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Reporte zur Charge U6691AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
VA 1 IA 1 WI 1

VAERS 1466663

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6691AB

schwer
Staat
VA
Alter
13,0
Geschlecht
F
Eingang
13.07.2021
Impfdatum
12.07.2021
Beginn
12.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dizziness Erythema Fall Pain in extremity Pallor Presyncope Syncope

Symptomtext

Client received Hep A, HPV, and MCV4 vaccine @ the Health Department Immunization Clinic on 07/12/21 @ 1030. Nurse administered Hep A & MCV4 to the client's L arm. Client appeared calm, alert. Nurse administered HPV in the client's R arm and went to place band-aid over the injection site. Client had vasovagal reaction and fainted. Client was sitting on the vaccination table, but ended up fainting into nurse's arms/floor. Nurse caught most of the client's fall. Client was placed on step of table. This writer asked client if she could tell me her name, DOB, location. Client answered all of these questions correctly. Client stated "what happened? Did I pass out?" Nurse and this writer explained she had vasovagal reaction to the vaccine. Client was able to sit on table w/ legs elevated. Client reported feeling dizzy and was instructed to keep legs raised. Client denied hx of vasovagal reaction prior to administration. She was given juice as a supportive measure. This writer noted lips/skin appeared pale. Client's dad and brother were @ the bedside. Brother was laughing uncontrollably and was asked to wait in lobby. Client reported her R lower extremity "hurt." Nurse and this writer assessed leg and noted redness over chin area. Client was able to move LE w/ no difficulty. Client instructed to ice area and monitor. If symptoms worsen, f/u with PCP. Client informed this writer and Nurse that she pictured herself dying-"I pictured myself getting hit by a car to lessen the pain of the shot." Client reported she did not eat breakfast. She was encouraged to eat prior to all vaccines and let staff know about vasovagal hx from now on. Client finished her juice and reported feeling better. This writer noted lips/skin were no longer pale-WNL. Client was gradually brought from a lying position to sitting upright. Client walked with her dad and brother out of the clinic @ 1130. Nurse and this writer encouraged PCP f/u if needed. EMS was not called.

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

VAERS 1105188

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6691AB

moderat
Staat
IA
Alter
17,0
Geschlecht
M
Eingang
16.03.2021
Impfdatum
15.03.2021
Beginn
15.03.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Dyskinesia Eye movement disorder Limb discomfort Musculoskeletal stiffness Pallor Tremor

Symptomtext

Client arrives with mother to receive vaccines for school. He sits in chair and answers questions. He is administered 5 vaccines, listed above. He verbalizes his left arm is stiff, so his mom rubs it. He then rolls his eyes back, head tilts back, legs out stiff, and body shakes. Client is lowered to floor then opens eyes and able to report his name. Vitals taken by PHNs and 911 called. Client pale. Mom denies any history of seizures or any other medical conditions. EMS arrives at 1505. Client able to walk to stretcher and taken to hospital.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Tremor
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Client's mom reports he was not feeling well last week.
Vorgeschichte
Client's mother denies.
Andere Medikamente
None reported by client's mother.
Allergien
None reported by client's mother.
Vorherige Impfungen
-

VAERS 1692834

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6691AB

gering
Staat
WI
Alter
16,0
Geschlecht
M
Eingang
11.09.2021
Impfdatum
30.08.2021
Beginn
30.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired MENACTRA was given to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and non-health care professional/consumer via Medical Information (Reference number- 00752479) and transmitted to Sanofi on 02-Sep-2021. This case involved 16-year-old male patient was given expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 30-Aug-2021, the patient received second 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U6691AB and expiry date: 21-Aug-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered). It was reported,"caller states that for some reason the vaccine was put back into rotation, caller also inquiring when a repeated Menactra vaccine can be administered. Management of Adverse Events and Product Technical Complaints Pasteur AE (adverse event) Reporting Refunds/Credits will not be issued due to adverse events". This case was an actual medication error due to expired vaccine used (latency: same day) At the time of reporting, no adverse 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 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 1605748

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6691AB

gering
Staat
-
Alter
14,0
Geschlecht
F
Eingang
22.08.2021
Impfdatum
15.08.2021
Beginn
15.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Inappropriate schedule of product administration

Symptomtext

Pt received second dose of series too early. Per the resource tool and provider, pt should have received second dose no earlier than 32 days from first dose. Pt received dose at day 26, therefore 6 days before minimum time between doses. Pt's parent was notified. Pt had no symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
N/a
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-