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Reporte zur Charge UT7330LA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 5 UT 1

VAERS 2569475

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7330LA

moderat
Staat
CA
Alter
12,0
Geschlecht
F
Eingang
27.01.2023
Impfdatum
08.09.2021
Beginn
02.11.2021
Tage bis Beginn
55,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Abdominal pain lower Autonomic nervous system imbalance Dizziness Dyspnoea Echocardiogram Electrocardiogram ambulatory normal Electrocardiogram normal Exercise electrocardiogram Heart rate increased Laboratory test normal Orthostatic heart rate test Palpitations Postural orthostatic tachycardia syndrome Tachycardia

Symptomtext

Discussion with Mom - Dysautonomia symptoms have increased in frequency over the past year. Pt.'s History likely started before Gardasil but symptoms worsened 1 month after it. ... 12-08-15 Tachycardia, Family history Long QT -> EKG, 48-hr Holter WNL ... 04-21-21 seen by me for Int Chr Abd Pain, Family history Crohn's in mom -> Labs WNL ... 09-08-21 seen by me for 12 3/12 yo WCC, Gardasil #1, Flu V x1 ... 11-02-21 ED: RLQ pain, Palpitations -> EKG, Pelvic USZ WNL ... 02-01-22 symptoms over the past year c/w Dysautonomia ... Symptoms x1 yr intermittent Palpitations, lightheaded, labored breathing ... Orthostatics HR increased 88 -> 114 ... w/u WNL: EKG, ECHO, Treadmill, 2 wk Monitor ... 12-14-22 meets criteria for Dysautonomia / POTS ... Orthostatics HR increased 71 -> 107, 116, 122

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dyspnoea
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Intermittent Chronic Abd Pain
Vorgeschichte
Intermittent Chronic Abd Pain
Andere Medikamente
Non listed
Allergien
Penicillin
Vorherige Impfungen
-

VAERS 1846993

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7330LA

mild
Staat
CA
Alter
58,0
Geschlecht
F
Eingang
05.11.2021
Impfdatum
26.10.2021
Beginn
27.10.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Alanine aminotransferase normal Albumin globulin ratio normal Aspartate aminotransferase normal Basophil count normal Basophil percentage decreased Blood albumin decreased Blood alkaline phosphatase normal Blood bilirubin normal Blood calcium decreased Blood chloride decreased Blood glucose normal Blood potassium normal Blood sodium decreased Blood urea nitrogen/creatinine ratio increased Blood urea normal Carbon dioxide normal Eosinophil count normal Eosinophil percentage decreased

Symptomtext

The patient had her Covid booster vaccine and Flu vaccine on 10/26/21. She was doing well not until 10/27/21 evening started to scratch her upper back shoulder. Around 10 pm noticed to have hives around the belly, upper and lower extremities. Her doctor was notified and ordered to start giving Benadryl 25 mg po every 6 hrs. until hives are gone and Tylenol po too. Recently she was treated for UTI with Augmentin from 10/20/21 ? 10/27/21. On 10/28/2021 morning, the rash did not get any better. Her vital sign was stable, no fever, O2 sat stable, not in any respiratory distress. Gave Claritin PRN orders with Tylenol at 9AM . RN was called and informed about the patient's condition and to relay message to her doctor. 12:20pm the rash become more worst and spread more to the face and eyes were slightly swollen. Called RN that we will bring the patient to emergency department at the Hospital for further management and to avoid anaphylactic response. Arrived at the hospital around 1:20 pm. The ED was fully packed and they were very busy during that time. Some of the patients have to wait outside. Luckily, we were able to get in on time at the waiting area. We waited for a long time to be seen by MD not until almost 5 pm. She was treated with Decadon 6 mg IM and was also given Vistaril 25 mg PO. The patient was discharged at 7:25 pm and arrived home at 7:40Ppm. Her doctor was called and informed about the patient's condition status. She was diagnosed to have Maculopapular rash, generalized and adverse reaction to COVID 19 vaccine. With new discharge order from the hospital to give Atarax mg po every 6 hrs. PRN for itching.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pruritus
Hospital-Tage
-
Labordaten
CBC Urinalysis complete metabolic panel 10/29/2021, WHITE BLOOD CELL COUNT 3.3 L 3.8-10.8 (Thousand/uL), RED BLOOD CELL COUNT 4.81 3.80-5.10 (Million/uL), HEMOGLOBIN 15.4 11.7-15.5 (g/dL), HEMATOCRIT 44.8 35.0-45.0 (%), MCV 93.1 80.0-100.0 (fL), MCH 32.0 27.0-33.0 (pg), MCHC 34.4 32.0-36.0 (g/dL), RDW 12.1 11.0-15.0 (%), PLATELET COUNT 140 140-400 (Thousand/uL), MPV 11.4 7.5-12.5 (fL), ABSOLUTE NEUTROPHILS 2264 1500-7800 (cells/uL), ABSOLUTE LYMPHOCYTES 828 L 850-3900 (cells/uL), ABSOLUTE MONOCYTES 188 L 200-950 (cells/uL), ABSOLUTE EOSINOPHILS 20 15-500 (cells/uL), ABSOLUTE BASOPHILS 0 0-200 (cells/uL), NEUTROPHILS 68.6 (%), LYMPHOCYTES 25.1 (%), MONOCYTES 5.7 (%), EOSINOPHILS 0.6 (%), BASOPHILS 0.0 (%), Complete Metabolic Panel GLUCOSE 137 65-139 (mg/dL), Non-fasting reference interval F UREA NITROGEN (BUN) 12 7-25 (mg/dL), CREATININE 0.36 L 0.50-1.05 (mg/dL), For patients >49 years of age, the reference limit - for Creatinine is approximately 13% higher for people - identified as. F eGFR 119 > OR = 60 (mL/min/1.73m2, eGFR 138 > OR = 60 (mL/min/1.73m2), BUN/CREATININE RATIO 33 H 6-22 ((calc)), SODIUM 134 L 135-146 (mmol/L), POTASSIUM 3.7 3.5-5.3 (mmol/L), CHLORIDE 95 L 98-110 (mmol/L) F CARBON DIOXIDE 29 20-32 (mmol/L) F CALCIUM 8.4 L 8.6-10.4 (mg/dL) F PROTEIN, TOTAL 5.9 L 6.1-8.1 (g/dL) F ALBUMIN 3.5 L 3.6-5.1 (g/dL) F GLOBULIN 2.4 1.9-3.7 (g/dL (calc),F ALBUMIN/GLOBULIN RATIO 1.5 1.0-2.5 ((calc)), BILIRUBIN, TOTAL 0.4 0.2-1.2 (mg/dL), ALKALINE PHOSPHATASE 60 37-153 (U/L), AST 26 10-35 (U/L), ALT 9 6-29 (U/L) Urinalysis - No UTI
Aktuelle Erkrankungen
UTI - Urinary Tract Infection treated with Augmentin for 7 days (10/21/2021-10/27/2021)
Vorgeschichte
Profound Intellectual Disability, Hypothyroidism, Epilepsy partial-complex,s/p VNS Implant, Osteopenia, GERD, Dysphagia, Left hydronephrosis due to renal cyst, Congenital Rubella, chronic constipation, Fibrocystic breast disease. Kidney stone s/p lithotripsy on 8/10/2021
Andere Medikamente
Levetiracetam 2000 mg tab Vimpat(Lacosamide) 150mg tabs Polyethylene Glycol (Miralax)3350 Calcium Citrate 250 mg tab Omeprazole 40 mg capsule KRILL OIL 500 mg PO Milk of Magnesia-400mg/5ml Senna Tablet 8.6mg (Senokot) Pregabalin (Lyrica
Allergien
No known allergies: Side effects include: Alendronate sodium (Fosamax) (Gastritis, Food Refusal) Clobazam (Onfi) (Agitation, Compulsive eating, screaming) Valproic Acid (Edema, Lethargy, Weight Gain, screaming)
Vorherige Impfungen
-

VAERS 1836833

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7330LA

mild
Staat
UT
Alter
43,0
Geschlecht
F
Eingang
02.11.2021
Impfdatum
29.10.2021
Beginn
29.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Influenza like illness Malaise Vomiting

Symptomtext

Patient is immunocompromised and felt very ill after receiving vaccine. Reactions include vomiting, flu-like symptoms, etc

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

VAERS 1735265

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge ut7330la

mild
Staat
CA
Alter
73,0
Geschlecht
F
Eingang
25.09.2021
Impfdatum
03.09.2021
Beginn
03.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site haemorrhage

Symptomtext

patient reported she had extra bleeding from shot and felt it was infected because it had white pimple near shot, she did not go to doctor and said she is fine now, but didnt notify us when it happened.

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

VAERS 1813125

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7330LA

gering
Staat
CA
Alter
50,0
Geschlecht
F
Eingang
23.10.2021
Impfdatum
20.09.2021
Beginn
20.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event Product administered to patient of inappropriate age Product storage error

Symptomtext

a portion of the doses were frozen/ no AE; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a Consumer via Regulatory authority (Reference number- 00814920) and transmitted to Sanofi on 15-Oct-2021. This case involves a 50-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and a portion of the doses were frozen with no adverse event (Product storage error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 20-Sep-2021, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7330LA and expiry date not provided] via intramuscular route in left deltoid for prophylactic vaccination, a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not reported] via unknown route in unknown administration site. It was reported "Doses of possibly frozen FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment". It was a case of actual medication error due to Product storage error temperature too low (latency was on same day). At the time of reporting, patient had no adverse 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 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. There will be no information available on batch number of FLUZONE HIGH-DOSE QUADRIVALENT and FLUZONE QUADRIVALENT for this case.

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

VAERS 1813124

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7330LA

gering
Staat
CA
Alter
52,0
Geschlecht
F
Eingang
23.10.2021
Impfdatum
16.09.2021
Beginn
16.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product storage error

Symptomtext

possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Medical information (under reference number - 00814790). This case involves 52-years-old female patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event (product storage error). The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On 16-Sep-2021, the patient received a 0.5ml {total} dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (injection, lot number UT7330LA and expiry date 30-06-2022) via intramuscular route at an unknown administration site for prophylactic vaccination (also reported as left). It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." It was case of an actual medication error due to product storage error temperature too low (latency was on same day) At the time of report, no adverse event was reported. Event outcome was 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-