Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: herpetic outbreak on my lip; 6x10 cm area of induration; Erythema 6X10 cm Injection Site; bell's palsy; injection site was itchy; increased heart rate; fever; chills; myalgia; fatigue; sore arm; This spontaneous case was reported by a physician and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HSV infection. Concomitant products included CALCIUM for Bone density abnormal, VALACICLOVIR for HSV infection, VITAMIN D3 for Vitamin D3 deficiency.   On 08-Jan-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 4:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced HEART RATE INCREASED (increased heart rate), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and FATIGUE (fatigue). 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 15-Jan-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (injection site was itchy). On 16-Jan-2021, the patient experienced ORAL HERPES (herpetic outbreak on my lip), VACCINATION SITE INDURATION (6x10 cm area of induration) and VACCINATION SITE ERYTHEMA (Erythema 6X10 cm Injection Site). On 09-Jan-2021, HEART RATE INCREASED (increased heart rate) had resolved. On 11-Jan-2021, PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia), FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm) had resolved. In January 2021, FACIAL PARALYSIS (bell's palsy) had resolved. On 19-Jan-2021, VACCINATION SITE INDURATION (6x10 cm area of induration) and VACCINATION SITE ERYTHEMA (Erythema 6X10 cm Injection Site) had resolved. At the time of the report, ORAL HERPES (herpetic outbreak on my lip) and VACCINATION SITE PRURITUS (injection site was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FACIAL PARALYSIS (bell's palsy) to be possibly related. No further causality assessments were provided for ORAL HERPES (herpetic outbreak on my lip), HEART RATE INCREASED (increased heart rate), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE INDURATION (6x10 cm area of induration), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Erythema 6X10 cm Injection Site) and VACCINATION SITE PAIN (sore arm).    Bell's Palsy.was treated with Valtrex for a week.   This case was linked to MOD-2021-090671 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Email added. Patient demographic added. Product details added. Events with outcome added. On 23-Apr-2021: Patient demographic added. Patient physical parameters added. Concomitant medications were added.  Events, bell's palsy, herpetic outbreak on my lip and sore arm were added with outcomes. Bell's palsy primary source reporter causality was updated to possible.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.