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Reporte zur Charge UJ788AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MN 1 OH 1 SD 1

VAERS 2562338

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ788AAA

mild
Staat
MN
Alter
0,3
Geschlecht
M
Eingang
18.01.2023
Impfdatum
06.01.2023
Beginn
07.01.2023
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Crying Electroencephalogram abnormal Erythema Eye movement disorder Fatigue Infant irritability Infantile spasms Insomnia Lacrimation increased Magnetic resonance imaging normal Malaise Middle insomnia Muscle spasms Musculoskeletal stiffness Ocular hyperaemia Rhinorrhoea Sneezing Vomiting projectile

Symptomtext

1/6/23 ? 11:30am immunizations. 4:30p pickup from daycare, eyes watery & red, nose runny, seems tired and sick. 1/7/23 ? fussy, sick (runny nose, sneezing, watery eyes, no fever). won't take a day nap but trying to get him to sleep around 2-3pm and notice first spasm. slept at night okay. 1/8/23 - still fussy, sick-ish, but no fever. still won't nap during day. finally at 10p get him to sleep for the night. 10:40p awakes with a spasm ? eyes alert, arms/legs stretched outward and stiff, crunches towards the stomach. after body relaxes cries hard for 15 minutes and then sleeps the night through okay. 1/9/23 ? sent to daycare, picked up around 4:30p, his right cheek is bright red (daycare says due to nap) but stays red for hours that night but observe no spasms 1/10/23 ? sent to daycare, picked up around 4:30p ? he is asleep as they hand them to me and as i get him into his snowsuit he has multiple spasms in a row ? cluster of about 6 then a minute off and another cluster. daycare said they had noticed these spasms too and thought it was colic. video tapped this called pediatrician head to Hospital ER. after two failed attemepts at inserting an IV he is upset and has a cluster of intense body spasms (arms/legs fling out, stiffen and crunch towards stomach; eyes roll up in head but focused and alert the whole time) that last about 2-3 minutes while ER dr is in the room. EEG conducted overnight at hospital.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Fatigue
Hospital-Tage
4,0
Labordaten
EEG test, abnormal Diagnosed as Infantile Spasms. MRI conducted, normal High-dose oral steriods started 1/11/23, 1/12/23 projectile vomiting keeps us in hospital until 1/13/23
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2689228

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ788AAA

gering
Staat
OH
Alter
0,3
Geschlecht
F
Eingang
02.10.2023
Impfdatum
21.09.2023
Beginn
21.09.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 4 months old female patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (Immunisation); and rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination (Immunisation). On 21-Sep-2023, the patient received a standard expired dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ788AAA, expiry date- 18-SEP-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asks what should they do? She asks how they should document the expired dose in the chart? Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. 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
PREVNAR 13; ROTARIX
Allergien
-
Vorherige Impfungen
-

VAERS 2614105

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ788AAA

gering
Staat
SD
Alter
0,3
Geschlecht
M
Eingang
12.04.2023
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

patient was administered pentacel, but it was not reconstituted with the HIB component with no adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis /IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], but it was not reconstituted with the hib component with no adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis /IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ788AAA, strength - standard, frequency - once, expiry dat - 18-Sep2023) via unknown route in unknown administration site for immunization but it was not reconstituted with the hib component with no adverse event (single component of a two-component product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. 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 guidelines. 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
-
Allergien
-
Vorherige Impfungen
-