Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Sluggishness, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Bell's Palsy; right arm developed  red rash which was described as   2 &1/2 inch swollen; Achy painful to touch; Heaviness; headache on her left side; left side of the face was achy; Patient's right arm developed red rash which was described as 2&1/2 inch swollen,achy,painful to touc/Red raised rash; Warm and painful; Itches; Right arm was sore; Fatigue/tiredness; Headache; Chills; Joint aches/aches in all joints; Feels like muscle ache/aches in all joints and muscle; sluggish; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Allergies include penicillin and IV chemo (unsure if it was mixed).) and Drug hypersensitivity (Allergies include penicillin and IV chemo (unsure if it was mixed).). Concomitant products included ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) for Cancer.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue/tiredness), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint aches/aches in all joints) and MYALGIA (Feels like muscle ache/aches in all joints and muscle). On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Patient's right arm developed red rash which was described as 2&1/2 inch swollen,achy,painful to touc/Red raised rash), VACCINATION SITE WARMTH (Warm and painful), VACCINATION SITE PAIN (Right arm was sore) and VACCINATION SITE PRURITUS (Itches). On 02-Mar-2021, the patient experienced FACIAL PAIN (left side of the face was achy) and HEADACHE (headache on her left side). On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), SLUGGISHNESS (sluggish), PAIN (Achy painful to touch), DISCOMFORT (Heaviness) and INJECTION SITE SWELLING (right arm developed  red rash which was described as   2 &1/2 inch swollen). At the time of the report, BELL'S PALSY (Bell's Palsy), VACCINATION SITE WARMTH (Warm and painful), FACIAL PAIN (left side of the face was achy), SLUGGISHNESS (sluggish), PAIN (Achy painful to touch), DISCOMFORT (Heaviness), VACCINATION SITE PAIN (Right arm was sore), INJECTION SITE SWELLING (right arm developed  red rash which was described as   2 &1/2 inch swollen), VACCINATION SITE PRURITUS (Itches), MYALGIA (Feels like muscle ache/aches in all joints and muscle) and HEADACHE (headache on her left side) outcome was unknown and RASH ERYTHEMATOUS (Patient's right arm developed red rash which was described as 2&1/2 inch swollen,achy,painful to touc/Red raised rash), FATIGUE (Fatigue/tiredness), HEADACHE (Headache), CHILLS (Chills) and ARTHRALGIA (Joint aches/aches in all joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After one week of vaccination, the patient developed a red rash that was 2.5 in, swollen, achy and painful to touch.  After 6 days the rash got bigger and faded and then finally resolved. On 02-Mar-2021, the patient stated that she felt sluggish and tired for 6 weeks. Patient reported visiting her doctor who ordered a brain and sinus scan.  The patient reported that the doctor suspected Bell's Palsy due to the vaccination and advised her not to get the 2nd dose.  The patient was not given any prescription for treatment medications and reported that she did not take any medications.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up  received on 09-Jul-2021 was significant and diagnostic tests, concomitant medication, additional events, outcome of events and case upgraded to serious (event: Bell's palsy).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.