Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Inappropriate schedule of product administration
Clinical narrative: she got Guillain-Barre after she took the booster shot; CIDP; April 2021 - Moderna 1st dose, September 2021 - Moderna 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of GUILLAIN-BARRE SYNDROME (she got Guillain-Barre after she took the booster shot) and CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (April 2021 - Moderna 1st dose, September 2021 - Moderna 2nd dose). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (she got Guillain-Barre after she took the booster shot) (seriousness criterion medically significant) and CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) (seriousness criteria disability and medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for CIDP, at a dose of UNK, qwk (once in a week). At the time of the report, GUILLAIN-BARRE SYNDROME (she got Guillain-Barre after she took the booster shot) and CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (April 2021 - Moderna 1st dose, September 2021 - Moderna 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  The patient was sick. The patient thought she pulled a muscle in her back. She was paralyzed from her collarbone down. Patient was disabled. She could not walk without a walker. She could not walk long distances without a wheelchair. She felt like she was left out there hanging on her own. The patient was told to not ever take another vaccine for the rest of her life because it will made her relapse.   Company comment. This spontaneous case concerns a 54  year  old female patient, with no medical history reported, who received a booster dose with mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant and disabling) AESI Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and the unexpected serious (medically significant) AESI Guillain  Barre Syndrome. Latency cannot be properly assessed since exact onset date was not provided. However, the report mentioned that 14 days after the booster shot, she got sick and was diagnosed with Guillain-Barre. She mentioned she was paralyzed from her collarbone down and at the time of the report she has CIDP. She was on weekly treatment with Immune globulin (Hizentra). She states she is disabled, unable to walk without a walker or long distances without a wheelchair. There is no information regarding a neurological assessment in the provided source document narrative and no lab data was reported (including electro-physiologic findings and lumbar puncture). It was noted the patient previously received two doses of mRNA  1273 vaccine in an inappropriate schedule of vaccination (5  months interval). The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-717262 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717262:Patient friend case.