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Reporte zur Charge UJ455AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

13Reporte angezeigt
0Todesfaelle
1Hospitalisiert
1Lebensbedrohlich
2Bleibende Schaeden
TN 4 NJ 3 MI 2 IN 2 WI 1 OH 1

VAERS 1110452

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

mild
Staat
WI
Alter
59,0
Geschlecht
F
Eingang
18.03.2021
Impfdatum
24.09.2020
Beginn
29.09.2020
Tage bis Beginn
5,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: ja ER: unbekannt Erholt: ja
Angiogram cerebral Blood pressure increased Blood thyroid stimulating hormone decreased Cerebellar infarction Computerised tomogram abnormal Dizziness Headache Hyponatraemia Subarachnoid haemorrhage Vasospasm

Symptomtext

On 9/29/2020, 5 days after dual vaccine at routine appt in the clinic and 2 hours PTA to ER, she had acute onset headache that was rapidly progressive over 15 minutes. NO focal deficits on exam in ER. CT scan confirmed "Acute diffuse subarachnoid hemorrhage most prominently noted in the suprasellar cistern extending into the fourth ventricle, sylvian fissures, quadrigeminal plate cistern, and cerebellar pontine angles suggestive of the aneurysmal rupture." There was no evidence for aneurysm. BP was elevated to max of 158/92 in ER. She was admitted to the hospital from 9/29/20-10/18/20 with consultations from neurosurgery and PM&R. After hospital admission, she developed vasospasm and was treated with 3% saline and nimodipine. She had 6 total catheter angiograms for diagnosis and IA verapamil infusions for vasospasm. On 10/9/2020, she developed large left cerebellar infarct with small foci of infarct throughout bilateral hemispheres due to vasospasm. She developed hyponatremia and was treated for that. She never required surgical intervention. TSH was normal prior to admission (9/12/20 was 1.99) and during hospital was found to be 0.18 and therefore levothyroxine was decreased to 100mcg. She is overall doing quite well now with ongoing chronic headaches, managed on TCA, and dizziness for which she has seen PT.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
20,0
Labordaten
as above
Aktuelle Erkrankungen
none known
Vorgeschichte
? Acquired short leg syndrome on left (8mm femur & 11mm sacral base) 04/10/2014 ? OSA on CPAP, ahi-56.8, al-2020 03/09/2020 ? PONV (postoperative nausea and vomiting) 06/11/2019 ? Spinal stenosis of lumbar region with neurogenic claudication 04/11/2019 ? Lumbar spine instability 03/11/2019 ? Degenerative spondylolisthesis 03/11/2019 ? Neuralgia of left sciatic nerve 02/19/2019 ? Acute right-sided low back pain with right-sided sciatica 10/23/2017 ? Lumbosacral spondylosis without myelopathy 09/28/2017 ? Cervical stenosis of spine 07/28/2016 ? Cervical radiculopathy 06/08/2016 ? Cervical spondylosis without myelopathy 05/26/2016 ? Migraine headache ? Postmenopausal ? Iatrogenic hypothyroidism ? Chronic rhinitis ? Esophageal reflux ? Psoriatic arthropathy (*) ? Sacroiliac joint dysfunction of both sides 11/22/2013 ? Lumbago 10/10/2013 ? Sciatica 10/10/2013 ? Menopausal symptoms 05/03/2013 ? Fibromyalgia 12/01/2011 ? Pure Hypercholesterolemia 02/22/2007
Andere Medikamente
? betamethasone dipropionate (DIPROSONE) 0.05 % external ointment Apply 1 Application topically twice daily as needed for psoriasis. ? celecoxib (CELEBREX) 200 mg oral capsule Take 200 mg by mouth every day. ? Coenzyme Q-10 100 MG oral CAPS
Allergien
? Lyrica Other (See Comments) dizziness ? Neurontin [Gabapentin] Palpitations Made her lightheaded
Vorherige Impfungen
-

VAERS 943153

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

mild
Staat
NJ
Alter
68,0
Geschlecht
U
Eingang
14.01.2021
Impfdatum
08.10.2020
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema

Symptomtext

the patient complained of redness at the injection site after receiving the Flublok; Initial information regarding an unsolicited valid non-serious case received from the other health professional via phone at call center (Reference Number: US-SANOFI-00418826) received on 06-Jan-2021. This case involved a 68-year old patient complained of redness at the injection site (Injection site erythema) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 08-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE 0.5 mL (lot number: UJ455AA, expiry date: 17-Mar-2021) via an unknown route in the left deltoid for prophylactic vaccination. On an unknown date, unknown latency, the patient complained of redness at the injection site after receiving the Flublok (Injection site erythema). No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment. Outcome was reported as unknown for the event of injection site erythema.

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

VAERS 940582

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

mild
Staat
NJ
Alter
60,0
Geschlecht
M
Eingang
13.01.2021
Impfdatum
21.10.2020
Beginn
21.10.2020
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: ja ER: unbekannt Erholt: nein
Injection site pain

Symptomtext

disabling pain in left shoulder after the vaccine- progressively worsened over days

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
referred to orthopedist; MRI ordered to rule out rotator cuff tendinitis- not yet done
Aktuelle Erkrankungen
-
Vorgeschichte
diabetes, hypertension, hyperlipidemia, megaloblastic red blood cells, obesity, fatty liver, prostate cancer, gallstones, GERD
Andere Medikamente
Amlodipine, azelastine, losartan, Rosuvastatin, Viagra
Allergien
benazepril/quinapril-AE: cough
Vorherige Impfungen
-

VAERS 1224947

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
MI
Alter
-
Geschlecht
U
Eingang
18.04.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

A patient receievd an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00327404) and transmitted to Sanofi on 25-Mar-2021. This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA and expiry date: ) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to expired vaccine used (latency same day). 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 holders compliance with the requirements set out in guidelines. 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 1178312

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
NJ
Alter
45,0
Geschlecht
M
Eingang
07.04.2021
Impfdatum
18.03.2021
Beginn
18.03.2021
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 No adverse event

Symptomtext

A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00525656) and transmitted to company on 18-Mar-2021. This case involves a 45-year-old male patient who received an expired 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA and expiry date: 17-Mar-2021) via an intramuscular route in the left deltoid for prophylactic vaccination on 18-Mar-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to expired vaccine used (latency same day). 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1128336

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
MI
Alter
26,0
Geschlecht
F
Eingang
24.03.2021
Impfdatum
19.03.2021
Beginn
19.03.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered No adverse event

Symptomtext

NO ADVERSE EVENT, ADMINISTRATION ERROR ONLY. PRODUCT EXPIRED 2 DAYS PRIOR TO ADMINISTRATION. NO SYMPTOMS

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
UNKNOWN
Vorgeschichte
UNKNOWN
Andere Medikamente
UNKNOWN
Allergien
NONE
Vorherige Impfungen
-

VAERS 1118246

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
OH
Alter
22,0
Geschlecht
F
Eingang
20.03.2021
Impfdatum
20.03.2021
Beginn
20.03.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

After administering the above vaccine to patient today, I realized that it expired 3/17/2021. And informed the patient. She is having no problems currently.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
NONE; PT STATES FEELS WELL.
Vorgeschichte
NONE
Andere Medikamente
UNKN.
Allergien
UNKN
Vorherige Impfungen
-

VAERS 1030315

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
IN
Alter
16,0
Geschlecht
F
Eingang
15.02.2021
Impfdatum
03.10.2020
Beginn
03.10.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
SYR / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

Patient received vaccine intended for use in 18 y/o and older, she was only 16 yrs 11 mths at the time of vaccination. Patient has had no adverse events related to administration

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1010999

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
TN
Alter
9,0
Geschlecht
F
Eingang
08.02.2021
Impfdatum
11.10.2020
Beginn
11.10.2020
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

A nine year old girl received Flublok Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00440411) and transmitted to Sanofi on 21-Jan-2021. This case involves a 9 years old female patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA, expiry date: 17-Mar-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 11-Oct-2020 (Product administered to patient of inappropriate age) Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other concomitant vaccines. It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day). On 11-Oct-2020, both the 9-year-old patient and her mother came into the clinic for their flu shot. It is possible that the Flublok was inadvertently given to the 9-year-old instead of to the mother, but that is not certain. It could have been a mix-up in the paperwork. Reporting nurse stated that she always double-checks for this, just before administering the flu vaccine, which is why she thinks it could just have been recorded incorrectly. At the time of report, 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 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 1005360

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
TN
Alter
17,0
Geschlecht
M
Eingang
05.02.2021
Impfdatum
08.10.2020
Beginn
08.10.2020
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 17 year old patient was administered Flublok, no AE; Initial information was received on 22-Jan-2021 regarding an unsolicited valid non-serious case from a Nurse. This case involves a 17 year old male patient who was administered 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA, expiry date: 17-Mar-2021, pre-filled syringe) once via intramuscular route in the left deltoid for prophylactic vaccination on 08-OCT-2020 (Product administered to patient of inappropriate age). Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day). At the time of report, 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 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 966085

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
TN
Alter
17,0
Geschlecht
M
Eingang
22.01.2021
Impfdatum
08.10.2020
Beginn
21.01.2021
Tage bis Beginn
105,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

Patient was accidentally given Flublok instead of Fluzone. As far as I know, he has had no adverse reaction from this vaccine. I found out about the error yesterday and attempted to all the patient, but there was no answer

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
none
Allergien
N.K.D.A.
Vorherige Impfungen
-

VAERS 963583

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
TN
Alter
9,0
Geschlecht
F
Eingang
21.01.2021
Impfdatum
11.10.2020
Beginn
11.10.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product administered to patient of inappropriate age

Symptomtext

On 10/11/21, the patient and her mother came in for a flushot. Documentation shows that this patient received Flublok which is only approved for patients 18 and older. There was no adverse effects, side effects, or illness from this.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 956958

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ455AA

gering
Staat
IN
Alter
16,0
Geschlecht
M
Eingang
19.01.2021
Impfdatum
18.09.2020
Beginn
18.09.2020
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

Flublok vaccine administered to 16 year old male on 9/18/20. No reactions noted.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
nka
Vorherige Impfungen
-