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Reporte zur Charge UT7081JA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 1116157

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7081JA

kritisch
Staat
-
Alter
1,0
Geschlecht
M
Eingang
19.03.2021
Impfdatum
23.09.2020
Beginn
15.10.2020
Tage bis Beginn
22,0
Dosis
UNK
Route/Site
OT / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Death

Symptomtext

the patient found deceased in bed (death); This spontaneous report was received from a physician via Sanofi (manufacturer control # 2020SA294858) on 15-MAR-2021, referring to a 13-month-old male patient. The patient's medical history included seizure and coronavirus disease of 2019 (COVID-19). He had no pre-existing physician-diagnosed allergies and birth defects and at the time of reporting. It was known if the patient had any additional medical history, concomitant disease or risk factor. Past medical treatment(s), vaccination(s) and family history were not reported. On 23-SEP-2020 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA) (lot # S038146, expiration date was not reported, upon internal validation established as 25-MAY-2021, strength was not reported) 0.5 milliliter, subcutaneously in the left thigh for prophylactic vaccination. On the same date, the patient was also vaccinated with hib conj vaccine (tet toxoid) (ACTHIB) (lot # UJ185AA, expiration date, strength and route were unknown) 0.5 milliliter in right vastus lateralis for prophylactic vaccination. On 14-OCT-2020, the patient was vaccinated with influenza virus split virion 4v vaccine inactivated (FLUZONE) prefilled syringe (lot # UT7081JA, expiration date was 30-JUN-2021, strength was not reported) 0.5 milliliter intramuscularly in left vastus lateralis for prophylactic vaccination. Either on 14-OCT-2020 or 15-OCT-2020, the patient received a dose (once) of acetaminophen (PARACETAMOL) (lot #, expiration date, strength and route were not reported) 4 ml for an unknown indication and then the patient was put to bed at usual time. At that time the body temperature of the patient was 97.7 degrees Fahrenheit. In the morning of 15-OCT-2020, the patient was found deceased in bed. No other illness and symptoms were reported. At the time of reporting, it was unknown if the autopsy was conducted, and the cause of death was not determined. The cation taken with acetaminophen(PARACETAMOL) was not applicable. The causality assessment between death and all suspect therapies was not provided.; Reported Cause(s) of Death: unknown cause of death; cause of death was not determined

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Drug use for unknown indication; Prophylaxis
Vorgeschichte
Medical History/Concurrent Conditions: COVID-19; Seizure
Andere Medikamente
acetaminophen
Allergien
-
Vorherige Impfungen
-

VAERS 890008

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7081JA

kritisch
Staat
TX
Alter
1,0
Geschlecht
M
Eingang
22.01.2021
Impfdatum
23.09.2020
Beginn
15.10.2020
Tage bis Beginn
22,0
Dosis
UNK
Route/Site
OT / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Death

Symptomtext

patient found deceased in bed, no reason of death has been determined (Death NOS); Initial information was received regarding an unsolicited valid serious case from the nurse (Reference number 00322310) on 19-Oct-2020. This case involved a 13 month old male patient who found deceased in bed (death) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], HIB (PRP/T) VACCINE [ACT-HIB], MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD] and after treatment with PARACETAMOL [ACETAMINOPHEN]. The patient's medical history included seizure and COVID-19 (coronavirus disease of 2019). The patient had no pre-existing physician-diagnosed allergies and birth defects and at the time of reporting, it was unknown if the patient had any additional medical history, concomitant disease or risk factor. Past medical treatment(s), vaccination(s) and family history were not reported. The patient did not receive any concomitant medication. On 23-Sep-2020, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ185AA and expiration date was not reported) via an unknown route in the right vastus lateralis and a 0.5 ml dose of suspect PROQUAD (not produced by Sanofi Pasteur, lot S038146 and expiration date was not reported) via subcutaneous route in the left thigh for prophylactic vaccination. On 14-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot UT7081JA and expiration date 30-Jun-2021) via an intramuscular route in the left vastus lateralis for prophylactic vaccination. Either on 14-Oct-2020 or 15-Oct-2020, the patient had received a 4 ml dose of PARACETAMOL (batch number, expiration date and route of administration not reported) for an unknown indication and then the patient put to bed at usual time. At that time, the patients body temperature was 97.7 Fahrenheit. On 15-Oct-2020 in the morning, the patient found deceased in bed (death), same day or 1 day following administration of PARACETAMOL, 1 day following the vaccination of INFLUENZA QUADRIVAL A-B VACCINE and 22 days following the vaccination of HIB (PRP/T) VACCINE and PROQUAD. No other illness and symptoms were reported. At the time of reporting, it was unknown if an autopsy was done and the cause of death was not known, as no reason of death was determined. Follow up information was received regarding an unsolicited valid serious case from the nurse on 10-Nov-2020. New suspect vaccines added and information on the medical history and concomitant medication updated. Follow up information was received regarding an unsolicited valid serious case from the physician on 12-Jan-2021. New suspect added and information regarding medical history and laboratory test updated.; Sender's Comments: Follow up information received on 12-Jan-2021, changes the previous medical assessment of the case. This case involves a 13 months old male patient who died, 1 day after receiving FLUZONE QUADRIVALENT, PARACETAMOL also 22 days after receiving ACT-HIB and PROQUAD (not produced by Sanofi Pasteur). Time to onset is compatible with FLUZONE QUADRIVALENT and ACETAMINOPHEN. The patient had history of seizure and COVID 19. Information regarding autopsy results for cause of death and laboratory data ruling out alternative etiology needed for complete assessment of the case. Based upon the reported information, the role of an individual product cannot be assessed.; Reported Cause(s) of Death: patient found deceased in bed, no reason of death has been determined (Death NOS)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
Test Date: 202010; Test Name: Body temperature; Test Result: 97.7 {DF}
Aktuelle Erkrankungen
-
Vorgeschichte
Medical History/Concurrent Conditions: COVID-19; Seizure
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-