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Reporte zur Charge UT 7081LA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
1Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OR 1 NV 1

VAERS 942246

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7081LA

kritisch
Staat
OR
Alter
1,0
Geschlecht
M
Eingang
13.01.2021
Impfdatum
11.12.2020
Beginn
20.12.2020
Tage bis Beginn
9,0
Dosis
2
Route/Site
IM / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Autopsy Blood glucose decreased Blood glucose increased Cardiac arrest Chest X-ray abnormal Cough Death Echocardiogram abnormal End-tidal CO2 decreased Endotracheal intubation Endotracheal intubation complication Faeces hard Infantile apnoea Pulse absent Pyrexia Resuscitation Retching Seizure

Symptomtext

On 12/20/2020, dad of patient called our office after hours. Nurse triage line took the call. Dad's reported that pt had a fever of 100.6 F (max temp) and hard stools. Pt was given a dose of Tylenol and 10-15 minutes later, pt vomited. Triage nurse advised that dad follow up with PCP office when open in the AM. Dad called our office at 10:25am on 12/21/2020 stating that pt fever had lifted, but pt vomited a total of 5 times since the night before, with the last episode at 7:45 am on 12/21/2020. Pt had adequate fluid intake and urine output and stool had softened. MA advised continued home care. Appropriate triage advice was given and documented. At 16:43(pm) on 12/21/20, dad called back to clinic stating patient symptoms had worsened and they were at the emergency department. Dad disconnected call before speaking with the MA. The MA attempted to call dad back, but there was no answer. A message was left for dad to return call. On 12/22/20 at 12:44(pm), dad called in to clinic to report that pt had died- cause unknown. Our clinic obtained records from Hospital. The ED report stated that pt presented to the emergency department via EMS Code 3 in cardiac arrest. Unknown downtime prior to the initiation of chest compressions. Pt was staying with grandparents. When grandma went to wake pt from his nap, he was not responsive. When grandma tried to pick him up, there was possibly some brief, generalized seizure activity as well as coughing and gagging. Child remained unresponsive and was taken by private vehicle to outside Urgent Care where pt was found to be apneic and in asystole. An AED was applied, no shock advised. EMS was called and CPR was started. EMS placed an endotracheal tube and established IO access. 4 rounds of epinephrine were administered during the course of the prehospital resuscitation which was approximately 15-20 minutes. Presenting rhythm was asystole. No change in rhythm upon transport and arrival. Immediately upon arrival the pediatric transport team was activated and the pediatric intensivist was paged. Chest compressions were resumed according to protocol. Additional inter osseous access was established in the left proximal tibia. Fluid bolus was initiated. Serial doses of epinephrine were administered every 4 minutes throughout the resuscitation. The child also received several boluses of IV bicarb. Online consultation by ED physician with PICU attending was established early in the resuscitation course. It was agreed by ED physician and PICU attending that the peds transport team would be dispatched urgently to the ED location in anticipation of possible ROSC and need for emergent transport to PICU. It was agreed by ED physician and PICU attending that transportation would not be initiated with the child still undergoing resuscitation requiring chest compressions prior to ROSC. Initially, endotracheal tube position felt to be acceptable based on the clinical evaluation, however chest x-ray did demonstrate some degree of right mainstem intubation, after which the tube was pulled back approx 2cm and subsequent x-ray showed the ETT tip in good position approx 1 cm above the carina. Initial end-tidal CO2 was 14 on arrival, this continued to trend downward until undetectable throughout the course of the resuscitation. At no point were there palpable pulses or other evidence of return of circulation throughout the resuscitation. Capillary blood glucose was initially undetectable. The child received serial boluses of D 25 via IO line for a tital of 30 g dextrose after which CBG ultimately came up to 244. Multiple efforts were made throughout the resuscitation to achieve IV access and to obtain blood for laboratory studies. All efforts were unsuccessful, making it impossible to obtain any labs throughout the course of the resuscitation. Attempts to obtain even capillary blood samples via heel stick for CBG measurements were extremely difficult. Resuscitation continued for 49 minutes after ED arrival. A total of at least 65 minutes of CPR time. Bedside ultrasound was used to look for cardiac activity during the last 5 pulse checks of the resuscitation, demonstrating cardiac standstill. Despite the efforts and interventions mentioned, ROSC was never obtained and the code was discontinued at 17:03(pm). The child's parents were informed of his death upon their arrival to the ED at approximately 17:40(pm). Family was given time with the pt. The medical examiner arrived and discussed case at 19:11(pm). At 19:49(pm) Medical Examiner was interviewing grandparents along with 2 County Detectives. The medical examiner took custody of the pt at 21:52(pm). Evidence bag was sent with the medical examiner. Pt received vaccinations 10 days prior to death. We are still waiting for M.E. report, as we do not have any further information as to why pt passed.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Cardiac arrest
Hospital-Tage
-
Labordaten
Initial cap glucose- Undetectable 12/21/2020 12/21/2020 16:29(pm) Glucose- 37 mg/dL 12/21/2020 16:36(pm) Glucose- 46 mg/dL 12/21/2021 16:50(pm) Glucose- 244 mg/dL
Aktuelle Erkrankungen
No known illness.
Vorgeschichte
No known chronic/ long-standing health conditions.
Andere Medikamente
Enfamil Gentlease Formula
Allergien
NKMA
Vorherige Impfungen
-

VAERS 1085203

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT 7081LA

mild
Staat
-
Alter
-
Geschlecht
M
Eingang
09.03.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Cough Pyrexia Rash

Symptomtext

dry cough; Fever; rash over entire body; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer. This case involves Infant male patient of an unknown age who experienced dry cough (cough), fever (pyrexia) and rash over entire body (rash), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient had no medical history, concomitant disease or risk factor. Medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7081LA and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious fever (pyrexia) 2-3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious dry cough (cough) and rash over entire body (rash) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was unknown if patient physician provided consent to be contacted It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the patient recovered from the pyrexia (also reported that lasted 3-4 days, then fever went down). The outcome of event cough and rash was reported as unknown.

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

VAERS 1030862

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7081LA

gering
Staat
NV
Alter
0,1
Geschlecht
M
Eingang
15.02.2021
Impfdatum
01.02.2021
Beginn
01.02.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

injection of FLUZONE QUADRIVALENT was given to a 1 month old/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other-health care professional via agency (Reference number- 00455292) and transmitted to Sanofi on 01-Feb-2021. This case involves a 1-month-old male patient who received 0.5 mL first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (injection, batch number: UT7081LA and expiry date: 30-Jun-2021 via an unknown route in left thigh) on 01-Feb-2021 (product administered to patient of inappropriate age) for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day). Reporter want to know what to do now, and what they should look out for as well as information they need to give to the family. The caller wanted to talk to a doctor about recommendations. The product was used for first time. No other vaccines or medications were given when FLUZONE QUADRIVALENT administered. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-