Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Syncope, Tachycardia, Tenderness
Clinical narrative: She faints, has to put her head down,; fast heartbeat; difficulty breathing; her arms are totally limp; diagnosed with shingles in her eye; silent migraine/silent migraine on the left side that later became more intense; joints in her hands a little less painful; still having pain/joints in her hands a little less painful/pain had diminished but was still evident; legs, specially the bottom half, were extremely swollen; left breast was extremely tender, it woke her up; rib cage hurt on the left and right side/rib cage was a little less painful; left breast was extremely painful, it woke her up; lump on her left thumb; diarrhea; cheek and cheek bones on the left side were "very very tender"; rash continued/rash was brighter; tongue was sore, heavily coated and swollen.; tongue was sore; The roof of her mouth ulcerated; The "normal dizziness after eating" increased for many days/"normal dizziness" continued to increase for several more days/ate and then became dizzy/dizziness was back; mouth was sore; pain on her teeth; rash on her upper torso and in the injection site; low appetite/ ate very little all day; pain at the site of injection; low fever (99.7° F); "very very tired"/tired; left side of her face was swollen; mouth and tongue were swollen/mouth and tongue were lumpy; back of her throat swollen/throat was swollen; mouth and tongue were lumpy/mouth and tongue were swollen; couldn't open her eyes; couldn't use her arms and legs/unable to walk/couldn't even attempt to walk; "It was like she was punched by the person who administered the vaccine"; "I knew that I was going to crash"/she "was crashing"/collapsed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (She faints, has to put her head down,), TACHYCARDIA (fast heartbeat), MOUTH SWELLING (mouth and tongue were swollen/mouth and tongue were lumpy), HERPES ZOSTER (diagnosed with shingles in her eye) and GLOSSODYNIA (tongue was sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental implantation (Tooth implant two years ago). Concurrent medical conditions included Rheumatoid arthritis, Allergy (allergic to some staff on Tooth implant.) and Faint (Faints after eating.). Concomitant products included PROBIOTICS NOS for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced OCULAR DISCOMFORT (couldn't open her eyes), MOBILITY DECREASED (couldn't use her arms and legs/unable to walk/couldn't even attempt to walk), FEELING ABNORMAL ("I knew that I was going to crash"/she "was crashing"/collapsed) and VACCINATION SITE DISCOMFORT ("It was like she was punched by the person who administered the vaccine"). On 09-Feb-2021, the patient experienced MOUTH SWELLING (mouth and tongue were swollen/mouth and tongue were lumpy), PHARYNGEAL SWELLING (back of her throat swollen/throat was swollen), SWELLING FACE (left side of her face was swollen), SWOLLEN TONGUE (mouth and tongue were lumpy/mouth and tongue were swollen), TOOTHACHE (pain on her teeth), DECREASED APPETITE (low appetite/ ate very little all day), VACCINATION SITE RASH (rash on her upper torso and in the injection site), VACCINATION SITE PAIN (pain at the site of injection), PYREXIA (low fever (99.7° F)) and FATIGUE ("very very tired"/tired). On 10-Feb-2021, the patient experienced GLOSSODYNIA (tongue was sore), TONGUE COATED (tongue was sore, heavily coated and swollen.), ORAL PAIN (mouth was sore), DIZZINESS (The "normal dizziness after eating" increased for many days/"normal dizziness" continued to increase for several more days/ate and then became dizzy/dizziness was back) and MOUTH ULCERATION (The roof of her mouth ulcerated). On 11-Feb-2021, the patient experienced TENDERNESS (cheek and cheek bones on the left side were "very very tender"), DIARRHOEA (diarrhea) and RASH (rash continued/rash was brighter). On 14-Feb-2021, the patient experienced SWELLING (lump on her left thumb). On 15-Mar-2021, the patient experienced BREAST PAIN (left breast was extremely painful, it woke her up), MUSCULOSKELETAL CHEST PAIN (rib cage hurt on the left and right side/rib cage was a little less painful) and BREAST TENDERNESS (left breast was extremely tender, it woke her up). On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (legs, specially the bottom half, were extremely swollen). On 31-Mar-2021, the patient experienced PAIN (still having pain/joints in her hands a little less painful/pain had diminished but was still evident). On 01-Apr-2021, the patient experienced TYPICAL AURA WITHOUT HEADACHE (silent migraine/silent migraine on the left side that later became more intense) and ARTHRALGIA (joints in her hands a little less painful). On 02-Apr-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles in her eye). On an unknown date, the patient experienced SYNCOPE (She faints, has to put her head down,), TACHYCARDIA (fast heartbeat), DYSPNOEA (difficulty breathing) and GAIT DISTURBANCE (her arms are totally limp). On 08-Feb-2021, OCULAR DISCOMFORT (couldn't open her eyes), MOBILITY DECREASED (couldn't use her arms and legs/unable to walk/couldn't even attempt to walk), FEELING ABNORMAL ("I knew that I was going to crash"/she "was crashing"/collapsed) and VACCINATION SITE DISCOMFORT ("It was like she was punched by the person who administered the vaccine") had resolved. On 12-Feb-2021, VACCINATION SITE RASH (rash on her upper torso and in the injection site) had resolved. On 29-Mar-2021, PERIPHERAL SWELLING (legs, specially the bottom half, were extremely swollen) had resolved. At the time of the report, SYNCOPE (She faints, has to put her head down,), TACHYCARDIA (fast heartbeat), MOUTH SWELLING (mouth and tongue were swollen/mouth and tongue were lumpy), HERPES ZOSTER (diagnosed with shingles in her eye), GLOSSODYNIA (tongue was sore), PHARYNGEAL SWELLING (back of her throat swollen/throat was swollen), BREAST PAIN (left breast was extremely painful, it woke her up), SWELLING FACE (left side of her face was swollen), TYPICAL AURA WITHOUT HEADACHE (silent migraine/silent migraine on the left side that later became more intense), TONGUE COATED (tongue was sore, heavily coated and swollen.), MUSCULOSKELETAL CHEST PAIN (rib cage hurt on the left and right side/rib cage was a little less painful), TENDERNESS (cheek and cheek bones on the left side were "very very tender"), BREAST TENDERNESS (left breast was extremely tender, it woke her up), SWOLLEN TONGUE (mouth and tongue were lumpy/mouth and tongue were swollen), ORAL PAIN (mouth was sore), TOOTHACHE (pain on her teeth), DYSPNOEA (difficulty breathing), DIZZINESS (The "normal dizziness after eating" increased for many days/"normal dizziness" continued to increase for several more days/ate and then became dizzy/dizziness was back), SWELLING (lump on her left thumb), GAIT DISTURBANCE (her arms are totally limp), PAIN (still having pain/joints in her hands a little less painful/pain had diminished but was still evident), MOUTH ULCERATION (The roof of her mouth ulcerated), DECREASED APPETITE (low appetite/ ate very little all day), DIARRHOEA (diarrhea), RASH (rash continued/rash was brighter), ARTHRALGIA (joints in her hands a little less painful), VACCINATION SITE PAIN (pain at the site of injection), PYREXIA (low fever (99.7° F)) and FATIGUE ("very very tired"/tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7 (Inconclusive) 99.7 F. On an unknown date, Mammogram: abnormal (abnormal) false positive diagnose of breast cancer.         Patient was allergic to some staffs (not specified) On 31-Mar-2021 she went to hospital as because of pain and took some test on rib cages,results were unknown Patient had seen heart specialist and did some tests, included heart monitor and said nothing was wrong. It was reported false positives for cancer with the vaccine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events Event syncope was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious., a causal relationship cannot be excluded.   This case was linked to MOD-2021-297711 (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 Event syncope was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious., a causal relationship cannot be excluded.