Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Influenza like illness, Ocular discomfort, Pain, Paraesthesia
Clinical narrative: Bell's Palsy; Felt like was having the flu; In the left side felt a tingling on the side of the face/tingling in my head; Had a hard time opening the left eye; When touched it, it would hurt; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21 and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like was having the flu), PARAESTHESIA (In the left side felt a tingling on the side of the face/tingling in my head), OCULAR DISCOMFORT (Had a hard time opening the left eye) and PAIN (When touched it, it would hurt). In April 2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE in April 2021 for Adverse event, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, BELL'S PALSY (Bell's Palsy), INFLUENZA LIKE ILLNESS (Felt like was having the flu), PARAESTHESIA (In the left side felt a tingling on the side of the face/tingling in my head), OCULAR DISCOMFORT (Had a hard time opening the left eye) and PAIN (When touched it, it would hurt) had resolved.            No concomitant medications were provided.  Treatment medication included the one that was used to treat mouth sores and the patient though it was Valtrex.  Patient reported that two weeks after the symptoms were worst, she went to the urgent center. The patient said that in the morning, she had a hard time opening the left eye and went to the urgent center because she thought she was having a stroke. She was told that she had Bell's Palsy for the symptoms that she had. She reported that she had such a tingling sensation that it would hurt when touched like when you have something sore or when you hurt your elbow. It was a Friday and by Monday she did not feel it as much. Once she started the medication, it started working. The symptoms went away after a whole week of medications.  Company comments: This case concerns a 38-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of Bell´s Palsy. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender's Comments: This case concerns a 38-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of Bell´s Palsy. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.