Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate abnormal, Hypersomnia, Myalgia, Nausea
Clinical narrative: still felt bad; weakness; body pain/sore arm; exhaustion, simply no energy, little tired/incredibly tired/still feels a little tired; body aches (for 1st dose); sensation of her heart working so hard due to the shivering; patient thought going to have stroke or heart attack/feel like she was going to die; feel cold; fever was 101,developing a fever /fever was 101/104 degrees/mild fever of 100 degrees; dual headache, slight headache, headache worsened/bad headache; shivering so bad, waken by her shivering; nauseous/milder nausea; slept for 4 days constantly; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (patient thought going to have stroke or heart attack/feel like she was going to die) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney atrophy in 2011. Concurrent medical conditions included Chronic kidney disease stage 3 (Left kidney is not functioning normally and had been diagnosed having chronic kidney stage 3.), Drug allergy (Medication allergies are; penicillin, cefdinir, erythromycin, bacterium, vancomycin, Zetia,) and Allergy (Latex and pepper spray). Concomitant products included LOSARTAN, PROPRANOLOL, LEVOTHYROXINE, CENTRUM SILVER +50, MAGNESIUM and PARACETAMOL (TYLENOL) for an unknown indication.    On 29-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced NEAR DEATH EXPERIENCE (patient thought going to have stroke or heart attack/feel like she was going to die) (seriousness criterion medically significant), FEELING COLD (feel cold), HEART RATE ABNORMAL (sensation of her heart working so hard due to the shivering), PYREXIA (fever was 101,developing a fever /fever was 101/104 degrees/mild fever of 100 degrees), HEADACHE (dual headache, slight headache, headache worsened/bad headache), CHILLS (shivering so bad, waken by her shivering) and NAUSEA (nauseous/milder nausea). On 30-Mar-2021, the patient experienced FEELING ABNORMAL (still felt bad), ASTHENIA (weakness), PAIN (body pain/sore arm), FATIGUE (exhaustion, simply no energy, little tired/incredibly tired/still feels a little tired) and MYALGIA (body aches (for 1st dose)). On an unknown date, the patient experienced HYPERSOMNIA (slept for 4 days constantly). On 30-Mar-2021, FEELING COLD (feel cold), PYREXIA (fever was 101,developing a fever /fever was 101/104 degrees/mild fever of 100 degrees), HEADACHE (dual headache, slight headache, headache worsened/bad headache), CHILLS (shivering so bad, waken by her shivering) and NAUSEA (nauseous/milder nausea) had resolved. On 31-Mar-2021, FEELING ABNORMAL (still felt bad), ASTHENIA (weakness), PAIN (body pain/sore arm), FATIGUE (exhaustion, simply no energy, little tired/incredibly tired/still feels a little tired) and MYALGIA (body aches (for 1st dose)) had resolved. At the time of the report, NEAR DEATH EXPERIENCE (patient thought going to have stroke or heart attack/feel like she was going to die) and HYPERSOMNIA (slept for 4 days constantly) had resolved and HEART RATE ABNORMAL (sensation of her heart working so hard due to the shivering) outcome was unknown. Event is serious as per Important medical event terms list (MedDRA version 24.0)    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 104 degrees (Inconclusive) 104 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that her symptoms were so bad from the first dose that she thought she was going to have a stroke or a heart attack and her fever was up to 104 degrees. She took Tylenol ( acetaminophen) for treatment. Today, 06-May-2021, the patient stated that she feels much more like herself but still feels a little tired.  Treatment details include, acetaminophen.  Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, fever, nausea chills fatigue and myalgia are consistent with the product safety profile.   This case was linked to MOD-2021-109712 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Events added, concomitant drug added.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, fever, nausea chills fatigue and myalgia are consistent with the product safety profile.