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Reporte zur Charge UJ523AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 1 WI 1 NJ 1 OH 1

VAERS 1536392

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ523AAA

mild
Staat
MI
Alter
1,8
Geschlecht
F
Eingang
09.08.2021
Impfdatum
03.08.2021
Beginn
05.08.2021
Tage bis Beginn
2,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Allergy test negative Rash erythematous Rash papular Rash pruritic

Symptomtext

acute onset of rash yesterday evening. Rash is red, itchy, raised, waxing and waning. No treatment to date Patient had vaccines on 8/3/21. Patient also diagnosed with RSV 7/23. Had cough and diarrhea--both have resolved for the last week Was prescribed amoxicillin on 7/26/21 for otitis media but only tolerated one dose. no reported new foods, no new detergents or soaps no previous episodes of hives mom reports that she had chronic hives for 2 years--allergy testing was entirely negative.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash erythematous
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
RSV+ on 7/23/21, acute bilateral otitis media on 7/26/21
Vorgeschichte
none
Andere Medikamente
1 dose of amoxicillin on 7/26/21, did not tolerate it ondansetron 4mg/5ml oral solution (5ml bid as needed)
Allergien
none
Vorherige Impfungen
-

VAERS 1055124

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ523AAA

mild
Staat
WI
Alter
1,3
Geschlecht
M
Eingang
25.02.2021
Impfdatum
01.02.2021
Beginn
08.02.2021
Tage bis Beginn
7,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: nein
Conjunctival hyperaemia Gait disturbance Immunoglobulin therapy Kawasaki's disease Pyrexia Rash Rash erythematous Soft tissue swelling Toe walking

Symptomtext

Patient developed fever, new onset erythematous rash on face and trunk, limping on L leg and toe walking, soft tissue swelling, and conjunctival injection. Patient admitted to hospital on 2/12/21 with diagnosis of Kawasaki disease and received treatment with IVIG and aspirin. Discharged on 2/15/21 with continued aspirin until follow-up. Re-admitted on 2/16/21 for overnight admission and received another dose of IVIG.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
4,0
Labordaten
-
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
N/A
Vorherige Impfungen
-

VAERS 2109232

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ523AAA

gering
Staat
NJ
Alter
-
Geschlecht
U
Eingang
12.02.2022
Impfdatum
-
Beginn
21.01.2022
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

PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case was received from an other health professional. This case involves an intercepted product storage error which involved diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) which was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (ae). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was supposed to receive a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot UJ523AAA and U6986AA, expiry date: 22-Jul-2022; ) via unknown route in unknown administration site to be given as prophylactic vaccination. It was reported that on 21-Jan-2022 the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (intercepted product storage error). The reporter enquired if she could still reconstitute and administer the vaccine and if she should wipe off the top of the vial. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae). At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae. 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 1873547

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ523AAA

gering
Staat
OH
Alter
0,2
Geschlecht
M
Eingang
16.11.2021
Impfdatum
15.11.2021
Beginn
16.11.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

Influenza was accidentally administered to patient on 11/15/21. Parent informed on 11/16/21, patient has no reactions and is doing well.

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