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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA||- / 1||- / OT|
Administered by: Unknown Purchased by: ??
Symptoms: Asthenia, Gait inability, Guillain-Barre syndrome
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Preexisting Conditions: Medical History/Concurrent Conditions: Pollinosis
Diagnostic Lab Data:
CDC 'Split Type': JPMODERNATX, INC.MOD20213
Write-up: Suspected Guillain-Barre-like reaction; Feelings of weakness; Gait inability; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP095967) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported by a physician, was received via the PMDA (Ref, v21127089). Guillain-Barre-like reaction was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of this vaccine. On 10-Sep-2021, at 19:15, the patient received the 2nd dose of this vaccine feelings of weakness and gait inability developed. Guillain-Barre-like reaction was suspected. On 16-Sep-2021, at present, muscle strength almost resolved (to around the level of 10-Sep-2021). Symptoms were resolving. The outcome of feelings of weakness, gait inability, and suspected Guillain-Barre-like reaction was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Guillain-Barre syndrome. The event occurred the following day the second dose of Moderna COVID vaccine was administered. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of Moderna COVID vaccine in not affected by this report.
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