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Reporte zur Charge U7549AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

38Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
AZ 5 CO 3 PA 3 CA 3 IN 3 KS 3 KY 2 MI 2 GA 2 WV 1 ND 1 MD 1

VAERS 2546341

SANOFI PASTEUR · TDAP (ADACEL) · Charge u7549aa

schwer
Staat
WV
Alter
26,0
Geschlecht
F
Eingang
29.12.2022
Impfdatum
29.12.2022
Beginn
29.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Syncope

Symptomtext

Adverse Event: patient fainted after receiving third vaccination. She received adacel and fluzone quad in left arm and then pfizer bivalent in right arm. Treatment: Caught patient when she was falling out of chair and gently laid her on the floor. She came back to consciousness within about 5-10 seconds. We provided her with water and orange juice and also gave her an ice pack. We had her remain at the pharmacy until she was feeling better. Outcome: patient recovered and said she was feeling ok within about 15 minutes.

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

VAERS 2483970

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

schwer
Staat
-
Alter
11,0
Geschlecht
F
Eingang
20.10.2022
Impfdatum
20.10.2022
Beginn
20.10.2022
Tage bis Beginn
0,0
Dosis
6
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Fall Syncope

Symptomtext

vaccines Tdap and Meningococcal were given in the left arm, and then influenza and HPV in the right arm. HPV was given last. Patient slumped forward less than one minute after receiving the HPV and had fainted. No injury came of this. Nurses safely repositioned to laying down on her back with legs elevated and she came to in two minutes or less. Vitals were obtained and appeared stable. MD was notified of incident and came to assess patient and deemed it safe for her to continue home after a few minutes.

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

VAERS 2601747

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

moderat
Staat
IN
Alter
11,0
Geschlecht
F
Eingang
22.03.2023
Impfdatum
21.03.2023
Beginn
21.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dyspnoea Feeling abnormal Injection site erythema Pyrexia Urticaria

Symptomtext

Mother states 2 hours after injections, pt. started developing hives on her face, which later started on her arms as well. She did have a small amount of redness around the Tdap injection site. She was given Benadryl which helped. Her mother did call the child's pediatrician and was instructed to just watch her and to immediately take her to the ER if she developed breathing difficulty. She also developed a low-grade fever that was treated with Tylenol. She appeared better today, but still "felt a bit off" per her mother.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dyspnoea
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Acid reflux, Bladder Reflux grade 2, Asthma
Vorgeschichte
same as above
Andere Medikamente
Multivitamin, Focalin, Flomax, Macrobid, Singulair, Advair, Xopenex, Erythromycin, Sennacot, Miralax, Famotidine
Allergien
Lactose intolerance, Cephalosporin
Vorherige Impfungen
-

VAERS 2522513

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

moderat
Staat
MN
Alter
58,0
Geschlecht
M
Eingang
03.12.2022
Impfdatum
25.11.2022
Beginn
26.11.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injected limb mobility decreased Injection site pain

Symptomtext

Patient was given TDAP in right deltoid. following injection patient has pain at site and decreased mobility in the right upper extemity. unable to lift arm above head.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injected limb mobility decreased
Hospital-Tage
-
Labordaten
not at this time
Aktuelle Erkrankungen
none known of
Vorgeschichte
HTN, hyperlipidemia, DM type 2
Andere Medikamente
ozempic, farxiga, lisinopril, HCTZ, atenolol, metformin, aspirin, viagra
Allergien
strawberries
Vorherige Impfungen
-

VAERS 2636696

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
MI
Alter
16,0
Geschlecht
F
Eingang
25.05.2023
Impfdatum
12.05.2023
Beginn
15.05.2023
Tage bis Beginn
3,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Vaccination site swelling Vaccination site warmth

Symptomtext

Vaccine was administered on 5/12 in the right deltoid muscle. Pt reports that on 5/15 she had a large bump at the vaccine site that was slightly red and warm to touch. On 5/18 Pt reports that the bump decreased in size and the redness increased. On 5/19 Pt presented to clinic with a red, warm to touch area 2.5 in X 2.0 in at the injection site. At the center of the area was a white circular area, 0.5 in diameter, that was a hard bump with palpation. Pt denied any pain at the injection site and stated "it is more itchy that painful". The red area was outlined in pen. Per the Pt the redness did not go outside on the pen outline. On 5/23 the Pt presented to the clinic for a another recheck. The injection site was no longer red, with palpation the bump decreased in size to approximately 0.4 mm.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
asthma
Andere Medikamente
-
Allergien
Peas, eggs, tree nuts, flax seed
Vorherige Impfungen
-

VAERS 2600088

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
IN
Alter
12,0
Geschlecht
M
Eingang
21.03.2023
Impfdatum
20.03.2023
Beginn
01.03.2023
Tage bis Beginn
-
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pain in extremity

Symptomtext

Per father, Pt experienced soreness in both arms with more in the right arm than the left last night. His son took Tylenol for discomfort in the evening and went to bet with no issues. This morning, he said the son had no complaints before going to school.

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

VAERS 2593280

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
CO
Alter
64,0
Geschlecht
F
Eingang
08.03.2023
Impfdatum
27.02.2023
Beginn
27.02.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Joint noise Pain Vaccination site movement impairment

Symptomtext

The client is experiencing pain, popping, and the inability to move her right shoulder 1 week post vaccination.

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

VAERS 2587282

SANOFI PASTEUR · TDAP (ADACEL) · Charge u7549aa

mild
Staat
PA
Alter
75,0
Geschlecht
F
Eingang
24.02.2023
Impfdatum
15.01.2023
Beginn
15.01.2023
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site nodule Injection site swelling

Symptomtext

Patient reported to the pharmacy today that she still felt like her arm swells up and forms a not at the site of injection. Patient was advised to contacther PCP

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

VAERS 2582728

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
NJ
Alter
13,0
Geschlecht
F
Eingang
15.02.2023
Impfdatum
14.02.2023
Beginn
15.02.2023
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Injection site pain

Symptomtext

Patient went to Pharmacy for Tdap and Varicella vaccine on 02/13/2023. patient received only Tdap vaccine from Pharmacy on 02/13/2023. Pharmacy referred her to another Pharmacy for varicella vaccine however patient showed up at Pharmacy on 02/14/2023 and asked for Tdap vaccine Pharmacy gave her Tdap at this point and realized the next day that patient received Tdap twice. We called patient and she is feeling ok only arm site soreness. We will give her refund and will give her follow up call.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
no
Aktuelle Erkrankungen
NO
Vorgeschichte
NO
Andere Medikamente
NO
Allergien
NO
Vorherige Impfungen
-

VAERS 2582060

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
WA
Alter
12,0
Geschlecht
M
Eingang
14.02.2023
Impfdatum
14.02.2023
Beginn
14.02.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dizziness Headache Nausea Nervousness Vision blurred

Symptomtext

Pt. started to feel dizzy and HA started while waiting in clinic x15 min. Pt. able to walk to room to lay down with legs elevated. Pt. reported feeling better/HA resolved but had him wait in clinic for the remaining 5 min. Felt fine upon leaving with mom but returned before getting to the car as pt. was feeling shaky, dizzy, nauseous and vision blurriness returned. Returned to clinic at 5:23 pm and had pt. lay down again with legs elevated. Took BP/HR at 5:29 pm while supine and WNL. Had pt. transition to sitting and at 5:51 pm BP/HR again WNL. Stood without difficulty and discharged at 5:52 pm.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
cats, dogs, grass pollen, dust mites
Vorherige Impfungen
-

VAERS 2503947

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
VA
Alter
12,0
Geschlecht
F
Eingang
10.11.2022
Impfdatum
21.10.2022
Beginn
21.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site haematoma Injection site pruritus

Symptomtext

hematoma at the site, and a red, itchy area also at the site.; hematoma at the site, and a red, itchy area also at the site; hematoma at the site, and a red, itchy area also at the site; when the vaccine was administered, a good amout of "serum" leaked out and ran down; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old female patient who experienced hematoma at the site, and a red, itchy area also at the site., hematoma at the site, and a red, itchy area also at the site, hematoma at the site, and a red, itchy area also at the site and when the vaccine was administered, a good amout of "serum" leaked out and ran down while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma and Immune system disorder. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Immunisation. On 21-OCT-2022 , the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7549AA; expiry date: 04-NOV-2024) via intramuscular route in the deltoid nos. On 21-OCT-2022 the patient developed a non-serious events hematoma at the site, and a red, itchy area also at the site. (injection site haematoma), (injection site erythema), (injection site pruritus) , when the vaccine was administered, a good amout of "serum" leaked out and ran down (incorrect dose administered) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Action taken: not applicable. Corrective treatment: the patient was treated with ice and it resolved. At time of reporting, the outcome was Unknown for the event incorrect dose administered and recovered/resolved for rest of the events. 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
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Asthmatic; Immune system disorder
Vorgeschichte
-
Andere Medikamente
MENQUADFI
Allergien
-
Vorherige Impfungen
-

VAERS 2477916

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

mild
Staat
-
Alter
31,0
Geschlecht
M
Eingang
13.10.2022
Impfdatum
13.10.2022
Beginn
13.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: unbekannt
Adverse reaction Impaired work ability Malaise Vomiting

Symptomtext

Patient received all three vaccines around 11:45 AM and felt fine, went to work and at some point while at work began feeling very sick and began vomiting. Patient left work to go to the emergency department around 4:45 due to severe vomiting. Patient's girlfriend called pharmacy to let us know about adverse reaction at that time.

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

VAERS 2702510

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
MD
Alter
12,0
Geschlecht
M
Eingang
26.10.2023
Impfdatum
19.10.2023
Beginn
19.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Circumstance or information capable of leading to medication error Extra dose administered

Symptomtext

TDAP vaccination was administered to this patient on 10/19/2023. The patient?s mom brought in a vaccine record that did not reflect that TDAP was given in Aug 2023, prior to her bringing in the vaccination record when she initially scheduled the visit, I had initially searched the system and could not find the patient?s record. Then I requested that the mom bring in vaccination records she has for him. I relied on the record she brought, I should have gone back to check again, to avoid giving the TDAP too close to the previous dose. It is obvious now that the patient's info was incorrectly entered in system that was why his record couldn't be found initially.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Circumstance or information capable of leading to medication error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
none
Vorgeschichte
None
Andere Medikamente
none involved
Allergien
Amoxicillin
Vorherige Impfungen
-

VAERS 2702337

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
LA
Alter
11,0
Geschlecht
F
Eingang
26.10.2023
Impfdatum
06.10.2023
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
- / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Unevaluable event

Symptomtext

None

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

VAERS 2678572

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge U7549AA

gering
Staat
CO
Alter
-
Geschlecht
M
Eingang
01.09.2023
Impfdatum
25.07.2023
Beginn
25.07.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

7 year old patient accidentally received a dose of TDaP; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number U7549AA) for prophylaxis. On 25-JUL-2023, the patient received Boostrix. On 25-JUL-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 year old patient accidentally received a dose of TDaP). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK receipt date: 22-Aug-2023 Pediatrician called in to report that a 7 year old patient accidentally received a dose of TDaP but was unsure if the product was actually a GSK product. During the call, the conversation was suspended due to a connectivity issue A call back was made but the health care professional (HCP) did not answer. The 7 year old patient Boostrix, which led to inappropriate age at vaccine administered. The reporter consented to follow up.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2677299

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
CO
Alter
7,0
Geschlecht
M
Eingang
28.08.2023
Impfdatum
25.07.2023
Beginn
25.07.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age Wrong product administered

Symptomtext

ADACEL was administered mistakenly to the patient, with no reported adverse event; ADACEL was administered mistakenly to the patient to 7 year old child, with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered mistakenly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis a vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR), polio vaccine (polio) and varicella zoster vaccine (varicella vaccine) for Prophylactic vaccination. On 25-Jul-2023, the patient received a 0.5 ml , once (Dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U7549AA, expiry date: 04-Nov-2024, strength: standard) via unknown route in the right thigh for Prophylactic vaccination (Immunisation) and was mistakenly administered Adacel, with no reported adverse event (wrong product administered) and (product administered to patient of inappropriate age) (Latency: same day). It was reported " Physician said he's calling to confirm if it will not count for tetanus vaccine or is it counted as a tetanus dose? He also said that ADACEL was administered mistakenly to the patient, since they thought DTaP can't be given after 7 years of age. Physician said that the patient was supposed to get his DTaP but he never got his DTaP at age 5 so he received Tdap at 7 years old as the 5th dose in his DTaP series." 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 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS A; MMR; POLIO; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2671561

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
KY
Alter
0,8
Geschlecht
F
Eingang
15.08.2023
Impfdatum
11.04.2023
Beginn
11.04.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

No adverse effects reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE REPORTED TO STAFF
Allergien
NONE REPORTED TO STAFF
Vorherige Impfungen
-

VAERS 2671556

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
KY
Alter
3,0
Geschlecht
F
Eingang
15.08.2023
Impfdatum
11.04.2023
Beginn
11.04.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product administered to patient of inappropriate age

Symptomtext

Nurse administered TDaP which is for ages over 7 years old instead of DTaP which is for her age range. Nurse stated that father was adament about patient getting the TDaP vaccine so she went ahead and gave the immunization he requested.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE THAT WERE MADE AWARE TO STAFF
Allergien
NONE THAT WERE MADE AWARE TO STAFF
Vorherige Impfungen
-

VAERS 2657682

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
ID
Alter
3,0
Geschlecht
F
Eingang
18.07.2023
Impfdatum
30.06.2023
Beginn
30.06.2023
Tage bis Beginn
0,0
Dosis
5
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

Child is age 3 and recommended vaccine is Dtap. She was given Tdap. State response when reported is that if dose 4 or 5-it can be considered valid and does not need to be repeated. (if dose 1,2, or 3-it would not count and need to be repeated) She has already received 4 doses of Dtap and this is dose #5. It is a valid dose and the child is protected. It will count as 5th dose and is now completed.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
none needed- no harm
Aktuelle Erkrankungen
patient had foot laceration at the time of vaccination
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2649200

SANOFI PASTEUR · DTAP (DAPTACEL) · Charge U7549AA

gering
Staat
KS
Alter
11,0
Geschlecht
M
Eingang
26.06.2023
Impfdatum
03.06.2023
Beginn
03.06.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age Wrong product administered

Symptomtext

DAPTACEL was incorrectly administered to 11 year old male patient instead of ADACEL with no reported adverse event; DAPTACEL was incorrectly administered to 11 year old male patient instead of ADACEL with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves medication error Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] was incorrectly administered to 11 year old male patient instead of adacel with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for and HPV vaccine both for Prophylactic vaccination. On 03-Jun-2023, the patient of 11 years received a dose 0.5 ml of suspect with standard strength Diphtheria-15/Tetanus/5 AC pertussis vaccine suspension for injection (frequency: twice) (lot: U7549AA, Expiry date: 04-Nov-2024) via intramuscular route in the left arm for immunization instead of adacel with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day). The information on the batch number will not be requested. Action taken: not applicable. At time of reporting, the outcome was Unknown for both the events. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MENACTRA; HPV VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2649065

SANOFI PASTEUR · DTAP (DAPTACEL) · Charge U7549AA

gering
Staat
KS
Alter
12,0
Geschlecht
F
Eingang
24.06.2023
Impfdatum
15.06.2023
Beginn
15.06.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age Wrong product administered

Symptomtext

daptacel was incorrectly administered to 3 different patients ages between 11 to 12 yrs old, patients should receive an adacel instead of a daptacel with no reported adverse event; vaccine administered to 12 year old patient with no adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2023SA190320. This case involves a 12 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was incorrectly administered to 3 different patients ages between 11 to 12 yrs old, patients should receive diphtheria, tetanus and acellular pertussis vaccine [Adacel] instead with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (Menactra); HPV vaccine (HPV Vaccine); and tozinameran (Pfizer Biontech Covid-19 Vaccine), all for Immunisation. On 15-Jun-2023, the 12 year old patient incorrectly received 0.5 mL dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U7549AA; expiry date: 04-Nov-2024) via intramuscular route in the left arm for immunization to 3 different patients ages between 11 to 12 yrs old, patients should receive an diphtheria, tetanus and acellular pertussis vaccine (adacel), (batch number, expiry, route, administration site unknown) instead of a daptacel with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for both the events. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649064

SANOFI PASTEUR · DTAP (DAPTACEL) · Charge U7549AA

gering
Staat
KS
Alter
12,0
Geschlecht
F
Eingang
24.06.2023
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age Wrong product administered

Symptomtext

patient should receive an ADACEL instead of a DAPTACEL, DAPTACEL was incorrectly administered with no reported adverse event; DAPTACEL was incorrectly administered to 11 to 12 yrs old with no reported adverse event; Initial information was received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA190290. This case involves 12 years Adolescent female patient who received an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel] instead of a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] was incorrectly administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (Lot: U7549AA, Expiry date: 04-Nov-2024, strength: standard) via intramuscular route in the left arm for Immunization and received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be requested. On an unknown date the patient receive an adacel instead of a daptacel, daptacel was incorrectly administered with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events. 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
-

VAERS 2631188

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
ND
Alter
31,0
Geschlecht
F
Eingang
12.05.2023
Impfdatum
11.05.2023
Beginn
-
Tage bis Beginn
-
Dosis
3
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Wrong product administered

Symptomtext

None. Pt. came in with out of state records and a note from her employer saying she needed, TDAP, 1 Varicella, and 1 MMR to be employed with them. Writer also recommended Pfizer Bivalent booster, to which patient wanted. Writer took MMRV instead of separated them. Writer called employee at the the local DOH to which writer was told to create a VAERS and contact patient. No adverse events at this time.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None.
Aktuelle Erkrankungen
NONE.
Vorgeschichte
NONE.
Andere Medikamente
UNKNOWN
Allergien
NONE
Vorherige Impfungen
-

VAERS 2611252

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
CA
Alter
12,0
Geschlecht
M
Eingang
07.04.2023
Impfdatum
28.03.2023
Beginn
28.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

ADACEL was exposed to temperature of 134.70F for 6 minutes and administered to patient with no reported adverse event; ADACEL was exposed to temperature of 134.70F for 6 minutes and administered to patient with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was exposed to temperature of 134.70F for 6 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Mar-2023, the patient received 0.5 ml (Suspension for injection) dose1 of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7549AA , expiry date: 04-NOV-2024) via intramuscular route in the deltoid NOS (Not otherwise specified) for Immunization. On 28-MAR-2023, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE was exposed to temperature of 134.70F for 6 minutes with no reported adverse event (product storage error), (poor quality product administered) (Latency: same day). Action taken was not applicable. At time of reporting, the outcome was Unknown for the events. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2611223

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
CA
Alter
10,0
Geschlecht
F
Eingang
07.04.2023
Impfdatum
28.03.2023
Beginn
28.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

ADACEL at 134.70F for 6 minutes due to a refrigerator malfunction with no reported adverse event; administered after the excursion, with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 10 years old female patient and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was unopened at 134.70 f for 6 minutes due to a refrigerator malfunction event and administered after the excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis b vaccine (Hepatitis B vaccine); influenza vaccine inact split 4V (Fluzone quadrivalent); and HPV vaccine (HPV vaccine) for prophylactic vaccination (immunisation). On 18-Mar-2023 diphtheria-2/tetanus/5 AC pertussis vaccine was unopened at 134.70 f for 6 minutes due to a refrigerator malfunction with no reported adverse event (product storage error) (unknown latency) and On 28-Mar-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine at dose of total (1x) 0.5 ml (lot number: U7549AA, expiry date: 04-Nov-2024, strength, formulation, administration site: Unknown) via intramuscular for Immunization (Immunisation) administered after the excursion, with no reported adverse event (poor quality product administered) (latency: same day) No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for both the events. 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. Cluster AE cases: 01562152, 01562191, 01562224, 01562233, 01562239 and 01562252

Weitere VAERSDATA-Felder
Praegender Schweregrund
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B VACCINE; FLUZONE QUADRIVALENT; HPV VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2611222

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
CA
Alter
8,0
Geschlecht
M
Eingang
07.04.2023
Impfdatum
21.03.2023
Beginn
21.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

adacel being administered post excursion with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received via office manager. GMI number: 01562233. This case involves 8 years old male patient who experienced Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] being administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA107297, 2023SA108312, 2023SA107202 and 2023SA108228. Concomitant medications included Hepatitis B vaccine for Prophylactic vaccination. It was reported that office manager reported a temperature excursion involving administered after the excursion, unopened ADACEL at 134.70F for 6 minutes due to a refrigerator malfunction on 18-MAR-2023 (not human error). The product did not support by the extended stability data, and the caller informed that ADACEL has been administered after the excursion. This situation is reported as a medication error due to IPOL and ADACEL being administered post excursion. On 21-Mar-2023, the 8-year-old patient administered post excursion suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection at dose 0.5ml once (lot: U7549AA, expiry date: 04-Nov-2024) via intramuscular route in the deltoid nos for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency. Action taken: Not applicable. At time of reporting, the outcome was Unknown for the event poor quality product administered. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2600258

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
PA
Alter
11,0
Geschlecht
M
Eingang
21.03.2023
Impfdatum
21.03.2023
Beginn
21.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Incorrect dose administered

Symptomtext

5-11 bivalent covid ordered/12 and up bivalent covid given

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
burning with urniation
Vorgeschichte
ADHD
Andere Medikamente
Daytrana patch 20mg
Allergien
none
Vorherige Impfungen
-

VAERS 2590438

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
GA
Alter
7,0
Geschlecht
F
Eingang
02.03.2023
Impfdatum
02.03.2023
Beginn
02.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event Wrong product administered

Symptomtext

Patient inadvertently received DTaP even though she was due for Tdap. She was subsequently administered Tdap immediately after. No adverse reactions in clinic. Error was discovered after patient left office.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Eczema
Vorgeschichte
Eczema
Andere Medikamente
N/A
Allergien
N/A
Vorherige Impfungen
-

VAERS 2559178

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
IN
Alter
65,0
Geschlecht
F
Eingang
13.01.2023
Impfdatum
09.01.2023
Beginn
09.01.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Inappropriate schedule of product administration Medication error No adverse event

Symptomtext

patient is administered an extra dose of Adacel after receiving it one year prior with no reported adverse event; inadvertently administering an extra dose of Adacel vaccine with no reported adverse event; Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 65 years old female patient and it was reported that patient administered an extra dose of adacel after receiving it one year prior and inadvertently administering an extra dose of adacel vaccine with no reported adverse event after receiving Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2023, the patient received a booster dose, 0.5 ml (milliliter) (1x) (once) of suspect Diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number: U7549AA, expiry date: 04-Nov-2024) (with unknown strength) via intramuscular route in the left deltoid for immunization. On 09-Jan-2023, Nurse reported that patient inadvertently administered an extra dose of adacel vaccine with no reported adverse event (extra dose administered) and patient administered an extra dose of Adacel after receiving it one year prior with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of Diphtheria-2/tetanus/5 AC pertussis vaccine. It was also reported that "Caller is requesting information on the possible side effects that can occur due to receiving the vaccine too soon". No lab data were reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for both events. 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2533776

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
PA
Alter
34,0
Geschlecht
F
Eingang
16.12.2022
Impfdatum
12.09.2022
Beginn
12.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Exposure during pregnancy No adverse event

Symptomtext

maternal vaccine exposure with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 34 years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC pertussis vaccine [ADACEL] in context of maternal vaccine exposure with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 17 weeks of pregnancy and the patient was exposed to Diphtheria-2/Tetanus/5 AC Pertussis vaccine at 17 weeks of pregnancy, during second pregnancy trimester for Diphtheria-2/tetanus/5 AC pertussis vaccine. The date of last menstrual period was reported as 20-May-2022. The estimated due date is 23-Feb-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 12-Sep-2022, the patient received a dose (dose number 1) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection; lot U7549AA (strength, dose, frequency and expiry date: not reported) via intramuscular route in unknown administration site as prophylactic vaccination (Immunisation). On 12-Sep-2022, the patient developed a non-serious event of maternal vaccine exposure with no reported adverse event (exposure during pregnancy) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine. No lab data was reported. Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event (maternal vaccine exposure with no reported adverse event). At time of reporting, the outcome was Unknown for the event maternal vaccine exposure with no reported adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.

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

VAERS 2533255

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
AZ
Alter
17,0
Geschlecht
M
Eingang
15.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect product formulation administered

Symptomtext

Patient received 0.5mL of the Moderna Bivalent covid vaccine instead of 0.5mL of the Moderna covid vaccine (primary series)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2533251

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
AZ
Alter
15,0
Geschlecht
M
Eingang
15.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect product formulation administered

Symptomtext

Patient received 0.5mL of the Moderna Bivalent covid vaccine instead of 0.5mL of the Moderna covid vaccine (primary series)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2533248

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
AZ
Alter
17,0
Geschlecht
M
Eingang
15.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect product formulation administered

Symptomtext

Patient was given 0.5mL of the Moderna Bivalent covid vaccines instead of 0.5mL of the Moderna Covid vaccine (primary series)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2533231

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
AZ
Alter
15,0
Geschlecht
M
Eingang
15.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect product formulation administered

Symptomtext

Patient was given 0.5mL of the Moderna Bivalent covid vaccines instead of 0.5mL of the Moderna covid vaccines (primary series)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2533205

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
AZ
Alter
17,0
Geschlecht
M
Eingang
15.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
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 Wrong product administered

Symptomtext

Patient was given 0.5mL of the Moderna Bivalent covid vaccine instead of 0.5mL of the Moderna covid-10 vaccine (primary series). no none symptoms

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2515359

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
GA
Alter
61,0
Geschlecht
F
Eingang
23.11.2022
Impfdatum
18.11.2022
Beginn
22.11.2022
Tage bis Beginn
4,0
Dosis
1
Route/Site
- / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Swelling

Symptomtext

raised skin 3 cc

Weitere VAERSDATA-Felder
Praegender Schweregrund
Swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
Centrum, Travatan, Fluticasone,Losartan, Rosuvastatin, Dexilant, Citalopram, Xyzal, Quetiapine, Levothyroxine, Famotidine, Alprazolam
Allergien
Atorvastain
Vorherige Impfungen
-

VAERS 2510738

SANOFI PASTEUR · TDAP (ADACEL) · Charge U7549AA

gering
Staat
MI
Alter
3,0
Geschlecht
F
Eingang
17.11.2022
Impfdatum
17.11.2022
Beginn
17.11.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Wrong product administered

Symptomtext

TDAP given instead of 4th DTAP (provider, mother made aware), no adverse effect noted, no repeat dose necessary

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none, past febrile seizure only
Andere Medikamente
-
Allergien
peanut, tree nut, NKDA
Vorherige Impfungen
-

VAERS 2455737

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U7549AA

gering
Staat
NY
Alter
79,0
Geschlecht
F
Eingang
23.09.2022
Impfdatum
13.09.2022
Beginn
13.09.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration No adverse event

Symptomtext

TENIVAC administration too early with no adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 79 years old female patient for whom tenivac administration was too early with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) for Immunisation. On 13-Sep-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml total (lot U7549AA, expiry date: 04-Nov-2024) via intramuscular route in the left deltoid for immunisation. On 13-Sep-2022 the tenivac administration was too early with no adverse event (inappropriate schedule of product administration) same day latency following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken: Not applicable. Corrective treatment: Not reported. Outcome: 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
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
FLUZONE HIGH DOSE QUADRIVALENT
Allergien
-
Vorherige Impfungen
-