Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate
Clinical narrative: "she also noted that her blood pressure went up to 131/65"; feeling really tired; heart palpitation; hives which come back daily; sensation that "something there was swelling" (she could not tell) in the middle part of her right back; sensation that "something there was painful (she could not tell) in the middle part of her right bac; itching on the right side of her face; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitation), BLOOD PRESSURE INCREASED ("she also noted that her blood pressure went up to 131/65"), URTICARIA (hives which come back daily), SWELLING (sensation that "something there was swelling" (she could not tell) in the middle part of her right back) and BACK PAIN (sensation that "something there was painful (she could not tell) in the middle part of her right bac) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included G6PD deficiency (G6PD), Palpitation and Hives.    On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced PALPITATIONS (heart palpitation), URTICARIA (hives which come back daily), SWELLING (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), BACK PAIN (sensation that "something there was painful (she could not tell) in the middle part of her right bac) and PRURITUS (itching on the right side of her face). On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (feeling really tired). On 26-Dec-2021, the patient experienced BLOOD PRESSURE INCREASED ("she also noted that her blood pressure went up to 131/65"). At the time of the report, PALPITATIONS (heart palpitation) and FATIGUE (feeling really tired) had not resolved and BLOOD PRESSURE INCREASED ("she also noted that her blood pressure went up to 131/65"), URTICARIA (hives which come back daily), SWELLING (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), BACK PAIN (sensation that "something there was painful (she could not tell) in the middle part of her right bac) and PRURITUS (itching on the right side of her face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, Blood pressure measurement: 131/65 (abnormal) 131/65. On an unknown date, Heart rate: 91 (abnormal) 91 or sometimes 119.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided. 4 days before the vaccine, patient had an environmental allergy test done on the same area (middle part of her back). Patient had a history of heart Palpitation in the past and was being worked up. Echocardiogram  was performed, but the results were not reported.  Patient reported she had another cardio appointment next month and they will "further study her heart" She states that she has hives which come back daily. And this was happening before she had the Moderna shot but this again recurred when she got the Moderna shot together with the palpitation. No medications were done and the itching and the palpitation but would still come and go. She was advised by her allergist to take Benadryl but she has G6PD and Benadryl is one medication that she should avoid. Following lab tests were ordered, results were not provided - Environmental test, Food profile(onion, garlic, coconut), Alpha -Gal panel, CBC with differential, IgE Antibody , Basic Metabolic Panel, Latex Screen, ANA w/reflex if positive , Serum alkaline phosphatase, Thyroid Antithyroglobulin antibody , Thyroid peroxidase antibodies, Thyroid profile plus TSH( T3, T4, TSH ) It was reported 2nd dose was due on 18-Jan-2022.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow up contains no new information: NNI On 26-Jan-2022: Significant follow up appended : HCP reporter details updated, Lot number updated, Patient race and ethnicity added, patients initial updated.  Company Comment : This is a spontaneous case concerning a 47-year-old, female patient with relevant medical history of palpitation and hives, who experienced the unexpected non-serious events of heart palpitation, hives which come back daily, swelling (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), back pain (sensation that "something there was painful (she could not tell) in the middle part of her right back) pruritus (itching on the right side of her face) and blood pressure increased (blood pressure went up to 131/65) and expected non-serious event of fatigue (feeling really tired). The events heart palpitation, hives which come back daily, swelling (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), back pain (sensation that "something there was painful (she could not tell) in the middle part of her right back) and pruritus (itching on the right side of her face) occurred the same day with the first dose of mRNA-1273 vaccine administration, the events fatigue (feeling really tired) occurred 2 days after the first dose of mRNA-1273 vaccine administration while the event blood pressure increased (blood pressure went up to 131/65) occurred 5 days after the first dose of mRNA-1273 vaccine administration. Patient underwent diagnostic exams as follows with unknown results, environmental test, food profile (onion, garlic, coconut), alpha-gal panel, CBC with differential, IgE antibody, basic metabolic panel, latex screen, ANA w/ reflex if positive, serum alkaline phosphatase, thyroid antithyroglobulin antibody, thyroid peroxidase antibodies and thyroid profile plus TSH (T3, T4, TSH ). No reported treatment information. The outcome of the events hives which come back daily, swelling (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), back pain (sensation that "something there was painful (she could not tell) in the middle part of her right back), pruritus (itching on the right side of her face) and blood pressure increased (blood pressure went up to 131/65) were unknown, the events heart palpitation and fatigue (feeling really tired) were not resolved from the time of last observation. The medical history of palpitation and hives remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47-year-old, female patient with relevant medical history of palpitation and hives, who experienced the unexpected non-serious events of heart palpitation, hives which come back daily, swelling (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), back pain (sensation that "something there was painful (she could not tell) in the middle part of her right back) pruritus (itching on the right side of her face) and blood pressure increased (blood pressure went up to 131/65) and expected non-serious event of fatigue (feeling really tired). The events heart palpitation, hives which come back daily, swelling (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), back pain (sensation that "something there was painful (she could not tell) in the middle part of her right back) and pruritus (itching on the right side of her face) occurred the same day with the first dose of mRNA-1273 vaccine administration, the events fatigue (feeling really tired) occurred 2 days after the first dose of mRNA-1273 vaccine administration while the event blood pressure increased (blood pressure went up to 131/65) occurred 5 days after the first dose of mRNA-1273 vaccine administration. Patient underwent diagnostic exams as follows with unknown results, environmental test, food profile (onion, garlic, coconut), alpha-gal panel, CBC with differential, IgE antibody, basic metabolic panel, latex screen, ANA w/ reflex if positive, serum alkaline phosphatase, thyroid antithyroglobulin antibody, thyroid peroxidase antibodies and thyroid profile plus TSH (T3, T4, TSH ). No reported treatment information. The outcome of the events hives which come back daily, swelling (sensation that "something there was swelling" (she could not tell) in the middle part of her right back), back pain (sensation that "something there was painful (she could not tell) in the middle part of her right back), pruritus (itching on the right side of her face) and blood pressure increased (blood pressure went up to 131/65) were unknown, the events heart palpitation and fatigue (feeling really tired) were not resolved from the time of last observation. The medical history of palpitation and hives remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.