Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Complement factor C3, Complement factor C4, Disturbance in attention, Dysphonia, Fatigue
Clinical narrative: body extremely inflammed/indicating a very high level of inflammation; joints ( ankle, knees, groin, right shoulder) continued to ve problematic; fatigue; P ANCA Positive Drug Induced Vasculitis; body was on fire; chills; his sweet speech got impaired; There was pressure behind his eyes; gave him vision difficulty.; very painful/ numbing pain; It also affected his thinking/Gave him focus difficulty/He had difficulty concentrating (May2021)  continued until June2021; His head was kind of foggy.; had headaches/top of his head became very sensitive to the touch/pain on top of his head/pain in front of the head/Pain on his temples/temporal pain on the side of his head/Still having head pains; his throat was swelling up; tingling/very sensitive to the touch; hoarseness; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (his throat was swelling up), VASCULITIS (P ANCA Positive Drug Induced Vasculitis), SPEECH DISORDER (his sweet speech got impaired), OCULAR DISCOMFORT (There was pressure behind his eyes) and VISUAL IMPAIRMENT (gave him vision difficulty.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  The patient's past medical history included Mental concentration difficulty from May 2021 to June 2021 and Mental concentration difficulty in July 2021. Previously administered products included for Adverse event: Ciprofloxacin on 26-Jun-2015. Past adverse reactions to the above products included Diarrhoea with Ciprofloxacin. Concurrent medical conditions included Prostate cancer (began use of Lupron Depot on 10/01/2019 which introduced chronic muscle and joint pain) since 26-Jun-2015, Hypertension and Arthritis. Concomitant products included GLUCOSAMINE from 01-Jan-2000 to an unknown date for Arthritis, CIPROFLOXACIN from 26-Jun-2015 to an unknown date for Diarrhea, DOXAZOSIN from 15-Mar-2021 to an unknown date for Hypertension, LEUPROLIDE ACETATE from 01-Oct-2019 to an unknown date for Prostate cancer, ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) from 01-Jan-2000 to an unknown date, CALCIUM from 01-Aug-2015 to an unknown date, ZINC from 03-Jan-2020 to an unknown date, ASCORBIC ACID from 03-Jan-2020 to an unknown date, CYANOCOBALAMIN from 03-Jan-2020 to an unknown date and CENTRUM SILVER +50 from 01-Jan-2000 to an unknown date for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PARAESTHESIA (tingling/very sensitive to the touch) and DYSPHONIA (hoarseness). On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (his throat was swelling up) (seriousness criterion medically significant), SPEECH DISORDER (his sweet speech got impaired) (seriousness criterion medically significant), OCULAR DISCOMFORT (There was pressure behind his eyes) (seriousness criterion medically significant), VISUAL IMPAIRMENT (gave him vision difficulty.) (seriousness criterion medically significant), PAIN (very painful/ numbing pain), DISTURBANCE IN ATTENTION (It also affected his thinking/Gave him focus difficulty/He had difficulty concentrating (May2021)  continued until June2021), FEELING ABNORMAL (His head was kind of foggy.), CHILLS (chills) and HEADACHE (had headaches/top of his head became very sensitive to the touch/pain on top of his head/pain in front of the head/Pain on his temples/temporal pain on the side of his head/Still having head pains). On 31-Jul-2021, the patient experienced SKIN BURNING SENSATION (body was on fire). On 08-Aug-2021, the patient experienced VASCULITIS (P ANCA Positive Drug Induced Vasculitis) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLAMMATION (body extremely inflammed/indicating a very high level of inflammation), MUSCULOSKELETAL DISCOMFORT (joints ( ankle, knees, groin, right shoulder) continued to ve problematic) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency; PREDNISONE ongoing from 22-Jul-2021 for Adverse event, at a dose of 40 milligram once a day and PREDNISONE on 31-Jul-2021 for Adverse event, at a dose of 20 mg once a day. At the time of the report, PHARYNGEAL SWELLING (his throat was swelling up), VASCULITIS (P ANCA Positive Drug Induced Vasculitis), SPEECH DISORDER (his sweet speech got impaired), OCULAR DISCOMFORT (There was pressure behind his eyes), VISUAL IMPAIRMENT (gave him vision difficulty.), DISTURBANCE IN ATTENTION (It also affected his thinking/Gave him focus difficulty/He had difficulty concentrating (May2021)  continued until June2021), FEELING ABNORMAL (His head was kind of foggy.), SKIN BURNING SENSATION (body was on fire), PARAESTHESIA (tingling/very sensitive to the touch), DYSPHONIA (hoarseness), INFLAMMATION (body extremely inflammed/indicating a very high level of inflammation), MUSCULOSKELETAL DISCOMFORT (joints ( ankle, knees, groin, right shoulder) continued to ve problematic), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (had headaches/top of his head became very sensitive to the touch/pain on top of his head/pain in front of the head/Pain on his temples/temporal pain on the side of his head/Still having head pains) outcome was unknown and PAIN (very painful/ numbing pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Red blood cell sedimentation rate: 59 (High) 59. On 21-Jul-2021, Blood pressure measurement: 118/64 (Low) low. On 21-Jul-2021, Body temperature: 97 (normal) 97. On 21-Jul-2021, Heart rate: 62 (Low) low. On 21-Jul-2021, Red blood cell sedimentation rate: 120 (High) 120. On 31-Jul-2021, Red blood cell sedimentation rate: 120 (High) 120. On 03-Aug-2021, Blood pressure measurement: 114/58 (Low) low. On 03-Aug-2021, Heart rate: 67 (Low) low. On 03-Aug-2021, Respiratory rate: 16 (Low) low. On 05-Aug-2021, Antineutrophil cytoplasmic antibody: positive (Positive) Positive. On 05-Aug-2021, Complement factor C3 (83-240): 152 mg/dl (normal) normal. On 05-Aug-2021, Complement factor C4 (13-60): 29 mg/dl (normal) normal. On 08-Aug-2021, Vasculitis: positive (Positive) positive. On 12-Aug-2021, Red blood cell sedimentation rate: 155 (High) 155. On 09-Sep-2021, Biopsy: negative (Negative) negative. On 11-Sep-2021, Red blood cell sedimentation rate: 9 (normal) 9. On 15-Sep-2021, Blood pressure measurement: 119/64 (normal) normal. On 15-Sep-2021, Body temperature: 96.5 (normal) 96.5. On 15-Sep-2021, Heart rate: 63 (Low) low. On 15-Sep-2021, Respiratory rate: 16 (Low) low.         patient was tested for ESR, Complementary C4, Complementary C3,  CRP, Anti NPO and AntiPr3 and the results were unknown.  Concomitant medication reported by patient was Leuprolide  Acetate for Prostate cancer as injection depot every 6 months once, calcium was used for maintaining bone density 630mg twice daily.  Company Comment: This case concerns a 72 year-old, male patient with a history of prostate cancer, hypertension and arthritis, who experienced the serious unexpected events of Pharyngeal swelling, Speech disorder, Ocular discomfort, vasculitis and Visual impairment. The events Pharyngeal swelling, Speech disorder, Ocular discomfort and Visual impairment occurred approximately 14 days after the second dose of Moderna COVID-19 vaccine and the event vasculitis 5 months after. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The medical history, of prostate cancer, hypertension and arthritis, remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: follow-up document contains no new information. On 26-Sep-2021: Significant follow up received on 26 Sep 2021 added Patients initials, race, ethnicity, height, concomitant, route of administration, lab tests and concomitant medications.; Sender's Comments: This case concerns a 72 year-old, male patient with a history of prostate cancer, hypertension and arthritis, who experienced the serious unexpected events of Pharyngeal swelling, Speech disorder, Ocular discomfort, vasculitis and Visual impairment. The events Pharyngeal swelling, Speech disorder, Ocular discomfort and Visual impairment occurred approximately 14 days after the second dose of Moderna COVID-19 vaccine and the event vasculitis 5 months after. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The medical history, of prostate cancer, hypertension and arthritis, remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.