Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: it was the more serious, her chest cramped the next morning, she could barely breathe, she fainted,; chest cramped/like a gorilla was gripping her chest; could barely breathe/difficulty breathing; sinus infection; feeling tired after a trip; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (it was the more serious, her chest cramped the next morning, she could barely breathe, she fainted,) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 028l20a and 011j20a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart racing (SUDAFED made her heart race.). Previously administered products included for Drug use for unknown indication: Flu vaccine (Had flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (codeine or Sudafed made her heart race.) and Seasonal allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (it was the more serious, her chest cramped the next morning, she could barely breathe, she fainted,) (seriousness criterion medically significant), CHEST DISCOMFORT (chest cramped/like a gorilla was gripping her chest), DYSPNOEA (could barely breathe/difficulty breathing), SINUSITIS (sinus infection) and FATIGUE (feeling tired after a trip). At the time of the report, SYNCOPE (it was the more serious, her chest cramped the next morning, she could barely breathe, she fainted,), CHEST DISCOMFORT (chest cramped/like a gorilla was gripping her chest), DYSPNOEA (could barely breathe/difficulty breathing), SINUSITIS (sinus infection) and FATIGUE (feeling tired after a trip) outcome was unknown.            Concomitant medications was not provided by the reporter. Patient  was not immunocompromised. After the 1st booster it was more serious, her chest cramped the next morning, she could barely breathe, she fainted, it was like a gorilla was gripping her chest, difficulty breathing. That only happened once. Patient was concerned about getting another booster. Patient also mentioned experiencing a sinus infection and feeling tired after a trip. About the 3rd dose HCP told her to get to the hospital if she was unable to breathe again. The patient never experienced a similar event in the past.  Company comment-This spontaneous case concerns an elderly female patient aged 74 years with no relevant medical history reported, who experienced the unexpected (listed for Fact sheet) serious (medically significant) event of Syncope on an unknown date after receiving first Booster dose of mRNA-1273 vaccine. She also experienced non-serious events of Chest discomfort, Dyspnoea, Sinusitis and Fatigue. Patient had neck cramps after first dose, hip cramps after second dose which lasted for about an year. After first booster she had chest cramp with breathing difficulty and fainted once. She also had sinus infection and tiredness. HCP advised her to visit hospital if breathing difficulty recurs.  No further details on clinical course, lab results and treatment given were reported. Outcome of the events was unknown at the time of report. Patient had received initial schedule of vaccination with Moderna at an interval of 28 days and first booster approximately 7 months later. Elderly age of the patient could be a risk factor to the event syncope. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-609502, MOD-2022-609561 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly female patient aged 74 years with no relevant medical history reported, who experienced the unexpected (listed for Fact sheet) serious (medically significant) event of Syncope on an unknown date after receiving first Booster dose of mRNA-1273 vaccine. She also experienced non-serious events of Chest discomfort, Dyspnoea, Sinusitis and Fatigue. Patient had neck cramps after first dose, hip cramps after second dose which lasted for about an year. After first booster she had chest cramp with breathing difficulty and fainted once. She also had sinus infection and tiredness. HCP advised her to visit hospital if breathing difficulty recurs.  No further details on clinical course, lab results and treatment given were reported. Outcome of the events was unknown at the time of report. Patient had received initial schedule of vaccination with Moderna at an interval of 28 days and first booster approximately 7 months later. Elderly age of the patient could be a risk factor to the event syncope. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.