Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Delirium; Diarrhea; Dizziness; Dehydration; Sweating when fever broke; Loss of Appetite; Panic/Same panic and anxiety; Anxiety/Same panic and anxiety; Even worse swelling; More pain; More redness; Hardness at injection site; Fever (mostly 102F to 103.6F)/High fever; Fatigue to the degree of immobile/Much worse fatigue; Nausea; Vomiting; Muscle pain throughout body; Joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection; Fatigue; Panic; Anxiety; Experience was terrifying/3 days of the same general body symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Passed out, Feeling sick and Infusion (Infusion for osteoporosis). Concurrent medical conditions included Contrast media allergy, Lactose intolerant, Osteoporosis and Thyroid disorder. Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DEHYDRATION (Dehydration), HYPERHIDROSIS (Sweating when fever broke), DECREASED APPETITE (Loss of Appetite), PANIC ATTACK (Panic/Same panic and anxiety), ANXIETY (Anxiety/Same panic and anxiety), SWELLING (Even worse swelling), PAIN (More pain), ERYTHEMA (More redness), VACCINATION SITE INDURATION (Hardness at injection site), PYREXIA (Fever (mostly 102F to 103.6F)/High fever), FATIGUE (Fatigue to the degree of immobile/Much worse fatigue), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Muscle pain throughout body) and ARTHRALGIA (Joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection). In April 2021, the patient experienced PANIC REACTION (Panic ), ANXIETY (Anxiety), FEELING ABNORMAL (Experience was terrifying/3 days of the same general body symptoms) and FATIGUE (Fatigue). On 14-Apr-2021, DELIRIUM (Delirium), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DEHYDRATION (Dehydration), DECREASED APPETITE (Loss of Appetite), PANIC ATTACK (Panic/Same panic and anxiety), ANXIETY (Anxiety/Same panic and anxiety), SWELLING (Even worse swelling), PAIN (More pain), ERYTHEMA (More redness), VACCINATION SITE INDURATION (Hardness at injection site), FATIGUE (Fatigue to the degree of immobile/Much worse fatigue), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Muscle pain throughout body) and ARTHRALGIA (Joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection) had resolved. In April 2021, HYPERHIDROSIS (Sweating when fever broke), PANIC REACTION (Panic ), ANXIETY (Anxiety), FEELING ABNORMAL (Experience was terrifying/3 days of the same general body symptoms), PYREXIA (Fever (mostly 102F to 103.6F)/High fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 to 103.6 (High) Mostly 102F to 103.6F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         On 10-Apr-2021, the patient received second dose of Moderna vaccine and has side effects as: even worse swelling, more pain, more redness, more hardness at injection site. Fever for 54 hours, mostly 102F to 103.6F, fatigue to the degree of immobile, nausea, diarrhea, vomiting, delirium, dizziness, dehydration, muscle pain throughout body, joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection, severe sweating when fever broke for 8 hours, loss of appetite, severe panic, and severe anxiety. Duration 4 days.  Two weeks later: the patient had 3 days of the same general body symptoms, including the high fever, much worse fatigue, plus the same panic and anxiety and state that all of this experience was absolutely terrifying.   Patient had all COVID-19 PCR tests before, during, and after these weeks: all negative.  Patient experienced severe reactions to other vaccines in past: flu vaccine, yellow fever etc. Patient did not go anaphylactic, but does experience severe swelling. On one opportunity, as a child, received a vaccine and had swelling being so strong, that patient passed out.  Patient was concerned to have a third dose in the future in part because local clinical does not have so much information on what to do.  Concomitant medication included Tyrod medication and a couple of Vitamins.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-284720 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.