Adverse Event Reporting

VAERS ID 2295249
Gender Female
Age 83
StateCode FR
Pharmaceutical Company MODERNA
Lot Number 3005886
Number of vaccinations
Vaccinated 2021-10-12
Onset 2022-03-30
Condition
Symptoms
  • Glomerular filtration rate
  • Neutrophil count
  • Blood creatinine
  • Lymphocyte count
  • Monocyte count
  • Platelet count
  • Haemoglobin
  • White blood cell count
  • Serology test
  • Electrophoresis protein
  • Flow cytometry
  • Coombs direct test
  • B-cell lymphoma
  • Bone marrow myelogram

Current Illness

Preexisting Conditions

Medical History/Concurrent Conditions: Arterial hypertension; Breast cancer (radiotherapy treated breast cancer); Cardiac flutter; Cataract; CVA; Genital prolapse; Pelvic fracture; Penicillin allergy; Thyroid disorder

Other Medications

ZYMAD; BISOPROLOLUM; KARDEGIC; LEVOTHYROX; TRAMADOL; DIOSMECTITE; COMIRNATY; IRBESARTAN; ANASTROZOLE; OROCALM

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 20220330; Result Unstructured Data: 112 umol/L; Test Date: 20220511; Result Unstructured Data: Sampling of medium richness infitated by mature, small-sized, phenotype lymphoid cells that do not evoke CLL or mantle lymphoma.
; Test Date: 20220511; Test Name: Coombs direct; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20220511; Result Unstructured Data: Hypoalbuminaemia.
Presence of monoclonal immunoglobulin of the IgG Lambda type (peak).
Presence of monoclonal immunoglobulin type IgM Lambda a minima migrating between beta- and gamma globulins; Test Date: 20220511; Result Unstructured Data: Monotypic B-lymphoid population CD5 -, CD20+ strong, FMC7+ strong, CD22/79B+ low, Lambda+ low, CD200-, CD148+ low, CD180+ low, CD23-.
Matutes score 2/5.
Does not evoke LLC or mantle lymphoma.
; Test Date: 20220330; Test Name: DFG; Result Unstructured Data: 39 mL/min; Test Date: 20220330; Test Name: Hb; Result Unstructured Data: 108 9/L; Test Date: 20220330; Test Name: Lymphocytes; Result Unstructured Data: 9.
58 billion per litre; Test Date: 20220511; Test Name: Lymphocytes; Result Unstructured Data: 17.
99 billion per litre; Test Date: 20220330; Test Name: Monocytes; Result Unstructured Data: 1.
28 billion per litre; Test Date: 20220511; Test Name: Monocytes; Result Unstructured Data: 1.
58 billion per litre; Test Date: 20220330; Test Name: PNN; Result Unstructured Data: 6.
87 billion per litre; Test Date: 20220511; Test Name: PNN; Result Unstructured Data: 7.
35 billion per litre; Test Date: 20220330; Test Name: Plq; Result Unstructured Data: 167 billion per litre; Test Date: 20220511; Test Name: HTLV, VHB, VHC et VIH; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20220330; Test Name: GB; Result Unstructured Data: 17.
98 billion per litre; Test Date: 20220511; Test Name: GB; Result Unstructured Data: 27.
64 billion per litre

Write-up

B-cell lymphoma; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NY20221439) on 23-May-2022 and was forwarded to Moderna on 23-May-2022.
This regulatory authority case was reported by a physician and describes the occurrence of B-CELL LYMPHOMA (B-cell lymphoma) in an 83-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
3005886) for COVID-19 vaccination.
The patient's past medical history included Genital prolapse, Cataract, Cardiac flutter in 2001, Pelvic fracture and CVA in 2017.
Previously administered products included for COVID-19 vaccination: COMIRNATY on 06-Mar-2021 and COMIRNATY on 02-Apr-2021.
Past adverse reactions to the above products included No adverse event with COMIRNATY and COMIRNATY.
Concurrent medical conditions included Arterial hypertension, Breast cancer (radiotherapy treated breast cancer ) in June 2020, Penicillin allergy and Thyroid disorder.
Concomitant products included BISOPROLOLUM and IRBESARTAN for Arterial hypertension, ANASTROZOLE for Breast cancer, TOZINAMERAN (COMIRNATY) from 06-Mar-2021 to 02-Apr-2021 for COVID-19 vaccination, ACETYLSALICYLATE LYSINE (KARDEGIC) for Cardiovascular event prophylaxis, DIOSMECTITE for Constipation, LEVOTHYROXINE SODIUM (LEVOTHYROX) for Hypothyroidism, BENZYDAMINE HYDROCHLORIDE (OROCALM) for Mineral supplementation, TRAMADOL for Pain, COLECALCIFEROL (ZYMAD) for Vitamin D supplementation.
On 12-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form.
On 30-Mar-2022, after starting mRNA-1273 (Spikevax), the patient experienced B-CELL LYMPHOMA (B-cell lymphoma) (seriousness criterion medically significant).
At the time of the report, B-CELL LYMPHOMA (B-cell lymphoma) had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2022, Blood creatinine: 112 umol/l 112 umol/L.
On 30-Mar-2022, Glomerular filtration rate: 39 ml/min 39 mL/min.
On 30-Mar-2022, Haemoglobin: 108 g/l 108 9/L.
On 30-Mar-2022, Lymphocyte count: 9.
58 billion per litre 9.
58 billion per litre.
On 30-Mar-2022, Monocyte count: 1.
28 billion per litre 1.
28 billion per litre.
On 30-Mar-2022, Neutrophil count: 6.
87 billion per litre 6.
87 billion per litre.
On 30-Mar-2022, Platelet count: 167 billion per litre 167 billion per litre.
On 30-Mar-2022, White blood cell count: 17.
98 billion per litre 17.
98 billion per litre.
On 11-May-2022, Bone marrow myelogram: abnormal (abnormal) Sampling of medium richness infitated by mature, small-sized, phenotype lymphoid cells that do not evoke CLL or mantle lymphoma.
.
On 11-May-2022, Coombs direct test: negative (Negative) Negative.
On 11-May-2022, Electrophoresis protein: abnormal (abnormal) Hypoalbuminaemia.
Presence of monoclonal immunoglobulin of the IgG Lambda type (peak).
Presence of monoclonal immunoglobulin type IgM Lambda a minima migrating between beta- and gamma globulins.
On 11-May-2022, Flow cytometry: abnormal (abnormal) Monotypic B-lymphoid population CD5 -, CD20+ strong, FMC7+ strong, CD22/79B+ low, Lambda+ low, CD200-, CD148+ low, CD180+ low, CD23-.
Matutes score 2/5.
Does not evoke LLC or mantle lymphoma.
.
On 11-May-2022, Lymphocyte count: 17.
99 billion per litre 17.
99 billion per litre.
On 11-May-2022, Monocyte count: 1.
58 billion per litre 1.
58 billion per litre.
On 11-May-2022, Neutrophil count: 7.
35 billion per litre 7.
35 billion per litre.
On 11-May-2022, Serology test: negative (Negative) Negative.
On 11-May-2022, White blood cell count: 27.
64 billion per litre 27.
64 billion per litre.
For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.
No treatment medication was reported.
Reporter's comments : 83-year-old woman with a history of radiotherapy treated breast cancer with type B lymphoma approximately 5 months after her covid vaccination recall with Spikevax.
The patient is not reinstated at the time of reporting.
Company Comment: This regulatory case from RA concerns an 83-year-old female patient with Breast cancer treated with radiotherapy in June 2020, who experienced the unexpected serious (medically significant) event of B-cell lymphoma 5 months and 18 days after receiving an unspecified dose of mRNA-1273 vaccine.
Blood tests revealed high Lymphocytes, monocytes and white blood cells done on 2 occasions 42 days apart and decreased glomerular filtration rate and hemoglobin.
Bone marrow myelogram showed abnormal sampling of medium richness infiltrated by mature, small-sized, phenotype lymphoid cells that do not evoke chronic lymphocytic leukemia or mantle lymphoma.
Electrophoresis protein showed hypoalbuminemia, and Flow cytometry showed abnormal Monotypic B-lymphoid population that does not evoke chronic lymphocytic leukemia or mantle lymphoma.
Outcome of the event was reported as not resolved.
Patient previously received 2 doses of non-company brand COVID-19 vaccine Pfizer Comirnaty (the 2nd dose given approximately 6 months prior to current mRNA-1273 vaccine).
Breast cancer and radiotherapy may be associated with increased risk of developing other types of cancers.
The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Case seriousness assessed as per Regulatory Authority report.
; Sender's Comments: This regulatory case from RA concerns an 83-year-old female patient with Breast cancer treated with radiotherapy in June 2020, who experienced the unexpected serious (medically significant) event of B-cell lymphoma 5 months and 18 days after receiving an unspecified dose of mRNA-1273 vaccine.
Blood tests revealed high Lymphocytes, monocytes and white blood cells done on 2 occasions 42 days apart and decreased glomerular filtration rate and hemoglobin.
Bone marrow myelogram showed abnormal sampling of medium richness infiltrated by mature, small-sized, phenotype lymphoid cells that do not evoke chronic lymphocytic leukemia or mantle lymphoma.
Electrophoresis protein showed hypoalbuminemia, and Flow cytometry showed abnormal Monotypic B-lymphoid population that does not evoke chronic lymphocytic leukemia or mantle lymphoma.
Outcome of the event was reported as not resolved.
Patient previously received 2 doses of non-company brand COVID-19 vaccine Pfizer Comirnaty (the 2nd dose given approximately 6 months prior to current mRNA-1273 vaccine).
Breast cancer and radiotherapy may be associated with increased risk of developing other types of cancers.
The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Case seriousness assessed as per Regulatory Authority report.