Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: Positive COVID-19 PCR test; Still has from time to time: Muscle knot and cramps on the back of the left leg.; Still has from time to time: Muscle knot and cramps on the back of the left leg.; Still has from time to time: dizziness; Still has from time to time headache; Diagnosed with  Costochondritis (Inflammation in the chest wall); Pneumonia; Had a seizure and went to the emergency room at a Hospital; Potassium keeps dropping; Pain on the right side of hip & knee cap; Could not eat; Shortness Of Breath; Foggy brain; Could not stand up; Black outs; Racing Heart/Palpitation/Heart Palpitation continues from time to time 3 months after first vaccine; Diagnosed with Premature Heart Beat; Immediately after vaccination, she had a metallic taste in the mouth; Immediately after vaccination, itchiness started on her forehead and spread down the entire body.; At night she had pain on her back; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia), SEIZURE (Had a seizure and went to the emergency room at a Hospital), LOSS OF CONSCIOUSNESS (Black outs), HYPOKALAEMIA (Potassium keeps dropping) and COVID-19 (Positive COVID-19 PCR test) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, the patient experienced DYSGEUSIA (Immediately after vaccination, she had a metallic taste in the mouth), PRURITUS (Immediately after vaccination, itchiness started on her forehead and spread down the entire body.) and BACK PAIN (At night she had pain on her back). On 09-Jan-2022, the patient experienced LOSS OF CONSCIOUSNESS (Black outs) (seriousness criterion medically significant), PALPITATIONS (Racing Heart/Palpitation/Heart Palpitation continues from time to time 3 months after first vaccine), EXTRASYSTOLES (Diagnosed with Premature Heart Beat), DYSPNOEA (Shortness Of Breath), FEELING ABNORMAL (Foggy brain), DYSSTASIA (Could not stand up), FEEDING DISORDER (Could not eat) and ARTHRALGIA (Pain on the right side of hip & knee cap). On 14-Jan-2022, the patient experienced SEIZURE (Had a seizure and went to the emergency room at a Hospital) (seriousness criterion medically significant) and HYPOKALAEMIA (Potassium keeps dropping) (seriousness criterion medically significant). On 15-Jan-2022, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On 03-Feb-2022, the patient experienced COVID-19 (Positive COVID-19 PCR test) (seriousness criterion hospitalization) and COSTOCHONDRITIS (Diagnosed with  Costochondritis (Inflammation in the chest wall)). On 18-Apr-2022, the patient experienced MUSCLE MASS (Still has from time to time: Muscle knot and cramps on the back of the left leg.), MUSCLE SPASMS (Still has from time to time: Muscle knot and cramps on the back of the left leg.), DIZZINESS (Still has from time to time: dizziness) and HEADACHE (Still has from time to time headache). The patient was hospitalized on 03-Feb-2022 due to COVID-19. The patient was treated with POTASSIUM for Supplementation therapy, at an unspecified dose and frequency; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Heartbeats premature and Costochondritis, at a dose of at different times and PREDNISONE for Heartbeats premature and Costochondritis, at a dose of at different times. At the time of the report, PNEUMONIA (Pneumonia), SEIZURE (Had a seizure and went to the emergency room at a Hospital), LOSS OF CONSCIOUSNESS (Black outs), HYPOKALAEMIA (Potassium keeps dropping), COVID-19 (Positive COVID-19 PCR test), EXTRASYSTOLES (Diagnosed with Premature Heart Beat), DYSGEUSIA (Immediately after vaccination, she had a metallic taste in the mouth), PRURITUS (Immediately after vaccination, itchiness started on her forehead and spread down the entire body.), BACK PAIN (At night she had pain on her back), DYSPNOEA (Shortness Of Breath), FEELING ABNORMAL (Foggy brain), DYSSTASIA (Could not stand up), COSTOCHONDRITIS (Diagnosed with  Costochondritis (Inflammation in the chest wall)), FEEDING DISORDER (Could not eat) and ARTHRALGIA (Pain on the right side of hip & knee cap) outcome was unknown and PALPITATIONS (Racing Heart/Palpitation/Heart Palpitation continues from time to time 3 months after first vaccine), MUSCLE MASS (Still has from time to time: Muscle knot and cramps on the back of the left leg.), MUSCLE SPASMS (Still has from time to time: Muscle knot and cramps on the back of the left leg.), DIZZINESS (Still has from time to time: dizziness) and HEADACHE (Still has from time to time headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, Blood potassium: low (Low) Keeps dropping. On 14-Jan-2022, Electrocardiogram: normal (normal) Normal. On 03-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any medications prior to or during vaccination.  In the morning of 09-Jan-2022, patient started having racing heart, premature heartbeat, palpitation, pain on the right side of hip and kneecap, and shortness of breath. The patient started wearing a heart monitor at home. On 03-Feb-2022, she ended up in the hospital. She states that she does not have a medical history of seizures and no medical history of heart disease. She was not breastfeeding during or after vaccination. She states that a month ago, she started getting better. On 18-May-2022, she was able to sit up and move around. She tried Betablockers, but she could not tolerate it and discontinued it. COMPANY COMMENT: This is an spontaneous case concerning an 37-years-old female patient with  no medical history who experienced the unexpected  events of COVID-19 (AESI, seriousness criterion Hospitalization), SEIZURE, PNEUMONIA, LOSS OF CONSCIOUSNESS, HYPOKALAEMIA (seriousness criterion IME), PRURITUS, BACK PAIN, DYSGEUSIA, PALPITATIONS, EXTRASYSTOLES, DYSPNOEA, FEELING ABNORMAL, DYSSTASIA, FEEDING DISORDER,  COSTOCHONDRITIS, MUSCLE MASS, MUSCLE SPASMS. PALPITATIONS and other expected events beginning the same day after  receiving the  1st  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 37-years-old female patient with  no medical history who experienced the unexpected  events of COVID-19 (AESI, seriousness criterion Hospitalization), SEIZURE, PNEUMONIA, LOSS OF CONSCIOUSNESS, HYPOKALAEMIA (seriousness criterion IME), PRURITUS, BACK PAIN, DYSGEUSIA, PALPITATIONS, EXTRASYSTOLES, DYSPNOEA, FEELING ABNORMAL, DYSSTASIA, FEEDING DISORDER,  COSTOCHONDRITIS, MUSCLE MASS, MUSCLE SPASMS. PALPITATIONS and other expected events beginning the same day after  receiving the  1st  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.