Adverse Event Reporting
| VAERS ID | 1838291 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2021-06-08 |
| Onset | 2021-06-08 |
| Condition | Life Threatening |
Symptoms
- Blood test
- Lymphadenopathy
- Ultrasound scan
- Biopsy
- Maternal exposure during pregnancy
- Lymphoma
Current Illness
Pregnancy (Estimated due date: 17Dec2021)
Preexisting Conditions
Medical History/Concurrent Conditions: Folic acid supplementation; Hashimoto's thyroiditis; Lymphoma; Thyroid disorder
Other Medications
FOLIC ACID
Previous Vaccinations
Allergies
Laboratory Data
Test Name: Biopsy; Result Unstructured Data: Test Result:positive for B cell lymphoma; Test Name: Blood tests; Result Unstructured Data: Test Result:3 enlarged lymph nodes; Comments: the biggest of which was 1.
5 cm; Test Name: Blood tests; Result Unstructured Data: Test Result:Normal; Test Name: Ultrasound; Result Unstructured Data: Test Result:3 enlarged lymph nodes; Comments: the biggest of which was 1.
5 cm
Write-up
Enlarged lymph nodes; Lymphoma; Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA).
Regulatory authority report number GB-MHRA-WEBCOVID-202110260110292400-HFF8A Safety Report Unique Identifier GB-MHRA-ADR 26120179.
A 31-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 08Jun2021 as dose 1, single for COVID-19 immunisation.
Medical history included thyroid disorder, lymphoma, ongoing pregnancy Estimated due date: 17Dec2021, Thyroid hashimoto, vitamin supplementation.
Prior to her lymphoma diagnosis she did not have any other medical history, no other diseases apart from thyroid hashimoto which has never been an issue and hence never required treatment or medication.
Patient has not had symptoms associated with COVID-19.
Not had a COVID-19 test.
Patient is not currently breastfeeding.
Concomitant medication included folic acid taken for vitamin supplementation.
The patient experienced enlarged lymph nodes with outcome of not recovered, maternal exposure during pregnancy with outcome of unknown, patient was exposed to the medicine first-trimester (1-12 weeks), lymphoma on 20Jun2021 with outcome of not recovered,.
The patient visited to an ENT in Greece, blood tests and an ultrasound showed 3 enlarged lymph nodes the biggest of which was 1.
5 cm.
The doctor told her that they are reactive and gave her antibiotics.
The lymph nodes did not go down in size and to her they seemed that they kept growing.
She visited the GP who agrees that they seems reactive and prescribes her more blood tests, which come back normal.
Her dentist was the one that referred her to and ENT, the ENT ordered a biopsy which came back positive for B cell lymphoma.
Not sure if the vaccine somehow contributed to the development of the disease.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient is not enrolled in clinical trial.
Patient was exposed to the medicine first-trimester (1-12 weeks).
The report was not related to possible inflammation of the heart (myocarditis or pericarditis).
The report was considered as serious as life threatening.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.