Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Investigation, Lyme disease, Nausea
Clinical narrative: Left side face dropped; Leg went numb and arm; allergy to the Moderna Covid-19 vaccine; Itching all over body; Rashes on both arms; chills (without fever); Vaccination site swelling; Nausea; Vomiting; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side face dropped) and HYPOAESTHESIA (Leg went numb and arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herpes simplex. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes infection.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced HYPERSENSITIVITY (allergy to the Moderna Covid-19 vaccine), CHILLS (chills (without fever)), NAUSEA (Nausea) and VOMITING (Vomiting). 23-Jan-2021, the patient experienced PRURITUS (Itching all over body), RASH (Rashes on both arms) and VACCINATION SITE SWELLING (Vaccination site swelling). On 30-Jan-2021, the patient experienced FACIAL PARALYSIS (Left side face dropped) (seriousness criterion hospitalization) and HYPOAESTHESIA (Leg went numb and arm) (seriousness criterion hospitalization). The patient was hospitalized on 30-Jan-2021 due to FACIAL PARALYSIS and HYPOAESTHESIA. At the time of the report, FACIAL PARALYSIS (Left side face dropped), HYPOAESTHESIA (Leg went numb and arm), HYPERSENSITIVITY (allergy to the Moderna Covid-19 vaccine), PRURITUS (Itching all over body), CHILLS (chills (without fever)), VACCINATION SITE SWELLING (Vaccination site swelling), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and RASH (Rashes on both arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 89/65 (abnormal) 89/65. On an unknown date, Body temperature: 99.1 f (Inconclusive) 99.1 F and 99.9 f (Inconclusive) 99.9 F. On an unknown date, Heart rate: 73 (normal) 73. On an unknown date, Hypersensitivity: positive (Positive) positive. On an unknown date, Investigation: negative (Negative) cancer testing negative. On an unknown date, Lyme disease: negative (Negative) Lyme disease test negative. On an unknown date, Respiratory rate: 19 (abnormal) 19. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) positive to IgG and IgM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with diphenhydramine 50mg/1ml given intramuscularly to  the left deltoid in the ER on 23 Jan 2021.  The patient was administered TPA in the critical care unit before stroke was ruled out. Reporter states "I  was tested for all allergies, PEG testing , cancer testing, limes disease all negative. The only positive is herpes simplex 1 and chicken pox which as per my infectious disease is the cause of my adverse reaction." The patient was diagnosed with allergy to Moderna COVID-19 vaccine.  This case concerns a 43-year-old female hospitalized with serious unexpected events of facial paralysis and hypoaesthesia, and nonserious unexpected hypersensitivity, pruritus and nonserious expected rash, vaccination site swelling, chills nausea, vomiting. Event onset 5 minutes after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-010198, MOD-2021-010198 (Patient Link).; Sender's Comments: This case concerns a 43-year-old female hospitalized with serious unexpected events of facial paralysis and hypoaesthesia, and nonserious unexpected hypersensitivity, pruritus and nonserious expected rash, vaccination site swelling, chills nausea, vomiting. Event onset 5 minutes after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.