VAERS Reports U7273BA

VAERS 2481819

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

schwer

Staat: OR
Alter: 12,0
Geschlecht: M
Eingang: 18.10.2022
Impfdatum: 18.10.2022
Beginn: 18.10.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Loss of consciousness Seizure Syncope

Symptomtext

MA administered HPV and MCV4 vaccines to patient's right deltoid. Patient tolerated well but then lost consciousness and convulsed. PCP was called into the room and assisted. Patient did attempt to sit up and experienced syncope a 2nd time. Patient was given juice and crackers and made to lie down for a few minutes prior to leaving. PCP gave instructions on after care and follow-up.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Loss of consciousness
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: N/A
Allergien: Penicillins
Vorherige Impfungen: -

VAERS 2402996

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge u7273ba

schwer

Staat: IL
Alter: 11,0
Geschlecht: M
Eingang: 05.08.2022
Impfdatum: 02.08.2022
Beginn: 02.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Asthenia Dizziness Fall Fatigue Flushing Hyperhidrosis Hypotension Lethargy Nausea Pallor Syncope Unresponsive to stimuli Vomiting

Symptomtext

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was being administered first dose of menactra and second dose of Tdap. Walked around after getting vaccines. Then started to fall mom caught him. Patient fainted for less than 10 seconds. Remained flushed, pale, weak. Nurse brought NP. Ice packs applied, water given, vitals monitored and EMS activated. EMS arrived patient still alert and oriented still weak and feeling dizzy. Patient transported to ER via ambulance with mom.

Weitere VAERSDATA-Felder

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

VAERS 2401330

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

schwer

Staat: VA
Alter: 11,0
Geschlecht: F
Eingang: 04.08.2022
Impfdatum: 26.07.2022
Beginn: 26.07.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Anaphylactic reaction Headache Hyperhidrosis Immediate post-injection reaction Nausea Oral discomfort Pallor Swelling face Throat tightness

Symptomtext

7/26/22 1:30 client(accompanied by mother) rec'd above immunizations. 1 min later c/o headaches, nausea, diaphoretic, color pale. Client assisted to exam table to lay down, legs elevated. BP 119/72, Pulse 72. Alert and oriented x3. Cool cloths to forehead, neck. 1:35-color improved, client engaging in conversation about school. no further c/o nausea, 1:45-Head elevated to semi-fowlers, cont to "I'm feeling better", Pulse 72 and regular. 1:55-continues to improve, no further complaints. color improved. Head elevated to fowler's position. 2:05-client and mother left facility in stable condition. 8/1/2022- mother called to report client was seen @ local ER on the evening following her immunizations. @ 11:30 she c/o face swelling, lips tight and throat tightening. "They said she had an anaphylactic reaction. The only thing that was different that day was the vaccines. Treated with epi. She will now carry an epi-pen with her. Client discharged home last that night.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Anaphylactic reaction
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: cats, mold, tomatoes-can eat
Vorherige Impfungen: -

VAERS 2286986

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

schwer

Staat: NH
Alter: 11,0
Geschlecht: F
Eingang: 20.05.2022
Impfdatum: 18.05.2022
Beginn: 18.05.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Hyperhidrosis Pallor Syncope

Symptomtext

Shortly after patient received all 3 vaccines she fainted for approximately 5-10 seconds. After she regained consciousness she was talking and laughing. She was pale and sweaty. She recovered and felt back to normal within 10 minutes, no further issues.

Weitere VAERSDATA-Felder

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

VAERS 2071705

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

schwer

Staat: -
Alter: 19,0
Geschlecht: M
Eingang: 28.01.2022
Impfdatum: 28.01.2022
Beginn: 28.01.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LA

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

Dyspnoea Pharyngeal swelling Syncope Throat tightness

Symptomtext

Received vaccines in addition to bicillin and with subsequent syncopal event. When awoke from syncope had throat swelling, tightness, and SOB. Given epi and benadryl.

Weitere VAERSDATA-Felder

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

VAERS 2603854

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

mild

Staat: -
Alter: 23,0
Geschlecht: F
Eingang: 26.03.2023
Impfdatum: 26.03.2023
Beginn: 26.03.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Dizziness Pallor

Symptomtext

Heplisav-B was administered first and pt was fine. However, after administering Menactra patient reported feeling lightheaded and about to pass out, and was visibly pale. She mentioned that she did have breakfast that morning. We got her some orange juice but it did not help her. As a result, EMS was called but patient refused to go to hospital with paramedics. Patient went home by car.

Weitere VAERSDATA-Felder

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

VAERS 2404205

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

mild

Staat: -
Alter: 17,0
Geschlecht: F
Eingang: 08.08.2022
Impfdatum: 12.07.2022
Beginn: 13.07.2022
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: OT / -

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

Arthralgia Chills Dysphagia Ear infection Eye swelling Headache Malaise Myalgia Neck pain Pain Pyrexia Renal function test normal Swelling Swelling face Urticaria

Symptomtext

body aches; Swelling; neck pain; hives; increase in eye and face swelling; increase in eye and face swelling; It was hard to swallow; face was swollen; eye swelling; ear infection; malaise; Joint pain; chills and fever; muscle pain; bad headaches; Initial information received on 28-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 17 years old female patient who noticed that it was hard to swallow, face was swollen, eye swelling, ear infection, body aches, swelling, neck pain, malaise, hives, joint pain, chills and fever, muscle pain and bad headaches while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient's past vaccination(s) included MENACTRA in 2016 with no issues. The patient's past medical history, medical treatment(s) and family history were not provided. On 12-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, injection (strength: unknown) lot U7273BA via intramuscular route in the left shoulder as Immunization. On 13-JUL-2022, within 12 hours, the patient had malaise, joint pain (arthralgia), chills and fever (pyrexia), muscle pain (myalgia) bad headaches (headache)1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 15-JUL-2022 the face was swollen (swelling face) eye swelling, ear infection 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to doctor with the swelling and they stated that it looks like an ear infection and was prescribed amoxicillin. Doctor visit on 15JUL2022 and given Amoxicillin, Benadryl, Advil, Zyrtec. On 16-JUL-2022 , it was hard to swallow (dysphagia) 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to Went to Emergency room due to this and they gave 80 mg injection prednisone. and discharged home with prednisone. Still having symptoms 2nd doctors visit on 19JUL2022 and was given famotidine and kidney function test performed(came back normal). Doctor recommended consult to infectious disease and ER if symptoms worsened On 19-JUL-2022 the patient had increase in eye and face swelling (condition aggravated) 7 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 22-JUL-2022 the patient had body aches (pain) swelling, neck pain and hives (urticaria) 10 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Relevant laboratory test results included: Renal function test - On 19-Jul-2022: [normal] Action taken was not applicable. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMOXICILLIN (AMOXICILLIN) for Eye swelling, Swelling face and Ear infection, PREDNISONE (PREDNISONE) for Dysphagia and FAMOTIDINE (FAMOTIDINE). At time of reporting, the outcome was Not Recovered / Not Resolved for all.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Arthralgia
Hospital-Tage: -
Labordaten: Test Date: 20220719; Test Name: kidney function test; Result Unstructured Data: normal
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2374681

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

mild

Staat: IN
Alter: 17,0
Geschlecht: F
Eingang: 27.07.2022
Impfdatum: 12.07.2022
Beginn: 13.07.2022
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / LA

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

Arthralgia Blood test Ear infection Ear pain Eye swelling Metabolic function test normal Pharyngeal swelling Swelling face Urine analysis normal Headache Hyperhidrosis Injection site pain Malaise Myalgia Neck pain Oropharyngeal pain Pain Pyrexia

Symptomtext

Tuesday 7/12/2022 - Injection site tenderness performed at Clinic. Wednesday 7/13 - 24hrs, headache, malaise, sore muscles. Thursday 7/14 - headache, fever, malaise and sore muscles. Friday 7/15 - Swollen throat/face/eyes, malaise, ear ache, sore throat and sore muscles - Scheduled afternoon visit w/ PCP Diagnosed ear infection Amoxicillin prescribed BID. Saturday 7/16 - Extreme swelling of face, throat/eyes, malaise, sore muscles - gave 2 Benadryl at 9:00 am waited 2 hours no change went to urgent care. 80 mg Prednisone given IM. 1 hour later throat swelling went down and left with a titrating dose of prednisone PO to take at home. Amoxicillin BID - ear infection improving. Sunday 7/17 - Eye/facial swelling and general malaise. Prednisone 60 mg PO am. Monday 7/18 - Eye/facial swelling, general malaise and reoccurring joint pain. 40 mg Prednisone PO Amoxicillin BID. Tuesday 7/19 - Increasing morning facial/eye swelling. Saw PCP started 20 mg Prevacid bid and Zyrtec am. PCP requested Kidney function tests. - Urinalysis and blood test. Extreme muscle and joint pain thru the night gave 500mg of Tylenol. 20 mg Prednisone PO Amoxicillin BID. Wednesday 7/20 - Increase in eye and facial swelling. Prevacid 20 mg, Zyrtec, last dose of 20 mg Prednisone PO and Amoxicillin BID. All kidney function tests were normal. Dr. Prescribed a higher dose of Prednisone for longer period. Thursday 7/21 - swollen eyes, neck pain, body aches, headache, hives. Prednisone to 40 mg po qd, 20 mg famotidine and Advil Friday 7/22 - swollen eyes, neck pain, body aches, headache, hives. Prednisone to 40 mg po qd, 20 mg famotidine and Advil Saturday 7/23 - swollen face/eyes, neck pain, body aches, headache, hives. Prednisone to 40 mg po qd, 20 mg famotidine and Advil Sunday 7/24 - swollen face/eyes, neck pain, body aches, headache, hives. Prednisone to 40 mg po qd, 20 mg famotidine and Advil. Monday 7/25 eyes, neck pain, body aches, headache and hives. Prednisone to 40 mg po qd, 20 mg famotidine and Advil. Epsom Salt Bath caused sweating and helped with body aches. Monday 7/26 eyes, neck pain, body aches, headache and hives. Prednisone to 40 mg po qd, 20 mg famotidine and Advil. Epsom Salt Bath caused sweating and helped with body aches.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Arthralgia
Hospital-Tage: -
Labordaten: Kidney function test which was normal.
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None.
Allergien: Mosquitos, pollen and sulpha meds
Vorherige Impfungen: -

VAERS 2320503

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

mild

Staat: TX
Alter: 11,0
Geschlecht: M
Eingang: 15.06.2022
Impfdatum: 15.06.2022
Beginn: 15.06.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Nausea Pallor

Symptomtext

I had an 11 year old male here in clinic for routine immunizations. He was given TD, MCV4 and HPV #1 at 9:20am and within 1-2 minutes while still in my office he became nauseated and his facial color went pale. I had two other nurses assist with getting him to lie down and elevate his feet; he was able to talk to us about how he was feeling. Vitals taken at 9:22am B\P 110/80 Pulse: 75. We then had his sit up after a few minutes and took his B/P 115/75 and his color started to return to normal and he was no longer nauseated. We then had his stand to retake his B/P 108/60 Pulse 68. He was alert and talking and able to walk out with his mom.

Weitere VAERSDATA-Felder

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

VAERS 2306856

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

mild

Staat: TX
Alter: 16,0
Geschlecht: F
Eingang: 02.06.2022
Impfdatum: 01.06.2022
Beginn: 01.06.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LA

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

Dizziness Pallor Vomiting

Symptomtext

Vaccines given ant 11:00 am. At 11:03 Pt felt dizzy after vaccination. Became pale, vomiting. Placed in room. BP 103/73, HR106, RR-16, SaO2 97%. Felt better after approx 5 min 11:34- Pt sitting in room no longer vomiting. Denies feeling faint or nauseated. Sat on exam table for approx 10-15min, drinking water. BP-108/68, HR82, RR-16 SaO2 98%. Color looks good. Pt denied any symptoms and was discharged to home

Weitere VAERSDATA-Felder

Praegender Schweregrund: Dizziness
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: Anxiety
Andere Medikamente: Lexapro 10mg
Allergien: NKA
Vorherige Impfungen: -

VAERS 2668704

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

gering

Staat: IN
Alter: 17,0
Geschlecht: M
Eingang: 09.08.2023
Impfdatum: 05.08.2023
Beginn: 05.08.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / LA

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

Expired product administered Medication error No adverse event

Symptomtext

pharmacist called in to report that they have administered menactra, that has expired on 24Apr2023 with no reported adverse event; Initial information received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 17 years old male patient and who have administered Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] that has expired on 24apr2023 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 5-Component, Tetanus Vaccine Toxoid (Adacel), Vaxoral And Hpv Vaccine Vlp Rl1 4v (Yeast) (Gardasil) for Prophylactic vaccination. On 05-Aug-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine solution for injection (frequency: once, strength: standard, expiry date: 24-Apr-2023 and lot U7273BA) via intramuscular route in the left arm for Prophylactic vaccination (immunization) and administered menactra, that has expired with no reported adverse event (expired product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Action taken: not applicable. At time of reporting, the outcome was 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 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2667851

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 08.08.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

administered an expired MENACTRA vaccine to a patient with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and unknown gender patient who got administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml (TOTAL) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Strength = Standard) Solution for injection (lot U7273BA) (expiration date- 24-Apr-2023) (expired product administered) (latency- same day)via unknown route in unknown administration site for Immunization. Action taken- not applicable. At time of reporting, the outcome was 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2627004

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

gering

Staat: PA
Alter: 17,0
Geschlecht: F
Eingang: 05.05.2023
Impfdatum: 01.05.2023
Beginn: 01.05.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

an expired menactra was administered to a patient, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who had an expired menactra was administered to a patient, with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-May-2023, the patient received 0.5 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U7273BA , Expiration Date: 24-Apr-2023 via intramuscular route in unknown administration site, strength for Immunization. On 01-May-2023 the patient developed a non-serious event an expired menactra was administered to a patient, with no reported adverse event (expired product administered) (latency: same day). Lab data was not reported. Action taken was not applicable. Outcome: Unknown for the event an expired menactra was administered to a patient, with no reported 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2601734

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

gering

Staat: OR
Alter: 18,0
Geschlecht: M
Eingang: 22.03.2023
Impfdatum: 16.03.2023
Beginn: 16.03.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: SC / LA

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

No adverse event

Symptomtext

No adverse events.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: None.
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None.
Allergien: NKA
Vorherige Impfungen: -

VAERS 2497808

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

gering

Staat: NM
Alter: 1,3
Geschlecht: M
Eingang: 03.11.2022
Impfdatum: 29.08.2022
Beginn: 29.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RL

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

No adverse event Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Patient received the wrong vaccine for age group by clinic RN. Patient was supposed to receive DtaP, IPV, Hib, Hep B, Hep A, and PCV-13. Mother opted to only get 2 vaccines and defer others at a later date. Patient did not experience adverse reaction or notified of any adverse reaction reported by mother. Clinic tried multiple attempts to contact mother to which she did not respond.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2494114

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

gering

Staat: MI
Alter: 11,0
Geschlecht: F
Eingang: 31.10.2022
Impfdatum: 26.10.2022
Beginn: 26.10.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Incorrect product formulation administered No adverse event

Symptomtext

Pt. was given Pfizer Monovalent instead of Pfizer Bivalent. As far as I am aware pt. has not suffered any adverse events but just only given the wrong vaccine. Our office has filled out an incident report and have contacted the manufacturer for recommendations on when/if an additional dose is needed.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: n/a
Vorgeschichte: n/a
Andere Medikamente: n/a
Allergien: n/a
Vorherige Impfungen: -

VAERS 2446242

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: MI
Alter: 16,0
Geschlecht: F
Eingang: 15.09.2022
Impfdatum: 12.09.2022
Beginn: 12.09.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RA

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

Incorrect dose administered

Symptomtext

Hep A dose was given as an adult dose instead of a pediatric dose. Patient did not report any negative symptoms.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect dose administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: Ortho- Try-Cyclen
Allergien: Penicillin
Vorherige Impfungen: -

VAERS 2414860

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: MI
Alter: 10,0
Geschlecht: M
Eingang: 18.08.2022
Impfdatum: 17.08.2022
Beginn: 17.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Inappropriate schedule of product administration No adverse event

Symptomtext

There was no adverse reaction. He was just given the vaccine too early.

Weitere VAERSDATA-Felder

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

VAERS 2400056

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: MA
Alter: 11,0
Geschlecht: F
Eingang: 02.08.2022
Impfdatum: 01.08.2022
Beginn: 01.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Incorrect dose administered No adverse event

Symptomtext

12 year old dose was given to a 11 year old child, No adverse effects noted.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect dose administered
Hospital-Tage: -
Labordaten: NONE
Aktuelle Erkrankungen: NONE
Vorgeschichte: MILD ASTHMA SPEECH DELAY ESOTROPIA PERVASIVE DEVELOPING DISORDER
Andere Medikamente: CULTURELLE KIDS CHEWABLE
Allergien: NONE
Vorherige Impfungen: -

VAERS 2366377

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: MI
Alter: 14,0
Geschlecht: F
Eingang: 12.07.2022
Impfdatum: 12.07.2022
Beginn: 12.07.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RA

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

Expired product administered

Symptomtext

Vaccine was given in error. Due date is 7/5/24, misread as 7/5/22. No signs and symptoms, no reaction.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: clonidine, fluoxetine, cetirizine, fluticasone, medroxyprogesterone, Vitamin D
Allergien: codeine
Vorherige Impfungen: -

VAERS 2356766

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: PR
Alter: 18,0
Geschlecht: F
Eingang: 03.07.2022
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / RA

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

Exposure during pregnancy

Symptomtext

has administered MENACTRA to a pregnant patient, with no reported adverse event; Initial information from received on 24-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 18 years old female patient who was exposed to vaccine Meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] during her pregnancy, with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported administration of Meningococcal A-C-Y-W135 (D conj) vaccine during pregnancy occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On an unknown date, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot: U7273BA, expiry date: 24-apr-2023; formulation not reported) via intramuscular route in the right deltoid for prophylactic immunization. On an unknown date, the meningococcal A-C-Y-W135 (D CONJ) vaccine was administered to a pregnant patient, with no reported adverse event (exposure during pregnancy). Action taken was not applicable. Outcome: Unknown Additionally, at time of reporting, the outcome of the pregnancy is unknown.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Exposure during pregnancy
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2311635

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: TX
Alter: 18,0
Geschlecht: F
Eingang: 07.06.2022
Impfdatum: 31.05.2022
Beginn: 31.05.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Product container issue Product leakage

Symptomtext

After giving the vaccine to the patient, I began cleaning up my vaccine area and picked up the empty vial to record the lot and expiration on our paperwork and the bottom of the vial completely came apart and glass shards were left on the countertop. After further inspection, there was no trace of residual vaccine and the counter wasn't wet. I next inspected the vial box and there were little tiny shards of glass in the box, barely visible to the naked eye. It is my assumption that the vial was damaged during shipment and all the vaccine leaked into the vial box and dried to the cardboard container.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product container issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2266993

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: TX
Alter: 30,0
Geschlecht: M
Eingang: 07.05.2022
Impfdatum: 07.05.2022
Beginn: 07.05.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SC / LA

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

Incorrect route of product administration Medication error

Symptomtext

Vaccine was administered subcutaneously instead of intramuscularly. Patient was called and told of the medication error and hs been prompted to call of any adverse reaction.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: HIV Mood Disorder Depression/Anxiety Acne
Vorgeschichte: -
Andere Medikamente: lithium carbonate Losartan Bupropion HCL ER Cymbalta
Allergien: nkda
Vorherige Impfungen: -

VAERS 2261729

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: TX
Alter: 17,0
Geschlecht: F
Eingang: 03.05.2022
Impfdatum: 02.05.2022
Beginn: 02.05.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Unevaluable event

Symptomtext

N/A.

Weitere VAERSDATA-Felder

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

VAERS 2177109

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U7273BA

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Staat: MO
Alter: -
Geschlecht: F
Eingang: 12.03.2022
Impfdatum: 04.03.2022
Beginn: 04.03.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RA

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

Inappropriate schedule of product administration

Symptomtext

patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. However, the second administration occurred after only 4 weeks with no reported adverse event; Initial information received on 07-Mar-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old female patient who experienced patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. however, the second administration occurred after only 4 weeks with no reported adverse event while receiving meningococcal a-c-y-w135 (d conj) vaccine [menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunocompromised. On 04-Mar-2022, the patient received 0.5ml of suspect meningococcal a-c-y-w135 (d conj) vaccine solution for injection lot U7273BAwith unknown expiration date via unknown route in the right deltoid. on the same day (04-MAR-2022) the Pharmacist reported that a patient received a dose meningococcal a-c-y-w135 (d conj) vaccine of at an earlier interval than prescribed. The patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. However, the second administration occurred after only 4 weeks (inappropriate schedule of product administration) following the administration of meningococcal a-c-y-w135 (d conj) vaccine. it was reported "The first administration occurred on 04FEB2022 and the second on 04MARCH2022". Action taken: Not applicable for the event. corrective treatment: not reported. outcome: 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: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Immunocompromised
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -