Age: 64.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Anaemia, Blood pressure increased, Blood test, Blood urine present, Chest X-ray
Clinical narrative: Arthritis in her hands has gotten so much worse/ fingers are much more twisted/unable to hold and pinch; blood in her stool; Severe case of Erythema nodosum/had tripled in size, swelling in legs,lumps in her leg; all the way up both legs,has bruises and divots in her legs,looks crinkly like elephant skin; iron capacity was only 37/leaking a little blood; Blood pressure which had gotten really high; Tendon in leg was super tight (and sore); Tendon in leg was super [tight and] sore; Throat got irritated; Twisted her ankle; Tore either partial or complete tear in the tendon (in foot); Tore either partial or complete tear in the tendon (in foot); Her shoulder went "crunch" real bad; Bilateral hilar-something in her lung; Hands and feet started to itchy; itchy; microscopic blood in her urine analysis; she did not get the other (second) COVID vaccine; This spontaneous case was reported by a nurse and describes the occurrence of RHEUMATOID ARTHRITIS (Arthritis in her hands has gotten so much worse/ fingers are much more twisted/unable to hold and pinch) and HAEMATOCHEZIA (blood in her stool) in a 64-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 products included non-company products METHOTREXATE (RASUVO) injection for Rheumatoid arthritis and MINOCYCLINE for Ocular rosacea.    The patient's past medical history included Osteoarthritis since an unknown date, Type 2 diabetes mellitus since an unknown date, Obesity, Ocular rosacea, Hepatic steatosis (Fatty liver), Narcolepsy, Blood cholesterol abnormal, Pain, Hiatus hernia, Gastroesophageal reflux disease, Sleep apnoea syndrome, Restless leg syndrome, Nephrolithiasis, Renal cyst, Renal haemorrhage (She bleeds from her kidneys from a kidney stone and cyst in her kidneys that don't cause her any problems normally.), Musculoskeletal disorder (It was already a bad shoulder; she'd had trouble for years), Anaemia, Nausea and Hernia hiatus repair. Previously administered products included for Ocular rosacea: Doxycycline; for Rheumatoid arthritis: Methotrexate, methotrexate (She discontinued methotrexate and the anemia resolved), Methotrexate (Provider said that she'd had nausea [on previous methotrexate vials] and that's why product was changed to Rasuvo and but she doesn't remember that.). Past adverse reactions to the above products included Anaemia with methotrexate; Nausea with Methotrexate; Nephrolithiasis with Methotrexate; and No adverse event with Doxycycline. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included VITAMIN D NOS for Nutritional supplement, METHYLPHENIDATE HYDROCHLORIDE (RITALIN), METHYLPHENIDATE HYDROCHLORIDE (RITALIN LA), ACETAMINOPHEN;HYDROCODONE, ATORVASTATIN, CELECOXIB (CELEBREX), ESOMEPRAZOLE MAGNESIUM (NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]), FOLIC ACID, HYDROXYCHLOROQUINE, PRAMIPEXOLE, VENLAFAXINE HYDROCHLORIDE and PREGABALIN for an unknown indication.   In 2019, the patient started METHOTREXATE (RASUVO) (unknown route) 15 milligram once a week. On 19-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient started MINOCYCLINE (unknown route) 100 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Arthritis in her hands has gotten so much worse/ fingers are much more twisted/unable to hold and pinch) (seriousness criterion medically significant), HAEMATOCHEZIA (blood in her stool) (seriousness criterion medically significant), ERYTHEMA NODOSUM (Severe case of Erythema nodosum/had tripled in size, swelling in legs,lumps in her leg; all the way up both legs,has bruises and divots in her legs,looks crinkly like elephant skin), ANAEMIA (iron capacity was only 37/leaking a little blood), BLOOD PRESSURE INCREASED (Blood pressure which had gotten really high), TENDON DISCOMFORT (Tendon in leg was super tight (and sore)), TENDON PAIN (Tendon in leg was super [tight and] sore), THROAT IRRITATION (Throat got irritated), LIGAMENT SPRAIN (Twisted her ankle), TENDON RUPTURE (Tore either partial or complete tear in the tendon (in foot)), PERONEAL NERVE PALSY (Tore either partial or complete tear in the tendon (in foot)), JOINT NOISE (Her shoulder went "crunch" real bad), LUNG DISORDER (Bilateral hilar-something in her lung), PRURITUS (Hands and feet started to itchy; itchy), BLOOD URINE PRESENT (microscopic blood in her urine analysis) and PRODUCT DOSE OMISSION ISSUE (she did not get the other (second) COVID vaccine). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Clot blood, at a dose of UNK dosage form; PENICILLIN NOS ongoing since an unknown date for Erythema nodosum, at a dose of 500 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Pruritus, at a dose of UNK dosage form; FUROSEMIDE (LASIX [FUROSEMIDE]) ongoing since an unknown date for Swelling of legs, at a dose of UNK dosage form; PREDNISONE ongoing since an unknown date for Erythema nodosum, at a dose of 20milligram  tapered to10 milligram and IRON for Anemia, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Arthritis in her hands has gotten so much worse/ fingers are much more twisted/unable to hold and pinch), HAEMATOCHEZIA (blood in her stool), ERYTHEMA NODOSUM (Severe case of Erythema nodosum/had tripled in size, swelling in legs,lumps in her leg; all the way up both legs,has bruises and divots in her legs,looks crinkly like elephant skin), ANAEMIA (iron capacity was only 37/leaking a little blood), BLOOD PRESSURE INCREASED (Blood pressure which had gotten really high), TENDON DISCOMFORT (Tendon in leg was super tight (and sore)), TENDON PAIN (Tendon in leg was super [tight and] sore), LIGAMENT SPRAIN (Twisted her ankle), TENDON RUPTURE (Tore either partial or complete tear in the tendon (in foot)), PERONEAL NERVE PALSY (Tore either partial or complete tear in the tendon (in foot)), JOINT NOISE (Her shoulder went "crunch" real bad), LUNG DISORDER (Bilateral hilar-something in her lung), BLOOD URINE PRESENT (microscopic blood in her urine analysis) and PRODUCT DOSE OMISSION ISSUE (she did not get the other (second) COVID vaccine) outcome was unknown and THROAT IRRITATION (Throat got irritated) and PRURITUS (Hands and feet started to itchy; itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: unknown (Inconclusive) Result not reported. In April 2021, Chest X-ray: unknown Bilateral hilar-something in her lung. In April 2021, Electrocardiogram: normal (normal) Normal. In April 2021, Streptococcus test: negative (Negative) Negative. In 2021, Full blood count: abnormal Anaemia. In 2021, Iron binding capacity total: 37 (Inconclusive) 37. In 2021, Stool analysis: abnormal (abnormal) Blood in stool sample. In 2021, Ultrasound scan: unknown ultrasound to see if there was a possible clot. In 2021, Urine analysis: abnormal Did have microscopic blood.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was being treated with Rasuvo (methotrexate). On an unspecified date in maybe Feb-2021 or Mar-2021, the patient was diagnosed at a doctor's clinic with severe anemia and was given three infusions of blood. Rasuvo was stopped but restarted again on an unspecified date because of her worsening arthritis in her hands. On 10-May-2021, additional information was received from the consumer, and COVID vaccine (Moderna, Inc.) and minocycline were added as co-suspects. Based on the information received, the case was reassessed as serious/unexpected. It was reported that on 20-MAR-2021, the day after receiving her first dose of the COVID vaccine. the patient experienced her first symptoms of erythema nodosum. The patient consulted her health care provider who suspected a blood clot in one of her veins and the patient was started on Aspirin (acetylsalicylic acid). Aspirin was stopped on an unspecified date, when blood clot was ruled out. On an unspecified date in APR-2021, the patient was seen in the emergency room (ER) for high blood pressure. Treatment details were not provided but she was given a prescription for penicillin which she took for seven days. On an unspecified date in APR-2021, the patient experienced itching of hands and feet and throat irritation. She took Benadryl (diphenhydramine hydrochloride) at home and went back to the ER. She was given a prescription for prednisone and an unspecified histamine blocker.On an unspecified date in APR-2021, patient was put on Lasix (furosemide) by the primary care physician for the swelling of her legs which she took for 3 weeks. On 30-APR-2021, the patient was seen in the ER for a third time for her ankle. The patient planned to get an orthopedic consult.  Company Comment :Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The causality for product dose omission is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Upon internal review on 03Aug2021, the event of rheumatoid arthritis was updated to serious.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The causality for product dose omission is not applicable.