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Reporte zur Charge UJ424AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

7Reporte angezeigt
0Todesfaelle
1Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
CA 2 WA 2 IA 1 TX 1 AZ 1

VAERS 1518850

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ424AAA

schwer
Staat
CA
Alter
0,3
Geschlecht
M
Eingang
01.08.2021
Impfdatum
29.07.2021
Beginn
30.07.2021
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
CSF test normal Febrile convulsion Laboratory test normal

Symptomtext

Complex febrile seizure, onset 7/30. Two brief episodes on 7/30, prompting hospitalization 7/30-7/31.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
-
Labordaten
Negative workup for sepsis and meningitis. Normal CSF studies (cellular and chemistry).
Aktuelle Erkrankungen
parainfluenza virus infection
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1418093

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ424AAA

schwer
Staat
WA
Alter
0,3
Geschlecht
F
Eingang
22.06.2021
Impfdatum
07.06.2021
Beginn
08.06.2021
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Abnormal faeces Alanine aminotransferase normal Anti-ganglioside antibody negative Apnoeic attack Aspartate aminotransferase normal Asthenia Bacterial test negative Blood bicarbonate normal Blood chloride normal Blood creatinine decreased Blood glucose normal Blood potassium normal Blood sodium normal Blood urea normal Body temperature decreased Chest X-ray normal Decreased appetite Endotracheal intubation

Symptomtext

Term 4-mo female infant presented to ED 6/9/21 with 1 day history of motor weakness. ~ 2 weeks ago she had mild URI symptoms (cough) for only a couple of days and recovered to baseline. On 6/7 she received her 4-mo old vaccine series without acute side effects. She passed stool that day that was more smelly than usual with green tinge. The following day 6/8 AM she appeared generally well, several sneezes produced green mucous and her eye lids were slightly puffy. She was sent to daycare as usual. In the afternoon when dad picked her up she appeared ill with eye lids being puffy, poor head control. She only ate 2 out of 4 bottles during the day, 4 being her usual feeds while at daycare. When dad attempted to bottle her she had trouble latching on and milk was running out the corner of her mouth. Through out the evening she progressively became weaker with decreased limb movements. She presented to local ED overnight and was noted to have temp of 36.1F, RR 24 sating 99% on RA. She was noted to be lethargic and hypotonic. There was concern for sepsis/meningitis. She received 20 mL/kg IVF bolus. Her glucose was 89. She had a urinalysis which showed 1+ ketones but was otherwise reassuring. Her rapid influenza/SARS-CoV-2/RSV was negative. White blood cell count 8.2 (43% neutrophils, 47% lymphocytes), hematocrit 33.9, platelets 343. Sodium 138, potassium 4.2, chloride 105, bicarb 21, BUN 9, creatinine less than 0.2, AST 22, ALT 14. Lumbar puncture demonstrated WBC count of 4, RBC 4, glucose 57, protein 125. CSF Gram stain did not show any organisms. Sterile CSF culture. Chest x-ray was normal. The patient was noted to have an apneic event with an associated desaturation and was placed on 6 L HFNC. She was subsequently transferred to Hospital PICU for further evaluation and management. Upon arrival she continued to have worsening respiratory status necessitating intubation. Per parents there had been no fever, N/V/D. She feeds breast milk and formula, no solids, no honey, no soil/dirt exposure. There's no family history of neuromuscular disorder. Baby remains intubated on mechanical ventilation in PICU

Weitere VAERSDATA-Felder
Praegender Schweregrund
Intensive care
Hospital-Tage
13,0
Labordaten
Stool test negative for botulism. Anti GQ1B Ab negative. MEDICATIONS: 1. S/p BabyBIG 6/10 2. S/p IVIG 2g/kg 6/11-6/15 Rapidly progressive motor weakness with respiratory failure as the admitting Dx, parents report more movements in the past 48 hours. Compared to physical exam one week ago, there has been small but demonstrable improvement in motor function, now with some limited spontaneous movements. Although previous clinical history and course appeared most consistent with infantile botulism, no clear exposure ever identified and now stool study negative. Although age of presentation and descending paralysis less typical for demyelinating process such as Guillain-Barr? syndrome, the cytoalbumin disassociation on CSF studies and nerve root enhancement more consistent with this process. Anti-GQ 1B antibody which is positive in a subset of Miller Fisher variant Guillain-Barr? syndrome and other similar demyelinating conditions with cranial nerve involvement was also negative, but certainly does not rule out Guillain-Barr? syndrome as potential etiology of her weakness. I am very pleased that she has started to show some, albeit modest, recovery of motor movement. Given negative stool study for botulism, would recommend repeat imaging of MRI brain with and without contrast with dedicated cuts through the IACs and brainstem, as well as MRI of total spine to assess for any evolution in prior findings. Would also revisit the option of obtaining EMG and nerve conduction studies. Continue supportive care. Neurology will continue to follow.
Aktuelle Erkrankungen
Gastroesophageal reflux disease (GERD) of infancy
Vorgeschichte
3-day hospitalization at 7-mo old (3/28-31, 2021) for BRUE secondary to choking episode with breastmilk. Chronic history of GERD and choking episodes with breastfeeding since 2 weeks of age. Echocardiogram 3/29/21 revealed PFO with left-to-right shunting and mild pulmonary valve stenosis, followed by Pediatric Cardiology
Andere Medikamente
Famotidine for gastroesophageal reflux of infancy
Allergien
Antibiotic CEFTRIAXONE (non-urticarial rash involving face, chest and groin during first IV Ceftriaxone infusion)
Vorherige Impfungen
-

VAERS 1391511

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj424aaa

schwer
Staat
IA
Alter
0,2
Geschlecht
F
Eingang
11.06.2021
Impfdatum
09.06.2021
Beginn
09.06.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Febrile convulsion Full blood count normal Influenza virus test negative Pyrexia Respiratory syncytial virus test negative SARS-CoV-2 test negative Urine analysis

Symptomtext

Simple febrile sz

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
-
Labordaten
cbc, ua, rvp, covid, flu--all negative
Aktuelle Erkrankungen
GERD
Vorgeschichte
NA
Andere Medikamente
Omeprazole
Allergien
none
Vorherige Impfungen
-

VAERS 1478881

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ424AAA

mild
Staat
CA
Alter
1,3
Geschlecht
M
Eingang
16.07.2021
Impfdatum
01.07.2021
Beginn
01.07.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Adverse reaction Diarrhoea Rash

Symptomtext

Mother called 07/15 to report that child had adverse reaction. Call returned on 07/16 and mother stated that child had rash on back and diarrhea for three days starting the same day vaccines were administered.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
Mother declined Telehealth and also to bring child back for evaluation.
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
NKA
Vorherige Impfungen
-

VAERS 1876131

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ424AAA

gering
Staat
TX
Alter
0,2
Geschlecht
M
Eingang
17.11.2021
Impfdatum
24.08.2021
Beginn
24.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

accidentally gave a 2 month old baby PENTACEL resulting in an extra does of HIB with no adverse event.;Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via phone call (under Medical Information Inquiry Number: 00843694). This case involves a 2 months old male patient who was accidentally given a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] resulting in an extra dose of HIB with no adverse event (extra dose administered). The patient's medical history, past medical treatments, vaccinations, and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and ROTAVIRUS VACCINE for prophylactic vaccination. On 24-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: uJ424AAA and expiry date: 21-May-2022) via intramuscular route in the left thigh (left vastus lateralis) for prophylactic vaccination. It was case of an actual medication error due to extra dose administered (latency: same day). It was reported "Caller states that she gave a two-month-old a pentacel injection and a pediarix which resulted in the patient receiving two doses of dtap and ipol. Caller states that she reported the incident to the physician, but she just wanted to check with the manufacturer." 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 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PNEUMOCOCCAL VACCINE CONJ 13V (CRM197); PEDIARIX; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1771411

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ424AAA

gering
Staat
WA
Alter
0,5
Geschlecht
M
Eingang
08.10.2021
Impfdatum
05.10.2021
Beginn
05.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

The child inadvertently was given Pediarix and Pentacel when Pediarix and HIB were intended therefore the child received a double dose of Dtap and IPV. At the time of this filing the child has not experienced any signs or symptoms related to this error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1487760

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj424aaa

gering
Staat
AZ
Alter
1,5
Geschlecht
M
Eingang
20.07.2021
Impfdatum
19.07.2021
Beginn
19.07.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Somnolence

Symptomtext

Patient mom came back to the office stating the child she wasn't able to wake up

Weitere VAERSDATA-Felder
Praegender Schweregrund
Somnolence
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
Patient was sent to the ER
Allergien
n/a
Vorherige Impfungen
-