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VAERS ID: 1000420

AGE: UNK| SEX: F|State: FR

Description

Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; This case was reported by a physician via regulatory authority and described the occurrence of paralytic ileus in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number AFLBA511AD, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis. On 26th October 2020, the patient received Fluarix Tetra 2020-2021 season (intramuscular) .5 ml and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. On 4th November 2020, 9 days after receiving Fluarix Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced paralytic ileus (serious criteria hospitalization and GSK medically significant), dysphagia (serious criteria hospitalization), paresthesia of limbs (serious criteria hospitalization), lumbalgia (serious criteria hospitalization) and hyposthenia (serious criteria hospitalization). On an unknown date, the outcome of the paralytic ileus, dysphagia, paresthesia of limbs, lumbalgia and hyposthenia were not recovered/not resolved. It was unknown if the reporter considered the paralytic ileus, dysphagia, paresthesia of limbs, lumbalgia and hyposthenia to be related to Fluarix Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: The age at vaccination was not reported however patient could be 58 or 59 years old at the time of vaccination. On an unknown date, CXR and Computerised axial tomogram was performed with no result. On 8th November 2020, Electrocardiogram was performed with no result. On 9th November 2020, Electromyogram normal was performed with no result. Batch number of Fluarix Tetra was reported as AFLB511AD, however upon safety data review, the batch number was corrected to AFLBA511AD Initial information was received from a physician via regulatory authority on 1st February 2021: Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus

Symptoms

Asthenia, Electrocardiogram, Back pain, Electromyogram normal, Chest X-ray, Ileus paralytic, Computerised tomogram, Paraesthesia, Dysphagia

Vaccines

VAX DATE: 25 October 2020 | ONSET DATE: 03 November 2020 | DAYS TO ONSET: 9
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • FLU4
  • GLAXOSMITHKLINE BIOLOGICALS
  • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)
  • UNK
  • IM

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
Test Name: CXR; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Name: Computerised axial tomogram; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201108; Test Name: Electrocardiogram; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201109; Test Name: Electromyogram normal; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:)
V_ADMINBY:
UNK
OTHER_MEDS:
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:
ITGLAXOSMITHKLINEIT202102
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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