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Reporte zur Charge UJ263AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 NY 1 KS 1 AZ 1

VAERS 1233619

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj263aa

mild
Staat
NY
Alter
1,3
Geschlecht
M
Eingang
20.04.2021
Impfdatum
15.04.2021
Beginn
18.04.2021
Tage bis Beginn
3,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
Blood glucose Decreased appetite Diarrhoea Full blood count Hypophagia Irritability Lethargy Metabolic function test Pyrexia Respiratory viral panel Urine analysis Urine output decreased

Symptomtext

Patient was brought into the ER on Sunday and reported that since vaccinations had been febrile, lethargic, and irritable. Patient was anorexic as well. Pushing fluids and discharged home. The next day patient was brought back to the ER, temp of 103, 2 wet diapers in a 48 hour period, 1 bout of diarrhea, poor PO intake both food and liquids. Patient was admitted to the hospital and given IV fluids, dextrose before patient started to feel better

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
2,0
Labordaten
CBC, BMP, Resp panel, Urinalysis, Finger stick glucose
Aktuelle Erkrankungen
None that we are aware of
Vorgeschichte
none
Andere Medikamente
Tylenol PRN
Allergien
None
Vorherige Impfungen
-

VAERS 1412614

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ263AA

gering
Staat
MI
Alter
1,5
Geschlecht
F
Eingang
19.06.2021
Impfdatum
09.06.2021
Beginn
09.06.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

expired dose of ACTHIB that was administered with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00635920) and transmitted to Sanofi on 10-Jun-2021. This case involved 18 month old female patient who administered second dose of 0.5ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ263AA, expiry date: 02-Jun-2021, strength: standard) via intramuscular route in right thigh on 09-Jun-2021 for prophylactic vaccination (expired product administered). The patient's past vaccination(s) included ACT-HIB on 27-Jan-2020 with First dose. Relevant medical history, medical treatment(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel) for prophylactic vaccination. This was an actual medication error case due to expired vaccine used (latency was same day). Receptionist stated that states that they knew that there was an ActHIB that was getting ready to expire so they placed an order to replace it 3 weeks in advance, however there was a delay and it did not get approved until yesterday, 09Jun2021. When the nurse pulled up the ActHIB vaccine and they double checked it, they did not catch the expired date. The dose is valid or needs to be re-administered. At the time of reporting, 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 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 1400095

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ263AA

gering
Staat
MI
Alter
1,5
Geschlecht
F
Eingang
15.06.2021
Impfdatum
09.06.2021
Beginn
09.06.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

Vaccination was 6 days post expiration upon administration. No adverse reactions noted.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1398655

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ263AA

gering
Staat
KS
Alter
1,0
Geschlecht
M
Eingang
15.06.2021
Impfdatum
04.06.2021
Beginn
04.06.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

An expired Act-Hib was administered to a patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional and pharmacist via Medical Information (reference number: 00628854) and transmitted to Sanofi on 04-Jun-2021. This case involves a 1-years-old male patient, who received expired fourth dose of 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, batch number: UJ263AA and expiry date: 02 June 2021 via an unknown route at an unknown administration site) (expired product administered) on 04 Jun 2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PNEUMOCOCCAL 13 VALENT VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1385343

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ263AA

gering
Staat
AZ
Alter
1,5
Geschlecht
F
Eingang
09.06.2021
Impfdatum
02.06.2021
Beginn
02.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered

Symptomtext

Medical Asistant administered Varicella and Proquad resulting in patient recieveing 2 varicella doses.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
Premarin Cream 0.625mg
Allergien
NKDA
Vorherige Impfungen
-