Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Body temperature, C-reactive protein
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERVENTILATION (deep breath), DYSURIA (pain or bleed with urination), COUGH (Coughing), NEPHROLITHIASIS (Kidney stone), NEPHROLITHIASIS (bleed with urination/Pain worsened), ABDOMINAL PAIN UPPER (Left upper quadrant pain), FATIGUE (Fatigue extreme), VACCINATION SITE PAIN (arm hurt), INJECTION SITE ERYTHEMA (Injection site redness), BACK PAIN (lower back pain), INJECTION SITE PRURITUS (Injection site itching), ARTHRALGIA (Joint pain), PAIN (body ache) and MYALGIA (Muscle pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028LZ0A and 039K20A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.- The patient's past medical history included Sedimentation rate increased, Joint pain and Removal of kidney stone on 07-Jun-2021. Previously administered products included for Drug use for unknown indication: Morphine, Plaquenil, ARAVA, XELJANZ and METHOTREXATE. Past adverse reactions to the above products included No adverse event with ARAVA, METHOTREXATE, Plaquenil and XELJANZ; and Rash all over with Morphine. Concurrent medical conditions included Seronegative rheumatoid arthritis, Polycystic ovaries, Drug allergy (Morphine), Hypothyroidism, Depression, Hypertension, Non-tobacco user, Alcohol use (Rarely), Vitamin B12 deficiency, Folic acid deficiency and Rheumatoid arthritis. Concomitant products included ESTRADIOL (ESTROGEN) for Birth control pill and Ovarian cyst, BUPROPION for Depression, FOLIC ACID for Folic acid deficiency, VALSARTAN for Hypertension, LEVOTHYROXINE for Hypothyroidism, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for Vitamin B12 deficiency, ETODOLAC (ETODOLAC ER) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 05-Feb-2021, the patient experienced FATIGUE (Fatigue extreme) (seriousness criteria hospitalization and medically significant), ARTHRALGIA (Joint pain) (seriousness criteria hospitalization and medically significant) and MYALGIA (Muscle pain) (seriousness criteria hospitalization and medically significant). In March 2021, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced HYPERVENTILATION (deep breath) (seriousness criteria hospitalization and medically significant), DYSURIA (pain or bleed with urination) (seriousness criteria hospitalization and medically significant), COUGH (Coughing) (seriousness criteria hospitalization and medically significant), NEPHROLITHIASIS (bleed with urination/Pain worsened) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN UPPER (Left upper quadrant pain) (seriousness criteria hospitalization and medically significant), VACCINATION SITE PAIN (arm hurt) (seriousness criteria hospitalization and medically significant), INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criteria hospitalization and medically significant), BACK PAIN (lower back pain) (seriousness criteria hospitalization and medically significant), INJECTION SITE PRURITUS (Injection site itching) (seriousness criteria hospitalization and medically significant) and PAIN (body ache) (seriousness criteria hospitalization and medically significant). The patient was treated with ETODOLAC (LODINE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, FATIGUE (Fatigue extreme), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. On 07-Jun-2021, NEPHROLITHIASIS (Kidney stone) had resolved. At the time of the report, HYPERVENTILATION (deep breath), DYSURIA (pain or bleed with urination), COUGH (Coughing), NEPHROLITHIASIS (bleed with urination/Pain worsened), VACCINATION SITE PAIN (arm hurt), BACK PAIN (lower back pain) and PAIN (body ache) outcome was unknown, ABDOMINAL PAIN UPPER (Left upper quadrant pain) had not resolved and INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itching) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, C-reactive protein: 45. In December 2020, Red blood cell sedimentation rate: 50. In August 2021, C-reactive protein: 51. In August 2021, Inflammatory marker test: Inflammatory markers were still high. In August 2021, Red blood cell sedimentation rate: 60. On an unknown date, Body temperature: Elevated. On an unknown date, Chest X-ray: Result unknown. On an unknown date, Computerised tomogram: Result unknown. On an unknown date, Laboratory test: Result unknown. On an unknown date, Ultrasound scan: Result unknown. On an unknown date, Urine analysis: Blood in urine. It was unknown if the patient was enrolled in covid-19 vaccine trials. Patient felt tired in 2021. The first Covid shot was good, for second patient had reactions hurt arm, extremely tired, body ache and elevated temperature. Treatment information included anti-itching cream, steroid dose packs to manage the levels of the inflammatory markers, alternative etiology for high c-reactive protein and joint pain. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This is a spontaneous case, reported by a consumer concerning a 47-year-old female patient with relevant medical condition of Rheumatoid arthritis, who was hospitalized due to the unexpected serious (medically significant) events of Hyperventilation, Cough, Nephrolithiasis, Pain, Abdominal pain upper, Fatigue, Vaccination site pain, Injection site erythema, Injection site pruritus, Arthralgia, Body temperature increased, Pain and myalgia. Nephrolithiasis occurred approximately 1 month after the second mRNA-1273 vaccination, Fatigue, Arthralgia, and Myalgia occurred on the same day of the second mRNA-1273 vaccination, while the other events occurred on the same year of the second mRNA-1273 vaccination. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 31 days which falls within the recommended vaccine dosing schedule. Five months after the second vaccination, the patient had a surgery for the left kidney stone removal. Patient had lower back pain, injection site itching and redness of half dollar size, which lasted about twenty four hours. Patient used anti itch cream as over the counter drug. Patient also had blood examination with result of high inflammatory markers. It was reported that the first COVID-19 vaccination shot was unremarkable, however after the second COVID-19 vaccination, patient experienced arm pain, extreme tiredness, body AC. Sender's Comments: This is a spontaneous case, reported by a consumer concerning a 47-year-old female patient with relevant medical condition of Rheumatoid arthritis, who was hospitalized due to the unexpected serious (medically significant) events of Hyperventilation, Cough, Nephrolithiasis, Pain, Abdominal pain upper, Fatigue, Vaccination site pain, Injection site erythema, Injection site pruritus, Arthralgia, Body temperature increased, Pain and myalgia. Nephrolithiasis occurred approximately 1 month after the second mRNA-1273 vaccination, Fatigue, Arthralgia, and Myalgia occurred on the same day of the second mRNA-1273 vaccination, while the other events occurred on the same year of the second mRNA-1273 vaccination. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 31 days which falls within the recommended vaccine dosing schedule. Five months after the second vaccination, the patient had a surgery for the left kidney stone removal. Patient had lower back pain, injection site itching and redness of half dollar size, which lasted about twenty four hours. Patient used anti itch cream as over the counter drug. Patient also had blood examination with result of high inflammatory markers. It was reported that the first COVID-19 vaccination shot was unremarkable, however after the second COVID-19 vaccination, patient experienced arm pain, extreme tiredness, body ache and elevated temperature. Patient took steroid dose packs to manage the high levels of the inflammatory markers, and the patient was treated with Lodine and Tylenol. The medical condition of Rheumatoid arthritis remains as a confounders for high C-Reactive Protein, high Sedimentation Rate and Inflammatory markers and Arthralgia. The benefit-risk relationship of mRNA-1273 is not affected by this report.