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Reporte zur Charge UJ319AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 2 IL 1 NY 1 DE 1

VAERS 1058657

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AA

mild
Staat
IL
Alter
0,3
Geschlecht
F
Eingang
26.02.2021
Impfdatum
26.02.2021
Beginn
26.02.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site swelling Irritability

Symptomtext

Red swollen thigh from hip to knee and patient fussy

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NKA
Vorgeschichte
None
Andere Medikamente
Vitamin D
Allergien
NKA
Vorherige Impfungen
-

VAERS 1052272

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AA

mild
Staat
PA
Alter
1,3
Geschlecht
F
Eingang
24.02.2021
Impfdatum
22.02.2021
Beginn
23.02.2021
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site swelling

Symptomtext

patient developed redness and swelling on left thigh around injection site.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
Pediatric Multivitamin
Allergien
None
Vorherige Impfungen
-

VAERS 1183989

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AA

gering
Staat
PA
Alter
-
Geschlecht
F
Eingang
09.04.2021
Impfdatum
16.03.2021
Beginn
16.03.2021
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 Product preparation issue

Symptomtext

A patient received only the Dtap and polio portion of the vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00524890) and transmitted to Sanofi on 18-Mar-2021. This case involves a four-month-old female patient who received only the dtap and polio portion of a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot UJ319AA and expiry date: 04-Jun-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 16-Mar-2021 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. This was a case of actual medication error case due to inappropriate reconstitution technique (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 holders 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
ROTAVIRUS VACCINE; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 1039456

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AA

gering
Staat
NY
Alter
0,2
Geschlecht
F
Eingang
18.02.2021
Impfdatum
11.02.2021
Beginn
12.02.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
Akinesia Electrocardiogram normal Electroencephalogram normal Enterovirus infection Laboratory test normal Respiratory viral panel Resuscitation Rhinovirus infection SARS-CoV-2 test negative Unresponsive to stimuli White blood cell count increased

Symptomtext

My patient received her 2-month vaccines on the morning of Thursday 2/11/21. The following morning, on 2/12/21, she had 2 episodes diagnosed as BRUE's within 5 minutes of each other. Per mom, she was being carried in a wearable baby carrier and when mom looked down, she was still and when mom tried to touch her, she got no response. Mom removed her from baby carrier and gave her mouth-to-mouth breaths until she seemed responsive again. Then she seemed fine. It happened again about 5 minutes later. She was taken to hospital.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Akinesia
Hospital-Tage
1,0
Labordaten
She had a respiratory panel PCR which came back positive for Rhino/Enterovirus. Labs unremarkable except for WBC 20. Negative Covid-19. She had a normal EKG and a normal EEG. She was admitted and observed overnight in the hospital.
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
Vit D infant drops, 400iu per day
Allergien
none
Vorherige Impfungen
-

VAERS 978319

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AA

gering
Staat
DE
Alter
-
Geschlecht
M
Eingang
27.01.2021
Impfdatum
04.01.2021
Beginn
04.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

dose of PENTACEL was administered last week, only the Dtap/Ipv portion was administered with no AE; Initial information received on 11-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who received an dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ319AA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh on 04-Jan-2021 for prophylactic vaccination (Product preparation issue). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ). It was an actual medication error due to Product preparation issue(latency 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 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
PREVNAR; ROTATEQ
Allergien
-
Vorherige Impfungen
-