Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Anxiety, Burning sensation, Hypoaesthesia, Insomnia
Clinical narrative: increased anxiety; increased insomnia; unintentional weight loss/muscle loss; muscle twitching; tremor; skin changed/discoloration; loss of menstrual cycle; numbness throughout entire body; numbness in scalp; systemic burning sensation; tinnitus; tinnitus; This spontaneous case was reported by a pharmacist and describes the occurrence of the first episode of TINNITUS (tinnitus), the second episode of TINNITUS (tinnitus), BURNING SENSATION (systemic burning sensation), SKIN DISCOLOURATION (skin changed/discoloration) and HYPOAESTHESIA (numbness throughout entire body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergy to mango), Allergy to antibiotic (Bacitracin allergy), Allergy (Allergy to lorazepam) and Allergy to antibiotic (voriconazole allergy).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced the first episode of TINNITUS (tinnitus). On 24-Apr-2021, the patient experienced the second episode of TINNITUS (tinnitus). On 27-Apr-2021, the patient experienced BURNING SENSATION (systemic burning sensation). On 05-May-2021, the patient experienced HYPOAESTHESIA (numbness throughout entire body) and HYPOAESTHESIA (numbness in scalp). On 14-May-2021, the patient experienced MENSTRUATION IRREGULAR (loss of menstrual cycle). On 01-Jun-2021, the patient experienced SKIN DISCOLOURATION (skin changed/discoloration). On an unknown date, the patient experienced ANXIETY (increased anxiety), INSOMNIA (increased insomnia), ABNORMAL LOSS OF WEIGHT (unintentional weight loss/muscle loss), MUSCLE TWITCHING (muscle twitching) and TREMOR (tremor). The patient was treated with CLONAZEPAM (oral) in May 2018 for Anxiety, at a dose of 0.5 mg; PREDNISONE for Burning sensation, at an unspecified dose and frequency and GABAPENTIN for Burning sensation, at a dose of 200-300mg daily. On 14-Aug-2021, MENSTRUATION IRREGULAR (loss of menstrual cycle) outcome was unknown. At the time of the report, last episode of TINNITUS (tinnitus), BURNING SENSATION (systemic burning sensation), SKIN DISCOLOURATION (skin changed/discoloration), HYPOAESTHESIA (numbness in scalp), ANXIETY (increased anxiety), INSOMNIA (increased insomnia), ABNORMAL LOSS OF WEIGHT (unintentional weight loss/muscle loss), MUSCLE TWITCHING (muscle twitching) and TREMOR (tremor) had not resolved and HYPOAESTHESIA (numbness throughout entire body) had resolved. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up received included: No new information