Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Pain in extremity, Suicidal ideation
Clinical narrative: Pain radiated through the whole body/body in so much pain; pain in shoulder/hip; contemplating suicide/just want to die; pain in the arm; can barely walk; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (contemplating suicide/just want to die) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 023C21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient had no allergies and no prior medical conditions.  Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced SUICIDAL IDEATION (contemplating suicide/just want to die) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in the arm), GAIT DISTURBANCE (can barely walk) and ARTHRALGIA (pain in shoulder/hip). On an unknown date, the patient experienced PAIN (Pain radiated through the whole body/body in so much pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Pain, at an unspecified dose and frequency. At the time of the report, SUICIDAL IDEATION (contemplating suicide/just want to die), GAIT DISTURBANCE (can barely walk), PAIN (Pain radiated through the whole body/body in so much pain) and ARTHRALGIA (pain in shoulder/hip) outcome was unknown and PAIN IN EXTREMITY (pain in the arm) had not resolved.            Patient took the tylenol and it did not work. Patient went to the doctor and was prescribed and took prednisone for a couple of days and it felt good, pain went away and then when she stopped taking it, it came back worse than before. Patient expected 2 days of pain in the arm and it never went away and radiated through the whole body. Patient spoke to someone about the suicide prevention hotline already.  Company comment: This spontaneous case concerns a 88-year-old, female patient with no relevant medical history reported, who experienced serious (Medically significant) unexpected event of suicidal ideation from the day of receiving third dose of mRNA-1273 Vaccine. Patient reports that after third dose of vaccination her body was in so much pain, pain in arm, shoulder, hip, she can barely walk, just wants to die and has not been good ever since. They are contemplating suicide. She took the Tylenol and it did not work. She went to the doctor and was prescribed and took prednisone for a couple of days and it felt good, pain went away and then when she stopped taking it, Pain came back worse than before. She also has spoken to someone about the suicide prevention hotline already. Treatment of the patient included Tylenol and prednisolone. At the time of report, event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-494240, MOD-2022-494249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up document contains no new information.; Sender's Comments: This spontaneous case concerns a 88-year-old, female patient with no relevant medical history reported, who experienced serious (Medically significant) unexpected event of suicidal ideation from the day of receiving third dose of mRNA-1273 Vaccine. Patient reports that after third dose of vaccination her body was in so much pain, pain in arm, shoulder, hip, she can barely walk, just wants to die and has not been good ever since. They are contemplating suicide. She took the Tylenol and it did not work. She went to the doctor and was prescribed and took prednisone for a couple of days and it felt good, pain went away and then when she stopped taking it, Pain came back worse than before. She also has spoken to someone about the suicide prevention hotline already. Treatment of the patient included Tylenol and prednisolone. At the time of report, event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.