Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: very strange adverse effect; small pain in the arm; something was not right with their liver; something was not right with their kidney; woke up with severe headache, like nails on the right side of their head, diagnosed with hemicrania continua,severe headaches for 7 months,pain was continuous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very strange adverse effect), PAIN IN EXTREMITY (small pain in the arm), LIVER DISORDER (something was not right with their liver), RENAL DISORDER (something was not right with their kidney) and HEADACHE (woke up with severe headache, like nails on the right side of their head, diagnosed with hemicrania continua,severe headaches for 7 months,pain was continuous) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D10A21A or H and 064M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, SIMVASTATIN and LISINOPRIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (woke up with severe headache, like nails on the right side of their head, diagnosed with hemicrania continua,severe headaches for 7 months,pain was continuous). On an unknown date, the patient experienced VACCINATION COMPLICATION (very strange adverse effect), PAIN IN EXTREMITY (small pain in the arm), LIVER DISORDER (something was not right with their liver) and RENAL DISORDER (something was not right with their kidney). The patient was treated with TIZANIDINE for Adverse event, at an unspecified dose and frequency; MELATONIN for Adverse event, at an unspecified dose and frequency; TOPIRAMATE (TROKENDI) for Adverse event, at an unspecified dose and frequency and INDOMETHACIN [INDOMETACIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (very strange adverse effect), PAIN IN EXTREMITY (small pain in the arm), LIVER DISORDER (something was not right with their liver) and RENAL DISORDER (something was not right with their kidney) outcome was unknown and HEADACHE (woke up with severe headache, like nails on the right side of their head, diagnosed with hemicrania continua,severe headaches for 7 months,pain was continuous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Patient had some blood tests show something was not right with their liver and kidney..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment: Indomethacin, but have to stop taking it after 2 months, when the headaches had really reduced.  Company Comment: This case concerns a 67 year-old female patient with no reported medical history who experienced the unexpected adverse events of special interest of liver disorder which occurred on an unknown date relative to vaccination withmRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case concerns a 67 year-old female patient with no reported medical history who experienced the unexpected adverse events of special interest of liver disorder which occurred on an unknown date relative to vaccination withmRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.