Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Off label use, X-ray
Clinical narrative: Could not sleep; cervical lymph node below is jaw on his right side was painful; cervical lymph node below is jaw on his right side was swollen and inflammed; Site was warm to the touch; Inflammation of joint but no damage; Right shoulder pain, which is now affecting joint; Pain at the injection site; His doctor told him not to get the 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), LYMPHADENOPATHY (cervical lymph node below is jaw on his right side was swollen and inflammed), LYMPH NODE PAIN (cervical lymph node below is jaw on his right side was painful), INJECTION SITE WARMTH (Site was warm to the touch) and ARTHRITIS (Inflammation of joint but no damage) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Could not sleep), LYMPHADENOPATHY (cervical lymph node below is jaw on his right side was swollen and inflammed), LYMPH NODE PAIN (cervical lymph node below is jaw on his right side was painful), INJECTION SITE WARMTH (Site was warm to the touch), ARTHRITIS (Inflammation of joint but no damage), ARTHRALGIA (Right shoulder pain, which is now affecting joint), INJECTION SITE PAIN (Pain at the injection site) and OFF LABEL USE (His doctor told him not to get the 2nd dose.). At the time of the report, INSOMNIA (Could not sleep), LYMPHADENOPATHY (cervical lymph node below is jaw on his right side was swollen and inflammed), LYMPH NODE PAIN (cervical lymph node below is jaw on his right side was painful), INJECTION SITE WARMTH (Site was warm to the touch), ARTHRITIS (Inflammation of joint but no damage) and INJECTION SITE PAIN (Pain at the injection site) outcome was unknown, ARTHRALGIA (Right shoulder pain, which is now affecting joint) had not resolved and OFF LABEL USE (His doctor told him not to get the 2nd dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inflammation (abnormal) inflammation but no damage.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was reported that the vaccine was received two and a half months ago. The patient's injection site pain was 4 inches in each direction (8 inches circumference). The patient has had Ultrasound to rule out cancer as said by HCP, but did not show anything. The patient has done X-ray for his shoulder pain which is also affecting joint which yielded results indicating inflammation but no damage. The patient is yet to do MRI his healthcare provider recommends physical therapy, but he has declined it. The patient has an O +ve blood group. It was also reported that the patient's HCP advised not to get the second dose. Concomitant medication information was not reported. Treatment information was not reported.  Company Comment: This case concerns a 51-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of arthritis. The event occurred at an unknown date after the first dose of Spikevax (no date was provided for vaccine administration). The rechallenge was not applicable since the events happened after the first dose and no additional dosing will be given (as reported in Source Document). Off label use was considered an additional event. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 51-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of arthritis. The event occurred at an unknown date after the first dose of Spikevax (no date was provided for vaccine administration). The rechallenge was not applicable since the events happened after the first dose and no additional dosing will be given (as reported in Source Document). Off label use was considered an additional event. The benefit-risk relationship of Spikevax is not affected by this report.