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Reporte zur Charge UJ943AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

11Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
GA 2 LA 1 NC 1 MI 1 TN 1 OH 1 AL 1 FL 1 KY 1

VAERS 2112599

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ943AA

schwer
Staat
LA
Alter
50,0
Geschlecht
F
Eingang
13.01.2023
Impfdatum
10.01.2022
Beginn
10.01.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Arthritis Asthenia Chest X-ray Chest pain Electrocardiogram Lymphoedema Malaise Pyrexia Swelling Guillain-Barre syndrome Hypoaesthesia Joint stiffness Limb discomfort Magnetic resonance imaging Muscle tightness Muscle twitching Neck pain Neurological symptom

Symptomtext

Serious guillian barr? syndrome; Twiching feet, top of feet; Numbness in hands and feet; Vertigo; Joint stiffness; Heart pounding; Vision is blurry; Neurologic symptom; Face, arm and leg tightness; Arthritic symptoms in hands and feet; Chest pain; tightness in throat; lymphedema; neck and glands swelling; Felt like something was in the back of throat; Neck pain; Tongue swelling; malaise; fever, 102 F; weakness; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE SANOFI) (batch number UJ943AA, expiry date unknown) for prophylaxis. On 10th January 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, the patient received FLUZONE SANOFI (intramuscular) .5 ml. On 10th January 2022, less than a day after receiving Shingrix, the patient experienced malaise, fever, weakness, throat tightness, lymphedema, neck swelling, oropharyngeal discomfort, neck pain and swollen tongue. On 7th November 2022, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), twitching of limbs, numbness of extremities, vertigo, stiff joint, heart pounding, blurred vision, neurological symptom, muscle tightness, arthritis and chest pain. On an unknown date, the outcome of the guillain barre syndrome, weakness, throat tightness, lymphedema, neck swelling, twitching of limbs, numbness of extremities, vertigo, stiff joint, heart pounding, blurred vision, neurological symptom, muscle tightness, arthritis and chest pain were not recovered/not resolved and the outcome of the malaise, fever, oropharyngeal discomfort, neck pain and swollen tongue were recovered/resolved. The reporter considered the guillain barre syndrome, malaise, fever, weakness, throat tightness, lymphedema, neck swelling, oropharyngeal discomfort, neck pain, swollen tongue, twitching of limbs, numbness of extremities, vertigo, stiff joint, heart pounding, blurred vision, neurological symptom, muscle tightness, arthritis and chest pain to be related to Shingrix. Additional Information: GSK Receipt Date: 10-Feb-2022. Reporter's Comments: The patient received a dose of Shingrix and experienced fever, malaise, weakness for 3 to 4 days, tightness in throat, lymphedema, and neck swelling. Consent to follow up was granted. Follow-up information received on 6-Jan-2023. Reporter's Comments: On 4th November 2022, 3 days after receiving FLUZONE SANOFI, the patient experienced Guillan barre syndrome, neurologic symptom neurological symptom, twitching joint stiffness, heart pounding palpitations, vision in right eye was blurry face, arm and leg tightness arthritis symptoms in hands and feet, chest pain On 10th January 2022, the patient received an unknown dose of suspect Shingrix not produced by Sanofi Pasteur lot number not reported in an unknown administration site for immunization. On 10th Jan 2022 the patient developed a non-serious event 102 F fever neck and throat symptoms and stated it felt like something was back of her throat(oropharyngeal discomfort) neck and gland may have been swollen (neck pain) tongue swelling same day following the administration of Shingrix. The patient saw physician on 13th Jan 2022 symptoms finally went away several months later. On 04th November 2022, the patient received a suspect Influenza quadrival A B vaccine Dose 0.5 ml strength standard batch number UJ943AA via intramuscular route in the left arm. On 07th November 2022 the patient developed a serious event Guillainn barre syndrome Guillain-Barre syndrome e Latency- 3 day On 07th November 2022 the patient developed a non-serious events other neurologic symptom neurological symptom, twitching joint stiffness, heart pounding palpitations, vision in right eye was blurry face, arm and leg tightness arthritis symptoms in hands and feet, chest pain following the administration of Influenza quadrival A B vaccine. The reporter stated that relevant laboratory test results included chest X-ray. On an unknown date physician on 14th Nov 2022,Ear, Eye and Throat physician has had magnetic resonance imaging, eye examination, electrocardiogram ophthalmological examination. An Ear, eye and throat physician PCP had an MRI,eye exam, chest x ray,EKG, no medication and was received corrective treatment for the events. At the time of reporting the outcome was recovered and resolved in 2022 for pyrexia oropharyngeal discomfort, neck pain and swollen tongue and not recovered and not resolved for all other events. Summary of Changes: The lab details, suspect details, event details and narrative were updated.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Guillain-Barre syndrome
Hospital-Tage
-
Labordaten
Test Date: 20220110; Test Name: Body tempreture; Result Unstructured Data: (Test Result:102,Unit:degree F,Normal Low:,Normal High:); Test Name: chest x ray; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20221114; Test Name: Electrocardiogram; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20221114; Test Name: MRI; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20221114; Test Name: eye exam; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:)
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2528288

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

schwer
Staat
-
Alter
51,0
Geschlecht
F
Eingang
10.12.2022
Impfdatum
04.11.2022
Beginn
07.11.2022
Tage bis Beginn
3,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Arthritis Chest X-ray Chest pain Electrocardiogram Guillain-Barre syndrome Hypoaesthesia Joint stiffness Magnetic resonance imaging Muscle tightness Muscle twitching Neurological symptom Palpitations Vertigo Vision blurred

Symptomtext

guillain barr? syndrome; other neurologic symptoms; twitching in feet top of feet; numbness in hands and feet; vertigo; joint stiffness; heart pounding; vision in right eye is blurry; face, arm and leg tightness; arthritic symptoms in hands and feet; chest pain; Initial information received on 06-Dec-2022 regarding an unsolicited valid serious case received from a patient and Non health care professional. This case involves a 51 years old female patient who experienced guillain barr? syndrome, other neurologic symptoms, twitching in feet top of feet, numbness in hands and feet, vertigo, joint stiffness, heart pounding, vision in right eye is blurry, face, arm and leg tightness, arthritic symptoms in hands and feet and chest pain after receiving vaccine Influenza quadrival a-b vaccine [fluzone qiv]. The patient's past vaccination(s) included Shingrix in Jan-2022. The patient's past medical history, medical treatment(s) and family history were not provided. On 04-Nov-2022, the patient received a suspect Influenza quadrival a-b vaccine(Dose- 0.5mL)(Frequency- Once)( Strength = standard )(Formulation- Suspension for injection) (Batch/lot number-UJ943AA) via intramuscular route in the left arm.(expiry date: not reported) for Immunization On 07-Nov-2022 the patient developed a serious event guillain barr? syndrome (guillain-barre syndrome)(Latency- 3 days)following the administration of Influenza quadrival a-b vaccine. On 07-Nov-2022 the patient developed a non-serious events other neurologic symptom (neurological symptom), twitching in feet top of feet (muscle twitching), numbness in hands and feet (hypoaesthesia), vertigo, joint stiffness, heart pounding (palpitations), vision in right eye is blurry (vision blurred), face, arm and leg tightness (muscle tightness), arthritic symptoms in hands and feet (arthritis) chest pain, following the administration of Influenza quadrival a-b vaccine.(Latency -3 Days) Relevant laboratory test results included: Chest X-ray - On an unknown date: [Saw doctors on 14NOV2022.( Ear, Eye and Throat doctor and PCP) has had an MRI, eye exam, chest x-ray, EKG],Electrocardiogram ,Magnetic resonance imaging, Ophthalmological examination. Action taken: Not applicable. An Ear, Eye and Throat doctor and PCP) has had an MRI, eye exam, chest x-ray, EKG, no medications. Was received as corrective treatment for the events At time of reporting, the outcome was Not Recovered / Not Resolved for all events Seriousness Criteria: Medically Significant for event guillain barr? syndrome.; Sender's Comments: Sanofi Company Comment dated 06-Dec-2022 : This case involves a 51 years old female patient who experienced guillain barr? syndrome, other neurologic symptoms, twitching in feet top of feet, numbness in hands and feet, vertigo, joint stiffness, heart pounding, vision in right eye is blurry, face, arm and leg tightness, arthritic symptoms in hands and feet and chest pain after receiving vaccine Influenza quadrival a-b vaccine [fluzone qiv].Based upon the reported information, the role of a vaccine cannot be assessed. However, lack of information of past and concomitant medication,any family history ,any concurrent conditions precludes comprehensive case assessment

Weitere VAERSDATA-Felder
Praegender Schweregrund
Guillain-Barre syndrome
Hospital-Tage
-
Labordaten
Test Name: chest x-ray; Result Unstructured Data: Saw doctors on 14NOV2022.( Ear, Eye and Throat doctor and PCP) has had an MRI, eye exam, chest x-ray, EKG; Test Name: EKG; Result Unstructured Data: Saw doctors on 14NOV2022.( Ear, Eye and Throat doctor and PCP) has had an MRI, eye exam, chest x-ray, EKG; Test Name: MRI; Result Unstructured Data: Saw doctors on 14NOV2022.( Ear, Eye and Throat doctor and PCP) has had an MRI, eye exam, chest x-ray, EKG; Test Name: Eye exam; Result Unstructured Data: Saw doctors on 14NOV2022.( Ear, Eye and Throat doctor and PCP) has had an MRI, eye exam, chest x-ray, EKG
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2504180

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

schwer
Staat
NC
Alter
17,0
Geschlecht
F
Eingang
10.11.2022
Impfdatum
06.11.2022
Beginn
06.11.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Syncope Unresponsive to stimuli

Symptomtext

Systemic: Fainting / Unresponsive-Mild

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

VAERS 2555756

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

moderat
Staat
MI
Alter
36,0
Geschlecht
F
Eingang
10.01.2023
Impfdatum
03.01.2023
Beginn
03.01.2023
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 pain Neuralgia Pain Paraesthesia Product administered at inappropriate site

Symptomtext

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient claims immunizations were given too high in left arm and is experiencing tingling/nerve pain. Patient is employee at a different store than given at. Advised patient to work with PM/SM and HR for a doctor visit. Rph told patient shots given to high, was not verified where given.

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

VAERS 2515927

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge uj943aa

moderat
Staat
TN
Alter
47,0
Geschlecht
F
Eingang
24.11.2022
Impfdatum
28.10.2022
Beginn
29.10.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / AR
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injected limb mobility decreased Injection site nodule Injection site pain Injection site swelling Loss of personal independence in daily activities

Symptomtext

Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient started experience a sore arm day after the injection. Says this has progressivly got worse each day and there is a nodule at the injection site. States that she is not able to use her arm for normal activity due to pain.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injected limb mobility decreased
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2502584

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

moderat
Staat
OH
Alter
29,0
Geschlecht
F
Eingang
08.11.2022
Impfdatum
07.11.2022
Beginn
07.11.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Abdominal pain Chills Dizziness Headache Hypoaesthesia Muscle spasms Nausea Tremor

Symptomtext

Onset of chills transitioned to full body tremors; after lying flat body went numb from neck down to lower legs, muscle cramps in thighs and hands (index finger and thumb constricted, unable to straighten) during tremors. Abdominal cramps also occurred at this time. Shaking subsided after blankets and heating pad applied. Numbness eventually subsided leaving entire body woosy with nausea, headache, and lightheadedness/dizziness. Event lasted from 9:30 PM - 12:30 AM.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Tremor
Hospital-Tage
-
Labordaten
N/a
Aktuelle Erkrankungen
N/a
Vorgeschichte
Hypothyroidism
Andere Medikamente
Levothyroxine, prenatal vitamin, lecithin, probiotic, vitamin D3
Allergien
Sulfa drugs
Vorherige Impfungen
Breast lump/swelling; 28, April 2022, Pfizer booster

VAERS 2505808

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge uj943aa

mild
Staat
AL
Alter
44,0
Geschlecht
M
Eingang
11.11.2022
Impfdatum
07.11.2022
Beginn
07.11.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site pain Injection site swelling Wrong technique in product usage process

Symptomtext

Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: tech stuck patient 3 times to give shot

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2495138

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

mild
Staat
FL
Alter
51,0
Geschlecht
F
Eingang
01.11.2022
Impfdatum
29.10.2022
Beginn
29.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Asthenia Hypoaesthesia Injection site pain

Symptomtext

Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: entire left arm and hand. It was clear to me the shot was administered much too low on the arm and likely hit radial nerve.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2558698

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

gering
Staat
KY
Alter
33,0
Geschlecht
M
Eingang
12.01.2023
Impfdatum
12.01.2023
Beginn
12.01.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Cold sweat Pallor Posture abnormal Unresponsive to stimuli

Symptomtext

PATIENT SLUMPED IN CHAIR, DID NOT RESPOND, BEGAN SHAKING, TURNED PALE AND CLAMMY. EMERGENCY SERVICES CALLED. PATIENT BECAME RESPONSIVE TO QUESTIONS AFTER ABOUT 1 MINUTES. HE DID NOT WANT TO LIE DOWN AND CONSCIOUSNESS WAS NOT LOST. HE REMAINED SEATED AND COLOR RETURNED TO FACE AFTER A FEW MINUTES.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Cold sweat
Hospital-Tage
-
Labordaten
NO TESTS OR LAB RESULTS OBTAINED
Aktuelle Erkrankungen
NONE DISCLOSED
Vorgeschichte
NONE DISCLOSED
Andere Medikamente
NONE DISCLOSED
Allergien
NONE DISCLOSED
Vorherige Impfungen
PATIENT STATED THIS HAS "HAPPENED BEFORE" BUT NO INFORMATION GIVEN ON DATES OR TYPE OF VACCINE. ON HIS FORM HE INDICATED THAT "N

VAERS 2506466

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

gering
Staat
GA
Alter
5,0
Geschlecht
F
Eingang
11.11.2022
Impfdatum
11.11.2022
Beginn
11.11.2022
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

Symptomtext

No adverse events reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
n/a
Vorherige Impfungen
-

VAERS 2501365

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ943AA

gering
Staat
GA
Alter
11,0
Geschlecht
M
Eingang
08.11.2022
Impfdatum
27.10.2022
Beginn
27.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental exposure to product No adverse event Syringe issue

Symptomtext

started to administer the product but fluid leaked onto her gloves and skin with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 11-year-old male patient to whom when started to administer the product INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] but fluid leaked onto her gloves and skin with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Oct-2022, to the patient when started to administer suspect INFLUENZA QUADRIVAL A-B VACCINE at dose of 0.25 ml total (strength: standard; formulation: unknown) (lot number: UJ943AA and expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for Immunization, but fluid leaked onto her gloves and skin with no reported adverse event (accidental exposure to product) (latency: same day). It was reported, that during the administration of the vaccine and got a lot of spill. Pharmacist was not sure how much of the vaccine the patient got. She would like to know do they need to re-dose the patient or leave it as is? Pharmacist reported that FLUZONE QUADRIVALENT PREFILLED SYRINGE, was used and after removing the air, the caller started to administer the product but there was significant leakage on the sides and bottom of the syringe. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable. At time of reporting, the 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
Accidental exposure to product
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-