VAERS ID: 2331056

AGE: 67| SEX: F|STATE: FR

Description

Covod 19 - Injection triggers an autoimmune disease (polymyalia rheumatica) in the temporal and factual context.; This case was received via Regulatory Authority (Reference number: DE-PEI-202200099360) on 20-Jun-2022 and was forwarded to Moderna on 20-Jun-2022. This regulatory authority case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Covod 19 - Injection triggers an autoimmune disease (polymyalia rheumatica) in the temporal and factual context.) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005290) for COVID-19 vaccination. It was reported that patient concerned no allergies. Risk factors or pre-existing conditions reported as no specific known by father's family disposition for rheumatism. Previously administered products included for Product used for unknown indication: AstraZeneca (Covid 19 primary vaccination (Hannover vaccination center)) on 02-May-2021; for COVID-19 prophylaxis: Moderna (second vaccination) on 25-Jul-2021. Past adverse reactions to the above products included No adverse reaction with AstraZeneca and Moderna. On 13-Dec-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jan-2022, after starting mRNA-1273 (Spikevax), the patient experienced POLYMYALGIA RHEUMATICA (Covod 19 - Injection triggers an autoimmune disease (polymyalia rheumatica) in the temporal and factual context.) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (Covod 19 - Injection triggers an autoimmune disease (polymyalia rheumatica) in the temporal and factual context.) had not resolved. No concomitant medication were provided. It was reported as patient took booster vaccination moderna by region vaccination team. It was reported as patient had the first obvious symptoms was appeared on 15-Jan-2022, Fatigue, massive muscle stiffness (thigh muscle), severe hip and shoulder pain (joints on one side each); then patient had orthopedic examination o.b., family doctor suspects polymyalgia rheumatica in mid-March due to very high inflammation rates (no signs of rheumatism) and referred to a specialist who on 04-Apr-2022 Confirmed the diagnosis and establishes a factual and temporal connection with the Covid 19 booster vaccination, as no other triggering factors exist (other similar cases are known in specialist practice. Therapy was started on 05-Apr2022 with high doses of cortisone, etc.; healing remains to be seen. Company comment- This regulatory authority case concerns a 67-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) event of Polymyalgia rheumatica 1 month and 2 days after vaccination with a third dose of mRNA-1273. The patient experienced fatigue, thigh muscle stiffness, severe hip and shoulder joint pain. She sought consult with an orthopedic surgeon, obstetrics and family doctor suspects polymyalgia rheumatica due to very high inflammation rates. She was referred to a specialist who confirmed the diagnosis. Therapy with high doses of cortisone was started. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.; Sender's Comments: This regulatory authority case concerns a 67-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) event of Polymyalgia rheumatica 1 month and 2 days after vaccination with a third dose of mRNA-1273. The patient experienced fatigue, thigh muscle stiffness, severe hip and shoulder joint pain. She sought consult with an orthopedic surgeon, obstetrics and family doctor suspects polymyalgia rheumatica due to very high inflammation rates. She was referred to a specialist who confirmed the diagnosis. Therapy with high doses of cortisone was started. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.

Symptoms

Polymyalgia rheumatica

Vaccines

VAX DATE: 12-13-2021| ONSET DATE: 01-15-2022| DAYS TO ONSET: 33
NameDose #TypeManufacturerLotRouteSite
COVID19 (COVID19 (MODERNA)) 3 COVID19 MODERNA 3005290 OT Unknown

RECVDATE:06-24-2022
RPT_DATE:
CAGE_YR:
CAGE_MO:
DIED:U
DATEDIED:
L_THREAT:U
ER_VISIT:U
HOSPITAL:U
HOSPDAYS:
X_STAY:U
DISABLE:U
RECOVD:N
LAB_DATA:
V_ADMINBY:
OTHER_MEDS:
CUR_ILL:
HISTORY:Comments: It was reported that patient concerned no allergies. Risk factors or pre-existing conditions reported as no specific known by father's family disposition for rheumatism.
PRIOR_VAX:
SPLTTYPE:DEMODERNATX, INC.MOD20225
FORM_VERS:2
TODAYS_DATE:06-23-2022
BIRTH_DEFECT:U
OFC_VISIT:U
ER_ED_VISIT:U
ALLERGIES:
V_FUNDBY:

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