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Reporte zur Charge U6621BA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OR 2 WI 1 GA 1 IL 1 OH 1

VAERS 1685123

PFIZER\BIONTECH · COVID19 (COVID19 (PFIZER-BIONTECH)) · Charge U6621BA

mild
Staat
OR
Alter
59,0
Geschlecht
F
Eingang
09.09.2021
Impfdatum
28.07.2021
Beginn
28.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Hypoaesthesia Injection site hypoaesthesia

Symptomtext

Numbness from right arm at site of vaccination up into right side of face. Lasted 3 hours, then resolved completely.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site hypoaesthesia
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
Cholecalciferol 5,000 Units, Ibuprofen 400 mg EVERY 6 HOURS PRN, Magnesium Citrate 100 MG 1 tablet Oral DAILY, Meclizine HCl 25 mg Oral 3 TIMES DAILY PRN, Triamcinolone Acetonide 0.5% Apply to affected area bid x 2 weeks
Allergien
NKA
Vorherige Impfungen
-

VAERS 1054046

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6621BA

mild
Staat
OR
Alter
58,0
Geschlecht
F
Eingang
25.02.2021
Impfdatum
01.09.2020
Beginn
11.09.2020
Tage bis Beginn
10,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Arthralgia Loss of personal independence in daily activities

Symptomtext

Patient reports no issues with original vaccination. "Good Shot" administered in the deltoid muscle away from bursa. Ten days after vaccination reports limited motion with discomfort in shoulder with some transit pain vaccinated left arm. "Interfering with quality of life". Condition has persisted since onset with no improvement at this time.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Arthralgia
Hospital-Tage
-
Labordaten
None Reported. Patent has made appointment to be evaluated by a physician. Appointment date to be in early April 2021.
Aktuelle Erkrankungen
Patient presented at time of vaccination with nail puncture wound to heal. Vaccination recommended by physician. No other conditions noted by patient at time of vaccination.
Vorgeschichte
Unknown
Andere Medikamente
Unknown
Allergien
None Reported
Vorherige Impfungen
-

VAERS 965794

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6621BA

mild
Staat
WI
Alter
62,0
Geschlecht
F
Eingang
22.01.2021
Impfdatum
16.10.2020
Beginn
16.10.2020
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dizziness Illness Nausea Nervousness Vomiting

Symptomtext

On 01/21/21, patient was in the next booth over and she stated the shot got her really sick. She stated she went to work and was extremely dizzy that night, and the next day she stated she felt even more dizzy, shaky, nauseated, and ended up vomiting a small amount that was all acid she stated. She fell asleep after vomiting, and stated she felt back to normal the next day.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2203580

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6621BA

gering
Staat
GA
Alter
48,0
Geschlecht
M
Eingang
29.03.2022
Impfdatum
23.03.2022
Beginn
23.03.2022
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 Medication error No adverse event

Symptomtext

inadvertently administered with an expired product with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 48-year-old male patient who was inadvertently administered with an expired product of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Mar-2022, the patient received a dose of 0.25 ml to 2 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once) (strength, formulation: unknown) (lot number: U6621BA and Expiration Date: 21-Mar-2022) via intramuscular route in the left deltoid for Immunization. On 23- Mar-2022 the patient had non-serious event, "inadvertently administered with an expired product with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported, "RN requesting information regarding ADACEL PFS. The product was inadvertently administered with an expired product to an employee. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age. 48 YEARS. Dosage Information o Frequency = once ONCE o Therapy Date: From = Date of immunization To = leave blank 23Mar2022 o Route = route & site INTRAMUSCULAR, LEFT DELTOID o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25mL o Strength = standard except for Fluzone HD o Indications = Immunization or TB skin test. Event Information o Treatment ADACEL." 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 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 1653307

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6621BA

gering
Staat
IL
Alter
15,0
Geschlecht
F
Eingang
29.08.2021
Impfdatum
29.07.2021
Beginn
29.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Exposure during pregnancy Inappropriate schedule of product administration

Symptomtext

19 weeks pregnant female received Adacel/ no AE; they were not supposed to give the vaccine to the patient until she was 27 weeks pregnant/no AE; Initial information regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00704218) and transmitted to Sanofi on 30-Jul-2021. This case involves a 15-year-old pregnant female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] at her 19 weeks of pregnancy she was not supposed to give this vaccine until she was 27 weeks pregnant (exposure during pregnancy and inappropriate schedule of product administration). Data regarding this pregnancy were received prospectively. The gestation period at onset 19 weeks. The date of last menstrual period was reported as March 2021. The estimated due date was not reported. The patient's past vaccination(s) included TETANUS TOXOID in 2019. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided. The patient had unknown previous pregnancy. On 29-Jul-2021, the patient received a first dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6621BA, expiry date: 31-Mar-2022) a via an unknown route in unknown administration site for prophylactic vaccination. It was a case of exposure during pregnancy (latency same day). It was actual medication error case due to inappropriate schedule of vaccine administered (latency same day). It was reported that, "the vaccine was given to a patient who is 19 weeks pregnant, and they realized that they were not supposed to give the vaccine to the patient until she was 27 weeks pregnant. Caller would like to know if there is anything they need to tell the patient or if there are any adverse effects". Additionally, at time of reporting, the outcome of the pregnancy is 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 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
Exposure during pregnancy
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1227985

SANOFI PASTEUR · TDAP (ADACEL) · Charge u6621ba

gering
Staat
OH
Alter
5,0
Geschlecht
M
Eingang
19.04.2021
Impfdatum
25.02.2021
Beginn
25.02.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Wrong product administered

Symptomtext

A patient received ADACEL instead of Daptacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00551959). This case involves a five-year-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot u6621ba and expiry date: 21-Mar-2022) via an intramuscular route in the right thigh for prophylactic vaccination on 25-Feb-2021 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination. This was a case of actual medication error due to wrong vaccine administered (latency same 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 holders compliance with the requirements. 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
PROQUAD
Allergien
-
Vorherige Impfungen
-