Adverse Event Reporting
| VAERS ID | 2484736 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FE6208 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-07-06 |
| Onset | 2021-07-07 |
| Condition | Permanent Disability |
Symptoms
- Diarrhoea
- Sleep disorder
- Investigation
- Colitis microscopic
Current Illness
Hypothyreosis
Preexisting Conditions
Other Medications
LEVAXIN
Previous Vaccinations
Allergies
Laboratory Data
Test Name: test; Result Unstructured Data: Test Result:lymphocytic colitis; Comments: tests showed lymphocytic colitis
Write-up
sleep problems; lymphocytic colitis; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB.
Regulatory number: SE-MPA-2022-019879 (RA).
A 50-year-old female patient received BNT162b2 (COMIRNATY), on 06Jul2021 as dose 1, single (Lot number: FE6208) for covid-19 immunisation.
The patient's relevant medical history included: "Hypothyreosis", start date: 2004 (ongoing).
Concomitant medication(s) included: LEVAXIN oral, start date: 29Nov2004.
The following information was reported: DIARRHOEA (disability) with onset 07Jul2021, outcome "not recovered", described as "diarrhea"; COLITIS MICROSCOPIC (disability, medically significant) with onset 20Jun2022, outcome "not recovered", described as "lymphocytic colitis"; SLEEP DISORDER (non-serious), outcome "not recovered", described as "sleep problems".
The patient underwent the following laboratory tests and procedures: test: lymphocytic colitis, notes: tests showed lymphocytic colitis.
Therapeutic measures were taken as a result of colitis microscopic, diarrhoea, sleep disorder.
Clinical course: The day after the vaccination, the woman suffered from diarrhoea.
After a month of problems, she sought medical care, but without any measures being taken.
After about a year of problems with constant diarrhoea and gases, rapidly developed regurgitation of gastric juice, dizziness, tiredness and sleep problems, which have limited the woman's everyday life, tests showed lymphocytic colitis.
Just over two months later, treatment was started with Entocort prolonged-release capsule, hard 3 mg.
According to the reporter, at the time of received adverse event report, eight weeks of treatment ongoing with the hope of symptom relief.
The case assessed as serious, persisting disability.
No follow-up attempts are possible.
No further information is expected.