- Staat
- TN
- Alter
- 71,0
- Geschlecht
- F
- Eingang
- 02.11.2021
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Mobility decreased
Pain in extremity
Peripheral swelling
X-ray limb
Symptomtext
Patient started experiencing alot of pain and swelling in the arm the next day. States that she has had limited range of motion and cannot lift her arm above her wrist currently.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- Went to have xrays on November 1st.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- High Blood Pressure
- Andere Medikamente
- Amlodipine, Triamterene/hctz, Vitamin D, B12 SL, ASA 81 mg every other day
- Allergien
- Sulfa drugs
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 80,0
- Geschlecht
- M
- Eingang
- 23.03.2022
- Impfdatum
- 19.11.2021
- Beginn
- 24.11.2021
- Tage bis Beginn
- 5,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: unbekannt
Acute left ventricular failure
Blood creatinine decreased
Echocardiogram
Polyuria
Symptomtext
Acute diastolic heart failure - Following admission, he was started on iv diuresis and 2 D Echo was done. Seen by heart failure navigator and plan for outpatient follow-up. IV diuresis changed to p.o. torsemide. Cr as low as 0.81 with diuresis on discharge. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Acute left ventricular failure
- Hospital-Tage
- 5,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VT
- Alter
- 68,0
- Geschlecht
- M
- Eingang
- 14.01.2022
- Impfdatum
- 09.12.2021
- Beginn
- 12.12.2021
- Tage bis Beginn
- 3,0
- Dosis
- 7+
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Atrial fibrillation
Symptomtext
atrial fibrillation with rapid ventricular response identified at acute office visit on 12/9/21. Transferred to Emergency Department. Treated with IV antiarrhythmics and converted to sinus rhythm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Atrial fibrillation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- hypertension, hyperlipidemia, prediabetes, lumbar radiculopathy
- Andere Medikamente
- acetaminophen, amlodipine, atorvastatin, carvedilol, docusate, triamterene-hydrochlorothiazide, valsartan
- Allergien
- lisinopril, almonds, sea salt
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 30.11.2021
- Impfdatum
- 12.11.2021
- Beginn
- 12.11.2021
- 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 storage error
Symptomtext
vaccine was exposed to 31 degrees Fahrenheit for a couple of days/ no AE; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist (under reference- 00864195) and transmitted to Sanofi on 18-Nov-2021. This case is linked to cases 2021SA389706, 2021SA392839 and 2021SA392836 (CLUSTER). This case involves a 76-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On 12-Nov-2021, the patient received 0.7 mL (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ764AC and expiry date 30-Jun-2022] via intramuscular route in left arm for prophylactic vaccination. It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?" It was case of an actual medication error due to product storage error temperature too low (latency was on same day). 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 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
- KY
- Alter
- 65,0
- Geschlecht
- F
- Eingang
- 30.11.2021
- Impfdatum
- 13.11.2021
- Beginn
- 13.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
vacccine exposed to temperatures 31 degrees Fahrenheit for a couple of days with no A/E; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (under reference- 00864179) and transmitted to Sanofi on 18-Nov-2021. This case is linked to cases 2021SA389706, 2021SA392836 and 2021SA392842 (CLUSTER). This case involves a 65 year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On 13-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ764AC and expiry date: 30-Jun-2022) (frequency : once) via intramuscular route in the left arm in prophylactic vaccination. It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?" It was case of an actual medication error due to product storage error temperature too low (latency was on same day). 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 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
- KY
- Alter
- 67,0
- Geschlecht
- M
- Eingang
- 30.11.2021
- Impfdatum
- 12.11.2021
- Beginn
- 12.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
vaccine was exposed to 31 degrees Fahrenheit for a couple of days/ no AE; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Global Media Information (under reference- 00864089) and transmitted to Sanofi on 18-Nov-2021. This case is linked to cases 2021SA389706, 2021SA392839 and 2021SA392842(CLUSTER). This case involves a 67-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On 12-Nov-2021, the patient received 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ764AC and expiry date 30-Jun-2022] via intramuscular route in left arm for prophylactic vaccination. It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?" It was case of an actual medication error due to product storage error temperature too low (latency was on same day). 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 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
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 27.11.2021
- Impfdatum
- 13.11.2021
- Beginn
- 13.11.2021
- 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 storage error
Symptomtext
vaccine exposed to 31 degrees Fahrenheit for a couple of days with no A/E; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via a consumer via physician via phone call (under Medical Information Inquiry Number: 00864185). This case is linked to cases 2021SA392836, 2021SA392839 and 2021SA392842(CLUSTER). This case involves a 66 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On 13-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination. It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?" It was case of an actual medication error due to product storage error temperature too low (latency was on same day). 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 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
- CO
- Alter
- 47,0
- Geschlecht
- M
- Eingang
- 04.11.2021
- Impfdatum
- 04.11.2021
- Beginn
- 04.11.2021
- 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
Patient has no adverse reaction to the high dose Fluzone vaccine. Patient stated he was feeling fine and did not report any symptom. Patient was advised to seek PCP if symptoms occurred.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- None.
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- unknown
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 58,0
- Geschlecht
- M
- Eingang
- 02.11.2021
- Impfdatum
- 20.10.2021
- Beginn
- 20.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administered to patient of inappropriate age
Symptomtext
High dose given to a patient not over the age of 65.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- DM
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 61,0
- Geschlecht
- F
- Eingang
- 01.11.2021
- Impfdatum
- 29.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
The patient received the Fluzone HD vaccine instead of the Quadravalent that was indicated by her 61 years of age.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 70,0
- Geschlecht
- M
- Eingang
- 01.11.2021
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Symptomtext
Low Grade Temperature of 99.5.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 82,0
- Geschlecht
- F
- Eingang
- 29.10.2021
- Impfdatum
- 27.10.2021
- Beginn
- 28.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Fall
Lethargy
Symptomtext
Increased Lethargy and falls.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fall
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 57,0
- Geschlecht
- F
- Eingang
- 28.10.2021
- Impfdatum
- 28.10.2021
- Beginn
- 28.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
Patient was given high dose flu vaccine (Fluzone High Dose). However, the high dose is only approved for those patients that are >65 years old. Patient is not older than 65, and therefore not indicated to receive that high dose flu vaccine. Patient was indicated for regular dose flu vaccine (Afluria).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 71,0
- Geschlecht
- F
- Eingang
- 28.10.2021
- Impfdatum
- 17.10.2021
- Beginn
- 17.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure via skin contact
Syringe issue
Underdose
Symptomtext
when she administered the product the medication leaked out/ no adverse event; medication leaked out on consumer's arm/ no adverse event; she only received about 0.1 ml dose of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and physician via Media Information (under reference: 00818407) in a specific country. This case involves a 71 years old female patient who when administered the product the medication leaked out on consumer's arm, that she only received about 0.1 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (syringe issue, exposure via skin contact, underdose). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included COVID-19 VACCINE for prophylactic vaccination. On 17-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, once, lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular route in the right deltoid for prophylactic vaccination. This case was a special situation due to (syringe leak, exposure via skin contact, vaccine underdose) (latency: same day). It was reported "Caller stated that when she administered the product the medication leaked out on consumer's arm. She believes it came out of the glass part. She stated that she only saw about 0.1 ml was actually administered into the patient. Caller wanted to know if there was any data on if the consumer should be revaccinated." At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure via skin contact
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- COVID-19 VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 3,0
- Geschlecht
- M
- Eingang
- 20.10.2021
- Impfdatum
- 18.10.2021
- Beginn
- 18.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKMA
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 6,0
- Geschlecht
- F
- Eingang
- 20.10.2021
- Impfdatum
- 18.10.2021
- Beginn
- 18.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKMA
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 40,0
- Geschlecht
- F
- Eingang
- 20.10.2021
- Impfdatum
- 18.10.2021
- Beginn
- 18.10.2021
- 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
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKMA
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 73,0
- Geschlecht
- M
- Eingang
- 16.10.2021
- Impfdatum
- 19.10.2020
- Beginn
- 05.10.2021
- Tage bis Beginn
- 351,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Inappropriate schedule of product administration
Medication error
Symptomtext
Patient had 3 other doses of flu vaccines given in the past year / NO AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Regulatory authority (Reference number- 00799351) and transmitted to Sanofi on 05-Oct-2021. This case involves a 73 years old male patient who administered 3 other doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the past year (inappropriate schedule of product administration). The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Memory impairment. On 19-Oct-2020, 06-Feb-2021, 06-Mar-2021, 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular at an unknown administration site for prophylactic vaccination. It was an actual medication error due to inappropriate schedule of vaccine administered (latency: same day). It was reported "Patient was given FLUZONE HD QIV on 05Oct2021, and practice found out afterwards he has had 3 other doses of flu vaccines administered in the past year. The original dose was given by the practice on 19Oct2020, with the two following on 06Feb2021 and 06Mar2021, which were not administered by the practice." HCP states that patient also received 2 flu vaccines in 2018. At the time of reporting, no adverse event 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Memory disturbance
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 30,0
- Geschlecht
- F
- Eingang
- 16.10.2021
- Impfdatum
- 05.10.2021
- Beginn
- 05.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure via skin contact
No adverse event
Product administered to patient of inappropriate age
Syringe issue
Symptomtext
Product leaked out from the back of the barrel with no adverse event; Product leaked out from the back of the barrel onto her hands and the floor with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health care professional (under the reference 00798927). This case involves a 30 year old female patient who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked out from the back of the barrel (device leakage) and onto her hands and the floor (exposure via skin contact). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 05-Oct-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot UJ764AC and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination It was an actual medication error due to device leakage and exposure via skin contact (same day latency). At time of reporting, the outcome was unknown for the reported 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure via skin contact
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 67,0
- Geschlecht
- F
- Eingang
- 06.10.2021
- Impfdatum
- 06.10.2021
- Beginn
- 06.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
Patient signed up for a flu vaccine at the pharmacy. She filled out the consent form and was counseled by the pharmacist. After receving the vaccine, she stated that she also received the flu vaccine at her doctor's office 1 month ago. The patient's doctor was notified. No adverse reactions have been observed .
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -