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Reporte zur Charge UJ509AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

15Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 11 OH 2 CA 1

VAERS 1842374

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

mild
Staat
CA
Alter
56,0
Geschlecht
F
Eingang
04.11.2021
Impfdatum
27.10.2020
Beginn
28.10.2020
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Discomfort Joint range of motion decreased Limb discomfort Magnetic resonance imaging Manipulation Pain X-ray limb

Symptomtext

10-28-20-Severe soreness and pain, arm felt heavy, lifting something became an effort d/t discomfort & pain picking up or getting something above my head. Home Tx: Ibuprofen, cold/warm compress, icy hot and Salonpas analgesic cream. Outcome- temporary relief. 11-18-20 - Dr. prescribed Diclofenac sodium topical gel. Outcome- Ineffective. 11-30-20 - Dr. prescribed Meloxicam and PT 12-04-20 to 01-11-21. Outcome- Pain reduced but ROM still limited. 02-22-21- Steroid injection & PT 03-09-21 to 04-13-21.Outcome- Pain/ROM improved then both came back after a few weeks. 08-18-21- Surgery: Manipulation under Anesthesia; 08-30-21- PT+ongoing. Outcome- Pain/ROM improved significantly.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain
Hospital-Tage
-
Labordaten
Xray of left arm- 11/30/2020 MRI- 02/04/2021
Aktuelle Erkrankungen
Migraine
Vorgeschichte
Migraine
Andere Medikamente
Lipitor,Esgic,Vit. C, B2, D, Magnesium, Fish Oil
Allergien
none
Vorherige Impfungen
-

VAERS 1119201

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
OH
Alter
15,0
Geschlecht
F
Eingang
20.03.2021
Impfdatum
10.10.2020
Beginn
10.10.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event

Symptomtext

15 yo female patient presented to clinic for influenza vaccine. Vaccine consent filled out and signed by parent. 0.5mL FluBlok Quad administered IM to L deltoid. Patient educated to remain at clinic for observation x 15 minutes. No adverse reaction or sx noted. 2/18/21 18:15 After two patient identifiers verified, father of patient notified FluBlok was given. States no unexpected effects or sx noted. Denies having other questions or concerns at this time.

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

VAERS 970191

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
3,0
Geschlecht
F
Eingang
25.01.2021
Impfdatum
29.12.2020
Beginn
29.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

Flublok had been administered to 3 year old patient with no AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old patient who received a 0.5 ml dose of vaccine QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] prefilled syringe (lot: UJ509AA, expiry date: 10-May-2021), via intramuscular route at the left deltoid, on 29-Dec-2020 (Product administered to patient of inappropriate age) The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration. (Latency same day). It was reported nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reported FLUBLOK had been administered to 11 patients and would like to know if they are "covered" for influenza vaccination for the season At the time of reporting, the patient had no 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 967511

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
-
Alter
16,0
Geschlecht
M
Eingang
23.01.2021
Impfdatum
10.10.2020
Beginn
10.10.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product administered to patient of inappropriate age

Symptomtext

Flublock is for 18 years and old and at the time the patient was 17 years old. Patient had no adverse reaction.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 942870

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
4,0
Geschlecht
F
Eingang
14.01.2021
Impfdatum
22.12.2020
Beginn
22.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

FLUBLOK was administered to 4 year old female patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00414233) and transmitted to Sanofi on 04-Jan-2021. This case was linked with 2021SA002156, 2021SA002607, 2021SA002631, 2021SA002726, 2021SA002799, 2021SA002850, 2021SA002575, 2021SA003127, 2021SA003182, 2021SA002085 (same reporter) This case involved a 4 year old female patient who was administered with a standard 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot UJ509AA, expiration date 10 May 2021) once via intramuscular route at the left deltoid for prophylactic vaccination on 22-Dec-2021 (Product administered to patient of inappropriate age). 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) (MMRVAXPRO) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) both for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day). Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season At the time of reporting, no adverse event reported (reported as none). 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMRVAXPRO; KINRIX
Allergien
-
Vorherige Impfungen
-

VAERS 939764

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
8,0
Geschlecht
M
Eingang
13.01.2021
Impfdatum
22.12.2020
Beginn
22.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

FLUBLOK had been administered to a 8 years old patient/ No AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a nurse via Medical Information (Reference number- 00414025). This case is linked to case 2021SA002575 (same reporter). This case involves an eight-years-old male patient who was administered a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] Prefilled Syringe, Strength: Standard (batch number: UJ509AA, expiry date: 10-MAY-2021) via intramuscular route in the left deltoid on 22-Dec-2020 for prophylactic vaccination (product administered to patient of inappropriate age). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration (latency: same day). Nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reports FLUBLOK had been administered to 11 pediatric patients and would like to know if they are covered for Influenza vaccination for the season. Adverse Event symptoms: None reported. First time product used and still using product: No. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 937745

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
14,0
Geschlecht
M
Eingang
12.01.2021
Impfdatum
30.12.2020
Beginn
30.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

FLUBLOK was administered to 14 years old patient with no adverse event; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case from other health professional. This case is linked to case 2021SA002575 (Same reporter). This case involves a 14 year old male patient who was administered with a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number: UJ509AA, expiry date:10-May-2021) via intramuscular route at the right deltoid for prophylactic vaccination on 30-Dec-2020 (Product administered to patient of inappropriate age). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day). Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season. At the time of reporting, no adverse event reported (reported as none). 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 937744

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
15,0
Geschlecht
M
Eingang
12.01.2021
Impfdatum
22.12.2020
Beginn
22.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

administration of FLUBLOK to patients under 18 years of age with no adverse event; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 15 years old male patient who was administered with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ509AA and expiry date : 10-May-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 22-Dec-2020, under 18 years of age with no adverse event (product administered to patient of inappropriate age) . Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. This was an actual medication error due to inappropriate age at vaccine administration [latency was same day]. No laboratory data reported. At the time of reporting, no adverse event was reported to the patient. 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 937268

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
10,0
Geschlecht
F
Eingang
12.01.2021
Impfdatum
22.12.2020
Beginn
22.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

FLUBLOK had been administered to 10 year old patient with no adverse event; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional (Nurse) via Medical Information (Reference number- 00413997). This case involves a 10 year old female patient who had been administered with Influenza Quadrivalent Recombinant Vaccine (Flublok QIV) (Product administered to patient of inappropriate age). Reporter would like to know if patients were "covered" for influenza vaccination for the season. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 22-Dec-2020, the patient received a once dose of suspect influenza quadrivalent recombinant vaccine (Prefilled Syringe) at a dose of 0.5 mL via intramuscular route in the right deltoid (lot number: UJ509AA, expiry date: 10-May-2021) for prophylactic vaccination. It was a case of actual medication error due to Inappropriate age at vaccine administration. (latency- same day) At the time of report, no adverse event was reported. (Adverse event (AE) symptoms: None 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 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 937267

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
2,0
Geschlecht
F
Eingang
12.01.2021
Impfdatum
29.12.2020
Beginn
29.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

administration of FLUBLOK to patients under 18 years of age (with no advers event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional via Agency (Reference number- 00413960). This case involves a 2 year old female patient for whom it was reported that administration of flublok to patients under 18 years of age (with no adverse event) (Product administered to patient of inappropriate age), while she received influenza quadrivalent recombinant vaccine (Flublok QIV). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It is also an actual medication error case due to inappropriate age at vaccine administration. On 29-Dec-2020, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 mL once via intramuscular route (lot number: UJ509AA, expiry date: 10-MAY-2021) as prophylactic vaccination in the left deltoid. On 04-Jan-2021 (i.e., 6 days) after taking the suspect, it was reported that administration of flublok to patients under 18 years of age (with no adverse event) (Product administered to patient of inappropriate age) (intensity: not applicable). The event was reported as adverse event of special interest (AESI) as per the AESI list. At the time of report, 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 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. No further information was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 936857

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
16,0
Geschlecht
M
Eingang
12.01.2021
Impfdatum
30.12.2020
Beginn
30.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

FLUBLOK was administered to 16 years old patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00414283) and transmitted to Sanofi on 04-Jan-2021. This case was linked with 2021SA002156, 2021SA002607, 2021SA002631, 2021SA002726, 2021SA002799, 2021SA002850, 2021SA003080, 2021SA003127, 2021SA003182, 2021SA002085 (same reporter) This case involves a 16 year old male patient who was administered with a standard 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot UJ509AA, expiration date 10 May 2021) once via intramuscular route at the left deltoid for prophylactic vaccination on 30-Dec-2021 (Product administered to patient of inappropriate age). Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day). Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season At the time of reporting, no adverse event reported (reported as none). 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MENACTRA
Allergien
-
Vorherige Impfungen
-

VAERS 934972

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
17,0
Geschlecht
F
Eingang
11.01.2021
Impfdatum
22.12.2020
Beginn
22.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

administration of FLUBLOK to 17 years of patient with no adverse event; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 17 year old female patient who was administered with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) (Product administered to patient of inappropriate age). Reporter would like to know if they were "covered" for influenza vaccination for the season. Medical history was not provided. Concomitant medications was not reported. On 22-Dec-2020, the patient received a 0.5 ml once dose of suspect QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (Prefilled syringe) via intramuscular route in the left deltoid (lot UJ509AA and expiry date 10-May-2021) for prophylactic vaccination. It was a case of actual medication error due to Inappropriate age at vaccine administration. (latency- same day) At the time of report, no adverse event was reported. (None- adverse event symptoms were 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 934971

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
2,0
Geschlecht
M
Eingang
11.01.2021
Impfdatum
29.12.2020
Beginn
29.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

FLUBLOK to patients under 18 years of age (with no adverse event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional. This case involves a 2 year old male patient who received 0.5 mL dose of influenza quadrivalent recombinant vaccine (Flublok QIV) (lot number: UJ509AA, expiry date: 10-MAY-2021) via intramuscular route in the left deltoid as prophylactic vaccination on 29-Dec-2020. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of an actual medication error due to inappropriate age at vaccine administration. At the time of report no adverse event was reported. It was reported that, administration of FLUBLOK to patients under 18 years of age. Caller reports FLUBLOK had been administered to 11 pediatric patients. 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
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
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VAERS 927953

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
MI
Alter
16,0
Geschlecht
M
Eingang
08.01.2021
Impfdatum
22.12.2020
Beginn
04.01.2021
Tage bis Beginn
13,0
Dosis
UNK
Route/Site
- / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

FLUBLOK had been administered to 11 pediatric patients (with no adverse event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional. This case involves a 16 years old male patient for whom it was reported that Flublok had been administered to 11 pediatric patients (with no adverse event) (Product administered to patient of inappropriate age), while he received vaccine influenza quadrivalent recombinant vaccine (Flublok QIV). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 22-Dec-2020, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 mL once via intramuscular route (lot number: UJ509AA, expiry date: 05-Oct-2020) as prophylactic vaccination in the right deltoid. On an unknown date (latency unknown) after taking the suspect, it was reported that Flublok had been administered to 11 pediatric patients (with no adverse event) (Product administered to patient of inappropriate age) (intensity: not applicable). No laboratory test was reported. Action taken was reported as not applicable. Corrective treatment was not reported. Outcome was reported as not applicable for the 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. No further information was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
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Vorgeschichte
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VAERS 924142

PROTEIN SCIENCES CORPORATION · INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) · Charge UJ509AA

gering
Staat
OH
Alter
13,0
Geschlecht
M
Eingang
06.01.2021
Impfdatum
30.10.2020
Beginn
30.10.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

Flublok administered to 13 yo , no adverse reaction occurred.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-