Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Giant cell arteritis, Inappropriate schedule of product administration, Red blood cell sedimentation rate decreased
Clinical narrative: temporal arteritis/ high fever/ chills/ sweats/ body ache/ quite miserable/ inflammation of the arteries; The booster dose was given after 9 months and 9 days of 2 doses of primary series of mRNA-1273 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of GIANT CELL ARTERITIS (temporal arteritis/ high fever/ chills/ sweats/ body ache/ quite miserable/ inflammation of the arteries) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster dose was given after 9 months and 9 days of 2 doses of primary series of mRNA-1273 vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 007M20A and 011J20A) for COVID-19 vaccination.     The patient did not experienced allergies (medications, food and other products). The patient did not experience COVID positive test or diagnosis. The patient did not receive other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes, Gout and Hypertension.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster dose was given after 9 months and 9 days of 2 doses of primary series of mRNA-1273 vaccine) (seriousness criterion hospitalization). On 12-Dec-2021, the patient experienced GIANT CELL ARTERITIS (temporal arteritis/ high fever/ chills/ sweats/ body ache/ quite miserable/ inflammation of the arteries) (seriousness criterion hospitalization). The patient was hospitalized from sometime in December 2021 to sometime in December 2021 due to GIANT CELL ARTERITIS and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, GIANT CELL ARTERITIS (temporal arteritis/ high fever/ chills/ sweats/ body ache/ quite miserable/ inflammation of the arteries) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster dose was given after 9 months and 9 days of 2 doses of primary series of mRNA-1273 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate decreased: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included: oral hypoglycemic, medication for hypertension, medication for gout. Treatment medications also included Steroids and IV injection. The patient got sick on 12-Dec-2021 and was hospitalized for 14-15 days. He experienced high fever, chills, sweats, body ache and was quite miserable. He was diagnosed with temporal arteritis, which was inflammation of the arteries. The AE cause patient to seek medical care. The patient did not experience a similar event in past. The patient was taking medicine, his sedimentation rate was low.  Company comment: This spontaneous case concerns a 74-year-old male patient, with relevant medical history of diabetes mellitus, gout, and hypertension, who experienced the unexpected serious (hospitalization) event of Giant cell arteritis that occurred 20 days after receiving the 3rd dose of mRNA-1273 vaccine. Patient presented with high fever with chills and sweat, and body ache. Patient sought medical consult, was hospitalized, and diagnosed with temporal arteritis. Intravenous prednisone was started as treatment medication. Red blood cell sedimentation rate was reported decreased (date not reported). Patient was hospitalized for 14-15 days. The outcome of event was unknown. Patient's co-morbidities could be considered as risk factors for the event. Patient received 2 doses of mRNA-1273 vaccine as primary series at an interval of 32 days, and the 2nd dose was given 9 months and 9 days prior to the 3rd dose mRNA-1273 vaccine (Inappropriate schedule of vaccine administration noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 74-year-old male patient, with relevant medical history of diabetes mellitus, gout, and hypertension, who experienced the unexpected serious (hospitalization) event of Giant cell arteritis that occurred 20 days after receiving the 3rd dose of mRNA-1273 vaccine. Patient presented with high fever with chills and sweat, and body ache. Patient sought medical consult, was hospitalized, and diagnosed with temporal arteritis. Intravenous prednisone was started as treatment medication. Red blood cell sedimentation rate was reported decreased (date not reported). Patient was hospitalized for 14-15 days. The outcome of event was unknown. Patient's co-morbidities could be considered as risk factors for the event. Patient received 2 doses of mRNA-1273 vaccine as primary series at an interval of 32 days, and the 2nd dose was given 9 months and 9 days prior to the 3rd dose mRNA-1273 vaccine (Inappropriate schedule of vaccine administration noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.