Adverse Event Reporting

VAERS ID	912030
Gender	Female
Age	35
StateCode	FR
Pharmaceutical Company	PFIZER\BIONTECH
Lot Number
Number of vaccinations
Vaccinated	2020-12-08
Onset	2020-12-08
Condition	Permanent Disability

Symptoms

• Diarrhoea

Current Illness

Preexisting Conditions

Other Medications

; VENTOLIN [SALBUTAMOL SULFATE]; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE];

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Loose stools/diarrhoea; This is a spontaneous report received from via Pfizer colleague (The Worldwide Unique Case Identification GB-MHRA-WEBCOVID-20201209165007) and downloaded manually from the Medicines Agency (MA) Regulatory authority-WEB received via Regulatory Authority from other healthcare professional.
A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Dec2020 at single dose for COVID-19 immunization.
Patient medical history was not reported.
Last menstrual period was provided as 25Nov2020.
Concomitant medications included cetirizine for asthma; salbutamol sulfate (VENTOLIN) for asthma; fluticasone furoate, vilanterol trifenatate (RELVAR ELLIPTA) for asthma; and naproxen for joint pain.
Unsure if patient has had symptoms associated with COVID-19.
Patient has not been tested/or has had an inconclusive test for COVID-19.
Patient is not enrolled in clinical trial.
On 08Dec2020, the patient experienced loose stools/diarrhoea started 10 hours after vaccine.
The event seriousness was reported as serious, disabling.
Outcome of the event was not recovered.
No follow-up attempts are needed.
No further information is expected, batch/lot number cannot be obtained.