VAERS Reports UJ562AA

VAERS 1094590

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

moderat

Staat: NC
Alter: 37,0
Geschlecht: F
Eingang: 12.03.2021
Impfdatum: 12.03.2021
Beginn: 12.03.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Dizziness Dyskinesia Feeling hot Flatulence Grunting Hyperhidrosis Nausea Pallor Paraesthesia Unresponsive to stimuli

Symptomtext

Flu vaccine and Tdap vaccine administered RN and Nursing Student. Within 30 seconds the pt stated that she was feeling dizzy and that her legs were feeling tingly. I helped the pt to elevate her legs and reclined her head slightly. on the exam chair. Pt leaned forward with eyes closed. Pt was slumped over and had some loss of color in the face and lips. I helped the pt to sit up while saying her name. No response from pt. Pt began to make grunting sounds, and her body appeared to be jerking. I was beside the pt to prevent her from falling. The pt appeared to be sweating. Her shirt was wet on the front and back. I heard flatulation sounds. This lasted for approximately 2 minutes. RN called for help. Two other RNs came to the room. Nurse was saying the pt's naame, and another nurse was holding an alcohol pad to the pt's nose. The pt's head was reclined slightly. I left the room to get the crash cart, and I notified, FNP about the situation. I arrived back to the pt's room with the crash cart, and FNP assessed the pt. At this time, the pt was alert and oriented. The other jerking and grunting had subsided. She was laying on her side holding an emesis bag. Pt stated that she was feeling nauseated. RN got the vials machine and checked the pt's vital signs starting at approximately 0920. The pt's BP was 97/65 ans trending up to 135/63 after 3 checks per RN. She instructed me to check again in 5 minutes. The pt stated that she was feeling better. I checked her VS again. Her BP had dropped to 78/52, and she stated that she was feeling hot, nauseated, and dizzy. I held an ice pack covered with a towel on her forehead. She stated that she did not eat anything today. She was given an orange juice and peanut butter crackers. She drank a few sips of juice, and she ate 2 crackers. The vital signs were checked every 5-10 minutes until approximately 1005. BP was trending up. Pt denied feeling dizzy, sweaty, nauseated, and hot. When asked how she felt, she stated that she felt good at this time. Pt stated that she did not need an ambulance to be called. Pt stood up slowly and walked. She stated that she was still feeling well, and that she did not have any concerns or abnormal symptoms. I encouraged the pt to notify her PCP of this occurrence.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Paraesthesia
Hospital-Tage: -
Labordaten: Vital signs every 5-10 minutes from 0920-1005.
Aktuelle Erkrankungen: Asthma.
Vorgeschichte: Asthma.
Andere Medikamente: Zoloft and ProAir inhaler.
Allergien: No.
Vorherige Impfungen: -

VAERS 1043575

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ562AA

mild

Staat: NY
Alter: 9,0
Geschlecht: F
Eingang: 20.02.2021
Impfdatum: 19.02.2021
Beginn: 19.02.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LA

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

Abdominal distension Injection site erythema Injection site induration Injection site pruritus

Symptomtext

redness, swelling and itching at injection site. indurated area of about 4cm in diameter

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: asthma
Andere Medikamente: flovent
Allergien: dust
Vorherige Impfungen: -

VAERS 1041644

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge uj562aa

mild

Staat: NY
Alter: 1,0
Geschlecht: F
Eingang: 19.02.2021
Impfdatum: 19.02.2021
Beginn: 19.02.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RL

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

Pallor Photosensitivity reaction Rash

Symptomtext

Pt developed pink, macular rash that was patchy and blanchable on face 1-5 min after she received her vaccines. Pt was given benadryl and monitored after. No other reactions noted, no redness or rash at injection site, no dyspnea, no stridor, no swelling around mouth or tongue.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: none
Vorgeschichte: -
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 1828073

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: IL
Alter: 11,0
Geschlecht: F
Eingang: 29.10.2021
Impfdatum: 22.10.2021
Beginn: 22.10.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Expired product administered No adverse event

Symptomtext

A patient received last years flu vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00825045) and transmitted to Sanofi on 22-Oct-2021. This case is linked to cases 2021SA355038 and 2021SA356217 (same reporter). This case involves a11 years old female patient who received last years INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered) by mistake. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given to the patient. On 22-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, lot UJ562AA, expiry: 30-Jun-2021) via an unknown route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Caller states that 3 patients received last years flu vaccine by mistake and would like to know how to proceed?" At the time of reporting, no adverse event was reported and the outcome was unknown for the reported 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 by the regulatory authority. 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1828072

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: IL
Alter: 7,0
Geschlecht: M
Eingang: 29.10.2021
Impfdatum: 22.10.2021
Beginn: 22.10.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / RL

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

No adverse event Wrong product administered

Symptomtext

A patient received last years flu vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00825044) and transmitted to Sanofi on 22-Oct-2021. This case is linked to cases 2021SA355038 and 2021SA356045 (same reporter). This case involves a 7 year old male patient who was received last years INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 22-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ562AA, expiry: 30-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Caller states that 3 patients received last years flu vaccine by mistake and would like to know how to proceed?" No other 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 by the regulatory authority. 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 1828071

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: IL
Alter: 5,0
Geschlecht: M
Eingang: 29.10.2021
Impfdatum: 22.10.2021
Beginn: 22.10.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

Expired product administered No adverse event

Symptomtext

Apatient received last year flu vaccine/ no AE; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from an Other healthcare professional via Global Media Information (under reference- 00825023) and transmitted to Sanofi on 22-Oct-2021. This case is linked to case 2021SA356217 and 2021SA356045. This case involves a five-year-old male patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] by mistake with no adverse event (Expired product used). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 22-Oct-2021, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ562AA and expiry date 30-Jun-2021] via intramuscular route in the left thigh for prophylactic vaccination. It was reported "3 patients received last years flu vaccine by mistake and would like to know how to proceed?" First time product used: Yes. Still using product: No. Was Device Used: Yes. It was a case of actual medication error due Expired vaccine used (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 by the regulatory authority. 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1384808

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: MI
Alter: -
Geschlecht: F
Eingang: 09.06.2021
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

patient was given products that were exposed to highest temperature excursion at 49 fahrenheit and for 45 minutes/ No AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case received from a other health care professional via Agency. This case is linked to case 2021SA178936 (consumer case). This case involves an unknown age female patient who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] pre-filled syringe lot number: UJ562AA expiration date: 30-Jun-2021, lot number: UJ507AA expiration date: 30-Jun-2021, lot number: UJ471AA expiration date: 30-Jun-2021, lot number: UT7073KA expiration date: 30-Jun-2021, lot number: UT7115KA expiration date: 30-Jun-2021, INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] lot number: UJ507AA expiration date: 30-Jun-2021, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: U676AA expiration date: 31-Jul-2022, lot number: U6900AA expiration date: 18-Nov-2022, lot number: U6927AA expiration date: 28-Jan-2023, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number: U6827BB expiration date: 18-Feb-2022, lot number: U6827BA expiration date: 18-Feb-2022, IPV (VERO) [IPOL] MULTI DOSE VIAL lot number: T1D482N expiration date: 25-Jul-2022, DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot number: C5688AA expiration date: 26-Nov-2021 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] lot number: UJ529A expiration date: 22-Jul-2022 for prophylactic vaccination and was tested with TUBERCULIN TEST [TUBERSOL] lot number: C5804AA expiration date: 03-Feb-2023 for tuberculin test via an unknown route and administration site that was exposed to highest temperature excursion at 49 Fahrenheit and for 45 minutes (Product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to incorrect product storage (latency: same day). Description: Clinical coordinator called to report stability information of vaccines exposed to temperature excursion. On 09-Apr-2021, the highest temperature was at 49 Fahrenheit and the excursion lasted 45 minutes. On 23-Apr-2021, the highest temperature was at 48.7 Fahrenheit and the excursion lasted 30 minutes. Reason for excursion is that the fridge was not closed correctly, it did not shut all the way. Product used. At the time of report, 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 holders 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: TUBERSOL
Allergien: -
Vorherige Impfungen: -

VAERS 1295249

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: NJ
Alter: 0,3
Geschlecht: M
Eingang: 07.05.2021
Impfdatum: 05.05.2021
Beginn: 05.05.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / UN

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

Product administered to patient of inappropriate age

Symptomtext

Flu vaccine given to 3month old in error

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product administered to patient of inappropriate age
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 1020145

NOVARTIS VACCINES AND DIAGNOSTICS · MENINGOCOCCAL B (BEXSERO) · Charge UJ562AA

gering

Staat: MA
Alter: 17,0
Geschlecht: F
Eingang: 08.02.2021
Impfdatum: 22.01.2021
Beginn: -
Tage bis Beginn: -
Dosis: N/A
Route/Site: IM / LA

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

Inappropriate schedule of product administration

Symptomtext

Flu shot given too soon - 1 mo. after last one - did not need booster dose

Weitere VAERSDATA-Felder

Praegender Schweregrund: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 998560

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: NY
Alter: 7,0
Geschlecht: F
Eingang: 03.02.2021
Impfdatum: 28.01.2021
Beginn: 28.01.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RA

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

Erythema Swelling face

Symptomtext

5 hours after receiving the flu shot, pt had diffuse redness of face and swelling of face. mother treated patient with a cool compress and redness improved by the next day. did not seek medical care at the time.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Erythema
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: not known
Allergien: none known
Vorherige Impfungen: -

VAERS 984655

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ562AA

gering

Staat: FL
Alter: 4,0
Geschlecht: M
Eingang: 29.01.2021
Impfdatum: 28.12.2020
Beginn: 14.01.2021
Tage bis Beginn: 17,0
Dosis: 2
Route/Site: OT / LL

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

Inappropriate schedule of product administration

Symptomtext

patient received first vaccination on 28-Dec-2020 and then mistakenly received the second vaccination on 14-Jan-2021 (18 days apart)/no AE; Initial information received on 15-Jan-2021 regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number-00432089) and transmitted to Sanofi on 17-JAN-2021. This case involves a 4 year-old male patient who was administered with second dose of FLUZONE QUADRIVALENT 18 days after initial dose (Inappropriate schedule of product administration). The caller stated that this dose was 14 days before the next scheduled dose. The patient reported that the health care professional administering the vaccine did not check the chart first to see the last date of the previous Fluzone Quadrivalent. The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. On 28-Dec-2020 and 14-Jan-2021, the patient received 0.5 mL first and second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ562AA and expiry date 30-Jun-2021) via intramuscular route at the left thigh for prophylactic vaccination. It was a case of actual medication error due drug dose administration interval too short (latency was on same day). At the time of reporting, no adverse event reported. Product used: Used, First time product used: No, Still using product : No, Was Device Used : Yes. 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: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -