Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear infection, Eye pain, Facial pain, Facial paralysis
Clinical narrative: Tinnitus in her ear; May have had an ear infection; Said the pain might have came from a different area in the neck.; stated all the left side of her face started drooping/Her mouth was drooping/eye was drooping, her eyebrow was drooping/couldn't move my eyebrows/ couldn't shut her eyes, couldn't smile on that side.; I was like paralyzed; Bells palsy; couldn't shut my eyes couldn't shut her eyes,  She states that it was also extremely painful, had horrible pain for 3 weeks; it was also extremely painful/still has pain but she healed pretty good, her face is almost back to normal; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (stated all the left side of her face started drooping/Her mouth was drooping/eye was drooping, her eyebrow was drooping/couldn't move my eyebrows/ couldn't shut her eyes, couldn't smile on that side.), PARALYSIS (I was like paralyzed) and BELL'S PALSY (Bells palsy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM (ATIVAN), FLUOXETINE HYDROCHLORIDE (PROZAC), FAMOTIDINE (PEPCID [FAMOTIDINE]) and MECLIZINE HCL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FACIAL PARALYSIS (stated all the left side of her face started drooping/Her mouth was drooping/eye was drooping, her eyebrow was drooping/couldn't move my eyebrows/ couldn't shut her eyes, couldn't smile on that side.) (seriousness criterion medically significant), PARALYSIS (I was like paralyzed) (seriousness criterion medically significant), BELL'S PALSY (Bells palsy) (seriousness criterion medically significant), EYE PAIN (couldn't shut my eyes couldn't shut her eyes,  She states that it was also extremely painful, had horrible pain for 3 weeks) and FACIAL PAIN (it was also extremely painful/still has pain but she healed pretty good, her face is almost back to normal). On an unknown date, the patient experienced TINNITUS (Tinnitus in her ear), EAR INFECTION (May have had an ear infection) and NECK PAIN (Said the pain might have came from a different area in the neck.). At the time of the report, FACIAL PARALYSIS (stated all the left side of her face started drooping/Her mouth was drooping/eye was drooping, her eyebrow was drooping/couldn't move my eyebrows/ couldn't shut her eyes, couldn't smile on that side.), PARALYSIS (I was like paralyzed), BELL'S PALSY (Bells palsy), EYE PAIN (couldn't shut my eyes couldn't shut her eyes,  She states that it was also extremely painful, had horrible pain for 3 weeks), FACIAL PAIN (it was also extremely painful/still has pain but she healed pretty good, her face is almost back to normal), TINNITUS (Tinnitus in her ear), EAR INFECTION (May have had an ear infection) and NECK PAIN (Said the pain might have came from a different area in the neck.) outcome was unknown.            Patient reported that she experienced  left side of her face started drooping,mouth was drooping, eye was drooping, eyebrow was drooping. She was like Paralyzed, couldn't move her eyebrows, couldn't shut her eyes, couldn't smile on that side. Patient states that it was extremely painful and she had horrible pain for 3 weeks.  Patient received steroid pills for 10 days, Pain medicines and antibiotics as a treatment.  Patient done with  neck x ray not results are not available.  Company Comment This case concerns a 70-year-old female with serious unexpected events of facial paralysis, paralysis, and Bell's palsy, as well as non-serious eye pain, facial pain, tinnitus, ear infection, and neck pain. Event onset 30 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 70-year-old female with serious unexpected events of facial paralysis, paralysis, and Bell's palsy, as well as non-serious eye pain, facial pain, tinnitus, ear infection, and neck pain. Event onset 30 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.