VAERS Reports UJ500AA

VAERS 928939

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge uj500aa

mild

Staat: NJ
Alter: 80,0
Geschlecht: M
Eingang: 07.01.2021
Impfdatum: 28.09.2020
Beginn: 29.09.2020
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Pain Pain in extremity

Symptomtext

Patient complains of right arm pain beginning the next morning following the vaccines. He was seen by his primary care physician and told to rest and use nsaids. Patient is now due for his second dose of Shingrix but is still having arm pain especially when the muscle is strenuously used.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pain
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1828946

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: OH
Alter: 89,0
Geschlecht: F
Eingang: 29.10.2021
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: nein

No adverse event

Symptomtext

No adverse reactions noted

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: See Item 12
Vorgeschichte: F03.90 Unspecified dementia without behavioral disturbance (Primary / Admission) I71.4 Abdominal aortic aneurysm, without rupture I48.91 Unspecified atrial fibrillation D64.9 Anemia, unspecified E03.9 Hypothyroidism, unspecified E44.1 Mild protein-calorie malnutrition F32.9 Major depressive disorder, single episode, unspecified E53.9 Vitamin B deficiency, unspecified E55.9 Vitamin D deficiency, unspecified M54.2 Cervicalgia S00.83XD Contusion of other part of head, subsequent encounter S70.02XD Contusion of left hip, subsequent encounter R42 Dizziness and giddiness K21.9 Gastro-esophageal reflux disease without esophagitis G47.00 Insomnia, unspecified K59.00 Constipation, unspecified M62.81 Muscle weakness (generalized) R39.14 Feeling of incomplete bladder emptying R41.0 Disorientation, unspecified R44.3 Hallucinations, unspecified R29.6 Repeated falls Z79.01 Long term (current) use of anticoagulants J84.9 Interstitial pulmonary disease, unspecified N20.0 Calculus of kidney N13.2 Hydronephrosis with renal and ureteral calculous obstruction E46 Unspecified protein-calorie malnutrition R26.2 Difficulty in walking, not elsewhere classified
Andere Medikamente: acetaminophen 500 mg tablet Every 6 Hours - PRN 1000mg, oral, Every 6 Hours - PRN, PRN Pain 10/20/2021 amiodarone 100 mg tablet Once A Day 100 mg, oral, Once A Day 09/25/2021 10/29/2021 10:13 AM ascorbic acid (vitamin C) 500 mg tablet
Allergien: hydrocodone-acetaminophen, oxycodone
Vorherige Impfungen: -

VAERS 1828927

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: OH
Alter: 85,0
Geschlecht: F
Eingang: 29.10.2021
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: nein

No adverse event

Symptomtext

No adverse reactions noted

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: See Item 12
Vorgeschichte: N39.0 Urinary tract infection, site not specified (Primary / Admission) N17.9 Acute kidney failure, unspecified I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I50.9 Heart failure, unspecified Note: CHF N18.30 Chronic kidney disease, stage 3 unspecified I48.91 Unspecified atrial fibrillation E44.1 Mild protein-calorie malnutrition M06.9 Rheumatoid arthritis, unspecified M35.3 Polymyalgia rheumatica E03.9 Hypothyroidism, unspecified E78.00 Pure hypercholesterolemia, unspecified F32.9 Major depressive disorder, single episode, unspecified F41.9 Anxiety disorder, unspecified K21.9 Gastro-esophageal reflux disease without esophagitis G47.00 Insomnia, unspecified M81.0 Age-related osteoporosis without current pathological fracture R26.2 Difficulty in walking, not elsewhere classified M19.90 Unspecified osteoarthritis, unspecified site M62.81 Muscle weakness (generalized) W19.XXXD Unspecified fall, subsequent encounter Z79.01 Long term (current) use of anticoagulants K51.90 Ulcerative colitis, unspecified, without complications
Andere Medikamente: acetaminophen 500 mg tablet Every 6 Hours - PRN 1000mg, oral, Every 6 Hours - PRN, Dx: Pain 09/27/2021 10/29/2021 09:21 AM alprazolam 0.25 mg tablet At Bedtime 0.25mg, oral, At Bedtime 09/27/2021 10/28/2021 08:12 PM aspirin 81 mg tablet
Allergien: Altace, Asacol HD, Augmentin, cefprozil, ciprofloxacin, Demerol, Dipentum, doxycycline hyclate, Enablex, Furadantin, ibuprofen, Lodine, Neurontin, nitrofurantoin, sulfamethoxazole-trimethoprim, Sulfonamides (Sulfa), vancomycin, Vibramycin
Vorherige Impfungen: -

VAERS 1828912

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: OH
Alter: 84,0
Geschlecht: F
Eingang: 29.10.2021
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

No adverse event

Symptomtext

No adverse reactions noted

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: See Item 12
Vorgeschichte: S42.001D Fracture of unspecified part of right clavicle, subsequent encounter for fracture with routine healing (Primary / Admission) S42.211D Unspecified displaced fracture of surgical neck of right humerus, subsequent encounter for fracture with routine healing S09.90XD Unspecified injury of head, subsequent encounter I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris N17.9 Acute kidney failure, unspecified G30.9 Alzheimer's disease, unspecified F03.90 Unspecified dementia without behavioral disturbance E55.9 Vitamin D deficiency, unspecified R63.8 Other symptoms and signs concerning food and fluid intake S00.03XD Contusion of scalp, subsequent encounter S05.11XD Contusion of eyeball and orbital tissues, right eye, subsequent encounter I10 Essential (primary) hypertension R13.10 Dysphagia, unspecified K21.9 Gastro-esophageal reflux disease without esophagitis J32.9 Chronic sinusitis, unspecified J30.9 Allergic rhinitis, unspecified R09.82 Postnasal drip R11.0 Nausea R32 Unspecified urinary incontinence R42 Dizziness and giddiness R19.7 Diarrhea, unspecified M62.81 Muscle weakness (generalized) K59.00 Constipation, unspecified Z91.81 History of falling R26.2 Difficulty in walking, not elsewhere classified S42.211A Unspecified displaced fracture of surgical neck of right humerus, initial encounter for closed fracture E78.5 Hyperlipidemia, unspecified
Andere Medikamente: acetaminophen 650 mg tablet extended release Every 8 Hours - PRN 2 tablets, oral, Every 8 Hours - PRN, PRN pain 05/30/2021 10/15/2021 07:45 PM amlodipine 10 mg tablet Once A Day 10 mg, oral, Once A Day 09/27/2021 10/29/2021 07:40 AM asp
Allergien: NKA
Vorherige Impfungen: -

VAERS 1828898

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: OH
Alter: 71,0
Geschlecht: F
Eingang: 29.10.2021
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

No adverse event

Symptomtext

No adverse reactions noted

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: See Item 12
Vorgeschichte: Fracture of unspecified part of neck of left femur, subsequent encounter for closed fracture with routine healing (Primary / Admission); Systemic lupus erythematosus, unspecified; Gout, unspecified; Unilateral primary osteoarthritis, left knee; Chronic obstructive pulmonary disease, unspecified; Respiratory failure, unspecified with hypoxia; Hypertensive heart disease with heart failure; Heart failure, unspecified; Paroxysmal atrial fibrillation; Pulmonary hypertension, unspecified; Type 2 diabetes mellitus without complications; Atherosclerotic heart disease of native coronary artery without angina pectoris; Morbid (severe) obesity due to excess calories; Hypotension, unspecified; Hypo-osmolality and hyponatremia; Vitamin B deficiency, unspecified; Vitamin D deficiency, unspecified; Sleep apnea, unspecified; Vitamin deficiency, unspecified; Acidosis; Unspecified open wound, left lower leg, subsequent encounter; Insomnia, unspecified; Ulcerative colitis, unspecified, without complications; Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation; Cyclical vomiting syndrome unrelated to migraine; Hypoxemia; Obstructive sleep apnea (adult) (pediatric); Pain in throat; Cough; Constipation, unspecified; Dry eye syndrome of unspecified lacrimal gland; Unspecified glaucoma; Edema, unspecified; Other disorders of electrolyte and fluid balance, not elsewhere classified; Weakness; History of falling; Personal history of Methicillin resistant Staphylococcus aureus infection; Major depressive disorder, single episode, unspecified; Hereditary and idiopathic neuropathy, unspecified
Andere Medikamente: acetaminophen 500 mg tablet; acetazolamide 250 mg; amitriptyline 50 mg; ascorbic acid (vitamin C) 1,000 mg tablet; Aspirin Low Dose (aspirin) 81 mg; atorvastatin 20 mg tablet bumetanide 1 mg tablet; bumetanide 2 mg; Cepacol Sore Throat (be
Allergien: NKA
Vorherige Impfungen: -

VAERS 1828867

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: OH
Alter: 93,0
Geschlecht: F
Eingang: 29.10.2021
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

No adverse event

Symptomtext

No adverse reaction noted

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Covid-19 positive within the last 30 days
Vorgeschichte: 2019-nCoV acute respiratory disease (Primary / Admission); Other intervertebral disc degeneration, lumbar region; Unilateral primary osteoarthritis, right hip; Other symptoms and signs involving the musculoskeletal system; Other low back pain; Major depressive disorder, single episode, unspecified; Hypothyroidism, unspecified; Anxiety disorder; Hypokalemia; Cardiac murmur, unspecified; Scoliosis, unspecified; Chronic atticoantral suppurative otitis media, unspecified ear; Other specified disorders of bone density and structure, unspecified site; Dysphagia, oropharyngeal phase; Essential (primary) hypertension; Insomnia, unspecified; Unspecified glaucoma; Other chronic pain; Unspecified osteoarthritis, unspecified site; Age-related osteoporosis without current pathological fracture; Otitis media, unspecified, bilateral; Dizziness and giddiness; Weakness; Dysuria; Pain in right hip; Constipation, unspecified; Muscle weakness (generalized); Difficulty in walking, not elsewhere classified; Trochanteric bursitis, right hip; Contact with and (suspected) exposure to other viral communicable diseases
Andere Medikamente: acetaminophen 325 mg tablet; Alphagan P (brimonidine) 0.1 % drops; amlodipine 5 mg; aspirin 81 mg; diphenoxylate-atropine 2.5-0.025 mg tablet; dorzolamide-timolol 22.3-6.8 mg/mL drops; duloxetine 30 mg; hydralazine 10 mg; hydrocodone-acetam
Allergien: NKA
Vorherige Impfungen: -

VAERS 1774858

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: CO
Alter: -
Geschlecht: U
Eingang: 09.10.2021
Impfdatum: 30.09.2021
Beginn: 30.09.2021
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 No adverse event

Symptomtext

unopened prefilled syringes of FLUZONE HIGH-DOSE QUADRIVALENT from last year which expired on 30-JUN-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-SEP-2021 with no reported adverse event; Initial information was regarding an unsolicited valid serious case was received from a consumer/non-health care professional via regulatory authority (Reference number- 00794818) and transmitted to Sanofi on 01-Oct-2021. This case involves an unknown demographic patient (unknown age and unknown gender) who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] unopened prefilled syringes from last year which expired on 30-Jun-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-Sep-2021 (expired product administered). Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 30-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ500AA, expiry date-30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired product administered (latency: same day). It was reported "box containing unopened prefilled syringes of FLUZONE HIGH-DOSE QUADRIVALENT from last year which expired on 30-Jun-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-Sep-2021". At 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1017026

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ500AA

gering

Staat: VA
Alter: 72,0
Geschlecht: F
Eingang: 09.02.2021
Impfdatum: 06.02.2021
Beginn: 08.02.2021
Tage bis Beginn: 2,0
Dosis: N/A
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Peripheral swelling Ultrasound Doppler

Symptomtext

Vaccine administered in left deltoid by RN. Swollen left arm noticed by RN on 2/8/2021 in AM (~0800). Patient did not notice swelling or complain of ADR.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Peripheral swelling
Hospital-Tage: -
Labordaten: Venous duplex ordered 2/8 which was negative for DVT.
Aktuelle Erkrankungen: Failure to thrive, Malnutrition, Anorexia with nausea/vomiting, Abdominal Pain.
Vorgeschichte: Depression
Andere Medikamente: Citalopram, Enoxaparin, Famotidine, Lisinopril, Pantoprazole, Sucralfate (routine) PRN meds include APAP, Maalox, Zofran, and Trazodone.
Allergien: No Known Drug Allergies (NKDA)
Vorherige Impfungen: -