Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Cough, Diarrhoea
Clinical narrative: broke out in a sweat; chills; cough; wheezing; doing nothing but sleeping; had to call out of work because the fatigue was so bad/extreme fatigue; slight sore throat; arm pain in right arm/painful arm; headache; nose has been running really bad; Local Urticaria; Hypersensitivity reaction; Swollen arn; Local erythema; swelling in the right elbow; diarrhea; pain in the right side; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), HYPERHIDROSIS (broke out in a sweat) and JOINT SWELLING (swelling in the right elbow) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09ID21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (persistent asthma), Seasonal allergy (she usually has seasonal allergy flare-ups in the fall and the spring.), Hypersensitivity, Hay fever, Allergy to antibiotic (Allergic to Augmentin causes upset of GI), Drug allergy (Allergic to Bromfed DM causes sedation), Allergy to antibiotic (Allergic to Doxycycline causes upset of GI), Drug allergy (Allergic to Flonase causes upset of epistaxis), Drug allergy (Allergic to Naproxen causes upset GI), Obesity, Chronic fatigue syndrome, Allergic rhinitis and GERD. Concomitant products included FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D 24 HOUR) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, FAMOTIDINE for GERD, ACETAMINOPHEN for Pain, ALBUTEROL [SALBUTAMOL] for Shortness of breath, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 03-Aug-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), RHINORRHOEA (nose has been running really bad), URTICARIA (Local Urticaria), HYPERSENSITIVITY (Hypersensitivity reaction), PERIPHERAL SWELLING (Swollen arn), ERYTHEMA (Local erythema) and HEADACHE (headache). On 05-Aug-2021, the patient experienced SOMNOLENCE (doing nothing but sleeping). 05-Aug-2021, the patient experienced FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue). On 08-Aug-2021, the patient experienced COUGH (cough) and WHEEZING (wheezing). On 13-Aug-2021, the patient experienced HYPERHIDROSIS (broke out in a sweat) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 03-Aug-2021 at a dose of 500 mg twice a day and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) (oral) from 17-Aug-2021 to 23-Aug-2021 at an unspecified dose and frequency. On 30-Aug-2002, ERYTHEMA (Local erythema) had resolved. On 30-Aug-2021, URTICARIA (Local Urticaria), HYPERSENSITIVITY (Hypersensitivity reaction) and PERIPHERAL SWELLING (Swollen arn) had resolved. At the time of the report, SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), HYPERHIDROSIS (broke out in a sweat), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), RHINORRHOEA (nose has been running really bad), FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue) and CHILLS (chills) outcome was unknown, PAIN IN EXTREMITY (arm pain in right arm/painful arm), COUGH (cough) and WHEEZING (wheezing) had not resolved and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Blood pressure measurement: 116 (normal) 116/70 mmHg. On 30-Aug-2021, Body temperature: 98 (normal) 98 F. On 30-Aug-2021, Heart rate: 87 (normal) 87 bpm. On 30-Aug-2021, Respiratory rate: 12 (normal) 12 breaths per minute..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) to be possibly related. No further causality assessments were provided for SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), HYPERHIDROSIS (broke out in a sweat), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), COUGH (cough), WHEEZING (wheezing), RHINORRHOEA (nose has been running really bad), URTICARIA (Local Urticaria), PERIPHERAL SWELLING (Swollen arn), ERYTHEMA (Local erythema), FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue), CHILLS (chills) and HEADACHE (headache).    The patient reports she began to have a cough and started wheezing, so she had to take her prescribed inhaler to work. Patient used ice as treatment. Patient seek medical care to doctors office. Patient race mentioned as black in source document.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new reporter, patient details, current conditions, lab details, concomitant medication, treatment medication, new events and narrative was updated accordingly.