VAERS Reports U6878BB

VAERS 2591627

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6878BB

schwer

Staat: PA
Alter: 16,0
Geschlecht: M
Eingang: 02.03.2023
Impfdatum: 01.04.2021
Beginn: 08.04.2021
Tage bis Beginn: 7,0
Dosis: 2
Route/Site: IM / RA

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

Blood electrolytes normal Drug screen negative Electroencephalogram normal Magnetic resonance imaging head normal Postictal state Seizure Tongue biting Tremor Unresponsive to stimuli Urinary incontinence

Symptomtext

Child found by sister unresponsive and on floor of their home around 4 pm, while he had been playing video games. Sister reported one hand shaking. Child was also incontinent of bladder, taken to Hospital and thought to have first time seizure. Records from hospital ER indicate he was thought to have a seizure as there was a period of reported unresponsiveness, incontinent bladder, biting tongue and a post-ictal period.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Seizure
Hospital-Tage: 1,0
Labordaten: Normal electrolytes and urine drug screen. Admitted 4/8/21 had normal brain MRI and EEG. Started on Keppra and following up with Pediatric Neurology in 4 weeks.
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: NKDA
Vorherige Impfungen: -

VAERS 1315399

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge u6878bb

schwer

Staat: TX
Alter: 25,0
Geschlecht: M
Eingang: 13.05.2021
Impfdatum: 13.05.2021
Beginn: 13.05.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Dizziness Head injury Headache Seizure

Symptomtext

Pt came to the pharmacy to get menactra shot for his school. H e filled out consent form and verified the only thing he is allergic to is the penicillins. He got the shot and about 5 or so min later, i heard a noise from people around him. I run to him with my emergency kit , picked him up and gave him epipen just to be sure incase if its anaphylactic reaction. I checked his breathing ,he was breathing fine. i asked him if he want me to call 911, he replied no. I helped him up to seat on the chair, he said he is feeling dizzy. I gave him water. He said his back of his head hurt and he thinks he might have hit the floor. He asked for ice pack. I gave him Ice pack. About 5 min or so, i check back with him , he said he is feeling alot better. I asked him again if he want me to call 911, he said no. After about 10 min or so, he start to have seizure where i moved him onto the floor from the chair and moved everything around him I have one of my tech call 911 and I have him on his sides. Th eseizure lacsted for about 1 or so. Once EMS get to the pharmacy, he had another seizure that lasted for about another min. EMS gave him Ketamin as he was very uncooperative

Weitere VAERSDATA-Felder

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

VAERS 1313608

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge u6878bb

moderat

Staat: NH
Alter: 11,0
Geschlecht: F
Eingang: 13.05.2021
Impfdatum: 12.05.2021
Beginn: 12.05.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Dyspnoea

Symptomtext

Difficulty taking deep breath Sent to ED

Weitere VAERSDATA-Felder

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

VAERS 1046334

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U6878BB ?

mild

Staat: -
Alter: 16,0
Geschlecht: F
Eingang: 22.02.2021
Impfdatum: 03.02.2021
Beginn: 03.02.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

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

Chills Fatigue Headache Injection site pain

Symptomtext

Pain at the injection site / only symptom that persisted; Fatigue / taking a nap at the 4 hour; Chills; Headache; This case was reported by a consumer and described the occurrence of injection site pain in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB27AA, expiry date unknown) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) (batch number U68788BB ?, expiry date unknown) for prophylaxis. On 3rd February 2021, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo). On 3rd February 2021, 3 hrs 30 min after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced injection site pain, fatigue, chills and headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fatigue, chills and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, fatigue, chills and headache to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo). This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: This case was reported by the patient's parent. The reporter reported an adverse reaction, the patient experienced after receiving the 1st dose of Bexsero and MCV4 shot on the day of reporting. Approximately 3.5 hours after the receiving the vaccine, the patient started to experience the symptoms of fatigue, pain at the injection site and headache. The patient took 2 Advil (200mg ea) right before taking the nap at the 4 hours. The patient woke up 45 minutes later feeling better. The only symptoms that persisted was the pain at the injection site. The reporter plead to let her/ him know if there was any further action that they need to take. The information regarding consent to follow up was not reported.

Weitere VAERSDATA-Felder

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

VAERS 1483653

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6878BB

gering

Staat: NY
Alter: -
Geschlecht: M
Eingang: 18.07.2021
Impfdatum: 01.07.2021
Beginn: 01.07.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Extra dose administered No adverse event

Symptomtext

accidently received 2 doses of MENACTRA with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional (Reference number- 00667570) and transmitted to Sanofi on 02-Jul-2021. This case involves a 12-years old male patient who received 2 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (accidental overdose) on 01-Jul-2021 (lot number: U6878BB and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP). It was a case of an off-label use and accidental overdose (latency same day). At the time of report, no adverse event was reported. It was reported that "patient accidently received 2 doses of MENACTRA and asked if there is any documentation regarding any adverse effects or cautions that should be considered. Warm transferred the RN to HCP. Call warm transferred from MIA. Extra Dose SRD sent" It was unknown if there were lab data/results available. Disclaimer: 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: TDAP
Allergien: -
Vorherige Impfungen: -