VAERS Reports U7294AC

VAERS 2522032

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

schwer

Staat: CA
Alter: 16,0
Geschlecht: M
Eingang: 02.12.2022
Impfdatum: 30.11.2022
Beginn: 30.11.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LA

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

Electrocardiogram normal Fall Head injury Presyncope Syncope

Symptomtext

Of note, STAT call for patient by MA upon immis as patient fainted, hit head on soft examination table and fell to the floor. Witnessed fall by MA, who reported on patient status. Upon quick evaluation, patient was quickly placed in trendelenburg position with pillow under head, vitals were checked, and an EKG was done, which showed low-normal heart rate but was otherwise reassuring. PAtient recovered well without sequelae. This is the first time this has happened to patient. Likely symptoms can be described as a vaso-vagal reaction and unlikely to be allergy to vaccination. In the future, it should be noted that patient should be in laying down position when administering vaccinations to avoid this potential complication in the future. The rest of physical exam was unremarkable.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Presyncope
Hospital-Tage: -
Labordaten: EKG -and an EKG was done, which showed low-normal heart rate but was otherwise reassuring. PAtient recovered well without sequelae.
Aktuelle Erkrankungen: No
Vorgeschichte: None
Andere Medikamente: None
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2459707

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

schwer

Staat: CA
Alter: 17,0
Geschlecht: M
Eingang: 24.09.2022
Impfdatum: 15.08.2022
Beginn: 15.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Seizure Syncope

Symptomtext

seizure; fainted; Initial information received on 19-Sep-2022 regarding an unsolicited valid serious case received from a other health professional. This case involves a 17 years old male patient who had seizure and fainted after receiving vaccines BEXSERO and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 15-Aug-2022, the patient received an unknown booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength was unknown, lot U7294AC and expiry date was unknown) via intramuscular route in unknown administration site for Prophylactic vaccination. On an unknown date, the patient received an unknown booster dose of suspect BEXSERO not produced by Sanofi Pasteur (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination. On 15-Aug-2022 the patient developed a serious event of seizure and fainted (syncope) (Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of BEXSERO. Action taken : not applicable. It was not reported if the patient received a corrective treatment for the events Outcome: Recovered / Resolved on 15-Aug-2022 for both events. Seriousness criteria: Medically significant for both events.; Sender's Comments: Sanofi company comment dated 23-Sep-2022: This case involves a 17 years old male patient who had seizure and fainted after receiving vaccines BEXSERO and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The time to onset is compatible with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Seizure
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2407388

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

schwer

Staat: TX
Alter: 12,0
Geschlecht: M
Eingang: 10.08.2022
Impfdatum: 10.08.2022
Beginn: 10.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RA

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

Nausea Pallor Syncope

Symptomtext

Patient observed pale and with syncope post HPV vaccination administration. Patient c/o nausea and syncope. Noted pale, skin dry to touch. BP taken at baseline: 112/70. BP taken after episode: 70/28. Patient given space and fanned. Pt allowed to lay back on exam bed. After 5 minutes, patient regained color and BP taken once again: 98/58. Pt observed for 10 more minutes and no longer c/o nausea or syncope. Pt BP taken again WNL at 102/68. Patient exited clinic self ambulating with Parent and cousin with no other questions/concerns.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syncope
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2401184

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

schwer

Staat: TX
Alter: 16,0
Geschlecht: F
Eingang: 02.08.2022
Impfdatum: 02.08.2022
Beginn: 02.08.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LA

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

Nervousness Syncope

Symptomtext

As per mother daughter with history of fainting at Dr. offices and dentist. Pt. nervous. Pt fainted and I and mother broke fall. Pt fainted less than a minute. As per pt ok and felt fine. Did not have breakfast.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syncope
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: No
Vorgeschichte: No
Andere Medikamente: No
Allergien: No
Vorherige Impfungen: -

VAERS 2412888

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

moderat

Staat: TX
Alter: 17,0
Geschlecht: M
Eingang: 16.08.2022
Impfdatum: 15.08.2022
Beginn: 16.08.2022
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / LA

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

Chest discomfort Chest pain Electrocardiogram ST segment depression Electrocardiogram T wave abnormal Electrocardiogram abnormal Left ventricular hypertrophy Palpitations Right atrial enlargement

Symptomtext

Woke up the next morning with chest pain and palpitations and chest tightness Came to office, normal exam and vitals. EKG ordered and abnormal. recommend going to ER

Weitere VAERSDATA-Felder

Praegender Schweregrund: Chest pain
Hospital-Tage: -
Labordaten: EKG abnormal- Right atrial enlargment, left ventricle hypertrophy, ST segment depression and non specific T wave abnormality
Aktuelle Erkrankungen: runny nose last week (not disclosed at time of vaccine administration)
Vorgeschichte: none
Andere Medikamente: none
Allergien: no
Vorherige Impfungen: -

VAERS 2364457

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

mild

Staat: -
Alter: 16,0
Geschlecht: M
Eingang: 11.07.2022
Impfdatum: 09.06.2022
Beginn: 09.06.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LA

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

Pruritus Pyrexia Urticaria

Symptomtext

Pt spiked "high fever" at night on same day he received these vaccines. Also had hives with the fever and c/o itching. Zyrtec was given and pt resumed sleep. Awoke at 0430 on 6/10/22 and hives were resolved.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pruritus
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: None
Vorherige Impfungen: -

VAERS 2464253

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

gering

Staat: AR
Alter: 2,0
Geschlecht: M
Eingang: 29.09.2022
Impfdatum: 22.09.2022
Beginn: 22.09.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Wrong product administered

Symptomtext

2 year old patient mistakenly received a MENQUADFI vaccine instead of the intended PREVNAR 13 vaccine with no reported adverse event; Initial information received on 22-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old male patient who had mistakenly received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccine instead of the intended PREVNAR 13 vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination. On 22-Sep-2022 the patient developed a non-serious event of 2 year old patient had mistakenly received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccine (dose: 0.5ml, batch number: U7294AC and expiry date: 24-May-2023, route, administration site was unknown for Immunization ) instead of the intended PREVNAR 13 vaccine with no reported adverse event (wrong product administered) (Latency: same day). Nurse asked if a follow up dose at age 11 or 12 of MENQUADFI was recommended. Action taken : not applicable. Outcome: 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 guidelines. 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: Wrong product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2450435

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

gering

Staat: CT
Alter: 11,0
Geschlecht: U
Eingang: 17.09.2022
Impfdatum: 05.08.2022
Beginn: 05.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / LA

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

Extra dose administered Inappropriate schedule of product administration No adverse event

Symptomtext

MENQUADFI given too early after first dose of MENACTRA on accident, with no reported adverse event; received an extra dose , with no reported AE; Initial information received on 07-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old and unknown gender patient who was given menquadfi too early after first dose of menactra on accident, with no reported adverse event and received an extra dose with no reported ae after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The patient's past vaccination(s) included MENACTRA on 22-MAR-2022 with first dose. The patient's past medical history, medical treatment(s) and family history were not provided. On 05-Aug-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7294AC and expiration date: 23-May-2024 at a dose of 0.5ml once via intramuscular route in the left deltoid as prophylactic vaccination. On 05-Aug-2022(latency: same day), the patient was given menquadfi too early after first dose of menactra on accident, with no reported adverse event (inappropriate schedule of product administration). It was also reported that the patient has received an extra dose with no reported ae (extra dose administered). Action taken :not applicable. It was not reported if the patient received a corrective treatment for the events. Outcome: unknown for both events 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 guidelines. 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2431058

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

gering

Staat: CT
Alter: 11,0
Geschlecht: F
Eingang: 07.09.2022
Impfdatum: 05.08.2022
Beginn: 05.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LA

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

Inappropriate schedule of product administration

Symptomtext

Menquadfi administered too soon. Last meningococcal vaccine administered 3/22/2022, Menquadfi administered 8/5/2022

Weitere VAERSDATA-Felder

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

VAERS 2420939

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

gering

Staat: AZ
Alter: 14,0
Geschlecht: M
Eingang: 26.08.2022
Impfdatum: 20.08.2022
Beginn: -
Tage bis Beginn: -
Dosis: 2
Route/Site: IM / LA

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

Inappropriate schedule of product administration No adverse event

Symptomtext

Patient was administered 2nd dose of meningococcal vaccine early. Patient was not due until 16 years old for 2nd dose of meningococcal, No reactions or treatment needed. Spoke to patients father patient had no symptoms after receiving vaccine.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: NONE
Allergien: NONE
Vorherige Impfungen: -

VAERS 2408269

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

gering

Staat: CT
Alter: 12,0
Geschlecht: M
Eingang: 11.08.2022
Impfdatum: 02.08.2022
Beginn: 02.08.2022
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 Wrong product administered

Symptomtext

had the Menactra 2 years ago and was given Menquadfi yesterday with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who experienced had the menactra 2 years ago and was given menquadfi yesterday with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Aug-2022, the patient received a o.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE once (lot U7294AC; expiry date: 23-May-2024) via intramuscular route in the left arm and On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, dose, formulation, route,lot number: not reported) both for prophylactic vaccination. On 02-AUG-2022 the patient reported had the menactra 2 years ago and was given menquadfi yesterday with no reported adverse event (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Action taken:not applicable. At time of reporting, the outcome was Unknown for the event wrong product administered. 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: -

VAERS 2400425

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENQUADFI) · Charge U7294AC

gering

Staat: CT
Alter: 12,0
Geschlecht: M
Eingang: 03.08.2022
Impfdatum: 02.08.2022
Beginn: 02.08.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LA

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

Extra dose administered Inappropriate schedule of product administration

Symptomtext

Patient 12 years old had Menveo administered at another facility on 9/10/2020. Patient was seen for 12 year PE- the nurse and provider did not realize they received the vaccine, and administered Menquadfi. Patient has now received two Meningococcal vaccines in a two year time frame

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: -
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -