Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diabetes mellitus, Gait disturbance, Hernia, Interchange of vaccine products
Clinical narrative: Hernia; Diabetes mellitus aggravated; Rheumatoid arthritis flare up; Spinal fracture; Knee osteoarthritis; Pain in Back; COULD NOT BARELY WALK; Hair loss; Pain; Swelling; Bone erosion; Patient had dose 1 of Moderna and unknown dose of Pfizer; Patient had dose 1 of Moderna and unknown dose of Pfizer; COULD NOT OPEN AND CLOSE LEFT HAND; SWELLING OF LEFT HAND; This spontaneous case was reported by a consumer and describes the occurrence of HERNIA (Hernia), DIABETES MELLITUS (Diabetes mellitus aggravated), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and SPINAL FRACTURE (Spinal fracture) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Internal bleeding (patient was hospitalized for ten days and was placed in the intensive care unit) in December 2018, Abdominal hernia from 2019 to 02-Jun-2021, Small bowel resection (scheduled for a small bowel resection procedure to remove the large mass in her small intestine then went to rehabilitation for two to three weeks) in December 2018 and Knee replacement on 15-Feb-2021. Concurrent medical conditions included Diabetes since 1960, Rheumatoid arthritis in 1987, Abstains from alcohol and Non-tobacco user. Concomitant products included WARFARIN SODIUM (JANTOVEN) for Blood disorder, FLECAINIDE for Bradycardia, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, METOPROLOL for Cardiac disorder, GABAPENTIN (NEURONTIN) and VENLAFAXINE for Pain, PARACETAMOL (TYLENOL) and PREDNISONE for Rheumatoid arthritis, METHOTREXATE for an unknown indication.   In October 2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 22-Feb-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 13-May-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (COULD NOT OPEN AND CLOSE LEFT HAND) and PERIPHERAL SWELLING (SWELLING OF LEFT HAND). On an unknown date, the patient experienced HERNIA (Hernia) (seriousness criterion hospitalization), DIABETES MELLITUS (Diabetes mellitus aggravated) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), SPINAL FRACTURE (Spinal fracture) (seriousness criterion medically significant), OSTEOARTHRITIS (Knee osteoarthritis), BACK PAIN (Pain in Back), GAIT DISTURBANCE (COULD NOT BARELY WALK), ALOPECIA (Hair loss), PAIN (Pain), SWELLING (Swelling), BONE EROSION (Bone erosion), COVID-19 IMMUNISATION (Patient had dose 1 of Moderna and unknown dose of Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (Patient had dose 1 of Moderna and unknown dose of Pfizer). In 2021, HERNIA (Hernia) had resolved. At the time of the report, DIABETES MELLITUS (Diabetes mellitus aggravated), ALOPECIA (Hair loss), PAIN (Pain) and SWELLING (Swelling) had not resolved, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), SPINAL FRACTURE (Spinal fracture), BACK PAIN (Pain in Back), GAIT DISTURBANCE (COULD NOT BARELY WALK), BONE EROSION (Bone erosion), COVID-19 IMMUNISATION (Patient had dose 1 of Moderna and unknown dose of Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (Patient had dose 1 of Moderna and unknown dose of Pfizer) outcome was unknown and OSTEOARTHRITIS (Knee osteoarthritis), JOINT RANGE OF MOTION DECREASED (COULD NOT OPEN AND CLOSE LEFT HAND) and PERIPHERAL SWELLING (SWELLING OF LEFT HAND) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, International normalised ratio: 2.1. In 2021, Blood glucose: elevated over 400 milligrams per deciliter and Went up. On an unknown date, Blood glucose: elevated sugar level and 173. On an unknown date, Computerised tomogram: Bone to bone on right knee. On an unknown date, X-ray: Bone to bone on right knee.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Since 2012, the patient was also on pacemaker and her physician informed her that her pacemaker had only one year left and needs to be replaced but she decided to wait for a few months in order for her to recuperate first. She also wears a compression brace on her left hand to manage swelling. Patient  had elevated blood sugar level with a result of over 400 milligrams per deciliter that was why she was advised by her physician not to take the second COVID-19 vaccine dose. She mentioned that her hernia was located in five different places, there were two on her left lower abdominal area and three on the right lower area. She stayed in the hospital for six days until 20 May 2021 and was treated with unrecalled antibiotics and pain relievers.  Patient Rinvoq was placed on hold one week prior and after those two procedures. Ablation in three nerves in back due to pain, experienced tiredness and pain in hands. Patient's lowered prednisone dosing.  It was unknown if she was enrolled in a COVID-19 vaccine trial. Patient had JANTOVEN for Blood thinner. In April 2021, Patient had knee surgery (NOS) which was been recovered. Patient had cardiac pacemaker replacement for which has been recovered. On May 2021, she had five hernias and had surgery in stomach. On 13 May 2021, she had another procedure for her abdominal hernia.  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.  This is a spontaneous case concerning a 76-year-old female patient with medical history of Abdominal hernia, Diabetes mellitus and Rheumatoid arthritis on Upadacitinib, who experienced the unexpected serious (hospitalization) event of Hernia, the unexpected serious (medically significant) events of Diabetes mellitus (Diabetes mellitus aggravated), Spinal fracture and the unexpected serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving the first dose of mRNA-1273 vaccine. Approximately 1 month after receiving the first dose the patient was hospitalized and underwent surgical procedure for the abdominal hernia and resolved. The events Spinal fracture (fracture in back), Diabetes mellitus (Diabetes mellitus aggravated) and  Rheumatoid arthritis (Rheumatoid arthritis flare up) occurred on unknown date and the outcome was unknown. Medical history of Abdominal hernia, Diabetes mellitus and Rheumatoid arthritis remain as risk factors for the respective events. Revaccination with different COVID-19 vaccine and Interchange of vaccine products was also reported as an additional event as the patient received other COVID-19 vaccine (Pfizer) on unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow-up received include Concomitant Pfizer vaccine added, Event Pain added.; Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with medical history of Abdominal hernia, Diabetes mellitus and Rheumatoid arthritis on Upadacitinib, who experienced the unexpected serious (hospitalization) event of Hernia, the unexpected serious (medically significant) events of Diabetes mellitus (Diabetes mellitus aggravated), Spinal fracture and the unexpected serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving the first dose of mRNA-1273 vaccine. Approximately 1 month after receiving the first dose the patient was hospitalized and underwent surgical procedure for the abdominal hernia and resolved. The events Spinal fracture (fracture in back), Diabetes mellitus (Diabetes mellitus aggravated) and  Rheumatoid arthritis (Rheumatoid arthritis flare up) occurred on unknown date and the outcome was unknown. Medical history of Abdominal hernia, Diabetes mellitus and Rheumatoid arthritis remain as risk factors for the respective events. Revaccination with different COVID-19 vaccine and Interchange of vaccine products was also reported as an additional event as the patient received other COVID-19 vaccine (Pfizer) on unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report.