Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lumbar puncture
Clinical narrative: bells palsy on the left side of his face; feeling like a like a piece of spaghetti/feared for his life; numbness; Guillen Barre Syndrome/diagnosed him with variety of GBS; Heart rate increase; High blood pressure; greater than 35 days between Moderna Covid-19 vaccinations; This spontaneous case was reported by a pharmacist and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillen Barre Syndrome/diagnosed him with variety), BELL'S PALSY (bells palsy on the left side of his face), FEELING ABNORMAL (feeling like a like a piece of spaghetti/feared for his life) and HYPOAESTHESIA (numbness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included PRAVASTATIN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations). In August 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillen Barre Syndrome/diagnosed him with variety of GBS) (seriousness criteria hospitalization prolonged, disability and medically significant), BELL'S PALSY (bells palsy on the left side of his face) (seriousness criteria hospitalization prolonged, disability and medically significant), FEELING ABNORMAL (feeling like a like a piece of spaghetti/feared for his life) (seriousness criteria hospitalization prolonged, disability and medically significant) and HYPOAESTHESIA (numbness) (seriousness criteria hospitalization prolonged, disability and medically significant). On 19-Oct-2021, the patient experienced HYPERTENSION (High blood pressure). On 29-Oct-2021, the patient experienced HEART RATE INCREASED (Heart rate increase ). The patient was hospitalized on sometime in August 2021 due to GUILLAIN-BARRE SYNDROME, then on sometime in August 2021 due to BELL'S PALSY, FEELING ABNORMAL and HYPOAESTHESIA. The patient was treated with PREDNISONE for Adverse event, at a dose of 40 milligram. On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) had resolved. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillen Barre Syndrome/diagnosed him with variety of GBS), BELL'S PALSY (bells palsy on the left side of his face), FEELING ABNORMAL (feeling like a like a piece of spaghetti/feared for his life), HYPOAESTHESIA (numbness) and HEART RATE INCREASED (Heart rate increase ) outcome was unknown and HYPERTENSION (High blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: high (High) Blood pressure high. In August 2021, Heart rate: high (High) pulse rate high. In August 2021, Lumbar puncture: abnormal (abnormal) diagnosed with variety of GBS. On an unknown date, Blood test: normal (normal) no negative results were reported. On an unknown date, Electrocardiogram: normal (normal) ECG normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had an adverse event GBS (Guillen barre syndrome) and was hospitalized for 3 weeks. He did not believe it is close enough to be an allergy. Caller reported he couldn't talk, walk down the hallway, so he went to the hospital for a suspected stroke. However, after the hospital did an ultrasound and some other tests, the results were negative for a stroke or TIA and he was discharged. On that Wednesday (caller is unsure of date), 2 days after being discharged from the emergency room, the patient went back to same hospital. When he arrived, his son got a wheelchair because the patient couldn't move. The patient asked to see a neurologist, who immediately diagnosed him with variety of GBS and did a spinal tap to confirm. After the spinal tap results came back positive, the hospital gave him a special IVIP for 5 days in a row.  Company's comment: This case concerns a 71-year-old male patient with a history of allergies, who experienced the unexpected, serious (hospitalization, disability and medically significant) adverse events of special interest Guillain-Barre syndrome and Bell's palsy. The event occurred approximately 6 months after the first dose of mRNA-1273 and 5 months after the second/most recent dose of mRNA-1273. The rechallenge was not applicable. Seriousness assessments has been retained as per source document, however there was no information supporting that the events resulted in a persistent or permanent incapacity. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received on 02-Nov-2021 included updated adverse event and lab data. Sender's Comments: This case concerns a 71-year-old male patient with a history of allergies, who experienced the unexpected, serious (hospitalization, disability and medically significant) adverse events of special interest Guillain-Barre syndrome and Bell's palsy. The event occurred approximately 6 months after the first dose of mRNA-1273 and 5 months after the second/most recent dose of mRNA-1273. The rechallenge was not applicable. Seriousness assessments has been retained as per source document, however there was no information supporting that the events resulted in a persistent or permanent incapacity. The benefit-risk relationship of mRNA-1273 is not affected by this report.