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Reporte zur Charge U6565AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 1 UT 1 IL 1

VAERS 851368

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6565AB

moderat
Staat
CA
Alter
17,0
Geschlecht
M
Eingang
05.01.2021
Impfdatum
02.12.2019
Beginn
03.12.2019
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
- / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
Chest pain Headache Immune system disorder Oropharyngeal pain Pain Photophobia Spinal X-ray normal Tachycardia White blood cell count increased

Symptomtext

symptoms more likely related to elevated immune response secondary multiple Innervation Zones (IZ); Information has been received from FDA (VAERS ID 851368) on 20-NOV-2020. This spontaneous report as received from a Registered Nurse refers to a 17 year old male patient. The patient had no illness at time of vaccination; his medical history, concurrent conditions and concomitant therapies were not reported. On 02-DEC-2019 at 14:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (first dose on the left deltoid, lot # 1621926 has been verified to be valid, expiration date not reported, but upon internal validation established as 28-NOV-2021; dosage information not provided) for prophylaxis.Other vaccines received for prophylaxis on the same date included hepatitis a vaccine, inactivated (VAQTA) (first dose on the right deltoid, lot # S010727 has been verified to be valid, expiration date not reported, but upon internal validation established as 26-JUL-2020; dosage information not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live Albumin status rHA (recombinant Human albumin) (M-M-R II) (second dose on the left arm, lot # S006051 has been verified to be valid, expiration date not reported, but upon internal validation established as 27-FEB-2021; dosage information not provided), varicella virus vaccine live (oka/merck) (VARIVAX) (first dose on the right arm, lot # S021321 has been verified to be valid, expiration date not reported, but upon internal validation established as 09-JUL-2021; dosage information not provided), influenza virus vaccine (unspecified) (trade name not reported but reported as manufactured by GSK) (first dose on the left deltoid, lot # 36633; expiration date and dosage information not provided), poliovirus vaccine inactivated (unspecified)(trade name not reported but reported as manufactured by Sanofi) (third dose on the left arm, lot # PIF491M; expiration date and dosage information not provided), meningococcal b vaccine (unspecified) (trade name not reported but reported as manufactured by GSK) (first dose on the left deltoid, lot # ABXA12BA; expiration date and dosage information not provided), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (third dose on the left arm, lot # U6565AB; expiration date and dosage information not provided) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (trade name not reported but reported as manufactured by Sanofi) (first dose on the right deltoid, lot # U63079A; expiration date and dosage information not provided). On 03-DEC-2019, the patient woke up a 2 AM with body aches, frontal headache, photophobia, some chest pain, throat pain and initially tachycardia. The patient was hospitalized, and the reporting nurse assessed the symptoms were more likely related to an elevated immune response secondary to multiple innervation zones (IZ) (immune system disorder). The patient's white blood cell count was 16.6 (units not provided), a lateral neck x ray showed normal soft tissue and all other tests (unspecified were normal). The patient was hospitalized for one day and on an unspecified date in December 2019, the patient recovered from the immune system disorder. The causality assessment between the event and the suspect therapies was not provided. Follow-up information has been received on 29-DEC-2020. As of 29-DEC-2020, all telephone attempts trying to obtain additional information have been unsuccessful. The nurse who filled out the VAERS form and typically handled all these questions just retired. The reporter unable to locate any patient information that was over a year old.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chest pain
Hospital-Tage
1,0
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
VAQTA SYRINGE (DEVICE); GARDASIL 9 SYRINGE (DEVICE);
Allergien
-
Vorherige Impfungen
-

VAERS 1230982

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6565AB

gering
Staat
UT
Alter
16,0
Geschlecht
M
Eingang
19.04.2021
Impfdatum
30.03.2021
Beginn
30.03.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient received expired dose of MENACTRA vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via call-center via Global Medical Information (GMI) (Reference number- 00545117) and transmitted to Sanofi on 01-Apr-2021 in the United States. This case involves a 16 years old male patient who received expired second dose of 0.5 mL MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [strength: standard, frequency: once, batch number: U6565AB and expiry date: 28-Mar-2021 via intramuscular route in deltoid not otherwise specified (NOS)] (expired vaccine used) on 30-Mar-2021 for prophylactic vaccination. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. It was an actual medication error case due to expired product administered (latency: 1 day). At the time of reporting, 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
IPOL [POLIO VACCINE INACT 3V (VERO)]
Allergien
-
Vorherige Impfungen
-

VAERS 1230979

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6565AB

gering
Staat
IL
Alter
16,0
Geschlecht
M
Eingang
19.04.2021
Impfdatum
30.03.2021
Beginn
30.03.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

a patient received an expired dose of Menactra/ No AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) in the . This case involves a 16 years old male patient who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Oral solution (batch number: U6565AB and expiry date: 28-MAR-2021, Strength: standard) via intramuscular route in the right arm on 30-Mar-2021 for prophylactic vaccination (Expired product administered). The patient's medical history, medical treatments, vaccinations and family history were not provided. List concomitant or no other vaccines: None. It was an actual medication error due to expired vaccine used (latency: same day). Potential Product Technique Complain: No, Reporter relationship: HCP, Product used and Still using product: No. 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-