- Staat
- MD
- Alter
- 56,0
- Geschlecht
- F
- Eingang
- 19.10.2023
- Impfdatum
- 26.10.2022
- Beginn
- 24.11.2022
- Tage bis Beginn
- 29,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
NONE, PATIENT HAS BEEN A RESIDENT AT THE FACILITY SINCE DECEMBER 2020, BEEN RECEIVING PALLIATIVE CARE. SHE EXPIRED IN HOUSE 11-24-22 WHICH WAS EXPECTED.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- N/A PALLIATIVE CARE
- Aktuelle Erkrankungen
- DYSPHAGIA,DM,MAJOR DEPRESSIVE DISORDER,CVA,SLEEP APNEA
- Vorgeschichte
- HEMIPLRGIA AND HEMIPARESIS DUE TO CVA,OSTEOPOROSIS
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 64,0
- Geschlecht
- F
- Eingang
- 22.11.2022
- Impfdatum
- 21.11.2022
- Beginn
- 21.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Chills
Headache
Incorrect product formulation administered
Pain
Symptomtext
Patient was given monovalent vaccine instead of bivalent vaccine. Patient states that they were feelin body aches, chills, and a horrible headache the evening after the vaccine was given. Patient also states that they took some Tylenol and that it helped with the headache.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- COPD
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 33,0
- Geschlecht
- M
- Eingang
- 07.11.2022
- Impfdatum
- 04.11.2022
- Beginn
- 05.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Headache
Nausea
Pain
Pyrexia
Symptomtext
Full body m aches began around 30 hours after injection. Around 45 hours after injection the body aches began to subside and a fever began (max 101 degrees) accompanied by a bad headache. Temperature remained elevated, but no longer over 100 after 72 hours. Headache subsided around 72 hours. Nausea was also experienced from about 30-72 hours.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Cold the prior week
- Vorgeschichte
- -
- Andere Medikamente
- Buspirone 5 mg 3x per day.
- Allergien
- Nut allergy
- Vorherige Impfungen
- COVID-19 J&J initial series produced similar side effects at age 31 (May 2021 vaccination).
- Staat
- MA
- Alter
- 52,0
- Geschlecht
- M
- Eingang
- 20.10.2022
- Impfdatum
- 20.10.2022
- Beginn
- 20.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bursitis
Injection site reaction
Pain in extremity
Symptomtext
patient reports injection felt "strange" L arm pain since injection, went to PCP and dx with Bursitis
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site reaction
- Hospital-Tage
- -
- Labordaten
- unknown
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- unknown
- Andere Medikamente
- -
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 49,0
- Geschlecht
- F
- Eingang
- 25.09.2022
- Impfdatum
- 20.09.2022
- Beginn
- 20.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Exposure during pregnancy
Injection site bruising
Injection site pain
Injection site reaction
Pain
Symptomtext
acheing, throbbing and bruising around injection site. never pregnant for 1 week
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site bruising
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- n/a.
- Vorgeschichte
- n/a.
- Andere Medikamente
- n/a
- Allergien
- n/a.
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 68,0
- Geschlecht
- F
- Eingang
- 08.05.2023
- Impfdatum
- 30.09.2022
- Beginn
- 30.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Symptomtext
There were no adverse events or symptoms at the time or now.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Constipation Depression Diabetes Osteoarthritis
- Andere Medikamente
- FLUTICASONE PROPIONATE DICLOFENAC SODIUM CETIRIZINE HCL LATANOPROST LINZESS FOLIC ACID LISINOPRIL PROZAC ROSUVASTATIN CALCIUM AMLODIPINE BESYLATE METHOCARBAMOL ASPIR 81
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 72,0
- Geschlecht
- U
- Eingang
- 26.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; adminstered to patients with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 72 years old and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date the patient developed a non-serious event that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) On 22-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization. On 22-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Unknown for all. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 43,0
- Geschlecht
- U
- Eingang
- 26.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion that exceeded the stability data and FLUZONE QUADRIVALENT multidose vial was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data and FLUZONE QUADRIVALENT multidose vial was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp). This case involves a 43-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent Multidose] vial was administered to patient, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (strength, formulation, dose , route: unknown) (lot number: UJ899AA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and on the same day Fluzone Quadrivalent Multidose vial was administered to patient, with no reported adverse event (poor quality product administered)(latency same day) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency). Action taken with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED was not applicable for both events. At time of reporting, the outcome was Unknown for both events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 43,0
- Geschlecht
- U
- Eingang
- 22.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
product administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; product administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp). This case involves a 43 years old and unknown gender patient to whom INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (dose, formulation, strength: unknown) (lot UJ899AA, 23-Jun-2023) via unknown route in unknown administration site for immunization post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event (product storage error)(poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 24,0
- Geschlecht
- U
- Eingang
- 22.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
temperature excursion that exceeded the stability data with no reported adverse event; administered to patient after excursion with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp. This case involves a 24 years old and unknown gender patient to whom administered influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] after excursion with no adverse event and temperature excursion that exceeded the stability data with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED at an unknown dose (lot UJ899AA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation). On 22-Sep-2022 there was temperature excursion that exceeded the stability data with no reported adverse event (product storage error) and administered to patient after excursion with no adverse event (poor quality product administered) same day following the administration of influenza quadrival A-B multidose vaccine preserved. Action taken: Not applicable. Outcome: Unknown for both the events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 59,0
- Geschlecht
- U
- Eingang
- 22.10.2022
- Impfdatum
- 26.09.2022
- Beginn
- 26.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion product administered to patient with no reported AE; medication error due to temperature excursion product administered to patient with no reported AE; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 59 years old of an unknown gender patient who was administered vaccines post medication error due to temperature excursion with no reporter adverse event , after receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED( lot UJ899AA and expiration date:30-Jun-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination. On 26-Sep-2022 ,the patient developed a non-serious event of medication error due to temperature excursion product administered to patient with no reported ae (poor quality product administered) (latency: same day)(Product storage error )(Latency: Unknown). Action taken :not applicable It was not reported if the patient received a corrective treatment for the events. Outcome: Unknown for both events 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. and unknown gender patient who experienced medication error due to temperature excursion product administered to patient with no reported ae and medication error due to temperature excursion product administered to patient with no reported ae while receiving vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 42,0
- Geschlecht
- U
- Eingang
- 21.10.2022
- Impfdatum
- 06.10.2022
- Beginn
- 06.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion product administered to patient with no reported AE; medication error due to temperature excursion product administered to patient with no reported AE; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 42 years old of an unknown gender patient who was administered vaccines post medication error due to temperature excursion with no reporter adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Oct-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED( lot UJ899AA and expiration date:30-Jun-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination. On 06-Oct-2022 ,the patient developed a non-serious event of medication error due to temperature excursion product administered to patient with no reported ae (poor quality product administered) (latency: same day)(Product storage error )(Latency: Unknown). Action taken :not applicable It was not reported if the patient received a corrective treatment for the events. Outcome: Unknown for both events 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 52,0
- Geschlecht
- U
- Eingang
- 21.10.2022
- Impfdatum
- 29.09.2022
- Beginn
- 29.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
Vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-Healthcare professional (hcp). This case involves a 52 years old and unknown gender patient to whom vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event for vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (dose, formulation, strength, expiry date: unknown) lot UJ899AA via unknown route in unknown administration site for immunization post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event (poor quality product administered) (product storage error). Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 56,0
- Geschlecht
- U
- Eingang
- 21.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion that exceeded the stability data, Fluzone Quadrivalent multidose vial was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data, Fluzone Quadrivalent multidose vial was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp). This case involves a 56-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] multidose vial was administered to patient, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, dose , route: unknown) (lot number: UJ899AA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and on the same day fluzone quadrivalent multidose vial was administered to patient, with no reported adverse event (poor quality product administered) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency). This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. Action taken with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED was not applicable for both events. At time of reporting, the outcome was Unknown for both events. 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 49,0
- Geschlecht
- U
- Eingang
- 21.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event; medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 49 years old and unknown gender patient and reporter stated that there was a medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event involving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) for Prophylactic vaccination. On an unknown date the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event (product storage error) (latency: unknown) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization. On 22-Sep-2022 the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- TENIVAC
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 48,0
- Geschlecht
- U
- Eingang
- 21.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
TENIVAC and FLUZONE QUADRIVALENT exceeded the stability data and were administered to patients with no reported AE; poor quality dose administered with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 48 years old (unknown gender) patient who reported tenivac and fluzone quadrivalent exceeded the stability data and were administered to patients with no reported adverse event and poor quality dose administered with no adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] . The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ899AA; 30-Jun-2023) via unknown route in unknown administration site and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, dose, formulation, route: unknown) both for Immunization. On 23-SEP-2022 the patient developed a non-serious event tenivac and fluzone quadrivalent exceeded the stability data and were administered to patients with no reported adverse event (product storage error) and poor quality dose administered (poor quality product administered) with no adverse event following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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.; Sender's Comments: 01318334: 01318560: 01318700: 01318713: 01318730: 01318644: 01318635: 01318655: 01318686: 01318695: 01318744: 01318785: 0131881: 01318811: 01318509: 01318553: 01318603: 01318593: 01318613: 01318624:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 54,0
- Geschlecht
- U
- Eingang
- 21.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- 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
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event; vaccine administered to patients after temperature excursion with no reported adverse event; Expired vaccine administered with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional). This case involves a 54 years old and unknown gender patient and reported temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event, vaccine administered to patients after temperature excursion with no reported adverse event and expired vaccine administered with no reported adverse event while receiving vaccine influenza quadrival a-b multidose vaccine preserved [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2022, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection (lot UJ899AA, expiry date- 30-Jun-2022) with an unknown strength via unknown route in unknown administration site for prophylactic vaccination. On 22-Sep-2022, the patient had developed a non-serious temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event (product storage error), vaccine administered to patients after temperature excursion with no reported adverse event (poor quality product administered) and vaccine administered with no reported adverse event (expired product administered), latency same day following the administration of influenza quadrival a-b vaccine. Action taken - not applicable. Outcome - Unknown for all the events 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
- -
- Staat
- TX
- Alter
- 51,0
- Geschlecht
- F
- Eingang
- 20.10.2022
- Impfdatum
- 12.10.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
Pt was given an expired vaccine exp. 10/18/22 Tdap (Boostrix). Pt Did not have adverse reaction
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 27,0
- Geschlecht
- M
- Eingang
- 20.10.2022
- Impfdatum
- 19.10.2022
- Beginn
- 19.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect product formulation administered
Symptomtext
Pt given COVID Booster Bivalent for first Covid vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- PTSD, Depression
- Vorgeschichte
- -
- Andere Medikamente
- Lamictal, lisinopril, fluoxetine
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 34,0
- Geschlecht
- U
- Eingang
- 20.10.2022
- Impfdatum
- 29.09.2022
- Beginn
- 29.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 34 years old and unknown gender patient and it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) On 29-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization On 29-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event, administered to patient with no reported adverse event). At time of reporting, the outcome was Unknown for all. 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 57,0
- Geschlecht
- U
- Eingang
- 20.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 58 years old and unknown gender patient who experienced temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date there was a temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error). On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as immunization. On 22-SEP-2022 the vaccine was administered to the patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; administered to patients with no reported adverse event, vaccine was adminstered to the patient with no reported adverse event). At time of reporting, the outcome was Unknown for all 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 59,0
- Geschlecht
- U
- Eingang
- 20.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 59 years old and unknown gender patient and it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) On 22-Sep-2022 the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization. On 22-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event, administered to patient with no reported adverse event). At time of reporting, the outcome was Unknown for all. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 59,0
- Geschlecht
- U
- Eingang
- 20.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
temperature excursion that exceeded the stability data with No adverse event; administered to patients post excursion with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp. This case involves a 59 years old and unknown gender patient who was administered influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] post excursion with no adverse event and temperature excursion that exceeded the stability data with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 23-Sep-2022, the patient received suspect influenza quadrival A-B multidose vaccine preserved at an unknown dose (lot UJ899AA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation). On 23-Sep-2022 there was temperature excursion that exceeded the stability data with no adverse event (product storage error) and administered to patients post excursion with no adverse event (poor quality product administered) same day latency following the administration of influenza quadrival A-B multidose vaccine preserved. Action taken: Not applicable. Outcome: Unknown for both the events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 46,0
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patients after temperature excursion with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 46 years old and unknown gender patient and reporter reported temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event and was administered to patients after tempearature excursion with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (lot UJ899AA) Suspension for injection (with an unknown strength, dose, frequency, route, expiry date, administration site) for immunization. On an unknown date the temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event (Product storage error) (latency unknown) and On 22-SEP-2022 the patient was administered with the vaccine influenza quadrival a-b vaccine with no reported adverse event (poor quality product administered) (latency same day). No lab data reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for both the events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 36,0
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- 29.09.2022
- Beginn
- 29.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
temperature excursion with no reported adverse event; temperature excursion / administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 36 years old and unknown gender patient who had temperature excursion with no reported adverse event and temperature excursion / administered to patient with no reported adverse event involving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC). On 29-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization. On 29-Sep-2022 the patient developed a non-serious event of temperature excursion with no reported adverse event (product temperature excursion issue) involving INFLUENZA QUADRIVAL A-B VACCINE. On 29-Sep-2022 the patient developed a non-serious event of temperature excursion / administered to patients with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- TENIVAC
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 42,0
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event; medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event; Initial information received from on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 42 years old and unknown gender patient and reporter stated that there was a medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse involving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC). It was reported regarding a medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization. On 22-Sep-2022 the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event (poor quality product administered) (Latency: same day)following the administration of INFLUENZA QUADRIVAL A-B VACCINE. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- TENIVAC
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 34,0
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event; administered to patients after tempearature excursion with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 34 years old and unknown gender patient and reporter reported temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event and was administered to patients after tempearature excursion with no reported adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and influenza quadrival a-b vaccine [Fluzone QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (lot UJ899AA and expiry date 30-Jun-2023) Suspension for injection (with an unknown strength, dose, frequency, route, administration site) for immunization. On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (with an unknown strength, dose, frequency, route, lot number, expiry date administration site) for prophylactic vaccination. On an unknown date the temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event (Product storage error) and On 23-SEP-2022 the patient was administered with vaccineinfluenza quadrival a-b vaccine and on unknown date administered with diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (poor quality product administered). No lab data reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for both the events. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 54,0
- Geschlecht
- M
- Eingang
- 14.10.2022
- Impfdatum
- 14.10.2022
- Beginn
- 14.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect product formulation administered
Symptomtext
Pt was given Pfizer Monovalent instead of Moderna Bivalent
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None that we were aware of.
- Vorgeschichte
- Major Depressive Disorder, Obesity, Impaired Mobility and ADL's, Hypertension, Prediabetic, Bilat Chronic Knee Pain
- Andere Medikamente
- Amlodipine, Atorvastatin, Escitalopram, Losartan, Aleve
- Allergien
- Aleve
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 20,0
- Geschlecht
- M
- Eingang
- 05.10.2022
- Impfdatum
- 03.10.2022
- Beginn
- 05.10.2022
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- - / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
no adverse effects, But I was notified by Dept of health that vaccine had expired on 9/30/2022, as it was transferred to me by them from another facility,.At time of transfer, i have in writing and was told verbally that the doses expired on 11/08/2022, so this was not an oversight on my part as i trusted what was written on the envelope and what I was told verbally. I contacted pfizer, who have sent me a letter saying that stability data DOES support the use of that product on that date. I am also contacting patient to inform him of what happened.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.10.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
FLUZONE QUADRIVALENT MDVS at a high of 52F for an unknown length of time and a low of 31F for an unknown time with no reported adverse event; the patient was vaccinated with the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of unknown demographics who was vaccinated with the fluzone quadrivalent with no reported adverse event and fluzone quadrivalent mdvs (INFLUENZA QUADRIVAL A-B VACCINE) at a high of 52f for an unknown length of time and a low of 31f for an unknown time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date the fluzone quadrivalent mdvs at a high of 52f for an unknown length of time and a low of 31f for an unknown time with no reported adverse event (product storage error) On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ899AA, expiration DATE: 30-Jun-2023, in unknown administration site as Immunization. On 22-SEP-2022 the patient was vaccinated with the fluzone quadrivalent with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was unknown whether products had experienced an excursion at the time of administration. This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.This case is for 1 patient, 30 patients were vaccinated. The vaccine had an excursion last weekend due to a power outage, caller also reporting for the past 8 months their products have not been stored properly. Caller reporting using an improper thermometer and the temperatures were either not recorded or not recorded accurately. Caller reporting they have periods of unknown temperatures and periods of recording temperatures too high or too low. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (the patient was vaccinated with the FLUZONE QUADRIVALENT with no reported adverse event, FLUZONE QUADRIVALENT MDVS at a high of 52F for an unknown length of time and a low of 31F for an unknown time with no reported adverse event). At time of reporting, the outcome was Unknown for all. 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 23,0
- Geschlecht
- F
- Eingang
- 15.09.2022
- Impfdatum
- 15.09.2022
- Beginn
- 15.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Incorrect dose administered
Syringe issue
Symptomtext
Student nurse reported to RN that patient was given half the dose because some squirted out of syringe. Patient then was revaccinated with an 0.5 mL dose in opposite deltoid.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -