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Reporte zur Charge U6968AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

13Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
2Bleibende Schaeden
CA 3 AZ 2 NV 2 SC 1 MO 1 IA 1 OH 1

VAERS 2699319

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge U6968AA

schwer
Staat
AZ
Alter
74,0
Geschlecht
M
Eingang
14.12.2023
Impfdatum
18.10.2023
Beginn
19.10.2023
Tage bis Beginn
1,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: ja ER: ja Erholt: nein
Asthenia Fall Guillain-Barre syndrome Intensive care Loss of personal independence in daily activities Dysstasia Gait disturbance Middle insomnia Walking aid user Wheelchair user

Symptomtext

Guillain Barre - Onset of 10./19. Patient woke at 2:30 am and felt weak returned to bed awakened again at 5:30 am and was very weak, fell to the ground. Called EMS went to hospital was admitted to ICU was diagnosed with Guillain Barre. Patient is home now and receiving home health, home PT and OT. Patient is in wheelchair and using walker. Prior to this patient was independent and did not use a walker or wheelchair.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Guillain-Barre syndrome
Hospital-Tage
15,0
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
Hypertension hypothyroid type II diabetes obesity
Andere Medikamente
Multivitamin Fish Oil 1200 mg Calcium +_ vitamin D3 600-800 mg Aspirin 81 mg Nifedipine ER 60 mg Metoprolol Tartrate 100 mg twice daily Valsartan-hydrochlorathiazide 320-12.5 levothyroxine 50 mcg rosuvastatin calcium 10 mg
Allergien
none
Vorherige Impfungen
-

VAERS 1872797

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6968AA

schwer
Staat
SC
Alter
11,0
Geschlecht
M
Eingang
16.11.2021
Impfdatum
11.11.2021
Beginn
11.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Computerised tomogram head normal Dyskinesia Electrocardiogram normal Fall Head injury Headache Pallor Syncope Vision blurred Visual impairment Vomiting

Symptomtext

Pt. had received his vaccines, and at check out, pt. fainted. He hit his right parietal/occipital area on the linoleum floor from a standing position. The nurses reported some jerky motions briefly after the head injury. He was assessed immediately afterwards by myself and looked pale in color and was conscious. There was no signs of external injury of his scalp. Patient was allow to lay in the recumbent position for a few minutes. He was sat up and given water and Sprite to drink. I reassessed him three times afterwards. The second time he had complained of red spots in his vision to the nurses which had resolved on my assessment. He had some blurriness of vision. The third time he complained of a HA and was given ibuprofen 300 mg. The blurriness of vision had resolved. Prior to discharge, pt. was conversant. His was discharged home with his mother to observe him for the next 24 hours. Mother reported several episodes of vomiting after leaving office. Advised to proceed to the local Emergency Room. Arrived there at 1232pm for evaluation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syncope
Hospital-Tage
-
Labordaten
CT of Head and EKG preformed at ER due to head injury. CT was negative and EKG read as normal.
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1519036

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6968AA

schwer
Staat
NV
Alter
12,0
Geschlecht
F
Eingang
01.08.2021
Impfdatum
01.08.2021
Beginn
01.08.2021
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

Symptomtext

Patient fainted after receiving the vaccination. She started to lean forward in her seat. I caught her before she fell. She recovered in under 20 seconds. The mother refused further medical attention but agreed to be monitored for 20 minutes after. The patient drank some water and felt better afterward. After the observation period no further issues or adverse event was noted and the patient decided to go home.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syncope
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1510735

SANOFI PASTEUR · TDAP (ADACEL) · Charge u6968aa

schwer
Staat
NV
Alter
11,0
Geschlecht
F
Eingang
28.07.2021
Impfdatum
28.07.2021
Beginn
28.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Hyperhidrosis Mydriasis Skin discolouration Syncope

Symptomtext

Patient started to faint, pupils looked dilated and she was sweating and her palms appeared blue. I administered benadryl in case she was having an allergic reaction. Patient was breathing, had a pulse and we sat her down and she started to wake up. Her oxygen and blood pressure were normal and she had normal color after 15 minutes. We iced the back of her neck and she started feeling better. She was able to drink water, and eventually had a pretzel with salt. She walked around the store a little and then was fine and left. Probably 30 minutes total

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syncope
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2476610

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6968AA

mild
Staat
CA
Alter
11,0
Geschlecht
M
Eingang
12.10.2022
Impfdatum
20.09.2021
Beginn
21.09.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: ja ER: unbekannt Erholt: nein
Asthenia Back pain Bone scan normal C-reactive protein normal Enterovirus test positive Fatigue Full blood count normal Headache Human rhinovirus test positive Inflammatory marker test Magnetic resonance imaging spinal normal Malaise Pain in extremity Pyrexia Red blood cell sedimentation rate normal

Symptomtext

Following well child visit and vaccinations 9/2021 developed higher fever along with developing profound fatigue, decreased energy, and headache whose only positive test was initially for rhinovirus/enterovirus on 10/5 done in the setting of fevers, who has had since that time a variable/waxing-waning course with most prominent symptoms of fatigue (and some reported post-exertional malaise), ongoing intermittent temperatures/fevers (100s-103s) with many repeated inflammatory lab checks both during and between fevers (ESR/CRP/CBC) which have been normal, and more recently with issues of back pain and shin pain who overall has findings and negative studies suggestive of CFS/ME like illness.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Back pain
Hospital-Tage
-
Labordaten
Normal inflammatory markers, no other positive infectious testing aside from initial 10/5/21 EV/rhino NP swab. Negative back MRI and bone scan.
Aktuelle Erkrankungen
Unclear did have +enterovirus/rhinovirus testing 10/5/21
Vorgeschichte
History of COVID-19 in December 2020
Andere Medikamente
None
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2536309

SANOFI PASTEUR · TDAP (ADACEL) · Charge u6968aa

mild
Staat
-
Alter
50,0
Geschlecht
M
Eingang
19.12.2021
Impfdatum
26.08.2021
Beginn
31.08.2021
Tage bis Beginn
5,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Hypersensitivity Injection site discomfort Injection site erythema Injection site pain Injection site warmth

Symptomtext

Narrative: pt presents for triage, c/o allergic reaction to TDAP given 8/26/21 pt rt upper arm, red below deltoid and above elbow...warm to touch. pt states didn't noticed till yesterday. took 2 benedryl tabs last night. states sore and burning sensation . Right upper arm with 3in X 3in area warm, red. No swelling. Feels like a sunburn. No blisters. Area appears to be allergic reaction and he di dhave some imprvement with burning discomfort after benadryl 50mg last night. VSS w/ no SOB, facial or throat edema, or wheezing. Afebrile

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

VAERS 1696136

SANOFI PASTEUR · DTAP (DAPTACEL) · Charge u6968AA

mild
Staat
CA
Alter
8,0
Geschlecht
F
Eingang
14.09.2021
Impfdatum
07.09.2021
Beginn
07.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
SYR / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Dyschezia Dysuria Haemorrhage Pain Proctalgia

Symptomtext

Started having stinging rectum pain. Moderate level pain . Moderate to high level when peeing or pooping . Lasted for 24hours . Family history of ulcerative colitis. On 9/10 had blood when wiping .

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain
Hospital-Tage
-
Labordaten
Went to doctor on 9/10 and urine test was done .
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
no
Allergien
no
Vorherige Impfungen
-

VAERS 1671584

SANOFI PASTEUR · TDAP (ADACEL) · Charge u6968aa

mild
Staat
MO
Alter
54,0
Geschlecht
F
Eingang
03.09.2021
Impfdatum
31.08.2021
Beginn
02.09.2021
Tage bis Beginn
2,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Pain in extremity Peripheral swelling

Symptomtext

2 days after Adacel injection in left arm, pt's arm turned red, swelled up, and turned painful. Pt wen't to dr and was given doxycyline for treatment.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain in extremity
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
healed burns over body from years ago
Andere Medikamente
morphine, percocet, ambien, promethazine, atorvastatin, hydroxyzine
Allergien
penicillin
Vorherige Impfungen
-

VAERS 1641169

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge U6968AA

mild
Staat
IA
Alter
35,0
Geschlecht
F
Eingang
27.08.2021
Impfdatum
23.08.2021
Beginn
23.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Abdominal discomfort Chills Dizziness Fatigue Hyperhidrosis Musculoskeletal stiffness Pain Pyrexia Rash Rash erythematous Rash pruritic

Symptomtext

Went to pcp for check up. got adult Dt and penumonia shot. Right after on Monday 8/23/21 evening she got fatigue and fever. Tuesday 8/24/21 she felt like she did when she had Covid. Sweating, chills, fever, stiff neck, aching all over. Her left arm and hand were stiff and sore. She was very dizzy with brain zaps. The next day, her stomach felt better and she went back to work. 8/25/21 evening, her migraine came back, then this am 8/26/21 the redness on her left upper arm had spread and it's been getting worse. by the time she got to work it got worse and the pain got worse. she lasted half an hour at work. PCP asked her to come in. itching rash left upper arm.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chills
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
possible viral sinus infection or allergies
Vorgeschichte
Diabetes; Endometriosis; Gastro-esophageal reflux disease without esophagitis; Headache; Hirsutism; HTN (hypertension); Migraines; Other allergic rhinitis; Polycystic ovaries; Post-COVID-19 syndrome; Sinus tachycardia; Temporomandibular joint disorder
Andere Medikamente
albuterol 90 mcg/inh inhalation aerosol; amoxicillin-clavulanate 875 mg-125 mg oral tablet; desvenlafaxine 100 mg oral tablet, extended release, 100 mg= 1 tab(s); hydrOXYzine hydrochloride 25 mg oral tablet; metFORMIN 500 mg oral tablet; Mi
Allergien
sulfa drugs (Rash)
Vorherige Impfungen
-

VAERS 1574285

SANOFI PASTEUR · TDAP (ADACEL) · Charge u6968AA

mild
Staat
OH
Alter
12,0
Geschlecht
F
Eingang
16.08.2021
Impfdatum
16.08.2021
Beginn
16.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dizziness

Symptomtext

Patient got light headed, was helped to the floor, remained conscious. after about 10 minutes was able to get to chair, offered water, then after a few more minutes was able to leave

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
none
Allergien
nka
Vorherige Impfungen
-

VAERS 2599042

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6968AA

gering
Staat
AZ
Alter
-
Geschlecht
U
Eingang
18.03.2023
Impfdatum
04.03.2023
Beginn
04.03.2023
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 No adverse event

Symptomtext

Administered the Adacel to a patient on Saturday, but after they left, noticed that the vaccine was expired with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age /gender patient who was administered the Diphtheria-2/tetanus/5 ac pertussis vaccine [ADACEL] on saturday, but after they left, noticed that the vaccine was expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Mar-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 milligram (mg) total (lot U6968AA and expiry date-07-Feb-2023) via intramuscular route in the left deltoid for immunisation but after they left, noticed that the vaccine was expired with no reported adverse event (expired product administered) (latency-same day). Action taken was not applicable. it was reported that Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age. At time of reporting, the outcome was Unknown for the 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1775326

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6968AA

gering
Staat
CA
Alter
34,0
Geschlecht
F
Eingang
09.10.2021
Impfdatum
07.10.2021
Beginn
07.10.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered Wrong product administered

Symptomtext

Patient came to our pharmacy to get a vaccine. Our technician at drop-off window initiated the registration and inputted in the computer for Adacel, as the technician understood that patient wanted Tdap based on their conversation. The vaccine was submitted to the pharmacist as Adacel in the computer. Prior to administration pharmacist informed patient that she was getting Adacel and it is good for 10 years then adminstered the vaccine. The patient was then given a vaccine record card to take with her. Then she looked at the card and looked over for the list of other vaccines, then she said I was supposed to get MMR and I got Tdap last week. We then asked where? then she responded at a clinic. We contacted her doctor and informed her that we will report the incident and that will be ok.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none was taken at the time of vaccination
Allergien
none
Vorherige Impfungen
-

VAERS 1512074

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6968AA

gering
Staat
-
Alter
10,0
Geschlecht
F
Eingang
29.07.2021
Impfdatum
19.07.2021
Beginn
19.07.2021
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 Syringe issue Underdose

Symptomtext

half of the dose given due to plunger broke with no reported adverse event; plunger broke with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Regulatory authority (Reference number- 00690029) and transmitted to Sanofi on 19-Jul-2021. This case involves a 10 year old female patient to whom half of the dose was given due to plunger broke with no reported adverse event (Underdose) and plunger broke with no reported adverse event (Syringe issue) at the time of receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. On 19-Jul-2021, the patient received a dose (0.3ml) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6968AA; expiry date: 07-Feb-2023) via intramuscular route in the left arm for prophylactic vaccination. It was case of vaccine under dose and syringe issue (latency: same day). It was reported, "we just have a question a Tdap (DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS) Adacel vaccine was given to a child, and the vaccine was broken so the MA (medical assistant) vaccinated the patient but the plunger broke um inside when the needle was inside and then plunger broke so that only half of the dose was given to the patient. So we have 2 questions, one we need to get this defective vaccine replaced and then two we needed to have um a nurse to call us back and let us know if the patient needs to be given another dose of the Tdap Adacel" Also, it was reported, "a medical assistant was administering an Adacel vaccine to a patient on 19jul2021. When she was administering the Adacel syringe broke right away (possible the plunger rod) and she was only able to give 0.3ml of the medicine. Caller states that she will send pictures because she is not sure what part it is. Number of units affected:1. Is dose not used or not available: yes. Whether product is available for return: no. No broken vials or syringes with needles can be returned. Plungers: First question if plunger fell out - Were you trying to aspirate: No. If loose-did vaccine leak out the barrel: No. Was the plunger intact upon opening the carton: Yes. Difficulty pushing the plunger during administration: yes Broken vial or syringe (these questions should also apply to cracked vials or syringes). State where it is broken or cracked according to the diagram: Plunger rod. Broke or cracked during preparation or use: Use. Received broken or cracked in the carton: No. Was there any damage to the carton upon receipt: No. Was there any product residue in the carton: No. Were there any signs of damage to any other vial in the carton: No" At the time of reporting, the no adverse event were 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
-