Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flat affect, Hypersomnia, Hypoaesthesia, Joint swelling
Clinical narrative: it is affecting her mental health; all of this is starting to affect her day to day life; chest pain that felt like a belt wrapped around her very tight; slept over 20 hours; her doctor said it sounded like a heart related issue more than heartburn; stress; anxiety; bug bite; Histamine build up rash; Joint pain; Fatigue with no drive to do anything; Heals itched badly\ Knuckles itched badly; Hives (welts)/hives on were on her arms & legs/hives are all over; Joint swelling; Tingling/numbness in hands and feet; Very sensitive skin; Tingling/numbness in hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (it is affecting her mental health) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported  .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PRURITUS (Heals itched badly\ Knuckles itched badly), URTICARIA (Hives (welts)/hives on were on her arms & legs/hives are all over), JOINT SWELLING (Joint swelling), HYPOAESTHESIA (Tingling/numbness in hands and feet), SENSITIVE SKIN (Very sensitive skin), PARAESTHESIA (Tingling/numbness in hands and feet), RASH (Histamine build up rash), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue with no drive to do anything). On an unknown date, the patient experienced MENTAL IMPAIRMENT (it is affecting her mental health) (seriousness criterion medically significant), FLAT AFFECT (all of this is starting to affect her day to day life), CHEST PAIN (chest pain that felt like a belt wrapped around her very tight), HYPERSOMNIA (slept over 20 hours), DYSPEPSIA (her doctor said it sounded like a heart related issue more than heartburn), STRESS (stress), ANXIETY (anxiety) and ARTHROPOD BITE (bug bite). The patient was treated with ALPRAZOLAM (XANAX) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Adverse event, at an unspecified dose and frequency; DESLORATADINE (CLARINEX [DESLORATADINE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE for Adverse event, at a dose of 10 milligram. At the time of the report, MENTAL IMPAIRMENT (it is affecting her mental health), FLAT AFFECT (all of this is starting to affect her day to day life), PRURITUS (Heals itched badly\ Knuckles itched badly), URTICARIA (Hives (welts)/hives on were on her arms & legs/hives are all over), JOINT SWELLING (Joint swelling), HYPOAESTHESIA (Tingling/numbness in hands and feet), SENSITIVE SKIN (Very sensitive skin), PARAESTHESIA (Tingling/numbness in hands and feet), CHEST PAIN (chest pain that felt like a belt wrapped around her very tight), HYPERSOMNIA (slept over 20 hours), DYSPEPSIA (her doctor said it sounded like a heart related issue more than heartburn), STRESS (stress), ANXIETY (anxiety), ARTHROPOD BITE (bug bite), RASH (Histamine build up rash), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue with no drive to do anything) outcome was unknown.            Per report, the patient saw her doctor on 13Jul2021 and her doctor said it sounded like a heart related issue. She reported being on an anxiety medication in the past and she was back on it due to feelings of stress and anxiety. On an unknown date, the patient received an electrocardiogram with a normal result.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-248314 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.