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Reporte zur Charge UT7319LA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

15Reporte angezeigt
0Todesfaelle
2Hospitalisiert
2Lebensbedrohlich
0Bleibende Schaeden
NY 4 IN 2 PA 2 MD 2 OH 2 MN 1 NJ 1 IL 1

VAERS 2499200

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge ut7319la

kritisch
Staat
IN
Alter
65,0
Geschlecht
M
Eingang
04.11.2022
Impfdatum
01.03.2022
Beginn
01.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
SYR / -
Tod: unbekannt Lebensbedrohlich: ja Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Angiogram cerebral normal Blindness unilateral Cerebrovascular accident

Symptomtext

Document Type: MRA Brain W/O IV Contrast Document Subject: MRA Brain W/O IV Contrast Performed on March 17, 2022 13:36 EDT Verified on March 17, 2022 16:25 EDT Hospital, Outpatient, 03/17/22 - 03/17/22 * Final Report * Reason For Exam acute left eye blindness Report EXAMINATION: MRA Brain W/O IV Contrast EXAM DATE: 03/17/2022 13:36 CLINICAL INFORMATION: Acute left eye blindness, CVA 2 weeks ago. No trauma, no brain surgery, no trauma. COMPARISON: None available. TECHNIQUE: 3-D time-of-flight MRA of the brain was performed. Source images and maximum intensity projection images were reconstructed and reviewed with respect to criteria. Normal flow is seen in both internal carotid arteries. The M1 and A1 segments are patent. The anterior communicating artery is patent. The orbital vessels are not visualized at this resolution. The posterior communicating arteries are not seen. The right vertebral artery is mildly dominant. The basilar artery has normal branching. There is no evidence of intracranial hemorrhage and diffusion-weighted imaging shows no evidence of recent infarct. There is no evidence of aneurysm, dissection or flow limiting stenosis. IMPRESSION: Normal MRA of the brain. Electronically Signed Dictated on: 3/17/2022 4:20 PM Signature Line This examination and reported findings have been reviewed and confirmed by the undersigned. I authorize my name to be Electronically affixed by using my unique signature access code. Click VIEW IMAGE icon to Display Image This document has an image

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

VAERS 1857642

SEQIRUS, INC. · INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) · Charge UT7319LA

schwer
Staat
MN
Alter
48,0
Geschlecht
F
Eingang
10.11.2021
Impfdatum
09.11.2021
Beginn
09.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Dyspnoea Electrocardiogram normal Fatigue Muscle rigidity Panic attack Screaming Seizure like phenomena Skin laceration

Symptomtext

EMPLOYEE BECAME TIRED, RESTED IN CHAIR FOR > 10 MINUTES. Offered water. Resting and drinking water. After 15 minutes, she started screaming and clawing at her throat saying she can't breathe., She flopped herself onto the floor. Her extremities became rigid, seizure like. (No hx. of seizures) A code was called, Code team came assessed her and she was taken to the ED for further assessments.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure like phenomena
Hospital-Tage
-
Labordaten
EKG completed. Compared with prior EKGs, normal. Provided Ativan - symptoms consistent with panic attack. After receiving, patient discharged home at 6:12 p.m.
Aktuelle Erkrankungen
None
Vorgeschichte
Breast cancer 4 -5 yrs ago
Andere Medikamente
-
Allergien
Monk fruit allergy Docetaxel Taxotere
Vorherige Impfungen
-

VAERS 1798434

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

schwer
Staat
NJ
Alter
61,0
Geschlecht
F
Eingang
19.10.2021
Impfdatum
29.09.2021
Beginn
06.10.2021
Tage bis Beginn
7,0
Dosis
1
Route/Site
SYR / RA
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
Cardiac stress test Computerised tomogram thorax Cough Dyspnoea Intensive care Nasopharyngitis Positive airway pressure therapy Respiratory distress Respiratory tract congestion Rhinorrhoea

Symptomtext

Vaccine 9/29/21, no problems until 10/06/21 when what seemed to be a small cold starting with dry cough, clear runny nose, small amount of congestion, by 10/10/21 shortness of breathe started to do breathing treatments, same on 10/11/21 at approx 5:45pm I was completed winded and out of breathe and was taken to Medical Center in respiratory destress. I spend the next 3 days in ICU then transferred to medical floor for the next 5 days. I am home now on oxygen and recovering slowly. I was also on a Bipap machine and slowly weaned off of that.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Intensive care
Hospital-Tage
7,0
Labordaten
Cat scan of the lungs, stress test of the heart.
Aktuelle Erkrankungen
No other illnesses at the time or within a month prior
Vorgeschichte
COPD, Diabetes, Crohn's Disease
Andere Medikamente
Farxiga - 5mg daily, Montelukast - 10 mg daily, Enalapril Maleate - 5mg daily, Atorvastatin - 40mg daily, Mesalamine 800 mg - 6 tables daily, Symbicort160/4.5 - 2 puffs twice daily, Proair - 2 puffs as needed
Allergien
Codeine
Vorherige Impfungen
-

VAERS 1846285

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

moderat
Staat
PA
Alter
48,0
Geschlecht
F
Eingang
05.11.2021
Impfdatum
17.09.2021
Beginn
17.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Paraesthesia

Symptomtext

She had pin and needles tingling feeling in her fingers on the first day. She went on for 3 days and still has not gone away. Went to dr and was told to monitor the situation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Paraesthesia
Hospital-Tage
-
Labordaten
no
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
no
Allergien
biaxin, zithromax
Vorherige Impfungen
-

VAERS 1822005

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
MD
Alter
44,0
Geschlecht
F
Eingang
27.10.2021
Impfdatum
07.10.2021
Beginn
07.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site pain Magnetic resonance imaging Product administered at inappropriate site Rotator cuff syndrome

Symptomtext

Patient received flu vaccine too high causing a shoulder impingement with significant pain. She is still in pain after more than 2 weeks and has received steroids, an MRI, and is going to physical therapy.

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

VAERS 1818627

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
OH
Alter
12,0
Geschlecht
F
Eingang
26.10.2021
Impfdatum
19.10.2021
Beginn
22.10.2021
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Headache

Symptomtext

Bad headache

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

VAERS 1818607

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
OH
Alter
9,0
Geschlecht
F
Eingang
26.10.2021
Impfdatum
19.10.2021
Beginn
21.10.2021
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Headache Hyperaesthesia Photophobia

Symptomtext

Severe headache, sensitivity to light and touch

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

VAERS 1808586

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
PA
Alter
63,0
Geschlecht
F
Eingang
22.10.2021
Impfdatum
19.10.2021
Beginn
20.10.2021
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Herpes zoster Rash

Symptomtext

Developed rash the next day after receiving flu shot that looks suspiciously like shingles. Had the 2 shot shingles vaccine 2 1/2 years ago, and have never had shingles before.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None
Vorgeschichte
Chronic sinusitis
Andere Medikamente
Simvastatin, Daily Vitamin, Calcium pill
Allergien
None
Vorherige Impfungen
-

VAERS 1783401

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
NY
Alter
21,0
Geschlecht
F
Eingang
13.10.2021
Impfdatum
26.09.2021
Beginn
26.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Pain in extremity

Symptomtext

PATIENT CALLED 10/13/2021 STATING THAT HER ARM HAS BEEN HURTING SINCE VACCINE ADMINISTRATION AND THAT SHE HAS CONTACTED HER PROVIDER AND HAS AN APPOINTMENT FOR 10/14/2021.

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

VAERS 1756598

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UT7319LA

mild
Staat
NY
Alter
58,0
Geschlecht
M
Eingang
02.10.2021
Impfdatum
30.09.2021
Beginn
30.09.2021
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site cellulitis

Symptomtext

acute cellulitis at injection site, that spread to the entire upper arm. and chest. Extreme fatigue, loss of appetite, headache, nausea, back/renal pain. continues to worsen. physician prescribed keyflex. It was given concomitantly with Pneumovax-23 (Merck) lot T031820, same left deltoid.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site cellulitis
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
bisoprolol, amlodipine, valsartan/hctz, sertraline.
Allergien
no
Vorherige Impfungen
-

VAERS 1713155

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
NY
Alter
-
Geschlecht
F
Eingang
18.09.2021
Impfdatum
08.09.2021
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Adverse reaction Pain Pain in extremity Product storage error

Symptomtext

body aches; pain in left arm; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00762056) and transmitted to Sanofi on 09-Sep-2021. This case is linked to case 2021SA300941 (same reporter). This case involves a 48-year-old female patient who had body aches (pain) and pain in left arm (pain in extremity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. Medical history, past vaccination, medical treatment(s), and family history were not provided. The patient had no other concomitant vaccines. On 08-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7319LA, expiry: 30-Jun-2022 and form: prefilled syringe) via intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date the patient developed a non-serious body aches (pain) and pain in left arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The intensity of events was moderate to severe It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller states that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08SEP2021 and that 3 coworkers had adverse reactions to the vaccine. Caller asked if patients were having more site reactions this year and asked if anything was added to the vaccine. Caller states that switching from the prefilled syringe to the multi dose vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 coworkers that experienced adverse reactions and stated that she would contact Medical Information when she obtained information on the third coworker. Caller states that she can be contacted by Sanofi Safety if further information is needed and asked for the direct phone number for Medical Information. This information is regarding the second of two reported patients that experienced an adverse reaction to FLUZONE QIV NP on 08SEP2021. Caller states that there was a third patient who experienced adverse reactions but that she does not have the information at this time and would call back. Caller states that a representative from pharmacy came to her facility on 08SEP2021 to administer FLUZONE QIV NP vaccines and that this patient experienced moderate to severe pain in left arm as well as moderate to severe body aches compared to past reactions. This patient was sent home to rest" Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them No laboratory data was reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the events was unknown.

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

VAERS 1700511

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
IN
Alter
61,0
Geschlecht
F
Eingang
15.09.2021
Impfdatum
13.09.2021
Beginn
14.09.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
SYR / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Dizziness Tinnitus

Symptomtext

Since waking up morning after vaccines, I have had lightheadedness and dizziness when moving my head to quickly. Also ringing (sounds like Cicadas) in both ears.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Meralgia Paresthetica (pinched femoral nerve right side)
Vorgeschichte
None
Andere Medikamente
Cymbalta (60 mg) daily; Fosamax (x1 weekly); Supplements-Zinc, Vit. C, Calcium, B12, garlic Received 2021 Seasonal Flu Vaccine at same time I received the Shingrix 2nd Dose Vaccine
Allergien
None
Vorherige Impfungen
-

VAERS 1666075

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

mild
Staat
MD
Alter
50,0
Geschlecht
F
Eingang
02.09.2021
Impfdatum
23.08.2021
Beginn
24.08.2021
Tage bis Beginn
1,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Anticoagulant therapy Balance disorder Blood test normal Deafness Dysphonia Dysstasia Echocardiogram normal Facial paresis Gait disturbance Hemiparesis Influenza Magnetic resonance imaging normal Malaise Meniere's disease Movement disorder Muscular weakness Nausea Neurological examination abnormal

Symptomtext

Aug 23- received Flu and Shingles vaccines from Pharmacy, 2PM Aug 24- Symptoms experienced: Body aches, Feverish but not over 100.4 degrees, general malaise, flu symptoms but NO respiratory issues. Aug 25- Symptoms: Continued body ache and general flu symptoms that resolved in the afternoon. Aug 26- Symptoms: I woke up with severe vertigo (room was spinning while in bed), nausea, vomiting and unable to walk straight. Hearing loss and loud ringing in left ear. Went to Urgent Care. Given and prescribed anti nausea medication. Ears were clear. Symptoms resolved within 2-3 hours of symptoms onset. Final diagnosis: tinnitus. Aug 30- Went to ENT doctor. Ears were also clear. Diagnosis: Miniere's. Prescribed Prednisone, 17 day course to resolve hearing loss. Aug 31- Symptoms: 6AM in shower stall. Generalized weakness on the right side. Body was leaning towards the right side with my right leg unable to hold my weight. Had to finally sit on shower floor. Unable to clench my right hand, left hand was OK. Unable to call out loudly for help, felt my mouth wasnt functioning. Visions blurred, foggy. Unable to stand up. Symptoms resolved within 10 minutes. Went to Urgent Care again but staff suggested I contact ENT doctor as Urgent Care was limited in what they can do for me. ENT doctor strongly suggested I go to ER. I was admitted to Hospital for observations. Tests taken included MRI with or without contrast, MRI, Echocardiogram, Ultrasound to examine carotid arteries, blood tests including tests to rule out genetic blood clotting issues, neurology consult. Discharged from hospital on Sept 1. Final diagnosis: TIA. Prescribed aspirin and statins.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Malaise
Hospital-Tage
1,0
Labordaten
Tests taken included MRI with or without contrast, MRI, Echocardiogram, Ultrasound to examine carotid arteries, blood tests including tests to rule out genetic blood clotting issues, neurology consult on Sept 1. Results indicated nothing unusual.
Aktuelle Erkrankungen
none
Vorgeschichte
high blood pressure anxiety
Andere Medikamente
lisinopril 20mg lexapro 5mg
Allergien
amoxicillin
Vorherige Impfungen
-

VAERS 1713165

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

gering
Staat
IL
Alter
-
Geschlecht
F
Eingang
18.09.2021
Impfdatum
09.09.2021
Beginn
09.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product storage error

Symptomtext

vaccine was exposed to 76-degree Fahrenheit for 5 days/ no AE; Initial information was received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from a Pharmacist via Medical Information (Reference number- 00766806) and transmitted to Sanofi on 13-Sep-2021. This case involves a 60-year-old female patient reported that INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was exposed to 76-degree Fahrenheit for 5 days with no adverse event (Product storage error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 09-Sep-2021, the patient received a 0.5 mL (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7319LA and expiry date 30-Jun-2022] via unknown route in left deltoid for prophylactic vaccination. It was reported, "Caller states they had a temperature excursion, in which a box of unopened pre-filled syringes of FLUZONE QIV were left out on the counter for 5 days, reaching room temperature of 76 degrees Fahrenheit. He then states nine of these doses were used on patients." It was a case of actual medication error due to incorrect product storage (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.

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

VAERS 1713154

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7319LA

gering
Staat
NY
Alter
-
Geschlecht
F
Eingang
18.09.2021
Impfdatum
08.09.2021
Beginn
08.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extensive swelling of vaccinated limb Product storage error Vaccination site cellulitis Vaccination site erythema Vaccination site inflammation

Symptomtext

a cellulitic patch around the right deltoid muscle; completely swollen right arm; vaccination site inflammation; irregular red ring shape around the whole deltoid muscle.; Caller also states that the pharmacy representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them; Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via phone call (under Medical Information Inquiry Number: 00761956). This case is linked to cluster case Id: 2021SA302683. This case involves a 55-years old female patient who experienced a cellulitic patch around the right deltoid muscle (vaccination site cellulitis), completely swollen right arm (extensive swelling of vaccinated limb), vaccination site inflammation and irregular red ring shape around the whole deltoid muscle. (vaccination site erythema) and Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them (Incorrect product storage) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patient's medical history, medical treatments, concomitant medications, vaccinations and family history were not provided. On 08-Sep-2021, the patient received a first 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number: UT7319LA and expiry: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination. On 08-Sep-2021, the patient developed a non-serious cellulitic patch around the right deltoid muscle (vaccination site cellulitis), completely swollen right arm (extensive swelling of vaccinated limb), vaccination site inflammation and serious irregular red ring shape around the whole deltoid muscle. (vaccination site erythema) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller stated that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08-Sep-2021 and that 3 co-workers had adverse reactions to the vaccine. She asked if patients were having more site reactions this year and asked if anything was added to the vaccine. She stated that switching from the prefilled syringe to the Multi Dose Vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 co-workers that experienced adverse reactions and stated that she would contact Medical Information when she obtaines information on the third co-worker. Caller stated that she could be contacted by Sanofi Safety if further information was needed and asked for the direct phone number for Medical Information. She also stated that the representatives did not had a cooler for the vaccines and that they appeared out at room temperature when she saw them." This case was an actual medication error due to Incorrect product storage. No lab data was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of events was 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
Extensive swelling of vaccinated limb
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
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Vorherige Impfungen
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