Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rales, Respiratory tract congestion, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: heart arrhythmia, racing heart began - pulse range from 44 to 170 sitting still; chest congestion; Excessive mucus production (yellow/gray) coughing up from chest; sore throat; sinus pressure; crackle in lungs and voice; ringing ears; can't sleep; sore arm; Had a fever of over 100.2 (normal temp is 97.2) but likely went higher during sleep/cold sweat with chills/Can't eat/illness/ bedridden/body aches/ headache; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (heart arrhythmia, racing heart began - pulse range from 44 to 170 sitting still) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043335) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Relapsing Polychondritis (rare autoimmune disease).  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot number: 013A21A and ROA: Intramuscular) on 02-Mar-2021, Moderna COVID-19 Vaccine (Lot number: 013A21A and ROA: Intramuscular) on 30-Mar-2021, Moderna COVID-19 Vaccine (Lot number: 014F21A and ROA: Intramuscular) on 04-Nov-2021, Spikevax (Lot number: 042521A and ROA: Intramuscular) on 04-Apr-2022, MODERNA COVID-19 VACCINE, BIVALENT (Lot number: A57163B and ROA: Intramuscular) on 27-Sep-2022, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Lot number: 019H22A and ROA: Intramuscular) on 16-May-2023. Past adverse reactions to the above products included No adverse effect with MODERNA COVID-19 VACCINE, BIVALENT, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Spikevax. Concurrent medical conditions included Relapsing polychondritis ((rare autoimmune disease)). Concomitant products included Propranolol hydrochloride (Propranolol) and Colecalciferol (Vitamin d) for an unknown indication.    On 21-Oct-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-Oct-2024, the patient experienced ARRHYTHMIA (heart arrhythmia, racing heart began - pulse range from 44 to 170 sitting still) (seriousness criterion medically significant). 25-Oct-2024, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion), COUGH (Excessive mucus production (yellow/gray) coughing up from chest), OROPHARYNGEAL PAIN (sore throat), PARANASAL SINUS DISCOMFORT (sinus pressure), RALES (crackle in lungs and voice), TINNITUS (ringing ears), INSOMNIA (can't sleep), PAIN IN EXTREMITY (sore arm) and PYREXIA (Had a fever of over 100.2 (normal temp is 97.2) but likely went higher during sleep/cold sweat with chills/Can't eat/illness/ bedridden/body aches/ headache). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at a dose of 25 milligram and Dextromethorphan hydrobromide, Doxylamine succinate, Ephedrine sulfate, Ethanol, Paracetamol (Nyquil) in 2024 at a dose of UNK, last night. At the time of the report, ARRHYTHMIA (heart arrhythmia, racing heart began - pulse range from 44 to 170 sitting still), RESPIRATORY TRACT CONGESTION (chest congestion), COUGH (Excessive mucus production (yellow/gray) coughing up from chest), OROPHARYNGEAL PAIN (sore throat), PARANASAL SINUS DISCOMFORT (sinus pressure), RALES (crackle in lungs and voice), INSOMNIA (can't sleep) and PAIN IN EXTREMITY (sore arm) was resolving, TINNITUS (ringing ears) outcome was unknown and PYREXIA (Had a fever of over 100.2 (normal temp is 97.2) but likely went higher during sleep/cold sweat with chills/Can't eat/illness/ bedridden/body aches/ headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, SARS-CoV-2 test: (Negative) Took 2 at-home covid tests during this time that came back negative.. On 25-Oct-2024, Body temperature: Had a fever of over 100.2 (normal temp is 97.2) but likely went higher during sleep. On 25-Oct-2024, Heart rate: Heart arrhythmia, racing heart began - pulse range from 44 to 170 sitting still.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   On 17-NOV-2023, patient received Spikevax 2023-2024 PFS with lot number 3031417 via intramuscular route.  It was reported that for the first few days after my 8th shot side effects were like all the others, sore arm, body aches, fatigue but then more severe reactions began. Began feeling chest pressure and chest congestion which turned severe, barely able to breathe. Had a fever of over 100.2 (normal temp is 97.2) but likely went higher during sleep, when I awaken in cold sweat with chills. Excessive mucus production (yellow/gray) coughing up from chest, sore throat, crackle in lungs and voice. Sinus pressure, ringing ears, complete exhaustion, cannot eat and cannot sleep. A week after the shot, heart arrhythmia, racing heart began - pulse range from 44 to 170 sitting still, chest pain/pressure, headache. Completely incapacitated, trouble breathing. Patient never had covid. This was now day 13 after the shot and Patient still sick and bedridden but fever was gone, and heart rate was beginning to look more normal.   It was unknown if the patient experienced any additional symptoms/events.   Patient daily take propranolol, quercetin supplement 1000mg, and Vitamin D.  In response to side effects patient began taking Benadryl 25mg and last night (day 12 after the shot) started NyQuil. Helped some.   It was unknown if the patient had any additional medical history, concomitant disease, or risk factor. There were no lab data/results available.   This case was linked to US-MODERNATX, INC.-MOD-2024-776451 (E2B Linked Report).; Reporter's Comments: Company comment: The medical history of relapsing Polychondritis could be a confounding factor for event arrhythmia.  The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776451:Same reporter but different patient (Husband Case)