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Reporte zur Charge UJ747AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

10Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
1Bleibende Schaeden
CA 3 CO 3 IL 2 NJ 1 CT 1

VAERS 2400551

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ747AA

moderat
Staat
CA
Alter
68,0
Geschlecht
M
Eingang
03.08.2022
Impfdatum
14.12.2021
Beginn
20.01.2022
Tage bis Beginn
37,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: ja ER: unbekannt Erholt: nein
Amino acid level Aphasia Babinski reflex test Balance disorder Burning sensation CSF protein increased CSF red blood cell count positive Disability Dysphemia Essential tremor Gait disturbance Hyperintensity in brain deep nuclei Lumbar puncture Magnetic resonance imaging head abnormal Muscle atrophy Pain in extremity Speech disorder Tremor

Symptomtext

1. Started in mid-January 2022, severe bilateral feet pain (burning) becoming chronic and disabling by March. Each step increases the burning feet pain. Neurologist prescribed gabapentin and lyrica which did NOT help the pain. Primary Care Physician prescribed duloxetine (replacing fluoxetine) which did NOT help the pain. thigh and calf muscles atropied due to non-use from disabling pain, which led to a 20lb weight loss in leg muscles from March through May. 2. Essential tremor of both hands started in June 2022 and is worsening. 3. Some difficulty with speech, e.g., stuttering, cannot recall the right word, starting June 2022 4. Balance problems trying to walk, starting June 2022 ---- OTHER Medical Tes

Weitere VAERSDATA-Felder
Praegender Schweregrund
Essential tremor
Hospital-Tage
-
Labordaten
Brain MRI [6/11/2022] = abnormal findings. Methylmalonic Acid [6/1/2022] = positive 385 nmol/L. Babinski signs [6/1/2022]. Lumbar puncture CSF [6/17/2022] = total protein = 68 mg/ Other medical tests related to these adverse reactions: 6/1/2022: Methylmalonic Acid: 385 nmol/L 6/11/2022: MRI of brain. 1. Extensive periventricular T2 hyperintensities, without acute mass effect or diffusion restriction. 6/17/2022: Lumbar puncture: CSF red blood cells = 26 cumm. CSF total protien = 68 mg/dL
Aktuelle Erkrankungen
none
Vorgeschichte
ulcerative colitis (in remission)
Andere Medikamente
flupxetine, rosuvastatin, mesalamine
Allergien
soy
Vorherige Impfungen
-

VAERS 1849025

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

mild
Staat
CA
Alter
76,0
Geschlecht
M
Eingang
06.11.2021
Impfdatum
04.11.2021
Beginn
06.11.2021
Tage bis Beginn
2,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Abdominal pain Night sweats Weight decreased

Symptomtext

PT report having night sweats for the 4 previous night after vaccine, lost weight with in the last 2 weeks. Pt was evaluated by PA and pt left and was seen at the urgent care for abdominal pain.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Abdominal pain
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
NO
Vorgeschichte
COLONIC POLYPS; ATRIAL FIBRILLATION
Andere Medikamente
FLECAINIDE 50MG; MECLIZINE 50MG; PRAVASTATIN 40MG; DONEPEZIL 5MG; TAMSULOSIN 0.4MG; VIRAMIN D 1.25MG; AZELASTINE 137mcg; KETOCONAZOLE 1%; CYCLOSPORINE 0.05% Ophth; ASPIRIN 81MG; CANNABIS
Allergien
NIGHT SWEATS FOR THE PREVIOUS 4 NIGHTS.
Vorherige Impfungen
-

VAERS 1774846

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

mild
Staat
IL
Alter
9,0
Geschlecht
U
Eingang
09.10.2021
Impfdatum
25.09.2021
Beginn
25.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Diarrhoea Medication error Overdose Product administered to patient of inappropriate age

Symptomtext

diarrhoea; 9 years patient received FLUZONE HIGH-DOSE QUADRIVALENT; 9 years patient received FLUZONE HIGH-DOSE QUADRIVALENT; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from nurse and consumer/non-healthcare professional via call center via Regulatory authority (Reference number- 00793047). This case is linked to case 2021SA328686 (CLUSTER). This case involves a 9-year-old patient (unknown gender) who experienced diarrhoea, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age, overdose). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 25-Sep-2021, the patient received a 0.7mL {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (solution for injection, lot number: UJ747AA and expiry date not reported) via an intramuscular route at a the left thigh for prophylactic vaccination. On an unknown date, the patient developed a non-serious diarrhoea (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was also a case of actual medication error due to Inappropriate age at vaccine administration and overdose. (latency was on same day). It was reported "Nurse manager reports that two of their patients; a 9 year-old child and a 7 year-old child, received a FLUZONE HIGH-DOSE QUADRIVALENT. She is seeking information to provide to the children's mother." Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment for the event (diarrhoea). At time of reporting, outcome of the events 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 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
Diarrhoea
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1749732

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

mild
Staat
CA
Alter
73,0
Geschlecht
F
Eingang
30.09.2021
Impfdatum
26.09.2021
Beginn
26.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site pain

Symptomtext

At time of injection, patient felt needle as if it hit something (possibly bone). About an hour later the pain escalated, and has not gotten any better since. Patient started taking Tylenol Extra Strength that same day. Tylenol has not relieved pain even a little bit. Patient has not contacted primary care yet. Today on Day 5, pain hasn't gotten any better, patient came to see us in pharmacy. She was hoping after a couple days pain would subside but it has not.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
meloxicam, compazine, sulfa
Vorherige Impfungen
-

VAERS 1935261

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

gering
Staat
CO
Alter
88,0
Geschlecht
M
Eingang
09.12.2021
Impfdatum
18.11.2021
Beginn
18.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

A patient received two doses of Fluzone HD Quad no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00878921) and transmitted to Sanofi on 30-Nov-2021. This case involves a 88 year old male patient was received two doses INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 18-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AA, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to extra dose administered (latency same day). It was reported "The caller is asking for direction regarding administering a double dose of FLUZONE HD QUAD to a patient." No other 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1910221

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

gering
Staat
CO
Alter
30,0
Geschlecht
F
Eingang
30.11.2021
Impfdatum
29.11.2021
Beginn
29.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

Patient was given a high dose flu shot instead of the regular quadrivalent shot. No adverse effect of the patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
Synthroid 75MCG
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1876135

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

gering
Staat
CO
Alter
76,0
Geschlecht
M
Eingang
17.11.2021
Impfdatum
14.10.2021
Beginn
28.10.2021
Tage bis Beginn
14,0
Dosis
2
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration No adverse event

Symptomtext

first and second dose of FLUZONE HIGH-DOSE QUADRIVALENT vaccines was received in in same month with no reported adverse event; Initial information received on 05-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 76 years old male patient who received first and second dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within same month (inappropriate schedule of product administration). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination. On 14-Oct-2021, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 28-Oct-2021 he also received a 0.7 mL second dose of the same vaccine (strength: high-dose, lot UJ747AA, expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (at a different facility). It was an actual medication error case drug dose administration interval too short (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 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
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1813061

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

gering
Staat
NJ
Alter
-
Geschlecht
F
Eingang
23.10.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Syringe issue Underdose

Symptomtext

Patient got a partial dose of Fluzone HD with no adverse event; syringe leaked on her arm with no advese event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00810589). This case involves a 67 years old female patient who got a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (underdose) but syringe leaked on her arm (syringe issue). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.6 ml, lot UJ747AA and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination. It was actual an medication error due to vaccine underose and syring leak (same day latency). It was reported "Consumer states that she just received the HD FLU vaccine 0.7 mL but when it was injected, the syringe leaked on her arm. The nurse thought it was a little bit but the consumer felt it was more than a little. she got a partial dose of Fluzone HD. She states the HCP said she felt she got 0.6 ml of the dose. The vaccine came out of the syringe and ran down her arm." At time of reporting, the outcome was unknown for the 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 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 1774845

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

gering
Staat
IL
Alter
7,0
Geschlecht
U
Eingang
09.10.2021
Impfdatum
25.09.2021
Beginn
25.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

7 year old child recevied fluzone HD QIV/no AE; Overdose; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00793015). This case is linked to case 2021SA328195(CLUSTER). This case involves a 7-year-old (unknown gender) patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On 25-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ747AA and expiry date not reported) via an intramuscular route at a the left thigh for prophylactic vaccination. It was an actual medication error case due to overdose and inappropriate age at vaccine administration (latency: same day). It was reported "Nurse manager reports that two of their patients; a 9 year-old child and a 7 year-old child, received a FLUZONE HIGH-DOSE QUADRIVALENT. She is seeking information to provide to the children's mother." 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 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 1754139

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ747AA

gering
Staat
CT
Alter
56,0
Geschlecht
F
Eingang
01.10.2021
Impfdatum
01.10.2021
Beginn
01.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

Patient was vaccinated with the high dose flu vaccine when she was supposed to receive the regular dose vaccine. Pt was vaccinated by a licensed APRN. Patient was immediately made aware of the vaccine administration error. Pt verbalized understanding.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
unknown
Vorgeschichte
unknown
Andere Medikamente
unknown
Allergien
no
Vorherige Impfungen
-