Adverse Event Reporting

VAERS ID 1959861
Gender Female
Age
StateCode FR
Pharmaceutical Company PFIZER\BIONTECH
Lot Number FC3095
Number of vaccinations 2
Vaccinated 2021-06-24
Onset 2021-06-24
Condition Died
Symptoms
  • Tremor
  • Nausea
  • Visual impairment
  • Malaise
  • Pruritus
  • Somnolence
  • Death

Current Illness

COPD; Diabetes mellitus

Preexisting Conditions

Medical History/Concurrent Conditions: Coronary heart disease

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Nausea; drowsiness; Unknown cause of death; tremor hand; Malaise; visual disturbances; Itch; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB.
Regulatory number: DE-PEI-CADR2021209464.
Other Case identifier(s): DE-CADRPEI-2021209464, DE-PEI-202100261598.
A 84 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Jun2021 (Lot number: FC3095) as dose 2, single for covid-19 immunisation.
Relevant medical history included: "COPD" (ongoing); "Diabetes mellitus" (ongoing); "coronary heart disease" (unspecified if ongoing).
There were no concomitant medications.
Vaccination history included: Comirnaty (1st dose, 0.
3 ml), administration date: 24May2021, for Prophylactic vaccination.
The following information was reported: DEATH (death) with onset 09Jul2021, outcome "fatal", described as "Unknown cause of death"; TREMOR (non-serious) with onset 24Jun2021, outcome "not recovered", described as "tremor hand"; MALAISE (non-serious) with onset 24Jun2021, outcome "not recovered", described as "Malaise"; VISUAL IMPAIRMENT (non-serious) with onset 24Jun2021, outcome "not recovered", described as "visual disturbances"; PRURITUS (non-serious) with onset 24Jun2021, outcome "not recovered", described as "Itch"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; SOMNOLENCE (non-serious), outcome "unknown", described as "drowsiness".
The patient date of death was 09Jul2021.
The reported cause of death was "Unknown cause of death".
It was unknown if an autopsy was performed.
The Regulatory Authority assessed the causality of the events with the vaccine as unclassifiable.
; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202101733826 the same patient, another dose of vaccine, another events; Reported Cause(s) of Death: Unknown cause of death