Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Sleep disorder, Tremor
Clinical narrative: trouble sleeping; GI issues..loose stools; lung inflammation; asthma; 3-4 monthly episodes of intense burning, flushing rash on face/neck/arms; itching at the back of the neck and chest; High blood pressure; rise up to 189/90 on occasion; shaking; intense, burning red rash on the chest, face, and neck, arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching at the back of the neck and chest), RASH ERYTHEMATOUS (intense, burning red rash on the chest, face, and neck, arms), HYPERTENSION (High blood pressure; rise up to 189/90 on occasion), TREMOR (shaking) and SLEEP DISORDER (trouble sleeping) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Renal agenesis (Incidental finding since her 20's). Concomitant products included AMLODIPINE for Hypertension, ALBUTEROL [SALBUTAMOL], FLUTICASONE FUROATE (ARNUITY ELLIPTA), GUAIFENESIN (MUCINEX), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZITHROMYCIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2011, the patient experienced RASH ERYTHEMATOUS (intense, burning red rash on the chest, face, and neck, arms). On 05-Apr-2021, the patient experienced PRURITUS (itching at the back of the neck and chest), HYPERTENSION (High blood pressure; rise up to 189/90 on occasion) and TREMOR (shaking). On an unknown date, the patient experienced SLEEP DISORDER (trouble sleeping), GASTROINTESTINAL DISORDER (GI issues..loose stools), PNEUMONITIS (lung inflammation), ASTHMA (asthma) and RASH (3-4 monthly episodes of intense burning, flushing rash on face/neck/arms). At the time of the report, PRURITUS (itching at the back of the neck and chest), TREMOR (shaking) and GASTROINTESTINAL DISORDER (GI issues.loose stools) outcome was unknown and RASH ERYTHEMATOUS (intense, burning red rash on the chest, face, and neck, arms), HYPERTENSION (High blood pressure; rise up to 189/90 on occasion), SLEEP DISORDER (trouble sleeping), PNEUMONITIS (lung inflammation), ASTHMA (asthma) and RASH (3-4 monthly episodes of intense burning, flushing rash on face/neck/arms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PNEUMONITIS (lung inflammation) to be possibly related. No further causality assessments were provided for PRURITUS (itching at the back of the neck and chest), RASH ERYTHEMATOUS (intense, burning red rash on the chest, face, and neck, arms), HYPERTENSION (High blood pressure; rise up to 189/90 on occasion), TREMOR (shaking), SLEEP DISORDER (trouble sleeping), GASTROINTESTINAL DISORDER (GI issues..loose stools), ASTHMA (asthma) and RASH (3-4 monthly episodes of intense burning, flushing rash on face/neck/arms).    Additional possible concomitant medications prescribed by the patient's allergist included fexofenadine (Allegra) or loratadine (Claritin) and cetirizine (Zyrtec) but were on hold for 7 days until patient had a skin test.   The patient reported treatment received while she was in the emergency room was methylprednisolone.(Medrol Dose Pack), famotidine and diphenhydramine (Benadryl) 50mg which she reported did not provided much relief. The patient also reported she was taking ciclesonide (Alvesco) inhaler and loratadine (Claritin) on daily basis for her lung inflammation.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Non-Significant F/U Case AE info Updates. On 28-May-2021: Email appended On 01-Jun-2021: Follow-up information received included additional events, medical history, concomitant medications and  treatment medications. On 01-Jun-2021: Follow-up information received with additional reporter information. On 02-Jun-2021: Follow-up information was received with updated list of concomitant medications prescribed by patient's allergist. On 02-Jun-2021: Non significant follow up On 02-Jun-2021: Initial Valid