Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Myocarditis, Pain in extremity, Peripheral swelling
Clinical narrative: new onset chest pain, chest pain coming and going, chest pain comes back over time, never fully recovered; Pressure; Very high blood pressure; Dizziness; Daily left leg pain; Ankle swollen; pain on the left side of the torax onset 10 days after vaccination; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (new onset chest pain, chest pain coming and going, chest pain comes back over time, never fully recovered), CHEST DISCOMFORT (Pressure), HYPERTENSION (Very high blood pressure), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Daily left leg pain) and JOINT SWELLING (Ankle swollen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Active and healthy patient until she received Moderna's vaccine.  Concurrent medical conditions included Penicillin allergy.    On 24-Mar-2021 at 2:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (pain on the left side of the torax onset 10 days after vaccination). On 14-Apr-2021 at 12:26 PM, the patient experienced CHEST PAIN (new onset chest pain, chest pain coming and going, chest pain comes back over time, never fully recovered) (seriousness criterion disability), CHEST DISCOMFORT (Pressure) (seriousness criterion disability), HYPERTENSION (Very high blood pressure) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), PAIN IN EXTREMITY (Daily left leg pain) (seriousness criterion disability) and JOINT SWELLING (Ankle swollen) (seriousness criterion disability). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHEST PAIN (new onset chest pain, chest pain coming and going, chest pain comes back over time, never fully recovered), CHEST DISCOMFORT (Pressure), HYPERTENSION (Very high blood pressure), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Daily left leg pain) and JOINT SWELLING (Ankle swollen) had not resolved and CHEST PAIN (pain on the left side of the torax onset 10 days after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood creatine phosphokinase MB (0.0-4.3): less than 1.0 mg/mL. On 14-Apr-2021, Blood pressure measurement: High upper above 180. On 14-Apr-2021, Brain natriuretic peptide (0.0-100): 64.4 pg/ml. On 14-Apr-2021, Electrocardiogram: normal electrocardiogram with sinus rhythm and normal cardiac axis. On 14-Apr-2021, Myoglobin blood (0.0-107): 50.6 ng/mL. On an unknown date, Blood pressure measurement: High elevated upper blood pressure above 140., between 110/115  55/60 and between 135/185  75/110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. On 14-Apr-2021 doctor did ECG check on heart with normal electrocardiogram with sinus rhythm and normal cardiac axis. On 14-Apr-2021, lab test TNI was performed and the result was less than 0.05ng/mL the normal range was provided as 0.00-0.40. On 14-Apr-2021, lab test DDIM was performed and the result was 101 ng/ml. Normal range was 0.0-400.  Patient experiendced chest pain, pressure, very high blood pressure, and dizziness direclty after take off from airport, she took high dose of constant ibuprofen, no medical assistance on board, flight crew escorted her to in airport Emergency Clinic. Doctors measured very high blood pressure (upper above 180) and did ECG check on heart. Disallowed to fly further to final destination. She was prescribed pain treatment course and rest. She never fully recovered. Chest pain, left leg pain comes back over time, she cannot be active and perform sports or being active. Stay on high altitude ended in daily left leg pain, ankle swollen, elevtated upper blood pressure above 140. She Cannot go on scheduled flight.  Company Comment: This is a spontaneous case regarding a 53-year-old female patient, with no relevant medical history, who experienced serious (disability) events of chest pain, chest discomfort, hypertension, dizziness, pain in extremity and swollen ankle after receiving first dose of mRNA-1273 vaccine. According to the report, patient experienced pain on the left side of the thorax 10 days after vaccination that subsided spontaneously. 21 days after vaccination, during a long haul flight, patient experienced new onset of chest pain accompanied by chest pressure, high blood pressure and dizziness. Patient took high dose of constant ibuprofen and was escorted to in airport Emergency Clinic where doctors measured blood pressure (upper above 180), performed ECG (normal result) and lab tests including CKMB, MYO, TnI, BNP and DDIM (all were between normal ranges). Patient was prescribed pain treatment course and rest, but she stated that she never fully recovered. Chest pain and left leg pain came back over time, she cannot perform sports or active life anymore and cannot fly. A stay on high altitude ended in daily left leg pain, ankle swollen, and elevated blood pressure above 140. She stated that her blood pressure was between 110/115  55/60 and is now between 135/185  75/110. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a 53-year-old female patient, with no relevant medical history, who experienced serious (disability) events of chest pain, chest discomfort, hypertension, dizziness, pain in extremity and swollen ankle after receiving first dose of mRNA-1273 vaccine. According to the report, patient experienced pain on the left side of the thorax 10 days after vaccination that subsided spontaneously. 21 days after vaccination, during a long haul flight, patient experienced new onset of chest pain accompanied by chest pressure, high blood pressure and dizziness. Patient took high dose of constant ibuprofen and was escorted to in airport Emergency Clinic where doctors measured blood pressure (upper above 180), performed ECG (normal result) and lab tests including CKMB, MYO, TnI, BNP and DDIM (all were between normal ranges). Patient was prescribed pain treatment course and rest, but she stated that she never fully recovered. Chest pain and left leg pain came back over time, she cannot perform sports or active life anymore and cannot fly. A stay on high altitude ended in daily left leg pain, ankle swollen, and elevated blood pressure above 140. She stated that her blood pressure was between 110/115  55/60 and is now between 135/185  75/110. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.