Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Computerised tomogram head, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Bell's palsy; Hypoaesthesia; Injected limb mobility decreased; Muscular weakness; Paraesthesia; Injection site swelling; This case was initially received via FDA VAERS (Reference number: 1490345) on 03-Aug-2021. The most recent information was received on 03-Aug-2021 and was forwarded to Moderna on an unknown date.     This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness) and PARAESTHESIA (Paraesthesia) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0352c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Meniere's disease. Concurrent medical conditions included Shellfish allergy, Bee sting, Drug allergy (aspirin), Penicillin allergy and Adhesive tape allergy. Concomitant products included IBUPROFEN, VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced BELL'S PALSY (Bell's palsy), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness), PARAESTHESIA (Paraesthesia) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, BELL'S PALSY (Bell's palsy), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness), PARAESTHESIA (Paraesthesia) and INJECTION SITE SWELLING (Injection site swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Computerised tomogram head: No results. On 19-Jul-2021, Computerised tomogram: No results.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient was diagnosed with bells palsy and patient will see a neurologist.  Company Comment:  This regulatory authority case concerns a 59-year-old female patient, with no relevant medical history reported, who experienced the non-serious expected AESI of Bell´s palsy the same day after the second dose of mRNA-1273.  A CT head was performed with no results available. Event outcome was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Upon internal review on 07-Mar-2022, significant correction was performed to add VAERS ID in the narrative and regulatory authority's case report number in the case. This case was downgraded from serious to non-serious as per the reporter; Sender's Comments: This regulatory authority case concerns a 59-year-old female patient, with no relevant medical history reported, who experienced the non-serious expected AESI of Bell´s palsy the same day after the second dose of mRNA-1273.  A CT head was performed with no results available. Event outcome was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.