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Reporte zur Charge UJ477AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
VA 3 WI 1 PA 1 OK 1

VAERS 1246804

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ477AB

schwer
Staat
VA
Alter
19,0
Geschlecht
F
Eingang
23.04.2021
Impfdatum
19.10.2020
Beginn
03.11.2020
Tage bis Beginn
15,0
Dosis
1
Route/Site
IM / AR
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Arthralgia Cardiac monitoring Chest pain Cold sweat Dizziness Erythema Feeling hot Joint swelling Laboratory test normal Mobility decreased Muscle spasms Odynophagia Pain Palpitations Peripheral swelling Postural orthostatic tachycardia syndrome Presyncope Pruritus

Symptomtext

Started with left arm pain in shoulder that would shoot down to wrist, muscle spasms in that arm, then head started itching.that night had pain in right thmb and it got red,swollen,hot to touch,itchy,painful. During that night entire body hurt,had sternum pain,especially when swallowing.Following morning had a rash on thighs,torso,very itchy and raised.Both knees very swollen,red,hot to touch and painful. Could feel my heart racing..Went to emergency room that day and was given a Medrol dose pack(which by the end of the day helped with the rash and joint pain) That night the bottom of my feet hurt bad when walking.Developed pain in the neck, couldn't turn head.On Thursday Nov.12 felt heart racing,broke out in a cold sweat,got lightheaded,had to lay down because almost passed out. Had seen Dr and was referred to a cardiologist. Had an event montor and a tilt table test and diagnosed with POTS. Have continued with tachycardia even though taking Midodrine 5mg TID.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Presyncope
Hospital-Tage
-
Labordaten
Event monitor 11/30/2020 Tilt Table test 12/2020 Lots of lab tests to rule out an autoimmune condition (which were all normal)
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 952051

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UJ477AB

schwer
Staat
VA
Alter
19,0
Geschlecht
F
Eingang
18.01.2021
Impfdatum
19.10.2020
Beginn
22.10.2020
Tage bis Beginn
3,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Dizziness Electrocardiogram abnormal Fall Palpitations Postural orthostatic tachycardia syndrome Syncope Tilt table test positive

Symptomtext

postural orthostatic tachycardia syndrome; experienced symptoms of syncope; Collapse; Heart palpitations; Dizziness; Initial information regarding an unsolicited valid serious case received from the other healthcare professional via phone at call center (Reference number: US-SANOFI-00426245) on 12-Jan-2021. This case involved a 19-year old female patient who experienced postural orthostatic tachycardia syndrome, after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant medications. On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED 0.5 mL multi-dose vial (lot number: UJ477AB, expiry date: 30-Jun-2021) via an unknown route in the right deltoid for prophylactic vaccination. On 22-Oct-2020, 3 days following the suspect product vaccinations, the patient experienced symptoms of syncope, collapse (Fall), heart palpitations (Palpitations), and dizziness. Reporter that the patient had visited the emergency room. After being symptomatic for a while, the patient was seen at the reporting primary care practice on 12-Nov-2020, where an electrocardiogram was performed, which was abnormal. Patient was referred to a neurologist on 11-Dec-2020, Doctor who suspected postural orthostatic tachycardia syndrome (POTS), and the patient was referred to Genetics on 21-Dec-2020. On 21-Dec-2020, 2 months 2 days following the suspect product vaccinations, at genetics, patient underwent a tilt table test, which confirmed postural orthostatic tachycardia syndrome (POTS). Patient had a follow-up appointment with neurologist on 28-Dec-2020. Final diagnosis was postural orthostatic tachycardia syndrome. The event of postural orthostatic tachycardia syndrome associated with accompanying symptoms of syncope, palpitations, dizziness and fall were assessed as important medical event as the accompanying symptom of syncope was assessed as medically significant as per important medical event list. It was not reported if the patient received a corrective treatment. Outcome of the event of postural orthostatic tachycardia syndrome with its accompanying symptoms was unknown. The neurologist and other members of the patient's healthcare team believe that the patients POTS was related to the Fluzone vaccine the patient received.; Sender's Comments: This case involved a 19-year old female patient who presented with postural orthostatic tachycardia syndrome (POTS) accompanied with symptoms of fall, dizziness, syncope and palpitations three days (although diagnosed on a later date) following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Time to onset is compatible. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syncope
Hospital-Tage
-
Labordaten
Test Date: 20201112; Test Name: Electrocardiogram; Result Unstructured Data: Abnormal; Test Date: 20201221; Test Name: Tilt table test; Result Unstructured Data: confirmed postural orthostatic tachycardia syndrome (POTS)
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1279451

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ477AB

moderat
Staat
VA
Alter
20,0
Geschlecht
F
Eingang
02.05.2021
Impfdatum
19.10.2020
Beginn
03.11.2020
Tage bis Beginn
15,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Chest pain Joint swelling Joint warmth Muscle contractions involuntary Odynophagia Pain Pain in extremity Peripheral swelling Pharyngeal swelling Postural orthostatic tachycardia syndrome

Symptomtext

chest pain when swallowing; left arm pain; POTS syndrome; muscle contractions; Swelling in her right thumb; Entire body pain; both knees were swollen and hot; both knees were swollen and hot/swelling in her right thumb and it was hot; swollen throat; swelling in her right thumb, it was red; Pain; Initial information was received on 22-Apr-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry number: 00573551). This case involves a 20 year old female patient who experienced pots syndrome (postural orthostatic tachycardia syndrome), left arm pain (pain in extremity), muscle contractions (muscle contractions involuntary), swelling in her right thumb (peripheral swelling), pain, entire body pain (pain), chest pain when swallowing (chest pain), both knees were swollen and hot (joint swelling), swollen throat (pharyngeal swelling), swelling in her right thumb, it was red (erythema) while received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number: UJ477AB, expiry date: 30-Jun-2021] via an unknown route at an unknown administration site for prophylactic vaccination. On 03-NOV-2020 the patient developed a non-serious pots syndrome (postural orthostatic tachycardia syndrome), left arm pain (pain in extremity), muscle contractions (muscle contractions involuntary), swelling in her right thumb (peripheral swelling), pain, entire body pain (pain), chest pain when swallowing (chest pain), both knees were swollen and hot (joint swelling), swollen throat (pharyngeal swelling), swelling in her right thumb, it was red (erythema) 15 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant laboratory test results included: Cardiac stress test - On an unknown date: [Result: heart rate got up to 201] Heart rate - On an unknown date: [Result: Rapid heart rate] Other relevant tests were not reported. She was taken to the ER and treated with steroids. It was not reported if the patient received a corrective treatment for the events. At the time of reporting, the patient was not recovered for the event postural orthostatic tachycardia syndrome and recovered from all the remaining events.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chest pain
Hospital-Tage
-
Labordaten
Test Name: Cardiac stress test; Result Unstructured Data: heart rate got up to 201; Test Name: Heart rate; Result Unstructured Data: Rapid heart rate
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1281826

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ477AB

mild
Staat
WI
Alter
60,0
Geschlecht
F
Eingang
03.05.2021
Impfdatum
06.10.2020
Beginn
06.10.2020
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Arthralgia

Symptomtext

Pt c/o of shoulder pain, thinks she has SIRVA from flu injection. No adverse reactions known.

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

VAERS 1032847

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ477AB

mild
Staat
PA
Alter
25,0
Geschlecht
F
Eingang
16.02.2021
Impfdatum
11.02.2021
Beginn
14.02.2021
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site reaction

Symptomtext

1. Local injection site reaction to vaccines received here on 2/11. - No signs of infection. - Reviewed the difference between local injection site reaction and generalized allergic reaction. - Ice vs heat, on for 20 minutes, off 2 hours, repeat, may alternate ice and heat or stick with 1 or the other. - Tylenol/ibuprofen if needed, follow directions of package. - Recommend getting vaccines in separate locations in the future and/or separate vaccines by several weeks. - Follow up if new or worsening symptoms or failure to improve over the next 1-2 weeks.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site reaction
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
Allergic rhinitis, Asthma, Murmur, GERD, Depression, Headaches
Andere Medikamente
N/A
Allergien
DIPHENHYDRAMINE HCL - Hives / Urticaria IODINATED CONTRAST MEDIA - Hives / Urticaria KIWI (ACTINIDIA CHINENSIS) - Hives / Urticaria PROMETHAZINE - Hives / Urticaria TUBERCULIN, PURIFIED PROTEIN DERIVATIVE - Other (document details in comments),Hives / Urticaria
Vorherige Impfungen
-

VAERS 1734345

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ477AB

gering
Staat
OK
Alter
59,0
Geschlecht
F
Eingang
25.09.2021
Impfdatum
16.09.2021
Beginn
16.09.2021
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

Symptomtext

administered expired vaccine with no reported adverse event; Initial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional via Media Information (under the reference 00773128). This case involved a 59 years old female patient who had administered expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient had no concomitant vaccine. On 16-SEP-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5ml, total, lot UJ477AB and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported, "they administered expired FLUZONE QUADRIVALENT to a patient; asks if they need to revaccinate following administration of expired product". At time of reporting, the outcome was unknown for the reported 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
-