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From the 5/7/2021 release of VAERS data:

This is VAERS ID 828941



Case Details

VAERS ID: 828941 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-12-10
Onset:2019-01-21
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2019-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 254690 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-06
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SENNA [SENNOSIDE A+B]; CYANOCOBALAMIN; OMEPRAZOLE; FOLIC ACID; CALCIUM +VIT D; CETIRIZINE; TRIMETHOPRIM
Current Illness: Dementia; Gastrooesophageal reflux disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201900716

Write-up: Patient died; Given 2nd Fluad vaccine; This is a serious spontaneous case, initially received from other health professional (registered nurse) on 21-Jan-2019, concerning a 95-year-old elderly female patient. The patient''s current condition included dementia (since 19-May-2015). The concomitant medications of the patient included omeprazole for gastro-oesophageal reflux disease (reported as GORD), trimethoprim for urinary tract infection (UTI) prophylaxis, Senna, cyanocobalamin, folic acid, vitamin D with calcium and cetirizine. On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 254690, expiration date: 30-Jun-2019 and anatomical location: left arm] as she was over 65 years. On 21-Jan-2019, 42 days after 1st administration, the patient was administered a second dose of Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 254690, expiration date: 30-Jun-2019 and anatomical location: left arm] (explicitly coded as extra dose administered) as she was over 65 years. At the time of reporting, it was unknown if the patient experienced any adverse event. It was reported that, there was not any planned surgery or any condition which required surgery. On 06-Feb-2019, 16 days after the administration of second dose of Fluad (TIV) the patient died. The cause of death was not reported. The autopsy was not performed. The reporter was unable to provide any information, as the notes did not belong to her, it belonged to GP surgery.Hence the case was considered as lost to follow-up. Follow up received from other health professional (lead nurse) on 01-Apr-2019: The case was upgraded from non-serious to serious, as new event ‘death'' was added. Added primary reporter''s email address and secondary reporter (lead nurse) in the general tab. Added GORD (gastro-oesophageal reflux disease) as current condition and start date of dementia (19-May-2015) in the patient tab. Anatomical location of vaccination was added as left arm for both the regimens in the product tab. Indication of Trimethoprim (UTI prophylaxis) and omeprazole were (GORD) added in the product tab. It was unknown if the patient experienced any adverse event. It was reported that that the patient died on 06-Feb-2019. The cause was death was not reported. It was unknown if the autopsy was performed or not. Added new event, "patient died" in the event tab. The narrative was amended accordingly. Non-significant follow up received from other health professional (lead nurse) on 17-Apr-2019: The details of secondary reporter (first name, institution, city, county, postal code and phone number) were added in the general tab. No changes were made in narrative. Follow up received from the other health professional (nurse) on 03-May-2019: The secondary reporter''s information details were added in the general tab. The reporter confirmed the vaccination dates as 10-Dec-2018 (1st dose) and 21-Jan-2019 (2nd dose). It was reported that, there was not any planned surgery or any condition which required surgery. The autopsy information updated in patient tab (no autopsy was performed). At the time of this report, no cause of death was available. The narrative was amended accordingly. Non-significant follow up received from other health professional on 14-May-2019: No additional information was received; hence no changes were made in the narrative. Non-significant follow up received from other health professional (nurse) on 15-May-2019: The reporter stated that, she was unable to pass on the follow up information as these notes were no longer belong to us as her GP surgery. No new information was received, hence no changes were made in the narrative.; Reporter''s Comments: A 95-year-old, female patient was administered 2 doses of Fluad TIV 42 days apart (considered as extra dose administered). The patient died, 16 days after receipt of second dose of Fluad TIV. Considering the lack of information regarding cause of death and the events prior to death, the causality assessed as unassessable. The progressive age of the patient, underlying conditions (gastro-oesophageal reflux disease, dementia) are considered as known risk factors. The company assessed the causality of the event extra dose administered as not related considering the accidental nature of the event. The case will be further assessed upon receipt of follow up information.; Reported Cause(s) of Death: Unknown cause of death


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