Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Diarrhoea, Guillain-Barre syndrome, Oral pain
Clinical narrative: Guillane barre syndrome; Aggravation of her guillane barre syndrome; Diarrhea; Sore throat; Lower back pain; Mouth sores; I had vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillane barre syndrome) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00DDZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaccination adverse reaction, Guillain-Barre syndrome and Long COVID. Concomitant products included METOPROLOL, CLONAZEPAM (KLONOPIN) and HYDROXYZINE for an unknown indication.    On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillane barre syndrome) (seriousness criterion medically significant), CONDITION AGGRAVATED (Aggravation of her guillane barre syndrome), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain), ORAL PAIN (Mouth sores), VOMITING (I had vomiting) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillane barre syndrome), CONDITION AGGRAVATED (Aggravation of her guillane barre syndrome), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain), ORAL PAIN (Mouth sores), VOMITING (I had vomiting) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GUILLAIN-BARRE SYNDROME (Guillane barre syndrome), CONDITION AGGRAVATED (Aggravation of her guillane barre syndrome), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain), ORAL PAIN (Mouth sores), VOMITING (I had vomiting) and PYREXIA (Fever) to be possibly related.    Company comment This spontaneous case concerns a 120-year-old, female patient with relevant medical history of Guillain-Barre Syndrome (GBS) and Klonopin (clonazepam) intake, who experienced the unexpected, serious ADR of Guillain-Barre Syndrome and the unexpected, non-serious event of condition aggravated with other associated unexpected and expected, non-serious events following administration of the first dose of the Moderna mRNA-1273. The event start dates were not provided. The patient took Tylenol (paracetamol) and Advil (ibuprofen); however, the events had not resolved at the time of the report. The rechallenge was not applicable as the events occurred after the first dose. The medical history of GBS as well as the history of Klonopin intake, which may cause the common side effects of sore throat and fever, and the less common side effects of vomiting and diarrhea, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 120-year-old, female patient with relevant medical history of Guillain-Barre Syndrome (GBS) and Klonopin (clonazepam) intake, who experienced the unexpected, serious ADR of Guillain-Barre Syndrome and the unexpected, non-serious event of condition aggravated with other associated unexpected and expected, non-serious events following administration of the first dose of the Moderna mRNA-1273. The event start dates were not provided. The patient took Tylenol (paracetamol) and Advil (ibuprofen); however, the events had not resolved at the time of the report. The rechallenge was not applicable as the events occurred after the first dose. The medical history of GBS as well as the history of Klonopin intake, which may cause the common side effects of sore throat and fever, and the less common side effects of vomiting and diarrhea, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.