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Reporte zur Charge UJ264AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 2

VAERS 985686

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ264AAA

schwer
Staat
PA
Alter
0,1
Geschlecht
F
Eingang
29.01.2021
Impfdatum
17.11.2020
Beginn
19.11.2020
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
Apnoea test abnormal Bacterial test negative Basophil count decreased Basophil percentage decreased Bilirubin urine Blood calcium normal Blood chloride increased Blood creatinine normal Blood culture negative Blood glucose normal Blood magnesium increased Blood phosphorus normal Blood potassium normal Blood sodium normal Blood urea normal Blood urine absent Bradycardia Carbon dioxide normal

Symptomtext

Presented because of brief (seconds long) episode of difficulty breathing (sounded congested and maybe SOB), self-resolved, no peri-oral cyanosis, was breathing the entire time. Brought to ED via EMS. No decreased PO, no fevers, no emesis, no increased spit-ups. Upon arrival to the ED, patient was noted to be hypothermic (on repeat) on 35.3 C. Sepsis work up was initiated including blood culture, urine culture, urinalysis, BMP, CBC and LP was unsuccessful x3. CBC was reassuring. COVID screen sent and negative Temps up to 36.3 prior to transfer to NICU with bundling and hat. Admission Date: 11/19/2020 Discharge Date: 12/4/2020 Patient was admitted for rule out sepsis workup given episode of hypothermia following a transient brief respiratory distress episode at home which was concerning for BRUE FEN: Continued on home regimen of 24 kcal FBM/Enfamil PO ad lib. Given persistent reflux , trial of Similac total comfort 24 kcal Formula on 11/27 with no improvement. Trial on chilled 22 kcal FBM/ Enfacare on 11/30 and continued until discharge. Resp: Remained stable on room air. CV: Remained hemodynamically stable. ID: Admitted for rule out sepsis workup given hypothermia in ED. She received at 48 hour course of Vancomycin and ceftriaxone (11/19-11/21).. Blood , CSF and urine cultures negative .US guided LP obtained on unit and CSF analysis not consistent with infectious etiology. Neuro: Baby had an event on day of admission - 45 second episode of desaturation and bradycardia with color change along with posturing/stiffening of body and eye deviation requiring stimulation and CPAP. Due to concern for seizure, obtained neurology consult and started on VEEG which showed background consistent with prematurity but no seizures and HUS which was unremarkable. Neurology signed off. GI: An apnea study with pH monitoring performed given concern for reflux with Sandifer syndrome , results as follows:"very mild desaturation events are associated with brief central apnea. I doubt that these are clinically relevant. Reflux index is higher than expected for age. There are no associated vital sign changes, except for occasional mild desaturations as described above. The combination of the description of the BRUE and the increased reflux index makes it plausible that the infant had a reflux associated event and appropriately protected her airway. Please keep in mind that none of the events that are charted by nursing were captured on this study " Given likelihood of reflux being etiology of events , patient started on omeprazole on 11/23 and continued until discharge . Continued to have apnea/bradycardia/desaturation events on omeprazole sporadically , with one significant event requiring PPV. Plan to discharge after remaining event free for 7 days and with home apnea monitor . Last event was on 11/27 and patient discharged on 12/4, event free with home monitor. Parents received bedside teaching and spent 12 hours at bedside for practice with usage of monitor. Home nursing visits to asses for comfort level/concerns with monitor use to be scheduled for parents ( representative will reach out after discharge)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Intensive care
Hospital-Tage
15,0
Labordaten
Glucose Nova, POC Collection Time: 11/19/20 2:25 AM Result Value Ref Range Glucose, Point-of-Care 71 (L) 74 - 127 mg/dL Enhanced UA Collection Time: 11/19/20 2:32 AM Result Value Ref Range Urine Color Yellow Urine Appearance Clear Urine Specific Gravity 1.020 1.003 - 1.035 Urine pH 7.0 4.8 - 7.8 Urine Leukocytes Negative Negative Urine Nitrite Negative Negative UR Protein 1+, 30 (A) Negative mg/dL Urine Glucose Negative Negative mg/dL Urine Ketone Negative Negative mg/dL Urine Urobilinogen 0.2 <2.0 mg/dL Urine Bilirubin Negative Negative Urine Blood Negative Negative Enhanced UA WBC Cell Count 10 (H) 0 - 9 /uL Gram Stain-Urine Collection Time: 11/19/20 2:32 AM Specimen: Urine, Catheter No additional details required Result Value Ref Range Gram Stain No organisms seen Narrative Enhanced UA shared with core Urine Culture Collection Time: 11/19/20 2:32 AM Specimen: Urine, Catheter Narrative Enhanced UA shared with core SARS-CoV-2 PCR Collection Time: 11/19/20 2:32 AM Result Value Ref Range COVID-19 Negative Negative Blood Culture Collection Time: 11/19/20 2:32 AM Specimen: Peripheral, Blood Peripheral (not drawn from a central line) Result Value Ref Range Blood culture Blood Culture received by Lab. No growth to date. CBC,Platelet With Differential Collection Time: 11/19/20 3:45 AM Result Value Ref Range WBC 7.5 7.1 - 14.7 K/uL RBC 3.24 2.70 - 4.90 M/uL HGB 9.4 9.0 - 13.5 g/dL HCT 28.5 28.0 - 42.0 % MCV 88.0 77.0 - 115.0 fL MCH 29.0 26.0 - 34.0 pg MCHC 33.0 29.0 - 37.0 g/dL RDW with Standard Deviation 48.7 43.0 - 55.0 fL RDW Coefficient of Variation 15.3 13.6 - 15.8 % Platelet Count 289 150 - 400 K/uL MPV 10.3 9.4 - 11.1 fL Nucleated RBC 0.9 (H) <0.1 /100 WBC Differential Method Automated Immature Granulocyte 0.3 0.0 - 0.9 % Neutrophils 32.8 8.9 - 68.2 % Lymphocytes 44.7 37.8 - 86.7 % Monocytes 13.6 3.8 - 15.5 % Eosinophils 8.5 (H) 0.0 - 4.1 % Basophils 0.1 0.0 - 0.5 % Absolute Immature Granulocyte 20 0 - 90 /uL Absolute Neutrophils 2,470 1,000 - 4,680 /uL Absolute Lymphocytes 3,360 2,290 - 9,142 /uL Absolute Monocytes 1,020 280 - 1,210 /uL Absolute Eosinophils 640 (H) 40 - 630 /uL Absolute Basophils 10 10 - 50 /uL Basic Metabolic Panel Collection Time: 11/19/20 3:45 AM Result Value Ref Range Sodium 141 (H) 133 - 140 mmol/L Potassium 4.4 4.1 - 5.8 mmol/L Chloride 112 (H) 96 - 106 mmol/L Carbon Dioxide 22 20 - 26 mmol/L Urea Nitrogen 9 2 - 19 mg/dL Creatinine 0.2 0.1 - 0.4 mg/dL Glucose 71 (L) 74 - 127 mg/dL Calcium 9.5 7.8 - 11.3 mg/dL Magnesium Collection Time: 11/19/20 3:45 AM Result Value Ref Range Magnesium 2.5 1.5 - 2.5 mg/dL Phosphorus Collection Time: 11/19/20 3:45 AM Result Value Ref Range Phosphorus 6.3 4.8 - 8.2 mg/dL Glucose Nova, POC Collection Time: 11/19/20 5:30 AM Result Value Ref Range Glucose, Point-of-Care 115 74 - 127 mg/dL
Aktuelle Erkrankungen
Hospitalized in the NICU for prematurity (gestational age 29 weeks) for 7 weeks.
Vorgeschichte
Prematurity Retinopathy of Prematurity
Andere Medikamente
Vitamin D
Allergien
-
Vorherige Impfungen
-

VAERS 1440133

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ264AAA

gering
Staat
PA
Alter
1,3
Geschlecht
F
Eingang
01.07.2021
Impfdatum
23.06.2021
Beginn
23.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Expired ACTHIB was administered to a patient, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory Authority (Reference number- 00653907) and transmitted to Sanofi on 23-Jun-2021. This case involves a 1-year-old female patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ264AAA, expiry date: 04-Jun-2021], via intramuscular route at the left thigh on 23-Jun-2021, for prophylactic vaccination (expired product administered). The patient received no other vaccination. Medical history, medical treatment, concomitant medication and family history were not reported. It was a case of actual medication error due to expired vaccine used. (Latency: on same day) At the time of report, no adverse event was reported. At time of reporting, the outcome was of event reported as unknown. 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
-
Allergien
-
Vorherige Impfungen
-