal intubation Hypotonia Immunoglobulin therapy Laboratory test Lumbar puncture normal Magnetic resonance imaging spinal normal Muscular weakness Paraesthesia Plasmapheresis Syncope Tracheostomy

Symptomtext

Four days after receiving flu vaccine (10/23/2023), patient started feeling pins and needles in his hands and his toes and then started getting weakness. On 10/28/2023, patient presented to emergency room; he got to the point where he could not hold himself up and collapsed as his legs were so weak. Patient was admitted for further work up. Providers believe possible Guillan-Barre syndrome possibly from influenza vaccine. During this admission, patient has received 0.4 g/kg IVIG x5 days (completed 11/2), followed by 7 days of plasmapheresis (completed 11/10). Patient was intubated (11/1) during hospital admission and ultimately received trachostomy (11/7). As of 11/11, patient is still with bilater lower extremity flaccid, although patient reports sensation. Upper extremities +2 off of the bed, but very weak, equal bilateral. Can raise shoulders. Can stick out tongue.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syncope
Hospital-Tage
15,0
Labordaten
MRI of lumber spine (10/28) = no acute changes MRI of spine (10/29) negative for cord compression LP (10/31) = negative for anything significant further labs pending per neurology
Aktuelle Erkrankungen
-
Vorgeschichte
COPD, pulmonary fibrosis, hypertension
Andere Medikamente
albuterol, budesonide/formoterol, nintedanib, olmesartan, pantoprazole, rosuvastatin
Allergien
-
Vorherige Impfungen
-

VAERS 2464936

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

schwer
Staat
CA
Alter
75,0
Geschlecht
M
Eingang
11.10.2022
Impfdatum
28.09.2022
Beginn
28.09.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: unbekannt
Cerebral small vessel ischaemic disease Computerised tomogram head normal Confusional state Lacunar infarction Tremor Seizure Urinary incontinence

Symptomtext

I am retired MD. About 6 hours after vaccine, I experienced moderate to severe symmetrical upper body and upper extremity trembling (no frank tremor or seizure activity) that was almost gone within an hour. I then went to sleep, awakening about an hour later with mild confusion although oriented x3, and noticed incontinence of urine. Still no seizure activity. The confusion resolved indicated a possible generalized seizure - No previous history of seizures - So I had my wife dive me to ER. After workup, I was released to home and told no driving till cleared by Neurologist.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure
Hospital-Tage
-
Labordaten
All on 09/29/2022 all Normal except as noted. Head CT w/o contract normal except one caudate chronic 5MM Lacunar infarct and white matter microvascular ischemic changes consistent
Aktuelle Erkrankungen
None
Vorgeschichte
Coronary Artery Disease, GERD, Sciatica, Dysphagia, All stable
Andere Medikamente
See Attached
Allergien
None
Vorherige Impfungen
-

VAERS 2477375

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

moderat
Staat
MT
Alter
76,0
Geschlecht
M
Eingang
16.11.2022
Impfdatum
10.10.2022
Beginn
11.10.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: ja ER: ja Erholt: nein
Adverse drug reaction Asthenia Axillary pain Back pain Bradykinesia Blister Fatigue Malaise Chest X-ray Cogwheel rigidity Computerised tomogram head Dehydration Dizziness Dysgraphia Electrocardiogram Full blood count Gait disturbance Herpes zoster

Symptomtext

10/12/22 and 10/13/22: seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home. 11/1/22 Seen in ER for: Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr. 11/16/22 Follow up with FNP,

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dehydration
Hospital-Tage
4,0
Labordaten
EKG, CXR, Head CT, UA, CBC, CMP, ESR
Aktuelle Erkrankungen
No acute illness at time of vaccines or within the prior month
Vorgeschichte
Depression,Arthritis,Vertigo, TIA, LUTS,
Andere Medikamente
ASA,Buproprion,Citalopram,Clopidogrel,Simvastatin,Vit D3,Vit B
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2477375

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

moderat
Staat
MT
Alter
76,0
Geschlecht
M
Eingang
16.11.2022
Impfdatum
10.10.2022
Beginn
11.10.2022
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: ja ER: ja Erholt: nein
Adverse drug reaction Asthenia Axillary pain Back pain Bradykinesia Blister Fatigue Malaise Chest X-ray Cogwheel rigidity Computerised tomogram head Dehydration Dizziness Dysgraphia Electrocardiogram Full blood count Gait disturbance Herpes zoster

Symptomtext

10/12/22 and 10/13/22: seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home. 11/1/22 Seen in ER for: Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr. 11/16/22 Follow up with FNP,

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dehydration
Hospital-Tage
4,0
Labordaten
EKG, CXR, Head CT, UA, CBC, CMP, ESR
Aktuelle Erkrankungen
No acute illness at time of vaccines or within the prior month
Vorgeschichte
Depression,Arthritis,Vertigo, TIA, LUTS,
Andere Medikamente
ASA,Buproprion,Citalopram,Clopidogrel,Simvastatin,Vit D3,Vit B
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2498156

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

moderat
Staat
OR
Alter
82,0
Geschlecht
M
Eingang
03.11.2022
Impfdatum
31.10.2022
Beginn
31.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Hyperhidrosis Hypoacusis Migraine Photopsia Tremor Visual impairment

Symptomtext

Patient states that 5 hours after receiving flu vaccine on 10/31/22 patient began having reaction. Migraine started in back of head, went to eyebrows, whole head aching pain. Hearing became "staticky like an old radio." Sight got dark with flashes of light. Persisted for 45 minutes. Patient also shook for 3 hours even though not cold. Wife thought patient was having seizure because patient was shaking. Patient was sweating. Patient states this is the sixth year patient has had these symptoms the evening after getting flu vaccine. Last two years have been the worst.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Migraine
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
-
Vorgeschichte
gout vitiligo LUTS actinic keratosis essential HTN ischemic cardiomyopathy senile purpura Hx of squamous cell carcinoma
Andere Medikamente
alfuzosin 10mg allopurinol 100mg atorvastatin 10mg coenzyme Q10 entresto 24 mg ferrous gluconate flaxseed oil fluticasone metoprolol 25mg mirabegron 50mg spironolactone 25mg
Allergien
NKDA
Vorherige Impfungen
patient reports similar reactions from high dose influenza vaccines for past six years

VAERS 2507335

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

mild
Staat
CA
Alter
80,0
Geschlecht
M
Eingang
14.11.2022
Impfdatum
09.11.2022
Beginn
-
Tage bis Beginn
-
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered Fatigue

Symptomtext

PT CAME TO THE PHARMACY AND ASKED FOR THE FLU SHOT. HE WAS GIVEN FLUZONE HD. AFTERWARD WE FOUND HE HAD ALREADY HD ONE IN OCTOBER AND HE DIDN'T KNOW AND HAD CAME FOR A SECOND ONE. i IMMIDIETLY CALLED THE PATIENT TALKED WITH HIM, CONSULTED THAT IF HE HAS ANY REACTION CALL EMS IMMIDIETLY AND HAVE SOME BENADRYL HANDY . HE SAID HE IS DOING OK AND HAS NO PROBLEMS. I CHECKED ON HIM 4 TIMES THAT DAY ( 11/9/220 AND TODAY AGAIN I CALLED HIM TWICE AND HE IS DOING GREAT . HE ONLY SAID HE FEEELS A LITTLE TIRED BUT HE HAD JUST CAME BACK FROM A WALK

Weitere VAERSDATA-Felder
Praegender Schweregrund
Fatigue
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
NONE
Vorgeschichte
-
Andere Medikamente
TAMSULOSIN, PROPRANOLOL, FAMOTIDINE, PRAVASTATIN, DUTASTERIDE, ASPIRIN, MAGNESIUM OXIDE, ALEANDRONATE, ISOSORBIDE
Allergien
NO KNOWN ALLERGIES
Vorherige Impfungen
-

VAERS 2478609

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

mild
Staat
AK
Alter
68,0
Geschlecht
F
Eingang
14.10.2022
Impfdatum
26.09.2022
Beginn
26.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site pain

Symptomtext

Pain in upper shoulder soon after following immunization. Pain started soon after immunization. Patient taking Ibuprofen, applying ice and heat to affected area for comfort.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
Physical examination. Referral from physician at Urgent Care Clinic to go to Physical Therapy.
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
Gluten
Vorherige Impfungen
-

VAERS 2470322

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

mild
Staat
WA
Alter
87,0
Geschlecht
M
Eingang
05.10.2022
Impfdatum
29.09.2022
Beginn
03.10.2022
Tage bis Beginn
4,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site rash

Symptomtext

Patient called the pharmacy on 10/5/22 stating that he started to notice a rash developing on his arm near the injection site around 10/3/22. He stated that today the rash has grown in size but has not caused more discomfort. He has had Fluzone-HD in the past with no issues.

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

VAERS 2506584

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
TN
Alter
65,0
Geschlecht
M
Eingang
12.11.2022
Impfdatum
07.11.2022
Beginn
07.11.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

temperature excursion due to a power outage, normal fridge temperature stays around 41 F, the temperature was 49 F when they discovered the vaccines after the power outage, with no reported adverse event; The FLUZONE HD QIV has been administered post excursion, with no reported adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 65-year-old male patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] has been administered post excursion and temperature excursion due to a power outage, normal fridge temperature stays around 41 F, the temperature was 49 F when they discovered the vaccines after the power outage, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2022, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) (lot number: UJ919AD and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization and it has been administered post excursion, with no reported adverse event (poor quality product administered) (latency: same day) and temperature excursion due to a power outage, normal fridge temperature stays around 41 f, the temperature was 49 f when they discovered the vaccines after the power outage, with no reported adverse event (product storage error. It was reported, they are not sure what the temperature reached over the weekend. They are not sure if the temperature went any higher than that. They were told that the power was out for approximately 6 hours. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. This situation is reported as a medication error due to the possible inappropriate administration of FLUZONE HD QIV to a patient post excursion. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. At time of reporting, the outcome was Unknown for both events. 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 2492212

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
MN
Alter
64,0
Geschlecht
F
Eingang
28.10.2022
Impfdatum
19.10.2022
Beginn
19.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

64 year old patients were given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported ae; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 64 years old female patient who was given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE). On 19-Oct-2022, the patient received a dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ919AD) (Frequency: once ) (Strength: Fluzone HD ) (expiry date: 30-Jun-2023) (formulation was unknown) via intramuscular route in the right deltoid as prophylactic vaccination. On 19-OCT-2022 the patient was given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported adverse event (Product administered to patient of inappropriate age) (latency: same day). Action taken: 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2492211

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
MN
Alter
64,0
Geschlecht
M
Eingang
28.10.2022
Impfdatum
19.10.2022
Beginn
19.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

64 year old patient given FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 64 years old male patient who was given fluzone high-dose quadrivalent with no reported adverse event while 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. Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for Immunisation. On 19-Oct-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ919AD and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination. On 19-Oct-2022, (latency: same day) the 64 year old patient was given fluzone high-dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported, two 64 year old patients were given FLUZONE HIGH-DOSE QUADRIVALENT per their request when they declined FLUZONE QIV. Action taken 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.; Sender's Comments: US-SA-2022SA439832:

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

VAERS 2486397

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
IN
Alter
69,0
Geschlecht
M
Eingang
22.10.2022
Impfdatum
05.10.2022
Beginn
05.10.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Feeling abnormal Nasopharyngitis

Symptomtext

That evening he started feeling "lousy" and proceeded into a really bad cold. As of today, 10;22.22 , it has only gotten a little better. He states he was not around anyone else that could have just given him a cold, without getting the flu shot.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Feeling abnormal
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
1 & 1/2 weeks before the vaccination he had the stomach flu, but this was cleared up before he got the vaccination.
Vorgeschichte
None
Andere Medikamente
Chlorhexidine oral rinse, Furosemide 40mg, Lisinopril 20mg, Potassium Chloride 20meq, Propranolol 40mg, Rosuvastatin 20mg.
Allergien
No known allergies.
Vorherige Impfungen
-

VAERS 2486164

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
IA
Alter
51,0
Geschlecht
F
Eingang
22.10.2022
Impfdatum
17.10.2022
Beginn
17.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

A fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 51 years old female patient to whom fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2022, the patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ919AD, expiry-30-06-23) (strength: unknown) via intramuscular route in the left deltoid for immunization. On 17-OCT-2022 the patient developed a non-serious a fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event (product administered to patient of inappropriate age) (latency same day) Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2483538

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
OR
Alter
56,0
Geschlecht
F
Eingang
19.10.2022
Impfdatum
16.10.2022
Beginn
01.10.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Dry mouth Product administered to patient of inappropriate age

Symptomtext

Patient (age 56) was accidentally given Fluzone HD while not indicated for it. The pharmacy contacted the patient to communicate that an error had occurred. The only issue the patient described was that of a dry mouth at the time of call on October 19th, 2022 but feeling fine, otherwise.

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

VAERS 2482185

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge uj919ad

gering
Staat
OR
Alter
61,0
Geschlecht
M
Eingang
18.10.2022
Impfdatum
18.10.2022
Beginn
01.10.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

PATIENT 61 WAS GIVEN THE HIGH DOSE FLUZONE, PT WAS CONTACTED LATER IN THE EVENING AND FEELS FINE WITH NO SIDE EFFECTS

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

VAERS 2480419

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
-
Alter
51,0
Geschlecht
M
Eingang
17.10.2022
Impfdatum
17.10.2022
Beginn
17.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Patient was administered high-dose flu shot instead of fluzone quadrivalent dose (age appropriate dose).

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
HIV, high blood pressure, hypothyroidism, hyperlipidemia
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2478586

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
CA
Alter
38,0
Geschlecht
F
Eingang
14.10.2022
Impfdatum
14.10.2022
Beginn
14.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

PT WAS SUPPOSED TO RECIEVE THE NEW MODERNA BIVALENT BOOSTER. HOWEVER, INSTEAD NURS ADMINISTERED FLUZONE HD

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

VAERS 2477381

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
CA
Alter
64,0
Geschlecht
F
Eingang
13.10.2022
Impfdatum
06.10.2022
Beginn
06.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

PATIENT ADMINISTERED THE HIGH DOSE FLU SHOT WHEN INELIGIBLE DUE TO AGE. PATIENT IS 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 2476510

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
OK
Alter
60,0
Geschlecht
M
Eingang
12.10.2022
Impfdatum
11.10.2022
Beginn
11.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

Patient was administered the high dose vaccine when he wasn't eligible. Patient experienced no adverse effects.

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

VAERS 2473072

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
-
Alter
61,0
Geschlecht
F
Eingang
09.10.2022
Impfdatum
05.10.2022
Beginn
01.10.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

At the time of the vaccination no sign of adverse symptoms or signs

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

VAERS 2470298

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge uj919ad

gering
Staat
MA
Alter
70,0
Geschlecht
M
Eingang
05.10.2022
Impfdatum
05.10.2022
Beginn
05.10.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect dose administered Syringe issue

Symptomtext

The safety needle was not tightly attached to the syringe and patient did not get the full dose. patient did not have any symptoms or side effect and he is aware of the incident

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
nka
Vorherige Impfungen
-

VAERS 2469356

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
NV
Alter
76,0
Geschlecht
F
Eingang
04.10.2022
Impfdatum
29.09.2022
Beginn
30.09.2022
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Asthenia Feeling abnormal Gait disturbance

Symptomtext

The patient reported to me that approximately 8-10 hours after receiving the vaccine, she experienced what she described as "whole body weakness", brain fog, and having an unstable gait. This lasted for approximately 24 hours, and she began to feel better thereafter.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Asthenia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none reported.
Vorgeschichte
-
Andere Medikamente
-
Allergien
NSAIDS, phenothiazines, sulfa antibiotics, tetracycline, iodides, iodine, dapsone, diltiazem.
Vorherige Impfungen
-

VAERS 2467790

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ919AD

gering
Staat
CA
Alter
77,0
Geschlecht
F
Eingang
03.10.2022
Impfdatum
03.10.2022
Beginn
03.10.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Medication error No adverse event

Symptomtext

PATIENT RECEIVED A SECOND DOSE OF FLUZONE HD WITHIN A YEAR DUE TO MISCOMMUNICATION FROM PATIENT TO STAFF DESPITE MULTIPLE ATTEMPT TO VERIFY THE VACCINE THE PATIENT WANTS THAT DAY. UPON CLARIFICATION AFTER ADMINISTRATION AND PATIENT ALREADY WENT HOME, PATIENT ORIGINALLY WANTED A COVID BOOSTER SHOT BUT FAILED TO COMMUNICATE IT CLEARLY WHEN ASKED BY PHARMACY STAFF. THE MEDICATION ERROR WAS DISCOVERED UPON THIRD-PARTY REJECTION FROM INSURANCE PLAN SAYING THAT THE PATIENT GOT A DOSE OF FLUZONE HD ALREADY ONE MONTH PRIOR. PATIENT WAS CONTACTED AND THE ISSUE WAS REVIEWED WITH THE PATIENT. PATIENT IS AWARE OF THE ERROR AND REPORTS NO ADVERSE EFFECTS THUS FAR. PATIENT AND PATIENT'S FAMILY MEMBER ARE AWARE OF THE MEDICATION ERROR.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
UNKNOWN
Vorgeschichte
UNKNOWN
Andere Medikamente
AMLODIPINE FLUCONAZOLE PRILOSEC
Allergien
QUINOLONES - NO REACTION DOCUMENTED
Vorherige Impfungen
-