Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Tachycardia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: severe allergic reaction to the vaccine; became incoherent, could not function; I couldn't comprehend or process what my children were saying to me, I could see their lips; Vision blurry; dizziness increased; heart was racing; 154 heart rate; woke up with a "fever"; started throwing up; face started tingling; injection site swollen; injection site with burning sensation; Covid arm; injection site hot; injection site itchy; brain fog; became dizzy, the more I moved around, the worse it would get; It like an out of body experience; I was confused; woke up with severe neck pain; neck to collarbones were swollen; low grade fever, 101.9 degrees.; ymph node in both armpits and both breast were swollen and hurt to touch; chills; extreme fatigue, had no energy at all; headache; injection site was sore to the touch, it hurt bad, but looked fine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), VISION BLURRED (Vision blurry) and DIZZINESS (dizziness increased) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), PYREXIA (low grade fever, 101.9 degrees.), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine). On 05-Apr-2021, the patient experienced DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused) and FEELING ABNORMAL (brain fog). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine) (seriousness criterion hospitalization), INCOHERENT (became incoherent, could not function) (seriousness criterion hospitalization), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips) (seriousness criteria hospitalization and disability), VISION BLURRED (Vision blurry) (seriousness criteria hospitalization and disability), DIZZINESS (dizziness increased) (seriousness criterion hospitalization), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE PAIN (injection site with burning sensation) and VACCINATION SITE SWELLING (injection site swollen). On 11-Apr-2021, the patient experienced PARAESTHESIA (face started tingling). On 11-Apr-2021 at 1:15 AM, the patient experienced TACHYCARDIA (heart was racing; 154 heart rate), PYREXIA (woke up with a "fever") and VOMITING (started throwing up). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to ANAPHYLACTIC REACTION, APHASIA, DIZZINESS, INCOHERENT and VISION BLURRED. At the time of the report, ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), DIZZINESS (dizziness increased), NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused), TACHYCARDIA (heart was racing; 154 heart rate), FEELING ABNORMAL (brain fog), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache), VACCINATION SITE PAIN (injection site with burning sensation), VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine), VACCINATION SITE SWELLING (injection site swollen), PYREXIA (woke up with a "fever") and VOMITING (started throwing up) outcome was unknown, VISION BLURRED (Vision blurry) and PYREXIA (low grade fever, 101.9 degrees.) had resolved and PARAESTHESIA (face started tingling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.9 (High) 101.9 degrees. On 11-Apr-2021, Heart rate: 154 (High) 154.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   The patient was taken to the emergency room on 06-Apr-2021 and was then hospitalized.  Treatment details included hydroxyzine and IV (intravenous) steroids, and dexamethasone as well as IV fluids. The patient was advised by her HCP (health care provider) to not take the second dose of the vaccine due to having an allergic reaction.  On 10-Apr-2021, the patient was released from the hospital but her injection site was sore, swollen and getting bigger.  The patient reported additional side effects on 11-Apr-2021 that are ongoing.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.