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Reporte zur Charge UJ765AC

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

9Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
WI 1 IA 1 MT 1 NJ 1 WV 1 GA 1 PA 1

VAERS 1902462

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge uj765ac

moderat
Staat
WI
Alter
74,0
Geschlecht
F
Eingang
26.11.2021
Impfdatum
16.11.2021
Beginn
19.11.2021
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Atelectasis Blood chloride decreased Blood creatinine normal Blood electrolytes normal Blood glucose normal Chest X-ray abnormal Chest discomfort Chills Computerised tomogram thorax abnormal Decreased appetite Dyspnoea Electrocardiogram ST-T change Fatigue Fibrin D dimer Haemoglobin normal Headache Injection site pain Malaise

Symptomtext

malaise and chills began the day after the vaccine but largely resolved the 2nd day after the vaccine. Beginning on the 3rd day after the vaccine there has been chills, headache, achiness tiredness and left shoulder pain. There has been some shortness of breath with tachycardia and a pleuritic chest discomfort. Appetite has been diminished, legs have been weak.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dyspnoea
Hospital-Tage
3,0
Labordaten
Laboratory included ESR that was 87 on November 23 and 107 on November 26. COVID-19 PCR was negative on November 23. white count was elevated at 10.57 on November 26 with a hemoglobin of 12.9 and platelet count 343. creatinine was 0.63. Her electrolytes were unremarkable except for a modestly low chloride at 94. her glucose was 118. high sensitivity troponin was 10. D-dimer was markedly elevated at 2867. Chest x-ray on November 26 demonstrated small pleural effusions bilaterally with no cardiomegaly or evidence of infiltrate. CT scan with contrast of the chest demonstrated no pulmonary emboli but did show a moderate pericardial fluid and small bilateral pleural effusions with atelectasis. Twelve lead EKG demonstrated sinus tachycardia with only nonspecific ST-T changes and normal voltage.
Aktuelle Erkrankungen
-
Vorgeschichte
hypertension, GERD, hyperlipidemia not treated pharmacologically, polymyalgia rheumatica for which systemic steroids had been discontinued in September 2021
Andere Medikamente
chlorthalidone, metoprolol tartrate, Tylenol, ibuprofen
Allergien
penicillin, sulfamethoxazole
Vorherige Impfungen
-

VAERS 1794993

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge uj765ac

moderat
Staat
-
Alter
79,0
Geschlecht
F
Eingang
18.10.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Dysphagia Paraesthesia oral

Symptomtext

tingling of lips and tongue, had trouble swallowing (no trouble breathing)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Paraesthesia oral
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2028456

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge uj765ac

mild
Staat
IA
Alter
74,0
Geschlecht
F
Eingang
12.01.2022
Impfdatum
02.11.2021
Beginn
02.11.2021
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Pain in extremity

Symptomtext

pt felt right away, came back mid december arm still hurt, pt advised to take ibuprofen regularly for 2 weeks. pt arm still sore as of today 1/12/22. informed pt to contact md

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain in extremity
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1801546

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ765AC

mild
Staat
MT
Alter
75,0
Geschlecht
F
Eingang
20.10.2021
Impfdatum
20.10.2021
Beginn
20.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site pruritus Injection site swelling

Symptomtext

slightly red, slightly raised, itching, 2 cm round area at deltoid left site.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
patient received cold compress and benadryl 50mg in the office. No SOB or facial or throat swelling. Waited 20 minutes before leaving, patient stable upon departure
Aktuelle Erkrankungen
Covid 19 positive, hematoma of leg, had monoclonal AB infusion for COVID
Vorgeschichte
CAD, fibromyalgia, obesity, hyperlipidemia, HTN, depression atrial fib, leukopenia
Andere Medikamente
eliquis, wellbutrin xl, clopidogrel, lasix, losartan, metoprolol succinate er, crestor, aldactone
Allergien
seasonal allergies
Vorherige Impfungen
-

VAERS 2597257

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ765AC

gering
Staat
NJ
Alter
55,0
Geschlecht
F
Eingang
14.03.2023
Impfdatum
29.11.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Unevaluable event

Symptomtext

Non noted at the time. Pt told this nurse that her age was 65 years old at the time of vaccination.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Unevaluable event
Hospital-Tage
-
Labordaten
non
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2588130

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ765AC

gering
Staat
WV
Alter
68,0
Geschlecht
F
Eingang
28.02.2023
Impfdatum
22.02.2023
Beginn
22.02.2023
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

Symptomtext

Expired fluzone high-dose quadrivalent, was administered to a patient with no reported adverse event; Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 68 years old female patient who was administered with expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Feb-2023, the patient received total, 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ765AC and expiry 30-Jun-22) (expired product administered) (strength: unknown) via intramuscular route in deltoid (UNKNOWN IF RIGHT OR LEFT) for prophylactic vaccination. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. At time of reporting, the outcome was Unknown for the event expired fluzone high-dose quadrivalent, was administered to a patient with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1876108

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) · Charge UJ765AC

gering
Staat
-
Alter
-
Geschlecht
U
Eingang
17.11.2021
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
Device connection issue No adverse event Occupational exposure to product Syringe issue

Symptomtext

had gone to administer the shot the needle disconnects and product splashed on the nurse with no adverse event reported; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency (under reference: 00821026). This case is linked to case 2021SA351020. This case involves adult patient (unknown gender) who had gone to administer the shot when the needle disconnects and product splashed on the nurse while giving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ765AC, expiry date: 30-Jun-2022) (occupational exposure to product). A Product Technical Complaint (PTC) details: Global PTC number: 100168466 Main Investigation ID: 200176567 lot number: UJ765AC Expiry date: 30-Jun-2022 Sample status: Requested & Awaited Requested Start Date: 21-Oct-2021 Issue status: In Process End date: not applicable Conclusion: A complaint for 372- FLUZONE HIGH DOSE vaccine, batch UJ765AC was reported and the complaint stated that Doctor calling in a PTC for FLUZONE HD PFS. Caller states that the hub on the end of the syringe is loose (like it's stripped) and needle will not properly attach. When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere. Product splashed on the nurse and the patient. It was a case of occupational exposure to product [Latency: on the same day]. It was reportedthat the hub on the end of the syringe is loose (like it's stripped) and needle will not properly attach. Product splashed on the nurse and the patient. Number of units affected: 17 PFS affected so Far. Information to be gathered on the type of needle that was used by the end-user: 25G Mckesson 1.5' same brand and size has been used for prior administration with no issue. At time of reporting, no adverse event reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Device connection issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1831423

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ765AC

gering
Staat
GA
Alter
-
Geschlecht
F
Eingang
30.10.2021
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
Device connection issue Exposure via skin contact No adverse event Occupational exposure to product Syringe issue Underdose

Symptomtext

states that the hub on the end of the syringe is loose (like its stripped) with no AE; Product splashed on the nurse and the patient with no AE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patientwith noAE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere with noAE; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a physician. This case involves a 48-year-old female patient for whom it was reported "when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere (Device leakage) states that the hub on the end of the syringe is loose (like its stripped) (syringe issue), product splashed on the nurse and the patient (Occupational exposure to product) and when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patient Underdose)" while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient past medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On 15-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ765AC and expiry date:30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to device leakage, syringe issue, underdose and occupational exposure to product [Latency: on the same day]. It was reported "product leaking from the tip of the syringe". At time of reporting, the outcome was unknown for the events. At the time of report, no adverse event was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Device connection issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1828069

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ765AC

gering
Staat
PA
Alter
82,0
Geschlecht
M
Eingang
29.10.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Syringe issue Underdose

Symptomtext

the medication leaks out and one time the needle just came off, with no AE; nurse went to inject the patient and the vaccine leaked down his arm, with no AE reported; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00824901). This case involves a 82-year-old male patient who was vaccinated with suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] experienced needle was loose under the luer lok adaptor and some of the vaccine leaked out (underdose and syringe issue). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 19-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ765AC and expiry date: 30-Jun-2022) (Frequency = once) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to vaccine underdose and syringe issue. (latency on same day). It was reported "when she attached the needle to the FLUZONE HIGH DOSE QUADRIVALENT vaccine the needle was loose under the luer lok adaptor and no matter how hard she tries to tighten it, it will not tighten and just continues to turn without locking. When a nurse preps the dose and or attempts to inject the dose, the medication leaks out and one time the needle just came off." At time of reporting, no adverse event was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syringe issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-