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Reporte zur Charge N3545

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NC 1 NJ 1

VAERS 2104993

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge N3545

moderat
Staat
NC
Alter
51,0
Geschlecht
F
Eingang
11.02.2022
Impfdatum
07.02.2022
Beginn
07.02.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Allergy to vaccine Feeling hot Hyperhidrosis Hypoaesthesia Joint contracture Muscle spasms Paraesthesia Product administered to patient of inappropriate age Radial pulse Vaccination complication

Symptomtext

51 yo F presented for wellness visit as first visit to clinic. Allergy to sulfa (hives) documented. First Shingrix vaccine was prescribed and given ~1200 2/7/22. Patient developed unusual reaction to this vaccine which was described as diaphoresis and feeling hot about 1-2 minutes following the injection. Patient then developed bilateral hand cramping with numbness/tingling of her hands and feet. Patient's muscles in upper forearms and upper arms were relaxed but both hands flexed at the MTP joins. Radial pulses @+ bilateral with symmetric sensation in hands and feet. No other symptoms. Symptoms began to resolve after ~15 minutes. Allergy to Shingrix was added to patient's medical record. Per family member, patient has never had a reaction to a vaccination but has had these symptoms in the past. Provided water, juice, ice packs, assisted with gentle opening of R hand. L hand able to relax on its own after ~5 minutes from vaccine administration, took longer for R hand to do so. Vitals re-checked and within normal limits.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Paraesthesia
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
OTC Vitamin D
Allergien
Sulfonamide antibiotics (hives)
Vorherige Impfungen
-

VAERS 2296506

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge N3545

mild
Staat
-
Alter
64,0
Geschlecht
F
Eingang
26.05.2022
Impfdatum
24.05.2022
Beginn
26.05.2022
Tage bis Beginn
2,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Injection site erythema Injection site pain Injection site swelling

Symptomtext

Mark able redness, swelling, and tenderness to left upper arm.

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

VAERS 2167648

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge N3545

gering
Staat
NJ
Alter
54,0
Geschlecht
F
Eingang
09.03.2022
Impfdatum
-
Beginn
03.03.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered Product complaint Product preparation issue

Symptomtext

Adjuvant vial incorrectly capped; Dose was given without using the antigen; Dose was given without using the antigen; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459K, expiry date 27th May 2023) and (batch number N3545, expiry date 27th May 2023) for prophylaxis. This case was associated with a product complaint. On 3rd March 2022, the patient received Shingrix .5 ml. On an unknown date, the dose was an unknown dose. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown. Additional details were provided as follows: The reporter stated that, the office had a Shingrix adjuvant vial with a brown cap. Two vials of adjuvant were used, and the dose was given to the patient without using the antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The GlaxoSmithKline field representative had driven out to the healthcare professional office on the date of reporting and stated that, the rest of the vials in the box were capped correctly. He took pictures of the 2 adjuvant vials used and would be sending the picture to GlaxoSmithKline. The agent called the healthcare professional to confirm and obtain further information for the case. As per the healthcare professional, the defect was not noticed until after the vaccine was administered. The reporter consented to follow up.

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