Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Contusion, Fall, Immunisation reaction, Joint injury, Limb injury
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (MODERNA COVID VACCINE SHOTS MADE PATIENT ILL), FALL (Fall/patient fell and hit left arm and right knee), JOINT INJURY (Knee injury/patient fell and hit left arm and right knee), LIMB INJURY (Arm injury/patient fell and hit left arm and right knee) and CONTUSION (Bruising of arm/Large bruise formed on her left arm) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Co-suspect product included non-company product UPADACITINIB (RINVOQ) prolonged-release tablet for Rheumatoid arthritis. Concurrent medical conditions included Allergy to antibiotic (Levofloxacin allergy), Penicillin allergy, Drug allergy (Buspirone allergy), Allergy to antibiotic (Cefaclor allergy), Allergy to antibiotic (Cipro allergy) and Sulfonamide allergy (Sulfamethoxazole allergy). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, ALLOPURINOL, LIDOCAINE, DICLOFENAC, VITAMIN B COMPLEX, VITAMIN C [ASCORBIC ACID], LISINOPRIL, ELDERBERRY [SAMBUCUS NIGRA], VITAMIN D2, CALCIUM, GLUCOSAMINE SULFATE (GLUCOSAM), PARACETAMOL (TYLENOL), ZINC, MUPIROCIN, FOLIC ACID, MELOXICAM, OXYBUTYNIN CHLORIDE, BIOTIN and FISH OIL for an unknown indication. On 30-Dec-2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (MODERNA COVID VACCINE SHOTS MADE PATIENT ILL), FALL (Fall/patient fell and hit left arm and right knee), JOINT INJURY (Knee injury/patient fell and hit left arm and right knee), LIMB INJURY (Arm injury/patient fell and hit left arm and right knee) and CONTUSION (Bruising of arm/Large bruise formed on her left arm). At the time of the report, IMMUNISATION REACTION (MODERNA COVID VACCINE SHOTS MADE PATIENT ILL) had resolved and FALL (Fall/patient fell and hit left arm and right knee), JOINT INJURY (Knee injury/patient fell and hit left arm and right knee), LIMB INJURY (Arm injury/patient fell and hit left arm and right knee) and CONTUSION (Bruising of arm/Large bruise formed on her left arm) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. No treatment information was provided. The first two Moderna COVID-19 vaccine shots made the patient very ill. The patient had easy bruising. The physician was aware. This condition was not new to the patient as it had been going for a long time. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. or not. The patient did not agree to have the physician contacted. The reporter assessed the causality for the events of fall, knee injury, arm injury, bruising of arm and Moderna COVID vaccine shots made patient ill to be not related with the co-suspect drug Rinvoq. Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2022: Follow up received contains significant information: Updated medical history of patient and concomitant medications added.