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Reporte zur Charge U6828AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 1 IA 1 MN 1 NY 1 IN 1

VAERS 1483648

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6828AB

schwer
Staat
IL
Alter
17,0
Geschlecht
F
Eingang
18.07.2021
Impfdatum
30.06.2021
Beginn
30.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Seizure

Symptomtext

seizure; Initial information regarding an unsolicited valid serious case from a pharmacist via Regulatory Authority (Reference number- 00663747) and transmitted to Sanofi on 30-Jun-2021. This case involves a 17-years old female patient who experienced seizure, while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported, and patient received no concomitant vaccines. On 30-Jun-2021, the patient received 0.5 ml total (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6828AB and expiration date: 09-Jan-2022) via intramuscular route in the left deltoid muscle for prophylactic vaccination. On 30-Jun-2021, the patient developed a serious, seizure, same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Seriousness criteria was assessed as medically significant as per important medical event Regulatory Authority list. It was reported "pharmacist ask about seizure as a potential side effect". It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of the event was unknown.; Sender's Comments: This case concerns a 17-years old female patient who had seizure same day following vaccination with MENACTRA. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.

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

VAERS 1591383

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6828AB

moderat
Staat
IA
Alter
16,0
Geschlecht
F
Eingang
20.08.2021
Impfdatum
20.08.2021
Beginn
20.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Aphasia Blood glucose Hypotonia Muscle rigidity Pallor Paraesthesia Unresponsive to stimuli

Symptomtext

Patient was talking to this nurse after receiving vaccines and suddenly stopped talking. She became rigid, flexing right arm and leg and pulling right hand into a fist. Called for help to the room. Patient became limp and unresponsive, color pale. Provider assessed patient. BP 86/52, Pulse 60-65, Oxygen 98% room air. Patient became responsive and able to answer questions, cool cloth applied to head. Continued to complain of tingling in bilateral arms. Patient's mother arrive (verbal consent from mother prior to visit). Ambulance service called for transfer to ER. Patient's condition improved while waiting for ambulance. BP 90/60. It was determined patient could be taken by family car to ER. Assisted to car via wheelchair. Mother escorting to ER. Report called to ER.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Paraesthesia
Hospital-Tage
-
Labordaten
Fingerstick glucose 96
Aktuelle Erkrankungen
Seen for sore throat 8/13/21
Vorgeschichte
None
Andere Medikamente
Sprintec, fluoxetine, cetirizine
Allergien
NKA
Vorherige Impfungen
-

VAERS 1663120

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6828AB

mild
Staat
MN
Alter
11,0
Geschlecht
M
Eingang
01.09.2021
Impfdatum
01.09.2021
Beginn
01.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Vomiting

Symptomtext

Patient vomited approx. 10 minutes after vaccination

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

VAERS 1980866

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6828AB

gering
Staat
NY
Alter
-
Geschlecht
U
Eingang
25.12.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

The products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) with no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves unknown gender patient for whom it was reported the products were exposed to highest temperature of 54.9 degrees Fahrenheit (12.72 degrees Celsius) and lowest temperature of 40.5 degrees Fahrenheit (4.72 degrees Celsius) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HIB (PRP/T) VACCINE [ActHIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product storage error). The patient medical history, medical treatment(s), vaccination(s),concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot U7328AA, expiry date: 30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ496AAA, expiry date:09-Jul-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date:07-Mar-20222] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6828AB, expiry date: 09-Jan-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5765BA and expiry date: 28-Aug-2022] via an unknown route in unknown administration site for prophylactic vaccination. It was case of actual medication error due to product storage error [Latency: on the same day]. 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1045649

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6828AB

gering
Staat
IN
Alter
4,0
Geschlecht
F
Eingang
22.02.2021
Impfdatum
08.02.2021
Beginn
08.02.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Wrong product administered

Symptomtext

a four year-old child was administered Menactra, rather than the intended MMR vaccine/no AE;Initial information regarding an unsolicited valid non-serious case was received from another health professional via medical information (Reference number- 00472867) and transmitted on 12-Feb-2021. This case involves a 4 year old female who received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] once, [injection, lot number: U6828AB, expiry date: 29-Jan-2022] via intramuscular route at right thigh on 28-Feb-2021 for prophylactic vaccination, rather than the intended MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] [lot number, expiry date and other dosing details not applicable] (wrong product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), INFLUENZA VACCINE and HEPATITIS A VACCINE. It was a case of actual medication error due to wrong vaccine administered. No adverse effect had been reported after vaccination. At the time of reporting it was reported that, the suspect was used first time. 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
PENTACEL; INFLUENZA VACCINE; HEPATITIS A VACCINE
Allergien
-
Vorherige Impfungen
-