VAERS Reports UJ716AC

VAERS 2216090

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ716AC

mild

Staat: FL
Alter: 75,0
Geschlecht: M
Eingang: 05.04.2022
Impfdatum: 30.09.2021
Beginn: 30.01.2022
Tage bis Beginn: 122,0
Dosis: 1
Route/Site: IM / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Biopsy skin Rash Rash erythematous Rash pruritic

Symptomtext

On about 3/30/22, Itchy rash, red bumps, on body, back, chest, arms, legs. Went to Dermatologist and got Rx on 2/5/22 for Methylprednisolone, 4 mg dspk, qty 21,d ays 6: Day 1: 6 , Day 2: 5, Day 3: 4. Day 4: 3, Day 5: 2. Day 6: 1. TRIAMCINOLONE 0.1% CREAM 2X A DAY. Rash went away after a day. Rash reappeared on 3/10/22 and got Rx: PREDNISONE 10 MG TAB 4/day for 4 days, 3/day for 4 days, 2/day for 4 days, 1/day for 4 days, ? a day for 4 days (Rash) 3/10-3/29/22.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: Biopsy of Rash.
Aktuelle Erkrankungen: -
Vorgeschichte: Afib; Restless Legs; Depression; Acid Reflux-Barrets Esophagus.
Andere Medikamente: CARTIA XT; ELIQUIS; ROPINIROLE HCL; OMEPRAZOLE; MIRTAZAPINE; SYNTHROID (LEVOTHYROXINE);VITAMINS;Shaklee Optiflora Probiotic; Bifidubacterium Longum;Lactobacillus Acidophilus ;Shaklee Nutriferon Tablets; Interferon Boosting Plant Extracts;
Allergien: Bactrim.
Vorherige Impfungen: -

VAERS 1755110

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ716AC

mild

Staat: HI
Alter: 72,0
Geschlecht: F
Eingang: 01.10.2021
Impfdatum: 29.09.2021
Beginn: 29.09.2021
Tage bis Beginn: 0,0
Dosis: N/A
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Rash Urticaria

Symptomtext

patient with rash/welts and urticaria over entire body, esp torso. administered own epipen and benadryl. no respiratory sx. Zyrtec daily x 1 wk.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: CAD
Andere Medikamente: -
Allergien: BEE VENOM
Vorherige Impfungen: -

VAERS 1901210

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ716AC

gering

Staat: AK
Alter: -
Geschlecht: U
Eingang: 26.11.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

FLUZONE HIGH-DOSE QUADRIVALENT at a high of 49.6F for 5 hours and 10 minutes with no reported adverse event; Initial information regarding this valid unsolicited non-serious case via Medical Information (Reference number- 00858018) was received from other health care professional and transmitted to Sanofi on 15-Nov-2021. This case involved an unknown age and unknown gender patient who experienced fluzone high-dose quadrivalent at a high of 49.6f for 5 hours and 10 minutes with no reported adverse event (Product storage error) when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ716AC and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, (unknown latency) the patient experienced and reported non-serious fluzone high-dose quadrivalent at a high of 49.6f for 5 hours and 10 minutes with no reported adverse event (product storage error) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "HCP reporting a temperature excursion due to a delay in transport between facilities." No laboratory data was reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the event outcome reported as unknown for the 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 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1774831

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ716AC

gering

Staat: OH
Alter: 77,0
Geschlecht: M
Eingang: 09.10.2021
Impfdatum: 20.09.2021
Beginn: 28.09.2021
Tage bis Beginn: 8,0
Dosis: 2
Route/Site: OT / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Inappropriate schedule of product administration No adverse event

Symptomtext

received that FLUZONE HD vaccine a week before with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and consumer/non-health care professional via Company (Reference number- 00790680) and transmitted to Sanofi on 29-Sep-2021. This case involves a 77-year-old male patient who experienced received that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] vaccine a week before (inappropriate schedule of product administration) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 20-Sep-2021, the patient received first 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 28-Sep-2021 he also received same second dose of the same vaccine (lot: UJ716AC and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration). It was reported "Patient who received two doses of FLUZONE HD within 8 days of each other. First dose was 20Sep2021 and second dose was 28Sep2021. Caller wants to know if there is anything they should do or watch for. The patient did not realize that he received that FLUZONE HD vaccine a week before and the HCP (health care professional) giving the second dose did not see the documentation of the first FLUZONE HD vaccine". This case was an actual medication error due to inappropriate schedule of vaccine administered (latency: same day) At the time of reporting, 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 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: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1708481

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ716AC

gering

Staat: MI
Alter: 61,0
Geschlecht: F
Eingang: 17.09.2021
Impfdatum: 17.09.2021
Beginn: 17.09.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SYR / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Incorrect dose administered

Symptomtext

High dose was ordered and administered, even though patient is only 61 years old.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect dose administered
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: Raynaud disease, rheumatoid arthritis, foot swelling, foot pain.
Vorgeschichte: Raynaud disease, rheumatoid arthritis.
Andere Medikamente: Acetazolamide, amlodipine, aspirin, caltrate, celebrex, cetirizine, crestor, ferrous sulfate, gabapentin, humira pen, leflunomide, losartan, pantoprazole, prednisone.
Allergien: NKA
Vorherige Impfungen: -