Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Hypersomnia, Lip blister, Muscular weakness
Clinical narrative: Irregular, fluttering heart; Vision became tunneled; Eyes felt hot and bulging; slept a long time; Felt close to fainting/slightly fainty; Heart rate increased; Became breathless, exactly as if in a high altitude/ Breathy/Didn't get enough oxygen/felt like my brain was lacking oxygen; Flushing on my cheeks/lips flushed; Eyes felt hot and bulging/Eyes felt blistered; Lips flushed and blistered; Feeling of general weakness; Arms and legs felt like noodles; Might have been feverish or may have just been flushing; Shivery; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Irregular, fluttering heart), TUNNEL VISION (Vision became tunneled) and EXOPHTHALMOS (Eyes felt hot and bulging) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shaky feelings (Reaction to allergy shot in past) and Faint (Reaction to allergy shot in past). Concurrent medical conditions included Post concussion syndrome, Drug allergy (Cortisone), Drug allergy (Novocaine), Drug allergy (Deconge), Allergic reaction NOS (Had slight reactions to allergy shots as a teenager) and Traumatic brain injury. Concomitant products included RHEUM RHAPONTICUM ROOT (ESTROVERA), MAGNESIUM, CYANOCOBALAMIN (B12-VITAMIIN) and VITAMIN D NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Irregular, fluttering heart) (seriousness criterion medically significant), TUNNEL VISION (Vision became tunneled) (seriousness criterion medically significant), EXOPHTHALMOS (Eyes felt hot and bulging) (seriousness criterion medically significant), HYPERSOMNIA (slept a long time), PRESYNCOPE (Felt close to fainting/slightly fainty), HEART RATE INCREASED (Heart rate increased), DYSPNOEA (Became breathless, exactly as if in a high altitude/ Breathy/Didn't get enough oxygen/felt like my brain was lacking oxygen), FLUSHING (Flushing on my cheeks/lips flushed), OCULAR DISCOMFORT (Eyes felt hot and bulging/Eyes felt blistered), LIP BLISTER (Lips flushed and blistered), ASTHENIA (Feeling of general weakness), MUSCULAR WEAKNESS (Arms and legs felt like noodles), PYREXIA (Might have been feverish or may have just been flushing) and CHILLS (Shivery). At the time of the report, CARDIAC FLUTTER (Irregular, fluttering heart), TUNNEL VISION (Vision became tunneled), EXOPHTHALMOS (Eyes felt hot and bulging), HYPERSOMNIA (slept a long time), PRESYNCOPE (Felt close to fainting/slightly fainty), HEART RATE INCREASED (Heart rate increased), DYSPNOEA (Became breathless, exactly as if in a high altitude/ Breathy/Didn't get enough oxygen/felt like my brain was lacking oxygen), FLUSHING (Flushing on my cheeks/lips flushed), OCULAR DISCOMFORT (Eyes felt hot and bulging/Eyes felt blistered), LIP BLISTER (Lips flushed and blistered), ASTHENIA (Feeling of general weakness), MUSCULAR WEAKNESS (Arms and legs felt like noodles), PYREXIA (Might have been feverish or may have just been flushing) and CHILLS (Shivery) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that none of the response was psychological, emotional or fear related.  Patient felt like the event could have hurt or damaged my heart muscle and Heart pounded and actually was painful during the more intense peaks imagine It felt exactly like a heart attack No treatment information was provided.  Company comment: This spontaneous case concerns a 56-year-old, female patient with relevant medical history of drug allergy, who experienced serious unexpected events exophthalmos, tunnel vision, serious unexpected AESI event of cardiac flutter and non serious unexpected AESI events of Hypersomnia, unspecified days after receiving first dose of mRNA-1273 Vaccine. Patient reported irregular, fluttering heart that continued to increase, shortness of breath that felt like lack of oxygen supply to brain, chest pain with near fainting experience that caused impaired driving ability. She stated that her EKG showed something. She also reports similar events after second dose. History of drug allergy could be risk factor for the events. At the time of reporting, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-458217 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with relevant medical history of drug allergy, who experienced serious unexpected events exophthalmos, tunnel vision, serious unexpected AESI event of cardiac flutter and non serious unexpected AESI events of Hypersomnia, unspecified days after receiving first dose of mRNA-1273 Vaccine. Patient reported irregular, fluttering heart that continued to increase, shortness of breath that felt like lack of oxygen supply to brain, chest pain with near fainting experience that caused impaired driving ability. She stated that her EKG showed something. She also reports similar events after second dose. History of drug allergy could be risk factor for the events. At the time of reporting, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.