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Reporte zur Charge UJ560AC

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

14Reporte angezeigt
0Todesfaelle
3Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
MD 2 OH 2 ND 2 MN 2 FL 1 ME 1 MI 1 AR 1 TX 1 NY 1

VAERS 1115959

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ560AC

schwer
Staat
FL
Alter
0,5
Geschlecht
F
Eingang
19.03.2021
Impfdatum
21.01.2021
Beginn
22.01.2021
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Chest X-ray normal Condition aggravated Electroencephalogram normal Endotracheal intubation Intensive care Laboratory test normal Magnetic resonance imaging head normal Mechanical ventilation Sedation Seizure

Symptomtext

Seizure (status epileptics) less then 24 hours after vaccines requiring intubation, sedation, ventilation for day in the PICU.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Intensive care
Hospital-Tage
8,0
Labordaten
EEG, MRI of brain, CXR, multiple labs - normal results
Aktuelle Erkrankungen
-
Vorgeschichte
IN UTERO DRUG EXPOSURE, PREVIOUS BENIGN SEIZURE
Andere Medikamente
NONE
Allergien
NO KNOWN
Vorherige Impfungen
single provoked seizure following vaccines at age 2 month, normal EEG, development, and neuro exam after. Age 2 months at time

VAERS 943212

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

schwer
Staat
MD
Alter
10,0
Geschlecht
M
Eingang
14.01.2021
Impfdatum
13.01.2021
Beginn
13.01.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
ID / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dyskinesia Eye movement disorder Loss of consciousness

Symptomtext

Patient was sitting on exam table; he was talkative and alert until after receiving third injection, HPV. Patient suddenly slumped forward and then backward. He was placed in the lying position onto his right side. Eye rolling and upper body jerking was noted for less than 30 seconds. Patient became alert and was able to recall the previous events after about 2 minutes. He was kept in an upright position and given ginger ale. Father of patient reported that the patient had nothing to eat or drink prior to visit. After another 10 minutes, patient was back to baseline. Nearly, 24 hours later, patient's family was contacted via phone. Patient has continued to do well and has no complaints

Weitere VAERSDATA-Felder
Praegender Schweregrund
Loss of consciousness
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
HEADACHE, ALLERGIC RHINITIS
Vorgeschichte
ALLERGIC RHINITIS
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 926137

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

schwer
Staat
ME
Alter
1,0
Geschlecht
M
Eingang
07.01.2021
Impfdatum
18.12.2020
Beginn
25.12.2020
Tage bis Beginn
7,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
C-reactive protein Differential white blood cell count Dyskinesia Electroencephalogram Fall Febrile convulsion Full blood count Metabolic function test Muscle twitching Pyrexia SARS-CoV-2 test negative Seizure

Symptomtext

Pt showed at the ER on 12/25/2020 after falling mid walk. Pt left hand was rhythmically opening and closing. Head was twitching and left arm and left leg twitching-sx lasted 10min. Fever of 103 documented by EMS, vaccines 1 wk prior to the ER visit. Sx resolved 2 hrs after seizure. Diagnosed with ? atypical febrile seizure. Patient then sent to Center where he had an EEG and neurology consult. Dx with complex febrile seizure- had felt possible febrile seizure vs epilepsy vs genetic predisposition secondary to TMPRSS3 genetic mutation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
2,0
Labordaten
EEG, covid negative, crp, bmp, cbc w/diff
Aktuelle Erkrankungen
no- did have a fever
Vorgeschichte
Deaf- has cochlear implant
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1024891

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

moderat
Staat
MD
Alter
11,0
Geschlecht
M
Eingang
12.02.2021
Impfdatum
05.01.2021
Beginn
06.01.2021
Tage bis Beginn
1,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Arthralgia Blood culture negative C-reactive protein increased Contusion Dehydration Differential white blood cell count normal Echocardiogram Electrocardiogram Fatigue Full blood count normal Headache Influenza Influenza virus test negative Joint swelling Pruritus Pyrexia Red blood cell sedimentation rate increased Respiratory syncytial virus test negative

Symptomtext

Received 3 vaccines (Tdap, Influenza and Meningococcal) same day. 24 hour later developed headache, fever, fatigue followed by fixed pruritic hives on arms, legs, trunk and back which left bruise on healing after ~ 10 days. 48 hours post vaccine, developed knee arthralgias with joint swelling. Day 3 post-vaccination, CBC, CMP, CPK, troponin normal. ESR and CRP mildly elevated, negative Lyme screen, Monospot and respiratory viral panel. Symptoms continued without improvement, manageable with NSAIDs. Day 6 developed worsening arthralgias, conjunctival injections, spread of hives, dehydration, treated with IV fluids and NSAIDs, followed by gradual recovery. Labs were notable for elevated CRP and ESR but normal CBC with normal differential counts, liver enzymes, ferritin, troponin, EKG and echocardiogram, negative infectious workup including influenza, RSV NAT, COVID PCR and blood cultures. Due to absence of alternate explanation, serum sickness like reaction was suspected to one of the vaccines, likely influenza due to earlier onset.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dehydration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
-
Allergien
None
Vorherige Impfungen
-

VAERS 2624760

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ560AC

mild
Staat
OH
Alter
2,8
Geschlecht
M
Eingang
02.05.2023
Impfdatum
15.12.2020
Beginn
17.12.2020
Tage bis Beginn
2,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Post vaccination fever

Symptomtext

Postvaccination fever on 2020-12-17.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Post vaccination fever
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Encounter for routine child health examination NOS
Vorgeschichte
-
Andere Medikamente
None
Allergien
-
Vorherige Impfungen
-

VAERS 1857206

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

mild
Staat
OH
Alter
16,0
Geschlecht
F
Eingang
18.02.2021
Impfdatum
15.02.2021
Beginn
16.02.2021
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Pyrexia Vaccination site swelling

Symptomtext

Fever up to 103, Tylenol & Ibuprofen. Resolved within 24 hours. Redness & swelling at vaccine site.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
Seasonal allergies, anxiety, Slohons
Andere Medikamente
Nymy O
Allergien
None
Vorherige Impfungen
-

VAERS 985270

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

mild
Staat
MI
Alter
17,0
Geschlecht
F
Eingang
29.01.2021
Impfdatum
13.01.2021
Beginn
13.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Immediate post-injection reaction Injection site pain Pain

Symptomtext

Pain at the Rt Upper Arm Immediately post Flu vaccine. Pain scale peak at 8/10, currently 4/10 after two 16 days. Rt upper arm intermittent shooting pain with Rt posterior form arm pulsating pain developed on day 3rd after the immunization (1/15/21), worse pain at 9/10 at the beginning, now 4/10. No numbness in the area, muscle strength was not affected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
Physical exam performed by Orthopedics.
Aktuelle Erkrankungen
none
Vorgeschichte
Mild intermittent asthma scoliosis
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 925468

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

mild
Staat
ND
Alter
17,0
Geschlecht
M
Eingang
07.01.2021
Impfdatum
05.01.2021
Beginn
05.01.2021
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site warmth Lymphadenopathy

Symptomtext

Right shoulder area became warm and erythematous, extending throughout deltoid area within hours after vaccine administration. He had tender axillary adenopathy over a similar time course. He reported to my clinic 2 days after vaccine administration. No fevers, headaches. Will treat with ice and ibuprofen.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None
Vorgeschichte
Varicocele
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1756435

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

gering
Staat
MN
Alter
12,0
Geschlecht
F
Eingang
02.10.2021
Impfdatum
23.09.2021
Beginn
23.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

12 years old patient received expired FLUZONE QUAD with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00786871) and transmitted to Sanofi on 27-Sep-2021. This case involves a 12-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (lot UJ560AC, expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 23-Sep-2021 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

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

VAERS 1292716

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

gering
Staat
ND
Alter
0,5
Geschlecht
M
Eingang
06.05.2021
Impfdatum
16.02.2021
Beginn
20.02.2021
Tage bis Beginn
4,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
Amino acid level normal Benign enlargement of the subarachnoid spaces Blood culture negative Blood pyruvic acid CSF test normal Dyskinesia Electroencephalogram abnormal Extrapyramidal disorder Full blood count normal Infantile spasms Magnetic resonance imaging head abnormal Metabolic function test Organic acid analysis Vitamin B1 Vitamin B6 normal

Symptomtext

Four days after vaccines, he developed abnormal movements. He was evaluated in the ED and by PCP over the next three days, and was eventually seen by neurology. initial EEG was concerning for infantile spasms, so he was hospitalized. He was treated with Keppra and then high dose steroids. Repeat EEG was normal, and on outside read of initial EEG, the diagnosis of infantile spasms was questioned. It is now thought that he has benign shudders.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Amino acid level normal
Hospital-Tage
5,0
Labordaten
2/23/21-EEG-inital read showed modified hypsarrhythmia, on outside read-movement artifact with no hypsarrhythmia 2/23/21-Amino acids, CBC, CMP, vitamins B1 and B6-all normal 2/24/21-CSF, blood culture, organic acids screen-all normal Pyruvic acid-low 2/24/21-Brain MRI-idiopathic enlargement of subarachnoid spaces during infancy
Aktuelle Erkrankungen
Mild viral URI
Vorgeschichte
None
Andere Medikamente
Vitamin D
Allergien
None
Vorherige Impfungen
Local reaction with Prevnar at 4 months

VAERS 1116720

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

gering
Staat
AR
Alter
1,5
Geschlecht
M
Eingang
19.03.2021
Impfdatum
16.12.2020
Beginn
16.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product administered to patient of inappropriate age

Symptomtext

Quadracel was administered to patient before recommended age of 4 years old by accident.

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

VAERS 1019175

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UJ560AC

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
10.02.2021
Impfdatum
01.12.2020
Beginn
01.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient (unspecified age and gender) for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination]. Details of laboratory data not reported. It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines. It was not reported if the patient received a corrective treatment. 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. There will be no information available on the batch number for this case.

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

VAERS 998851

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

gering
Staat
MN
Alter
57,0
Geschlecht
F
Eingang
03.02.2021
Impfdatum
03.02.2021
Beginn
03.02.2021
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 route of product administration No adverse event

Symptomtext

MMR vaccination was accidentally administered via IM route instead of needed SC route. Pt was informed of this immediately, all questions and concerns were answered. Pt sustained no injuries, was monitored for 15 minutes post-vaccination. Pt encouraged to call with questions or concerns.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
none
Vorgeschichte
Diabetes and High Cholesterol
Andere Medikamente
Metformin Humalog 75/25 Sumatriptan Tylenol Vitamin D3
Allergien
none
Vorherige Impfungen
-

VAERS 920660

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ560AC

gering
Staat
NY
Alter
1,0
Geschlecht
M
Eingang
05.01.2021
Impfdatum
29.12.2020
Beginn
31.12.2020
Tage bis Beginn
2,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered

Symptomtext

The patient had already received his second influenza vaccine for the 2020-2021 influenza season (2 doses for his first immunization to the flu) and he accidently received a third influenza vaccine dose. The first dose was 9/20 and second dose was 1 month later 10/20 to complete the course. He received a third dose 12/30 accidently

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
Mistake noticed following day, his mother was called. Nothing significant was except for erythema and pain at the site of the influenza injection. Mother told to observe for any fever or unusual behaviors, none presented.
Aktuelle Erkrankungen
macrosomic baby
Vorgeschichte
-
Andere Medikamente
Poly-Vi-Sol, Nasal saline solution
Allergien
No Known allergies
Vorherige Impfungen
-