Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Anxiety, Asthenia, Autonomic nervous system imbalance, Bipolar disorder
Clinical narrative: Fibromyalgia; Feeling cold; Aching joints; Agitation; Perceived rapid heart beat; Feeling chronic nausea; Tendency toward hositily(not violence)/ Nut ball phase; Incredibly sore injection arm; Inability to self sooth/ Unable to stand in line; Emotional distress/ Felt suicidal; Anxiety; Irritability; Diarrhoea; Burning limbs/ Heat arise from toe to head; Swollen arm left; Patient has been experiencing, mania and other psychological changes the past week.; Canker sores; Burning feeling in eyes; Burning feeling in lips; Lyme disease; Neuropathy in fingers and toes; Feels more aggressive/ Frustration/ Rudeness/ Impatience; Cannot sleep/poor sleep; A rash that does not go away; Myalgia; Wired but tired feeling/ Moderate fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION SUICIDAL (Emotional distress/ Felt suicidal), LYME DISEASE (Lyme disease) and NEUROPATHY PERIPHERAL (Neuropathy in fingers and toes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Augmentin), Drug allergy (Allergy to Depakote), Drug allergy (Allergy to Tegaderm), Lyme's disease (Including Babesia, has been well managed since 2017) since 1988 and Mania (With steroids before). Concomitant products included ESTRIOL from 01-Jun-2008 to an unknown date for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Neuropathy in fingers and toes) (seriousness criterion medically significant), AGGRESSION (Feels more aggressive/ Frustration/ Rudeness/ Impatience), INSOMNIA (Cannot sleep/poor sleep), APHTHOUS ULCER (Canker sores), ORAL DISCOMFORT (Burning feeling in lips), DIARRHOEA (Diarrhoea), FEELING HOT (Burning limbs/ Heat arise from toe to head), PERIPHERAL SWELLING (Swollen arm left), RASH (A rash that does not go away), MYALGIA (Myalgia) and FATIGUE (Wired but tired feeling/ Moderate fatigue). 01-Apr-2021, the patient experienced MENTAL DISORDER (Patient has been experiencing, mania and other psychological changes the past week.) and EYE IRRITATION (Burning feeling in eyes). On 02-Apr-2021, the patient experienced ANXIETY (Anxiety) and IRRITABILITY (Irritability). On 10-Apr-2021, the patient experienced DEPRESSION SUICIDAL (Emotional distress/ Felt suicidal) (seriousness criterion medically significant), HOSTILITY (Tendency toward hositily(not violence)/ Nut ball phase) and VACCINATION SITE PAIN (Incredibly sore injection arm). 10-Apr-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Inability to self sooth/ Unable to stand in line). On 14-Apr-2021, the patient experienced TACHYCARDIA (Perceived rapid heart beat) and NAUSEA (Feeling chronic nausea). On 21-Apr-2021, the patient experienced AGITATION (Agitation). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia), FEELING COLD (Feeling cold) and ARTHRALGIA (Aching joints). The patient was treated with LORAZEPAM on 11-Apr-2021 at a dose of 1 dosage form. On 08-Apr-2021, LYME DISEASE (Lyme disease), INSOMNIA (Cannot sleep/poor sleep), MYALGIA (Myalgia) and FATIGUE (Wired but tired feeling/ Moderate fatigue) had resolved. On 10-Apr-2021, PERIPHERAL SWELLING (Swollen arm left) and RASH (A rash that does not go away) had resolved. On 20-Apr-2021, TACHYCARDIA (Perceived rapid heart beat) had resolved. On 02-May-2021, AGITATION (Agitation) had resolved. At the time of the report, DEPRESSION SUICIDAL (Emotional distress/ Felt suicidal), NEUROPATHY PERIPHERAL (Neuropathy in fingers and toes), AGGRESSION (Feels more aggressive/ Frustration/ Rudeness/ Impatience), MENTAL DISORDER (Patient has been experiencing, mania and other psychological changes the past week.), APHTHOUS ULCER (Canker sores), EYE IRRITATION (Burning feeling in eyes), ORAL DISCOMFORT (Burning feeling in lips), FIBROMYALGIA (Fibromyalgia), DIARRHOEA (Diarrhoea), IRRITABILITY (Irritability), HOSTILITY (Tendency toward hositily(not violence)/ Nut ball phase), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Inability to self sooth/ Unable to stand in line), FEELING HOT (Burning limbs/ Heat arise from toe to head), FEELING COLD (Feeling cold), ARTHRALGIA (Aching joints) and NAUSEA (Feeling chronic nausea) outcome was unknown and ANXIETY (Anxiety) and VACCINATION SITE PAIN (Incredibly sore injection arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 01-May-2021, SARS-CoV-2 antibody test: 250 (Inconclusive) SARS-CoV-2 spike protein receptor binding domain were detected.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment information includes benzodiazepines.  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 MOD21-073065, MOD21-073598, MOD21-073751, MOD21-074176 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received on 12-APR-2021 contains significant information. Patient contact details and an Event Mental disorder were updated. On 04-May-2021: Patient's all medical history, laboratory data, Concomitant medications, Treatment medications were added. Events include Irritability, Hostility, Feeling hot, Neuropathy Peripheral, Feeling cold, Tachycardia, Fibromyalgia, Agitation, Lyme disease, Depression Suicidal, Myalgia, Arthralgia, vaccination site pain, Fatigue, Nausea, Aphthous ulcer, Diarrhea, Loss of personal independence in daily activities, Peripheral swelling, Oral discomfort, Eye irritation were added. Case upgraded from non-serious to serious.; 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. MOD21-073065: MOD21-073598: MOD21-073751: MOD21-074176: