Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash, Tachycardia, Throat irritation, Tongue discomfort
Clinical narrative: Panic Attack with heart rate 117-122; Tachycardia; Flank pain; getting pacemaker put in; tongue tingling and burning; muscle pain around chest and breast; Slight rash on chin; Burning sensation on throat; neck muscle pain; welts on side of nose; itchy eyes; rash under armpit; left eye burning; right leg muscle pain; pain to left side of rib cage; My heart rate go up and down and not sure if Benadryl is doing it; I had tingling on tongue off and on; I had diarrhea twice; I don't sleep; I am anxious; burning throughout the body, feet burning, vas burning, mouth burning; pain in arms and legs; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (I had tingling on tongue off and on), DIARRHOEA (I had diarrhea twice), THROAT IRRITATION (Burning sensation on throat), HEART RATE ABNORMAL (My heart rate go up and down and not sure if Benadryl is doing it) and RASH (Slight rash on chin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM for Anxiety, FAMOTIDINE (PEPCID AC), OMEGA-3-ACID ETHYL ESTER (LOVAZA), MAGNESIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE, PITAVASTATIN CALCIUM (LIVALO), EZETIMIBE (ZETIA), GLYCERYL TRINITRATE (NITROGLYCERIN LINGUAL), DENOSUMAB (PROLIA), VITAMIN B COMPLEX, FOLIC ACID, CALCIUM, VITAMIN D3, DOCUSATE SODIUM (COLACE), PROBIOTICS NOS, SODIUM CHLORIDE (AYR SALINE) and MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA ORAL (I had tingling on tongue off and on), DIARRHOEA (I had diarrhea twice), HEART RATE ABNORMAL (My heart rate go up and down and not sure if Benadryl is doing it), EYE PRURITUS (itchy eyes), RASH (rash under armpit), INSOMNIA (I don't sleep), ANXIETY (I am anxious), BURNING SENSATION (burning throughout the body, feet burning, vas burning, mouth burning), PAIN IN EXTREMITY (pain in arms and legs), CHILLS (chills), URTICARIA (welts on side of nose), EYE IRRITATION (left eye burning), PAIN IN EXTREMITY (right leg muscle pain) and MUSCULOSKELETAL CHEST PAIN (pain to left side of rib cage). On 25-Feb-2021, the patient experienced NECK PAIN (neck muscle pain). On 26-Feb-2021, the patient experienced THROAT IRRITATION (Burning sensation on throat). On 27-Feb-2021, the patient experienced RASH (Slight rash on chin). On 02-Mar-2021, the patient experienced MYALGIA (muscle pain around chest and breast). On 03-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue tingling and burning). In April 2021, the patient experienced CARDIAC PACEMAKER INSERTION (getting pacemaker put in). On an unknown date, the patient experienced PANIC ATTACK (Panic Attack with heart rate 117-122), TACHYCARDIA (Tachycardia) and FLANK PAIN (Flank pain). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Symptomatic treatment, at a dose of 60 mg. At the time of the report, PARAESTHESIA ORAL (I had tingling on tongue off and on), DIARRHOEA (I had diarrhea twice), THROAT IRRITATION (Burning sensation on throat), HEART RATE ABNORMAL (My heart rate go up and down and not sure if Benadryl is doing it), RASH (Slight rash on chin), EYE PRURITUS (itchy eyes), RASH (rash under armpit), MYALGIA (muscle pain around chest and breast), INSOMNIA (I don't sleep), ANXIETY (I am anxious), BURNING SENSATION (burning throughout the body, feet burning, vas burning, mouth burning), PAIN IN EXTREMITY (pain in arms and legs), CHILLS (chills), NECK PAIN (neck muscle pain), URTICARIA (welts on side of nose), TONGUE DISCOMFORT (tongue tingling and burning), EYE IRRITATION (left eye burning), PAIN IN EXTREMITY (right leg muscle pain) and MUSCULOSKELETAL CHEST PAIN (pain to left side of rib cage) had not resolved and CARDIAC PACEMAKER INSERTION (getting pacemaker put in), PANIC ATTACK (Panic Attack with heart rate 117-122), TACHYCARDIA (Tachycardia) and FLANK PAIN (Flank pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Benadryl oral, Benadryl IV, IV Pepcid and Allegra. Patient informed that none of the events had subsided and waiting for safety to call-back.  .   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded. On 15-Apr-2021: Significant follow up appended. On 20-May-2021: Additional information, AE Added