Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Joint pain; feeling extreme hopelessness/ organic mood coming on quickly of heavy hopelessness very sudden, not being able to manage her mood; stiffness feeling like Rheumatoid arthritis affecting her ability to move; severe stomach cramps; eye itchiness; severe stiffness/stiffness on her joints, on her feet, her knees; inflammation on her hip; severe stiffness/stiffness on her joints, on her feet, her knees; itchiness; Severe body aches; soreness on her arm; Fatigue/tiredness; chills; arm swelling immediately after vaccination; Stuffy nose; COVID-like symptoms, breakthrough case of COVID; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (severe stiffness/stiffness on her joints, on her feet, her knees), JOINT SWELLING (inflammation on her hip) and JOINT STIFFNESS (severe stiffness/stiffness on her joints, on her feet, her knees) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006320003 and 7006320006) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clinical depression (she had one episode on the past of Clinical Depression.).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced NASAL CONGESTION (Stuffy nose), VACCINATION COMPLICATION (COVID-like symptoms, breakthrough case of COVID) and PERIPHERAL SWELLING (arm swelling immediately after vaccination). On 28-Dec-2021, the patient experienced PAIN (Severe body aches), PAIN IN EXTREMITY (soreness on her arm), FATIGUE (Fatigue/tiredness) and CHILLS (chills). On 29-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (severe stiffness/stiffness on her joints, on her feet, her knees) (seriousness criterion medically significant), JOINT SWELLING (inflammation on her hip) (seriousness criterion medically significant), JOINT STIFFNESS (severe stiffness/stiffness on her joints, on her feet, her knees) (seriousness criterion medically significant), PRURITUS (itchiness), ABDOMINAL PAIN UPPER (severe stomach cramps), EYE PRURITUS (eye itchiness) and JOINT RANGE OF MOTION DECREASED (stiffness feeling like Rheumatoid arthritis affecting her ability to move). On 30-Dec-2021, the patient experienced FEELINGS OF WORTHLESSNESS (feeling extreme hopelessness/ organic mood coming on quickly of heavy hopelessness very sudden, not being able to manage her mood). On 30-Dec-2021 at 11:30 AM, the patient experienced ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN for Adverse event, at a dose of 3 dosage form three times a day; FAMOTIDINE for Adverse event, at a dose of 20 mg; FAMOTIDINE for Adverse event, at a dose of 40 mg; CETIRIZINE for Adverse event, at a dose of 10 mg and VIT D [VITAMIN D NOS] for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (severe stiffness/stiffness on her joints, on her feet, her knees), JOINT SWELLING (inflammation on her hip), JOINT STIFFNESS (severe stiffness/stiffness on her joints, on her feet, her knees), NASAL CONGESTION (Stuffy nose), VACCINATION COMPLICATION (COVID-like symptoms, breakthrough case of COVID), PAIN (Severe body aches), PAIN IN EXTREMITY (soreness on her arm), PRURITUS (itchiness), PERIPHERAL SWELLING (arm swelling immediately after vaccination), ABDOMINAL PAIN UPPER (severe stomach cramps), EYE PRURITUS (eye itchiness), FEELINGS OF WORTHLESSNESS (feeling extreme hopelessness/ organic mood coming on quickly of heavy hopelessness very sudden, not being able to manage her mood), JOINT RANGE OF MOTION DECREASED (stiffness feeling like Rheumatoid arthritis affecting her ability to move), FATIGUE (Fatigue/tiredness), CHILLS (chills) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) she received a negative test result..         Concomitant product use was not provided by reporter. Following vaccination with the booster dose patient experienced the following: stuffy nose, COVID-like symptoms, breakthrough case of COVID (although she received a negative test result), the following day patient experienced severe body aches, fatigue, chills, tiredness, soreness on her arm, the next morning severe stiffness and inflammation on her hip, stiffness on her joints, on her feet, her knees, itchiness, arm swelling immediately after vaccination, severe stomach cramps, eye itchiness, stiffness feeling like Rheumatoid arthritis affecting her ability to move, feeling like she had aged 40 years, joint pain around 11:30 am 30Dec2021 patient experienced: feeling extreme hopelessness, organic mood coming on quickly of heavy hopelessness very sudden, not being able to manage her mood "so black". Patient mentioned she had one episode on the past of Clinical Depression and that the feeling reminded her of that situation.  This is a spontaneous case concerning  a 57-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Musculoskeletal stiffness, Joint swelling, Joint stiffness. The events occurred approximately 2 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a 57-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Musculoskeletal stiffness, Joint swelling, Joint stiffness. The events occurred approximately 2 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.