Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Fatigue, Feeling abnormal, Heat stroke
Clinical narrative: bells palsy/right side of my face wasn't working; like I had heat stroke; throat started to hurt; head cold; felt bad; pain behind my right ear; tired; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bells palsy/right side of my face wasn't working) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (bells palsy/right side of my face wasn't working) (seriousness criterion medically significant), HEAT STROKE (like I had heat stroke), OROPHARYNGEAL PAIN (throat started to hurt), NASOPHARYNGITIS (head cold), FEELING ABNORMAL (felt bad), EAR PAIN (pain behind my right ear) and FATIGUE (tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (bells palsy/right side of my face wasn't working) and EAR PAIN (pain behind my right ear) had not resolved and HEAT STROKE (like I had heat stroke), OROPHARYNGEAL PAIN (throat started to hurt), NASOPHARYNGITIS (head cold), FEELING ABNORMAL (felt bad) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment included sleep, antibiotics, steroids, drinking a lot of water and physical therapy. At the end of august patient had a day where patient was out in the sun for a long time then felt like  had heat stroke. That Saturday night the throat started to hurt, patient had a head cold, felt bad, and tired. Patient took Theraflu, started sleeping more, and drinking a lot of water. Patient  did not have any fever, trouble breathing, or congestion. The symptoms lasted a week before resolving. After this all went away, the next day patient woke up with a pain behind the right ear. The day after the ear pain continued and patient woke up with the right side of the face not working. Patient went to see the HCP who gave a covid test which was negative, and prescribed antibiotics and steroids. Patient was diagnosed with bells palsy. Patient had follow-up with her HCP and now was doing physical therapy with the face 2x a week. The right side of the face was still not completely back to normal at this point.  Company comment:  This case concerns a 60 year old female, with no medical history reported, who experienced  Serious ( Medically Significant )  , expected  event of Bell's palsy and other non-serious events which occurred on an unknown date with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) .  The  patient was treated with Steriods  , antibiotics and underwent physical therapy. The re-challenge for this case is not applicable since the event has not yet resolved and the events occurred after the 2nd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 60 year old female, with no medical history reported, who experienced  Serious ( Medically Significant )  , expected  event of Bell's palsy and other non-serious events which occurred on an unknown date with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) .  The  patient was treated with Steriods  , antibiotics and underwent physical therapy. The re-challenge for this case is not applicable since the event has not yet resolved and the events occurred after the 2nd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.