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Reporte zur Charge UJ465AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
1Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
KY 1 CT 1 WA 1 GA 1

VAERS 1924310

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AAA

kritisch
Staat
KY
Alter
0,2
Geschlecht
M
Eingang
30.08.2021
Impfdatum
23.08.2021
Beginn
25.08.2021
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Death Resuscitation Unresponsive to stimuli

Symptomtext

@ 4:00 am on 8/25/21 - baby was in bed with mother asleep in her arms. Mother woke up and found baby unresponsive. Family initiated CPR & called 911. Baby was pronounced dead at the hospital.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
8/8/21 - nasal congestion- evaluated in walk-in clinic
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2231127

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AAA

mild
Staat
CT
Alter
0,3
Geschlecht
M
Eingang
13.04.2022
Impfdatum
12.04.2022
Beginn
12.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Urticaria

Symptomtext

Hives starting around evening time of day of vaccination that continued spreading into the next day. No vomiting or difficulty breathing. No other symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
No known
Vorherige Impfungen
-

VAERS 1678031

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AAA

gering
Staat
WA
Alter
0,2
Geschlecht
M
Eingang
07.09.2021
Impfdatum
04.08.2021
Beginn
04.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

patient received PENTACEL but did not get the ACT-HIB portion/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Medical Information (Reference number- 00736108). This case involves a 3-month-old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] but did not get the ACT-HIB portion (product preparation issue). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination. On 04-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (suspension, lot number: UJ465AAA and expiry date: 21-Mar-2021) via an intramuscular route in the right lateral thigh for prophylactic vaccination. It was an actual medication error case due to inappropriate reconstitution technique (latency: same day). It was reported "caller is wanting to know what to do." 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 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PNEUMOVAX; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1515391

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AAA

gering
Staat
GA
Alter
4,0
Geschlecht
M
Eingang
30.07.2021
Impfdatum
29.07.2021
Beginn
29.07.2021
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Product administered at inappropriate site

Symptomtext

Varicella vaccine was administered with a 5/8" needle syringe intramuscularly in the right deltoid rather than subcutaneously. The patient did not experience any adverse effects. The manufacturer was contacted to confirm if series needed to be repeated, which they confirmed that it would not. The patient's guardian was notified of the administration error and recommended to return in the specified timeframe to receive the second vaccine in the series.

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