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Reporte zur Charge UJ323ABA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NY 1 IL 1 CO 1

VAERS 988627

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ323ABA

schwer
Staat
NY
Alter
0,3
Geschlecht
F
Eingang
29.01.2021
Impfdatum
26.01.2021
Beginn
27.01.2021
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Apnoeic attack Bacterial test Chest X-ray normal Computerised tomogram head normal Dyspnoea Electrocardiogram normal Fatigue Joint contracture Lumbar puncture Muscle contractions involuntary Muscle twitching Seizure like phenomena Wheezing

Symptomtext

Pt began with left eye, arm, and leg twitching, followed by tongue fasciculations, trouble breathing & wheezing that lasted 10-15 minutes Per mother patient became tired after the event & was subsequently brought to ED by ambulance. Peripheral IV; @9:50am seizure like activity, lt eye twitch, followed by fist clenching - lasted 10-15 min. Pt was apneic- bagging & 2 doses ativan given Treated further with keppra, Neurology consulted & pt. observed. No further episodes, d/c home 1/28/21 on keppra. Neuro f/u in 2 mos. PCP 01/29/2021

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure like phenomena
Hospital-Tage
-
Labordaten
full septic workup and LP done. Twelve lead EKG, Chest XRay, Head CT completed & normal
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1004918

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ323ABA

mild
Staat
IL
Alter
1,3
Geschlecht
M
Eingang
04.02.2021
Impfdatum
01.02.2021
Beginn
02.02.2021
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Injection site erythema Injection site swelling

Symptomtext

Pt woke with swelling & redness on left thigh at injection site

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
1/15/21 ARl (J22) fever
Vorgeschichte
Hypogammaglobulinemia
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
Local reaction at injection site MMR 11/23/20 (parent's report)

VAERS 1518321

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ323ABA

gering
Staat
CO
Alter
0,2
Geschlecht
M
Eingang
31.07.2021
Impfdatum
20.07.2021
Beginn
20.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient received an expired dose of PENTACEL/no AE; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Regulatory Authority (Reference number- 00694634). This case involves a 2-month-old male patient who was vaccinated with an expired dose of suspect IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 20-Jul-2021, the patient received a 0.5mL of first dose of suspect IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number : UJ323ABA and expiry date : 13-Jun-2021) via an intramuscular route in the right thigh administration site 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 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
HEPATITIS B VACCIN; PREVNAR 13
Allergien
-
Vorherige Impfungen
-