- Staat
- KY
- Alter
- 80,0
- Geschlecht
- F
- Eingang
- 10.01.2022
- Impfdatum
- 03.03.2021
- Beginn
- 26.12.2021
- Tage bis Beginn
- 298,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood pressure immeasurable
COVID-19
COVID-19 pneumonia
Death
SARS-CoV-2 test positive
Symptomtext
Resident was admitted to Hospital on 12/26/2021 and returned to facility on 12/28/2021 with a diagnosis of Pneumonia due to COVID. On 01/08/2022 Physical Therapy asked nursing to assess her and they could not find a blood pressure. MD was notified and orders to send to the emergency room and resident expired before they sent her out. She was a DNR.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- 2,0
- Labordaten
- SARS COVID positive
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Pneumonia due to CORONAVIRUS, HTN, Megaloblastic Anemia, Hypothyroidism, Type II Diabetes, Hyperlipidemia, Anxiety, GERD GOUT
- Andere Medikamente
- Allopurinol, Aspirin ,Atenolol, Atorvastatin, Celecoxib, Famotidine, Furosemide, Gabapentin, Isosorbide, Levothyroxine, Lisinopril, Metformin, Oxybutynin, Pantoprazole, Potassium, Ranolazine, Ropinirole, Tylenol
- Allergien
- Amoxicillin, Meperidine, Sulfacetamide, Tropicamide
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- -
- Geschlecht
- M
- Eingang
- 30.12.2021
- Impfdatum
- 13.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Angiogram cerebral
Blood glucose
Blood magnesium
Body temperature increased
Cerebral infarction
Cerebral microangiopathy
Computerised tomogram head
Dizziness
Echocardiogram
Full blood count
Lacunar infarction
Magnetic resonance imaging
Metabolic function test
Nausea
Procalcitonin
Troponin
Vertigo
Vomiting
Symptomtext
dizziness - spinning sensation - Before going to hospital Nausea vomiting low grade temp Acute Subacute infarcts with Left cerebellar Hemiphere microangiopathic diseas Sm chronic Lacunar infarcts - Bilateral Frontal Coronal
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- 3,0
- Labordaten
- Echo CMP MRI Loprd Procalcitonin CT Head CBC Glucose Troponin MRA Head Mag
- Aktuelle Erkrankungen
- Nasal congestion, runny nose, watery eyes, sneezing Results from cancer treatment.
- Vorgeschichte
- Enlarged prostate with lower urinary tract symptoms (Chronic) N40.1 10/19/2010-Present Malignant neoplasm of nasopharynx (Chronic) C11.9 2/19/2004-Present Stricture and stenosis of esophagus (Chronic) K22.2 10/19/2010-Present Abnormal glucose R73.09 05/27/2014-Present Hyperlipidemia E78.5 11/12/2004-Present Hypothyroidism (Chronic) E03.9 08/03/2004-Present Esophageal dysphagia (Chronic) R13.9 08/30/2017-Present Tracheostomy in place (Chronic) Z93.0 08/30/2017-Present S/P percutaneous endoscopic gastrostomy (PEG) tube placement Z93.1 08/30/2017- Present Malnutrition (Chronic) E46 08/30/2017-Present Chronic obstructive pulmonary disease (Chronic) J44.9 10/11/2017-Present Thrush of mouth and esophagus B37.81, B37.0 06/04/2020-Present
- Andere Medikamente
- Current Medications Directions Kenalog BID Stiolto QD acetaminophen (TYLENOL) 500mg tablet Take 2 tablets by mouth. albuterol 108 (90 Base) MCG/ACT inhaler INHALE 2 PUFFS BY MOUTH EVERY 4 HOURS AS
- Allergien
- Noted Reaction Type Reactions Iodinated Diagnostic Agents 01/13/2015 Allergy Rash Metrizamide 01/13/2015 Allergy Rash Contrast 01/28/2004 Allergy Itching Gadolinium Derivatives 01/19/2004 Allergy Itching Iodine 01/28/2004 Allergy Itching Other 01/28/2004 Allergy Itching, Other (See Comments)
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 75,0
- Geschlecht
- M
- Eingang
- 22.11.2021
- Impfdatum
- 11.10.2021
- Beginn
- 01.10.2021
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Pain
Shoulder injury related to vaccine administration
Symptomtext
shoulder pain that has not improved. worse with movement/ cannot lay down on right arm. MD diagnosed vaccine related shoulder injury
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 72,0
- Geschlecht
- F
- Eingang
- 02.11.2021
- Impfdatum
- 29.09.2021
- Beginn
- 30.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Injection site erythema
Injection site pruritus
Injection site swelling
Injection site urticaria
Symptomtext
Pt had redness, hives, and itchness around site of injection. Hives travelled down to elbow. Pt went to Urgent care, and swelling went down the next day
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 69,0
- Geschlecht
- F
- Eingang
- 12.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- 11.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Circumstance or information capable of leading to medication error
Headache
Malaise
Symptomtext
interested in getting her pneumonia and flu shot yesterday 10/11/21. She stated on the form she had a pneumonia shot in the past but when MCIR checked she has not received a pneumonia vaccine before. She was given PCV 13 and a high dose flu vaccine based on her age. She tolerated well at time of injection and VIS sheets were given. She called today 10/12 at approximately 1330. She stated later yesterday she started to develop a bad headache and was not feeling well. She ended up calling her local ED last evening as she was concerned. She states they instructed her to take otc acetaminophen and use ice. She states she did. She slept and today is feeling much better. I encouraged her to drink fluids and monitor for further symptoms and go to ED symptoms return.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- none at this time
- Aktuelle Erkrankungen
- none mentioned at time of vaccine
- Vorgeschichte
- non mentioned at time of vaccine
- Andere Medikamente
- unknown
- Allergien
- unknown
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 05.10.2021
- Impfdatum
- 29.09.2021
- Beginn
- 29.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Vomiting
Symptomtext
patient developed 104 fever and started vomiting
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.10.2021
- Impfdatum
- 23.09.2021
- Beginn
- 23.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chills
Cough
Pain
Pyrexia
Symptomtext
chills; low grade fever; cough; aches; Initial information regarding an unsolicited valid non-serious case from the Agency (Reference number- 00790611) was received from a consumer and transmitted to Sanofi on 29-Sep-2021. This case involved a 71-year-old female patient who experienced chills, low grade fever (pyrexia), cough and aches (pain) while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ716AA (expiry date not provided) via intramuscular route in the left deltoid. On 23-SEP-2021 the patient developed a non-serious chills, low grade fever (pyrexia), cough and aches (pain) following the administration of vaccine. No relevant laboratory data was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was resolved for the event chills, low grade fever, and pain and was not resolved for the event cough.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 84,0
- Geschlecht
- F
- Eingang
- 30.09.2021
- Impfdatum
- 27.09.2021
- Beginn
- 28.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Nausea
Vision blurred
Symptomtext
blurred vision, nausea
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 67,0
- Geschlecht
- F
- Eingang
- 29.09.2021
- Impfdatum
- 21.09.2021
- Beginn
- 21.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Feeling cold
Pain
Sleep disorder
Symptomtext
Approximately 11 hours post vaccine administration, patient woke middle of the night up with body aches, joint pain & chills. She self treated with Tylenol. Continued with joint pain, chills on 9/22/2021. Was improved on 9/23/2021, back to normal on 9/24/2021.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 71,0
- Geschlecht
- F
- Eingang
- 22.09.2021
- Impfdatum
- 21.09.2021
- Beginn
- 22.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Injection site erythema
Injection site swelling
Symptomtext
PATIENT REPORTED REDNESS, ERYTHEMA, AND SWELLING AT THE INJECTION SITE. IT STARTED ABOUT 12-24 HOURS AFTER VACCINATION .
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 88,0
- Geschlecht
- M
- Eingang
- 29.10.2021
- Impfdatum
- 21.09.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
frozen product was accidently administered with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via a physician under Medical Information Inquiry Number: 00814948. This case is linked to cluster case 2021SA345065. This case involves an 88 years old male patient who was accidently administered a frozen INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] 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 21-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ716AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination. It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen, that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." 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
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 29.09.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
FLUZONE HIGH-DOSE doses were administered from the frozen shipment with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Agency (under the reference 00815032). This case is linked to case 2021SA345065 (same reporter). This case involves a 71 years old male patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from the frozen shipment (product storage error). The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided. Patient had no other vaccines. On 29-Sep-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.7 ml, total, lot UJ716AA and expiration date: 30-Jun-2021) via intramuscular route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to product storage error temperature too low (latency same day). It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." At time of reporting, the outcome was unknown for the reported event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 28.09.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment arrived frozen with no AE; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via Agency (under reference:00815026). This case is linked to case 2021SA345065 (same reporter). This case involves a 76-year-old male patient who was administered doses of possibly frozen INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on accident after a shipment arrived frozen (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 28-Sep-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot UJ716AA, expiry date:30-Jun-2022) via intramuscular route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual case of medication error due to product storage error temperature too low (same day latency) It was reported "Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund. An Office manager reporting that doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. There will be no information available on the lot number for FLUZONE QUADRIVALENT in this case.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 81,0
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 27.09.2021
- Beginn
- 27.09.2021
- 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
possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Global Medical information (GMI under reference number - 00815021). This case is linked to case 2021SA345065(CLUSTER). This case involves 81-years-old female patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error). The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On 27-Sep-2021, the patient received a 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ716AA expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." 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. Event outcome was 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 by the regulatory authority. 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
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 27.09.2021
- Beginn
- 27.09.2021
- 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
possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency under reference number - 00815014). This case is linked to case 2021SA345065(CLUSTER). This case involves 87-years-old male patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error). The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On 27-Sep-2021, the patient received a 0.7ml {total} once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ716AA expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." 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. Event outcome was 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 27.09.2021
- Beginn
- 27.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen with no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non-healthcare professional and physician via Medical Information number: 00815008. This case is linked to case 2021SA345065(CLUSTER). This case involves a 74 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error). The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. On 27-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to Product storage error temperature too low (latency: same day). It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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
- CA
- Alter
- 81,0
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 27.09.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product storage error
Symptomtext
Doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via Medical Information (MI) number: 00814993 '. This case was linked to case 2021SA345065 (CLUSTER). This case involves an 81-year-old female patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] were administered on accident from the frozen shipment (product storage error). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 27-Sep-2021 01:59, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Influenza Quadrival A-B High Dose Hv Vaccine, Strength : high-dose, frequency: once, Dose :0.70 mL , lot UJ716AA, expiry: 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination. On unknown date, dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to product storage error temperature too low (latency same day). It was reported " The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. There will be no information available on the batch number for the FLUZONE QUADRIVALENT.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 24.09.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
FLUZONE HIGH-DOSE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen with no ae; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non-healthcare professional and physician via Regulatory authority number: 00814971. This case is linked to case 2021SA345065(CLUSTER). This case involves a 66 years old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On 24-Sep-2021, the patient received a 0.7 ml of dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to product storage error temperature too low (latency: same day). It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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
- CA
- Alter
- 81,0
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 21.09.2021
- Beginn
- 21.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
FLUZONE HIGH-DOSE dose was administered from the frozen shipment no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00814956) and transmitted to Sanofi on 29-Sep-2021. This case is linked to cases 2021SA344085, 2021SA344225, 2021SA344344, 2021SA344823, 2021SA345076, 2021SA345205, 2021SA345236, 2021SA345293, 2021SA345361, 2021SA345367, 2021SA345483 and 2021SA345780 (same reporter). This case involves an 81-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from the frozen shipment (product storage error). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 21-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ716AA, expiry: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to product storage error temperature too low (latency same day). It was reported "Can you please contact this customer re the stability of Influenza vaccines. Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund. An Office manager reporting that doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." No other 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 by the regulatory authority. 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
- CA
- Alter
- 70,0
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 15.10.2021
- Beginn
- 15.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen with no reported adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via Medical Information (MI) number: 00814937. This case involves a 79 years old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error). The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. On 15-Oct-2021 01:59, the patient received a0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site and a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination respectively. It was case of an actual medication error due to Product storage error temperature too low (latency: same day). It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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
- CA
- Alter
- 93,0
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 15.09.2021
- Beginn
- 15.09.2021
- 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
doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE were administered on accidently with no reported adverse event; Initial information was regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00814928) and transmitted to Sanofi on 29-Sep-2021. This case is linked to case 2021SA345065, 2021SA345205, 2021SA345076, 2021SA344823 and 2021SA344344 (CLUSTER). This case involves a 93-year-old female patient who accidently received frozen dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALEN (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 15-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot UJ716AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error. (latency: same day). It was reported "doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The doses were accidently used before realizing the shipment was frozen". 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
- CA
- Alter
- 70,0
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 15.09.2021
- Beginn
- 15.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
accidently used before realizing the shipment was frozen with no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/Non-healthcare professional via call center via Medical Information (reference number- 00814783). This case is linked to cases 2021SA345065, 2021SA345236, 2021SA345205, 2021SA345076 and 2021SA344344(CLUSTER). This case involves a 70-year-old male patient who accidently received frozen vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error). The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On 15-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ716AA and expiry date: 30-Jun-2022) via an intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to product storage error temperature too low. It was reported "Can you please contact this customer re the stability of Influenza vaccines. Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- DC
- Alter
- 61,0
- Geschlecht
- F
- Eingang
- 10.09.2021
- Impfdatum
- 08.09.2021
- Beginn
- 08.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Symptomtext
Patient got High dose rather than regular dose
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -