Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Oropharyngeal discomfort, Paralysis, SARS-CoV-2 test
Clinical narrative: Felt like getting paralyzed or something; I have contracted all the symptoms of Bell's palsy; I can't lift a spoon to my mouth to eat/ hard to chew anything or to eat anything; Yesterday when swallowing felt like there was an obstruction on his throat and there was not; I keep the door closed as my speech is slurred/ hard to talk; I am embarrassed; Muscle in his neck and jaw are frozen up/ being frozen up; Upper body weakness; I fear this is either going to kill me or make me wish I were dead; I've lost 25 pounds; This spontaneous case was reported by a patient and describes the occurrence of PARALYSIS (Felt like getting paralyzed or something) and BELL'S PALSY (I have contracted all the symptoms of Bell's palsy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032b21a, 041c21a and 058hala) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu Vaccine (He got sick in 2014 after a flu vaccine.) in 2014. Past adverse reactions to the above products included Sickness with Flu Vaccine. Concurrent medical conditions included Drug allergy (He had reaction to Tetracycline 40 years ago.).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PARALYSIS (Felt like getting paralyzed or something) (seriousness criterion medically significant), BELL'S PALSY (I have contracted all the symptoms of Bell's palsy) (seriousness criterion medically significant), FEEDING DISORDER (I can't lift a spoon to my mouth to eat/ hard to chew anything or to eat anything), OROPHARYNGEAL DISCOMFORT (Yesterday when swallowing felt like there was an obstruction on his throat and there was not), DYSARTHRIA (I keep the door closed as my speech is slurred/ hard to talk), EMOTIONAL DISTRESS (I am embarrassed), MUSCULOSKELETAL STIFFNESS (Muscle in his neck and jaw are frozen up/ being frozen up), MUSCULAR WEAKNESS (Upper body weakness), FEAR OF DEATH (I fear this is either going to kill me or make me wish I were dead) and WEIGHT DECREASED (I've lost 25 pounds). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PARALYSIS (Felt like getting paralyzed or something), BELL'S PALSY (I have contracted all the symptoms of Bell's palsy), FEEDING DISORDER (I can't lift a spoon to my mouth to eat/ hard to chew anything or to eat anything), OROPHARYNGEAL DISCOMFORT (Yesterday when swallowing felt like there was an obstruction on his throat and there was not), DYSARTHRIA (I keep the door closed as my speech is slurred/ hard to talk), EMOTIONAL DISTRESS (I am embarrassed), MUSCULOSKELETAL STIFFNESS (Muscle in his neck and jaw are frozen up/ being frozen up), MUSCULAR WEAKNESS (Upper body weakness), FEAR OF DEATH (I fear this is either going to kill me or make me wish I were dead) and WEIGHT DECREASED (I've lost 25 pounds) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative, (Negative) Negative and (Negative) Negative.         Concomitant medication include a couple of blood pressure pills. Patient stated that he do not drink, smoke or take drugs. Patient was healthy before taking the Moderna vaccination. He had no history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. He never had COVID + test or diagnosis. He went to the doctor many times and to hospital back and forth for 9 months. With Flonase, he had no slightest change in his condition.  Patient underwent 3 MRIs and a CAT scan, at least 10 blood draws and will have a radiology Barium swallow tomorrow at 10:30 and that he went to the doctor many times.  Treatment included ibuprofen and only diagnostic work he had been going to the hospital back and forward for 9 months.  Company Comment: This spontaneous case reported by a patient concerns a 67-year-old male patient, with concomitant medications of unspecified blood pressure pills, who experienced unexpected, serious (medically significant) event paralysis and expected, serious (medically significant) Bell's palsy, after receiving first dose of mRNA-1273.  He reports that after first vaccination, he got symptoms of upper body weakness, lost 25 pounds, had difficulty swallowing with neck and jaw feeling frozen up, difficulty talking, feeling like getting paralyzed and it feels like Bell's palsy. The symptoms persisted for more than 9 months causing him fear, embarrassment, and emotional distress. He had numerous tests including unspecified MRI, Cat scan, and unspecified blood tests; results not reported. He was given Flonase and ibuprofen with no improvement.  The use of unspecified blood pressure pills suggestive of hypertension could be a risk factor for Bell's palsy.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2022: Follow-up received on 11-Jul-2022 included added gender as per narrative. On 11-Jul-2022: Follow-up received on 11-Jul-2022 included added reporter details, patient details, new events, lab data and dosage information. Concomitant info added in I-narrative. Reporter occupation changed from other HCP to patient.; Sender's Comments: This spontaneous case reported by a patient concerns a 67-year-old male patient, with concomitant medications of unspecified blood pressure pills, who experienced unexpected, serious (medically significant) event paralysis and expected, serious (medically significant) Bell's palsy, after receiving first dose of mRNA-1273.  He reports that after first vaccination, he got symptoms of upper body weakness, lost 25 pounds, had difficulty swallowing with neck and jaw feeling frozen up, difficulty talking, feeling like getting paralyzed and it feels like Bell's palsy.  The symptoms persisted for more than 9 months causing him fear, embarrassment, and emotional distress.  He had numerous tests including unspecified MRI, Cat scan, and unspecified blood tests; results not reported.    He was given Flonase and ibuprofen with no improvement.  The use of unspecified blood pressure pills suggestive of hypertension could be a risk factor for Bell's palsy.  The benefit risk relationship of mRNA-1273 is not affected by this report.