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Reporte zur Charge UT8134KA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

10Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NJ 4 VA 2 PA 1 MI 1 MD 1 NY 1

VAERS 2696258

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UT8134KA

schwer
Staat
VA
Alter
18,0
Geschlecht
F
Eingang
15.10.2023
Impfdatum
15.10.2023
Beginn
15.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Anaphylactic reaction Dyspnoea Loss of consciousness Vision blurred

Symptomtext

Flu vaccine was given first. No immediate reactions. Then 1-2 minutes later, the MenACWY was given and almost immediately, pt c/o blurry vision. About 3 minutes later she had difficulty breathing, almost apneic and passed out (never lost a pulse).- anaphylactic reaction. 911 was called while an Epipen was immediately and simultaneously given. About 1.5 minutes later, she gained consciousness and began to breathe normally again. Vital signs were stable. 911 appeared and transported to the hospital.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Anaphylactic reaction
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
None, per patient
Andere Medikamente
Duloxetine; also received flu vaccine
Allergien
None
Vorherige Impfungen
-

VAERS 2727485

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

mild
Staat
PA
Alter
17,0
Geschlecht
F
Eingang
26.12.2023
Impfdatum
26.12.2023
Beginn
26.12.2023
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
- / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dizziness Hyperhidrosis Immediate post-injection reaction Vomiting

Symptomtext

The patient, aged 17, came in to get a FLU shot and a COVID shot. She was accompanied by her mother and brother, who also got the same two shots. Immediately after administering them to the patient, she said she felt dizzy. She was informed that she would have to sit in the booth for an additional 30 minutes, while her brother was already waiting on the pharmacy bench for 15 minutes. Within a couple of minutes, she stated that she had to throw up, which she did, and the Pharmacy protocol for responding to adverse events was immediately implemented. Store management was alerted (code white), and the patient remained under observation for 30 minutes. She stated that she felt better after throwing up. She stopped sweating and had no breathing difficulties neither did she collapse. She was offered some water to drink, which she refused; she was more interested in washing her hands. She was directed to the rest rooms at the end of the 30-minute observation and the Market Leader was informed of the incident. Every other requirement following this incident is being implemented as per the Pharmacy Administered Immunizations: Responding to Adverse Events document (Revised 7/2023) located on the database.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None known as patient states she was feeling fine for the shots.
Vorgeschichte
Patient takes fluoxetine
Andere Medikamente
Fluoxetine 10 mg and Fluoxetine 20 mg
Allergien
Ibuprofen
Vorherige Impfungen
-

VAERS 2701645

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

mild
Staat
MI
Alter
44,0
Geschlecht
M
Eingang
25.10.2023
Impfdatum
25.10.2023
Beginn
25.10.2023
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Headache Hyperhidrosis

Symptomtext

After receiving Flu, Spikevax and Adacel vaccine, Patient felt light Headache and Sweating. Patient was asked to lay down on his back with elevated legs. Patient was feeling good within 5 mins.

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

VAERS 2691051

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

mild
Staat
MD
Alter
16,0
Geschlecht
M
Eingang
05.10.2023
Impfdatum
02.10.2023
Beginn
02.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Chills Erythema Fatigue Headache Pain Pain in extremity Peripheral swelling SARS-CoV-2 test negative

Symptomtext

arm pain, redness and swelling 2-3hrs later then severe headache, chills, fatigue + body aches - started 4-6 hrs later + lasted 24 hrs

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chills
Hospital-Tage
-
Labordaten
Rapid Covid (-) on 10/2/23
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2689000

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge ut8134ka

mild
Staat
NY
Alter
60,0
Geschlecht
F
Eingang
30.09.2023
Impfdatum
25.09.2023
Beginn
26.09.2023
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Chills Injection site cellulitis Injection site discharge Injection site erythema Injection site swelling Injection site warmth Pyrexia

Symptomtext

patient received Fluzone Quad and Arexvy in left arm (flu vaccine higher / RSV lower part of muscle) on Monday, Starting Tuesday morning patient had Fever, chills, Thurs redness started at injection site, and by Friday the area was hot, wet, swollen. Patient went to Urgent Care and was diagnosed with Cellulitis

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chills
Hospital-Tage
-
Labordaten
Urgent Care- diagnosed with Cellulitis
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
none
Vorherige Impfungen
-

VAERS 2720859

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

gering
Staat
NJ
Alter
13,0
Geschlecht
M
Eingang
05.12.2023
Impfdatum
27.11.2023
Beginn
27.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

extra dose of FLUZONE QIV with no reported adverse event; Initial information received on 27-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2023SA371005(CLUSTER). This case involves a 13 years old male patient who received extra dose of Influenza Quadrival A-B Vaccine [Fluzone Qiv] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Nov-2023, the patient received 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT8134KA) (Expiry date: 30-Jun-2024) (Strength: standard) (Frequency: once) via intramuscular route in the right arm for immunization. On 27-Nov-2023, the patient received an extra dose of Influenza Quadrival A-B Vaccine [Fluzone Qiv] with no reported adverse event (extra dose administered) (latency: same day). It was reported, Caller reporting 2 patients (siblings) received an extra dose of FLUZONE QIV this season, reporting they received their first dose last week at their primary care office. Today the patients received their doses as a walk in at the pharmacy. Caller with questions on expected adverse reactions. This situation is pre-assessed as a medication error/an inappropriate use due to inadvertently administering multiple influenza doses per season. 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 2720858

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

gering
Staat
NJ
Alter
11,0
Geschlecht
F
Eingang
05.12.2023
Impfdatum
27.11.2023
Beginn
27.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

extra dose of FLUZONE QIV with no reported adverse event; Initial information received on 27-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2023SA371873(CLUSTER). This case involves a 11 years old female patient who had extra dose of Influenza Quadrival A-B Vaccine [Fluzone QIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Nov-2023, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (lot UT8134KA, expiry date: 30-JUN-2023 with unknown strength) via intramuscular route in the left arm as immunization. On 27-Nov-2023 the patient had extra dose of Influenza Quadrival A-B Vaccine with no reported adverse event (extra dose administered) (Latency: same day). It was reported "2 patients (siblings) received an extra dose of FLUZONE QIV this season, reported they received their first dose last week at their primary care office. On 27-Nov-2023, the patients received their doses as a walk in at the pharmacy." 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 2718109

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

gering
Staat
NJ
Alter
11,0
Geschlecht
F
Eingang
27.11.2023
Impfdatum
27.11.2023
Beginn
27.11.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

PATIENT RECIEVED 2 FLUZONE QUADRIVALENT VACCINES IN THE SAME SEASON. THERE WAS NO ANY ADVERSE REACTIONS AT THE TIME OF VACCINATION. PATIENT KNOWS TO CALL IF THERE IS ANY ADVERSE REACTIONS

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

VAERS 2718105

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

gering
Staat
NJ
Alter
13,0
Geschlecht
M
Eingang
27.11.2023
Impfdatum
27.11.2023
Beginn
27.11.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

THE PATIENT RECIVED 2 FLUZONE QUADRIVALENT IN THE SAME SEASON.CURRENTLY THERE ARE NO SYMPTOMS OBSERVED. PATIENT KNOWS TO CALL IF THERE IS ANY ADVERSE EFFECTS

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

VAERS 2700761

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT8134KA

gering
Staat
VA
Alter
0,3
Geschlecht
F
Eingang
24.10.2023
Impfdatum
24.10.2023
Beginn
24.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

Flu vaccine was ordered for this patient who was 4 months old and the fluzone vaccine is for patients who are 6 months of age and older. There are no specific adverse events that were noted - needed guidance on next steps

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