VAERS Reports KN5ZR

VAERS 1519037

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

schwer

Staat: PA
Alter: 24,0
Geschlecht: M
Eingang: 01.08.2021
Impfdatum: 01.08.2021
Beginn: 01.08.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SYR / RA

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

Dizziness Dyspnoea Hyperhidrosis Loss of consciousness Vision blurred

Symptomtext

Patient reported feeling dizzy to his caregiver while seated during observation period and then completely passed out. By this time Pharmacist had requested the technician to call 911. Patient gained consciousness within seconds but reported dizziness and blurry vision. Patient stated being able to breath fine, but pharmacist noticed labored breathing, pharmacist checked pulse and breathing and pulse was 60 bpm. Police officer arrived on sight by 3:10pm, followed by EMT. Vitals were checked BP 104/64. Patient declined medical care and being taken to the hospital, stating feeling normal now. During 911 call, emergency agent informed pharmacy staff to inform patient to remove any tight clothing so patient willfully removed his T-shirt since he was sweating. Patient waited in the sitting area and left around 3:50pm

Weitere VAERSDATA-Felder

Praegender Schweregrund: Loss of consciousness
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: PENICILLIN
Vorherige Impfungen: -

VAERS 1586550

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

moderat

Staat: MA
Alter: 67,0
Geschlecht: M
Eingang: 19.08.2021
Impfdatum: 23.07.2021
Beginn: 23.07.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RA

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

Blepharospasm Eye irritation Full blood count Headache Injection site pain Injection site paraesthesia Metabolic function test Neck pain New daily persistent headache Pain Pain in extremity Tinnitus

Symptomtext

pain and swelling at injection site which extended into arm and neck associated with paresthesias, resolved low grade left hemicranial daily headache, persistent since vaccine bilateral blepharospam, intermittent bilateral tinnitus intermittent, worse on left side bilateral eye irritation, persistent pain with certain movements of right arm, persistent

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site paraesthesia
Hospital-Tage: -
Labordaten: CBC 8/17/21 CMP 8/17/21
Aktuelle Erkrankungen: none reported
Vorgeschichte: medical problems listed in record: obesity impotence GERD allergic rhinitis depressive disorder elevated blood glucose
Andere Medikamente: Viagra 100 mg PRN
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2085397

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

mild

Staat: MI
Alter: 42,0
Geschlecht: M
Eingang: 03.02.2022
Impfdatum: 19.08.2021
Beginn: 01.09.2021
Tage bis Beginn: 13,0
Dosis: 7+
Route/Site: IM / LA

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

Aspiration joint Injection site pain Joint range of motion decreased Pain in extremity Periarthritis X-ray normal

Symptomtext

Patient was seen in the office on 12/29/21 for Left Arm Pain, gradual onset. 1st Symptoms Began: 9/2021 after tetanus vaccine Cause of Pain: pain in his L deltoid after the tetanus shot. Over time the pain has increased and the ROM has been going down. Cannot abduct much over 90 degrees on the L due to getting stuck and pain. Has good use of the arm down low. No weakness. No numbness. No swelling. ROM down over the past month. Progression: worsening Treatments: Ibuprofen, tylenol. Effective: not at all effective Patient was diagnosed with adhesive capsulitis and given a handout regarding home care, prescribed meloxicam 15 mg, an xray of the left shoulder was ordered and patient was referred to orthopedics for evaluation and further treatment. Patient was seen by Orthopedics, Doctor on 2/2/22. That physician ordered a left shoulder joint arthrocentisis. Their visit notes were as follows: Patient is a very pleasant 43-year-old male here for evaluation of left shoulder pain. He reports ongoing left shoulder pain after receiving his tetanus vaccine in September of 2021. He did not notice anything unusual about the injection other than the post injection soreness that he typically has. Unfortunately that soreness continued to evolve and was eventually associated with decreased range of motion. He was seen by his primary care suspected adhesive capsulitis and was referred to our office today for further evaluation. On physical exam he does have restricted active and passive range of motion. Abduction is approximately to 80?. Flexion is approximately to 140? internal rotation is to L 3. He has good strength with rotator cuff testing. I do not appreciate any discomfort or pain with any rotator cuff testing. X-rays were obtained. No acute osseous pathology noted. Overall I do agree he is struggling with adhesive capsulitis. I do question whether this is a adverse effect of his vaccination. He was not having any pain or issues prior to the injection. I did discuss with him the pathophysiology of adhesive capsulitis, the freezing frozen and thawing stages as well as the typical recovery. Almost these cases to get better on their own we did discuss the typical recovery time can be anywhere from 6 months to a 18 months. I discussed the treatment options moving forward and given his failure of adequate control with ibuprofen and meloxicam I did recommend a ultrasound-guided corticosteroid injection in the glenohumeral joint. He tolerated this well. I will follow up with him as needed. If these injections are effective but his pain returns I can do these injections every 6 weeks until resolution of the adhesive capsulitis. I will follow up with him as needed.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site pain
Hospital-Tage: -
Labordaten: Patient completed xray order on 1/12/22, the findings were as follows: There is no bone or joint abnormality.
Aktuelle Erkrankungen: unknown
Vorgeschichte: Snoring, Central serous retinopathy-right, dysthymia, erectile dysfunction, posterior neck pain, occasional esophageal reflux
Andere Medikamente: buPROPion (WELLBUTRIN XL) 150 MG 24 hr tablet Taking Take
Allergien: No known allergies
Vorherige Impfungen: -

VAERS 1515579

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

mild

Staat: NC
Alter: 1,5
Geschlecht: F
Eingang: 30.07.2021
Impfdatum: 29.07.2021
Beginn: 29.07.2021
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Agitation Crying Vomiting Wrong product administered

Symptomtext

Wrong vaccine given. Dtap should have been given. Tdap was given. Mom called back 2 hrs after OV to report that pt had vomited. Pt had been very upset and crying in car on the way home. Vomited 2h after vaccine given.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Vomiting
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: NKA
Vorherige Impfungen: -

VAERS 1433923

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

mild

Staat: CO
Alter: 18,0
Geschlecht: F
Eingang: 29.06.2021
Impfdatum: 29.06.2021
Beginn: 29.06.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Blood pressure decreased Dizziness

Symptomtext

WHILE PATIENT WAS SITTING IN OUR WAITING ROOM, SHE BEGAN TO FEEL DIZZY. SHE MOVED HERSELF TO THE FLOOR. WHILE LETTING HER REST COMFORTABLY, WE MADE ASKED QUESTIONS TO BE SURE SHE WAS STAYING AWAKE, WE MONITORED HER BLOOD PRESSURE AND PULSE. BLOOD PRESSURE WAS LOW AND PULSE REMAINED WITHIN NORMAL LIMITS. SHE WAITED FOR ABOUT 30 MINUTES, WAS GIVEN WATER AND SHE GRADUALLY MOVED INTO A CHAIR. THEN WHEN SHE FELT BETTER, SHE LEFT. WILL TOUCH BASE WITH HER AGAIN TO BE SURE SHE IS NO LONGER EXPERIENCING SYMPTOMS

Weitere VAERSDATA-Felder

Praegender Schweregrund: Dizziness
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: NONE
Vorgeschichte: NONE
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1924423

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

gering

Staat: FL
Alter: 11,0
Geschlecht: F
Eingang: 04.08.2021
Impfdatum: 27.07.2021
Beginn: 30.07.2021
Tage bis Beginn: 3,0
Dosis: 1
Route/Site: IM / LA

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

Dyskinesia

Symptomtext

involuntary movements in right cheek, seen at ER, doing better but still some movement in area.

Weitere VAERSDATA-Felder

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

VAERS 1517858

GLAXOSMITHKLINE BIOLOGICALS · TDAP (BOOSTRIX) · Charge KN5ZR

gering

Staat: IN
Alter: 1,0
Geschlecht: F
Eingang: 31.07.2021
Impfdatum: 20.07.2021
Beginn: 20.07.2021
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 Wrong product administered

Symptomtext

15 months old patient / received / Boostrix (T-dap); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5ZR, expiry date 16th April 2023) for prophylaxis. Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 20th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The medical assistant reported a 15-months-old patient received Boostrix (Tdap) instead of receiving D-tap, which led to inappropriate age at vaccine administration. 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: BOOSTRIX Pre-Filled Syringe Device
Allergien: -
Vorherige Impfungen: -