Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Mastoid disorder, Pruritus
Clinical narrative: fluttering of the heart; bit hard to catch a breath; Mastoid popped out; began as itchy; Odd Chest pain/odd feeling in the middle of the chest/between a slight push on the chest; She just come down with shingles /behind the left ear; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering of the heart) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colorectal cancer. Concurrent medical conditions included Penicillin allergy. Concomitant products included LOSARTAN from 01-Jan-2019 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 01-Jan-2019 to an unknown date for Blood pressure high, ATORVASTATIN from 01-Jan-2019 to an unknown date for Hypertension.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced HERPES ZOSTER (She just come down with shingles /behind the left ear). On 31-Jul-2021, the patient experienced CHEST PAIN (Odd Chest pain/odd feeling in the middle of the chest/between a slight push on the chest). On an unknown date, the patient experienced CARDIAC FLUTTER (fluttering of the heart) (seriousness criterion medically significant), DYSPNOEA (bit hard to catch a breath), MASTOID DISORDER (Mastoid popped out) and PRURITUS (began as itchy). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. On 28-Jul-2021, HERPES ZOSTER (She just come down with shingles /behind the left ear) had resolved. At the time of the report, CARDIAC FLUTTER (fluttering of the heart), DYSPNOEA (bit hard to catch a breath), CHEST PAIN (Odd Chest pain/odd feeling in the middle of the chest/between a slight push on the chest), MASTOID DISORDER (Mastoid popped out) and PRURITUS (began as itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 116/72 (normal) 116/72 and no signs of an abnormal rhythm.. On an unknown date, Heart rate: 105 (High) Heart Rate up to about 105 from a resting normal 72-74 bpm.         No treatment was reported.  Patient experienced odd feeling in the middle of the chest, hard to explain, it's between a slight push on the chest and a fluttering of the heart at the same time, it was a bit hard to catch a breath, she stopped what she was doing, relax for a moment and wait until it passes which can be seconds.  It seems to come on when lifting items, even her handbag or climbing stairs or walking on an incline.  Even walking short distances.  She have not sought medical advice at this time.  Whether the two are related was unseen at this time, but the timing seems suspicious.  This case concerns a 60-year-old female with a serious unexpected event of cardiac flutter, and non-serious dyspnoea, chest pain, mastoid disorder, pruritus, and herpes zoster. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received, updated reporter details, patient demographics, past medical history, suspect product (batch number, anatomical location), Concomitant medication indication for use and dosage details were added and additional events were added and also updated the start date and outcome for Shingles as recovered.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of cardiac flutter, and non-serious dyspnoea, chest pain, mastoid disorder, pruritus, and herpes zoster. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.