Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Head discomfort, Headache, Incorrect route of product administration
Clinical narrative: Anxiety/depression worse since these headaches after COVID shot; Anxiety/depression worse since these headaches after COVID shot; Left eye pain; ear pressure; Bad headache in temple area/pain fluctuating to temples, top of head, back to head and sides of head/intense dailypressure headache; exhaustion/extreme fatigue; left side face pain/sided nose and facial pain; Severe pressure in head/facial pain/pressure; Pressure behind eye; Floaters in my eye; Vaccine administered subsutaneously; chills; Low grade temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of FACIAL PAIN (left side face pain/sided nose and facial pain), HEAD DISCOMFORT (Severe pressure in head/facial pain/pressure), OCULAR DISCOMFORT (Pressure behind eye), VITREOUS FLOATERS (Floaters in my eye) and EYE PAIN (Left eye pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Anxiety since February 2019, Drug allergy, Drug allergy and Depression since February 2019. Concomitant products included DULOXETINE for Anxiety and Depression, ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 11-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subsutaneously). On 13-Jan-2021, the patient experienced FACIAL PAIN (left side face pain/sided nose and facial pain), HEAD DISCOMFORT (Severe pressure in head/facial pain/pressure), OCULAR DISCOMFORT (Pressure behind eye), VITREOUS FLOATERS (Floaters in my eye) and FATIGUE (exhaustion/extreme fatigue). On 13-Jan-2021 at 6:30 AM, the patient experienced EYE PAIN (Left eye pain) and EAR DISCOMFORT (ear pressure). 13-Jan-2021 at 6:30 AM, the patient experienced HEADACHE (Bad headache in temple area/pain fluctuating to temples, top of head, back to head and sides of head/intense dailypressure headache). In January 2021, the patient experienced CHILLS (chills). January 2021, the patient experienced PYREXIA (Low grade temperature). On an unknown date, the patient experienced ANXIETY (Anxiety/depression worse since these headaches after COVID shot) and DEPRESSION (Anxiety/depression worse since these headaches after COVID shot). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 11-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subsutaneously) had resolved. At the time of the report, FACIAL PAIN (left side face pain/sided nose and facial pain), HEAD DISCOMFORT (Severe pressure in head/facial pain/pressure), OCULAR DISCOMFORT (Pressure behind eye), VITREOUS FLOATERS (Floaters in my eye), FATIGUE (exhaustion/extreme fatigue) and CHILLS (chills) outcome was unknown, EYE PAIN (Left eye pain), EAR DISCOMFORT (ear pressure), ANXIETY (Anxiety/depression worse since these headaches after COVID shot), DEPRESSION (Anxiety/depression worse since these headaches after COVID shot) and HEADACHE (Bad headache in temple area/pain fluctuating to temples, top of head, back to head and sides of head/intense dailypressure headache) had not resolved and PYREXIA (Low grade temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter considered EYE PAIN (Left eye pain), EAR DISCOMFORT (ear pressure) and HEADACHE (Bad headache in temple area/pain fluctuating to temples, top of head, back to head and sides of head/intense dailypressure headache) to be related. No further causality assessments were provided for FACIAL PAIN (left side face pain/sided nose and facial pain), HEAD DISCOMFORT (Severe pressure in head/facial pain/pressure), OCULAR DISCOMFORT (Pressure behind eye), VITREOUS FLOATERS (Floaters in my eye), ANXIETY (Anxiety/depression worse since these headaches after COVID shot), DEPRESSION (Anxiety/depression worse since these headaches after COVID shot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subsutaneously), FATIGUE (exhaustion/extreme fatigue), CHILLS (chills) and PYREXIA (Low grade temperature).    Description. On 29 Jan 2021, the patient saw emergency room, and the health care provider thought it to be side effects of COVID vaccine. The patient tried Methylprednisolone but no change. On 01 Feb 2021, the patient saw allergist who just gave another Methylprednisolone which did not help.  Other treatment medications included antibiotics, decongestant.   This case was linked to MOD-2021-111164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: The follow up received updated patient's information, medical history, new events and concomitant medications added, first dose date and action taken updated.