Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Blood pressure measurement, Insomnia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells Palsy / droopy mouth on the left side/left side of patient face and left/couldn't close left eye / can blink left eye, but not as much as my right eye / The doctor gave him an eye patch) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bradycardia and Pacemaker insertion (cardiac). Concurrent medical conditions included Seizure (medication was lowered last year) and Blood pressure. Concomitant products included COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced BELL'S PALSY (Bells Palsy / droopy mouth on the left side/left side of patient face and left/couldn't close left eye / can blink left eye, but not as much as my right eye / The doctor gave him an eye patch) (seriousness criterion medically significant). On 24-Sep-2022, the patient experienced INSOMNIA (couldn't get much sleep last night). At the time of the report, BELL'S PALSY (Bells Palsy / droopy mouth on the left side/left side of patient face and left/couldn't close left eye / can blink left eye, but not as much as my right eye / The doctor gave him an eye patch) and INSOMNIA (couldn't get much sleep last night) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Blood pressure was 120/81 at the doctor's and 119/79 in the hospital.         It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included unspecified medications for seizure, blood pressure, water pill, and multivitamin for 50 plus.  Dose Number one for Moderna, Lot number: 014M20A Dose was unknown, date administered was 20-Feb-2021. Dose Number twofor Moderna, Lot number: 006B21A Dose was unknown, date administered was 29-Mar-2021. Dose Number 1st booster for Moderna, Lot number: 034F21A Dose was unknown, date administered was 10-Nov-2021. Dose Number 2nd booster for Moderna, Lot number: 057M21A Dose was unknown, date administered was 27-Apr-2022.   The patient's family was vegetarian. He listed the medications that he took, and he mentioned that the dosages of his blood pressure and seizure medications were lowered. On the last night and this morning of report, the left side of his face and left with unintelligible. He went to the emergency room. They have given him a medication to help with the problem. They thought It was Bell's Palsy. He had a droopy mouth on the left side. He could not close his left eye. The doctor gave him an eye patch. He could not get much sleep last night. On the day of this report he could close that eye and blink it a bit, but it was not as much as his right eye. On the patient's forehead wrinkles were there, so it indicated he did not have a stroke. The patient had a follow up with his physician on Wednesday 28-Sep-2022. They had tested him for Lyme's Disease. patient states that there is wrinkling of the forehead in the right side.  company comment-This spontaneous case concerns a 78-year-old male patient with unspecified concomitant medications indicated for seizure and blood pressure, who experienced the expected, serious  (medically significant) adverse event of special interest Bell's palsy in the context of having received mRNA-1273 .222 Bivalent (Original AND Omicron BA.4/BA.5)  vaccine given as  fifth dose in the COVID-19 vaccination series.  Onset latency could not be determined as the exact onset date of the event was not provided. Patient presented to the emergency room with  normal blood pressure, droopy mouth on the left side, and inability to close the left eye for which he was given an eye patch and unspecified medication. On follow-up, it was reported that patient can close that eye and blink it a bit, but  not as much as his right eye.  Wrinkling of the forehead was present. Patient was tested for Lyme disease with undisclosed result. Patient previously received 4 other doses of mRNA-1273 vaccines consisting of a 2-dose primary series, and 2 booster doses.  Concurrent medical conditions of seizure and blood pressure control (as reported indications of unspecified concomitant medications) could be considered as risk factors since impaired immunity from stress brought on by medical conditions have been considered as triggers. The benefit-risk relationship of mRNA-1273 .222 Bivalent (Original AND Omicron BA.4/BA.5)  is not affected by this report.   This case was linked to MOD-2022-650861 (Patient Link). Sender's Comments: This spontaneous case concerns a 78-year-old male patient with unspecified concomitant medications indicated for seizure and blood pressure, who experienced the expected, serious  (medically significant) adverse event of special interest Bell's palsy in the context of having received mRNA-1273 .222 Bivalent (Original AND Omicron BA.4/BA.5)  vaccine given as  fifth dose in the COVID-19 vaccination series.  Onset latency could not be determined as the exact onset date of the event was not provided. Patient presented to the emergency room with  normal blood pressure, droopy mouth on the left side, and inability to close the left eye for which he was given an eye patch and unspecified medication. On follow-up, it was reported that patient can close that eye and blink it a bit, but  not as much as his right eye.  Wrinkling of the forehead was present. Patient was tested for Lyme disease with undisclosed result. Patient previously received 4 other doses of mRNA-1273 vaccines consisting of a 2-dose primary series, and 2 booster doses.  Concurrent medical conditions of seizure and blood pressure control (as reported indications of unspecified concomitant medications) could be considered as risk factors since impaired immunity from stress brought on by medical conditions have been considered as triggers. The benefit-risk relationship of mRNA-1273 .222 Bivalent (Original AND Omicron BA.4/BA.5)  is not affected by this report.