Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Flushing, Heart rate increased, Pruritus, Syncope, Vomiting
Clinical narrative: her whole face and ears went red; her heart rate went sky high; felt terrible chills; throwing up; fainted; extreme cramping in her stomach; Her face looked really flushed; itchy; her daughter started having terrible pains in her upper stomach the night after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 28-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Relevant Medical History: Autoimmune thyroid. Allergies: Cephalosporin, beeswax, lanolin, povidone. COVID-19 diagnosis: No.  Concurrent medical conditions included Autoimmune thyroiditis, Drug allergy, Allergy and Gastritis.    On 19-Oct-2023 at 4:30 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (extreme cramping in her stomach), FLUSHING (Her face looked really flushed), PRURITUS (itchy), ABDOMINAL PAIN UPPER (her daughter started having terrible pains in her upper stomach the night after receiving the vaccine.), CHILLS (felt terrible chills) and VOMITING (throwing up). On 22-Oct-2023, the patient experienced ERYTHEMA (her whole face and ears went red) and HEART RATE INCREASED (her heart rate went sky high). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainted), ABDOMINAL PAIN UPPER (extreme cramping in her stomach), FLUSHING (Her face looked really flushed), PRURITUS (itchy), ABDOMINAL PAIN UPPER (her daughter started having terrible pains in her upper stomach the night after receiving the vaccine.), CHILLS (felt terrible chills) and VOMITING (throwing up) had not resolved and ERYTHEMA (her whole face and ears went red) and HEART RATE INCREASED (her heart rate went sky high) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.  Company Comment: This is a Spontaneous case concerning a 28-year-old female patient with medical history of concurrent gastritis, drug allergy and autoimmune thyroiditis, who experienced the serious (per medically significant) unexpected event of syncope which occurred on the day after a dose of mRNA-1273.815 received as the fifth dose for COVID-19 Vaccination. The mentioned medical history remains as confounding risk factors. No further clinical information or diagnostic tests results were disclosed for analysis. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   No concomitant medications were reported.  The night after receiving the vaccine, the patient ate her dinner and then had extreme cramping in her stomach, after which she fainted. After she came back, she felt fine. But on 22-Oct-2023, her whole face and ears went red. Her face looked really flushed and her heart rate went sky high. At this time, the patient complained that she felt like she was going to faint. Patient had to lay down on the couch and felt terrible chills. After laying for some time, the patient got up from the couch and ended up throwing up. The patient had an autoimmune thyroid issue as well as gastritis, the patient was feeling itchy all over, but caller stated that there are no visible rashes. The caller explained further that her daughter started having terrible pains in her upper stomach the night after receiving the vaccine and got up to go to bathroom and passed out, she came around and took tums and felt better. However, last night, around the same time she was eating dinner and her face turned red. Her ears, ear lobes, and around her neck were red as well. The caller explained that the patient's face was red as a beet. Patient started complaining that she doesn't feel right. Her heart had started to race, her heart rate went sky high, and her chest felt funny and laid down, her face started to get back to a normal color. However, patient then started experiencing chills. Within the next hour, patient vomited. Patient then went upstairs to lay down and her stomach started hurting, which the caller thinks could be due to the vomiting. Caller has spoken with patient's physician as well as the pharmacist and both have said that they have heard of these symptoms with the new vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746823 (E2B Linked Report). This case was linked to MOD-2023-746868, MOD-2023-746884 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 28-year-old female patient with medical history of concurrent gastritis, drug allergy and autoimmune thyroiditis, who experienced the serious (per medically significant) unexpected event of syncope which occurred on the day after a dose of mRNA-1273.815 received as the fifth dose for COVID-19 Vaccination. The mentioned medical history remains as confounding risk factors. No further clinical information or diagnostic tests results were disclosed for analysis. The benefit-risk relationship of mRNA-1273.815 is not affected by this report. US-MODERNATX, INC.-MOD-2023-746823:DIfferent patient