Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Asthenia, Asthma, Bronchitis, Emotional distress
Clinical narrative: Worse asthma; Bronchitis; allergic to ingredients; Burning stool; Feeling not herself / Has been miserable; Feeling weak; believes that she has poison in her body; suffering for four months/ suffering the past couple of months; Whole stomach is covered with red bumps/has more bumps in the crack of her behind, under her behind, in between her legs,all over the inside of her arms; Hives all over her body/temperature hives. itchy and painful to touch/hurt like shingles; Painful to touch; Itchy bumps in the crack of the behind/ under the behind/ between legs/inside of the arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Worse asthma), BRONCHITIS (Bronchitis) and AUTOIMMUNE DISORDER (Autoimmune disease got affected/ autoimmune system affected) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Pregnancy (Had 2 natural child birth), Surgery (Spine, patient has implants in spine) and Surgery. Concurrent medical conditions included Sulfonamide allergy, Disability, Hives, Autoimmune disorder and Allergy to chemicals.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Hives all over her body/temperature hives. itchy and painful to touch/hurt like shingles), PAIN (Painful to touch), PRURITUS (Itchy bumps in the crack of the behind/ under the behind/ between legs/inside of the arms), EMOTIONAL DISTRESS (suffering for four months/ suffering the past couple of months) and RASH ERYTHEMATOUS (Whole stomach is covered with red bumps/has more bumps in the crack of her behind, under her behind, in between her legs,all over the inside of her arms). On an unknown date, the patient experienced ASTHMA (Worse asthma) (seriousness criterion hospitalization), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), AUTOIMMUNE DISORDER (Autoimmune disease got affected/ autoimmune system affected) (seriousness criterion medically significant), ALLERGY TO VACCINE (allergic to ingredients), FAECES HARD (Burning stool), FEELING ABNORMAL (Feeling not herself / Has been miserable), ASTHENIA (Feeling weak) and FEELING ABNORMAL (believes that she has poison in her body). The patient was treated with ALBUTEROL [SALBUTAMOL] for Bronchitis, at a dose of UNK dosage form, qid; CETIRIZINE for Hives, at a dose of 1 dosage form four times per day and LEVOCETIRIZINE for Hives, at a dose of 1 dosage form four times per day. At the time of the report, ASTHMA (Worse asthma) and AUTOIMMUNE DISORDER (Autoimmune disease got affected/ autoimmune system affected) had not resolved, BRONCHITIS (Bronchitis), ALLERGY TO VACCINE (allergic to ingredients), PAIN (Painful to touch), PRURITUS (Itchy bumps in the crack of the behind/ under the behind/ between legs/inside of the arms), FAECES HARD (Burning stool), FEELING ABNORMAL (Feeling not herself / Has been miserable), ASTHENIA (Feeling weak), EMOTIONAL DISTRESS (suffering for four months/ suffering the past couple of months), RASH ERYTHEMATOUS (Whole stomach is covered with red bumps/has more bumps in the crack of her behind, under her behind, in between her legs,all over the inside of her arms) and FEELING ABNORMAL (believes that she has poison in her body) outcome was unknown and URTICARIA (Hives all over her body/temperature hives. itchy and painful to touch/hurt like shingles) had resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.  Other treatment information includes Breathing machine and Breo Ellipta hand haler. The patient went to pulmonologist for treatment of lungs. The patient took  antibiotics for bronchitis.   The patient was an allergic hives patient and disabled. Her whole stomach is covered with red bumps and started getting the adverse event symptoms the night of getting the vaccine. She had more bumps in the crack of her behind, under her behind, in between her legs, all over the inside of her arms, and burning stool.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received added new events, Medical history and treatment medications. On 25-May-2021: Follow-up information received on 25-May-2021 and information regarding serious events and case upgraded to serious, additional medical history and newtreatment medications added. On 26-May-2021: Follow-up received on 26-May-2021 contains information regarding medical history (allergy) and additional event (allergy to ingredients).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.