Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Postural Tachycardia; Hypertension; Swelling (local symptoms near injection site)/delayed large local reaction; Pain (local symptoms near injection site)/delayed large local reaction; This literature-non-study case was reported in a literature article and describes the occurrence of TACHYCARDIA (Postural Tachycardia) and HYPERTENSION (Hypertension) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included Face angioedema (isolated episode, approximately 40 years before). Concurrent medical conditions included Anaphylaxis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Postural Tachycardia) (seriousness criterion medically significant), HYPERTENSION (Hypertension) (seriousness criterion medically significant), VACCINATION SITE SWELLING (Swelling (local symptoms near injection site)/delayed large local reaction) and VACCINATION SITE PAIN (Pain (local symptoms near injection site)/delayed large local reaction). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN + CLAVULANIC ACID) for Adverse event, at a dose of 875 mg + 125 mg, bid, started on day 9 for 7 days.. At the time of the report, TACHYCARDIA (Postural Tachycardia), HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Swelling (local symptoms near injection site)/delayed large local reaction) and VACCINATION SITE PAIN (Pain (local symptoms near injection site)/delayed large local reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 140-156 mmhg systolic, 90-112 mmhg diastolic 140-156 mmHg systolic,  90-112 mmHg diastolic. On an unknown date, Heart rate: 130 bpm 130 bpm.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TACHYCARDIA (Postural Tachycardia), HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Swelling (local symptoms near injection site)/delayed large local reaction) and VACCINATION SITE PAIN (Pain (local symptoms near injection site)/delayed large local reaction) to be related.    No concomitant medication reported.  No COVID-19 infection in past.  Maximum lesion diameter was 19.5 cm/3.  Complete resolution status before mRNA-1273 dose 2.  Company Comment: This literature non-study case concerns a 52-year-old female patient, with medical history of facial angioedema (approximately 40 years ago), no history of COVID-19 infection, had received 3 doses of mRNA-1273 vaccines, who experienced the unexpected serious (medically significant) events of Tachycardia (reported as postural tachycardia) and Hypertension, and expected non-serious events Vaccination site swelling and Vaccination site pain that occurred after receiving mRNA-1273 vaccines. Patient reported postural tachycardia (130bpm), hypertension (140-156/90-122mmHg, vaccination site pain and swelling at around 19.5cm/3 eight days after the 1st dose. Patient started Amoxicillin-Clavulanic acid on day 9 completed for 7 days and showed complete resolution on day 14. On the 2nd mRNA-1273 vaccine dose, there was no large local recurrence, but with slight erythema noted between days 2 and 3 and systemic symptoms fever, chills, nausea, myalgias, and lymphadenopathy. Dose 2 and dose 3 were administered at median duration of 9 months. Initial symptoms reported after dose 3 were fatigue, fever 101?, myalgias, nausea, and pain as local injection site symptoms. No post vaccination treatment was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2021-126540, US-MODERNATX, INC.-MOD-2021-185699, US-MODERNATX, INC.-MOD-2021-185900, US-MODERNATX, INC.-MOD-2021-185901, US-MODERNATX, INC.-MOD-2021-185902, US-MODERNATX, INC.-MOD-2021-185903, US-MODERNATX, INC.-MOD-2021-185904, US-MODERNATX, INC.-MOD-2021-185905, US-MODERNATX, INC.-MOD-2021-185906, US-MODERNATX, INC.-MOD-2021-185907, US-MODERNATX, INC.-MOD-2021-185908, US-MODERNATX, INC.-MOD-2021-185909, US-MODERNATX, INC.-MOD-2021-076819, US-MODERNATX, INC.-MOD-2021-185674, US-MODERNATX, INC.-MOD-2021-185693, US-MODERNATX, INC.-MOD-2021-185741, US-MODERNATX, INC.-MOD-2021-185815, US-MODERNATX, INC.-MOD-2021-185816, US-MODERNATX, INC.-MOD-2021-185817, US-MODERNATX, INC.-MOD-2021-185819, US-MODERNATX, INC.-MOD-2021-185812, US-MODERNATX, INC.-MOD-2021-185814, US-MODERNATX, INC.-MOD-2021-185813 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received by safety on 18-MAY-2022  has Email with FTA received and contains significant information. Literature information On 20-May-2022: Follow up received by safety on 20-May-2022 has Email with FTA received and contains significant information including citation, historical condition, dosage information, and causality updated.; Sender's Comments: This literature non-study case concerns a 52-year-old female patient, with medical history of facial angioedema (approximately 40 years ago), no history of COVID-19 infection, had received 3 doses of mRNA-1273 vaccines, who experienced the unexpected serious (medically significant) events of Tachycardia (reported as postural tachycardia) and Hypertension, and expected non-serious events Vaccination site swelling and Vaccination site pain that occurred after receiving mRNA-1273 vaccines. Patient reported postural tachycardia (130bpm), hypertension (140-156/90-122mmHg, vaccination site pain and swelling at around 19.5cm/3 eight days after the 1st dose. Patient started Amoxicillin-Clavulanic acid on day 9 completed for 7 days and showed complete resolution on day 14. On the 2nd mRNA-1273 vaccine dose, there was no large local recurrence, but with slight erythema noted between days 2 and 3 and systemic symptoms fever, chills, nausea, myalgias, and lymphadenopathy. Dose 2 and dose 3 were administered at median duration of 9 months. Initial symptoms reported after dose 3 were fatigue, fever 101?, myalgias, nausea, and pain as local injection site symptoms. No post vaccination treatment was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement. US-MODERNATX, INC.-MOD-2021-126540:37-year-old-female, second dose US-MODERNATX, INC.-MOD-2021-185699:61-year-old-female, second dose US-MODERNATX, INC.-MOD-2021-185900: US-MODERNATX, INC.-MOD-2021-185901: US-MODERNATX, INC.-MOD-2021-185902: US-MODERNATX, INC.-MOD-2021-185903: US-MODERNATX, INC.-MOD-2021-185904: US-MODERNATX, INC.-MOD-2021-185905: US-MODERNATX, INC.-MOD-2021-185906: US-MODERNATX, INC.-MOD-2021-185907: US-MODERNATX, INC.-MOD-2021-185908: US-MODERNATX, INC.-MOD-2021-185909: US-MODERNATX, INC.-MOD-2021-076819: US-MODERNATX, INC.-MOD-2021-185674: US-MODERNATX, INC.-MOD-2021-185693: US-MODERNATX, INC.-MOD-2021-185741: US-MODERNATX, INC.-MOD-2021-185815: US-MODERNATX, INC.-MOD-2021-185816: US-MODERNATX, INC.-MOD-2021-185817: US-MODERNATX, INC.-MOD-2021-185819: US-MODERNATX, INC.-MOD-2021-185812: US-MODERNATX, INC.-MOD-2021-185814: US-MODERNATX, INC.-MOD-2021-185813: