Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Circumstance or information capable of leading to medication error, Headache
Clinical narrative: Rheumatoid arthritis/Fatigue/Pyrexia/Arthralgia; The Pharmacist who administered the vaccine hit a vein or a capillary when administering to the patient and there was blood everywhere.The patient was concerned that she may not have received full dose of the Moderna; Had Covid Arm, the area was like a half circular dome; Did not have the energy to do anything/I was so dead; Headache; The area where I got the shot on my left arm turned into this huge lump immediately after getting the shot; The area was a little bit red and hung around for at least a couple of days maybe 3 or more days; The lymph nodes under my chin hurt and swell; The lymph nodes under my chin hurt and swell; Had crazy chills a few hours after third dose the patient was freezing, had chills that made me shake like a leaf, my teeth were chattering; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Fatigue/Pyrexia/Arthralgia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20F, 029A21A, 044621A and 054A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product GOLIMUMAB (SIMPONI) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started GOLIMUMAB (SIMPONI) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Had Covid Arm, the area was like a half circular dome), ASTHENIA (Did not have the energy to do anything/I was so dead), HEADACHE (Headache), VACCINATION SITE MASS (The area where I got the shot on my left arm turned into this huge lump immediately after getting the shot), VACCINATION SITE ERYTHEMA (The area was a little bit red and hung around for at least a couple of days maybe 3 or more days), LYMPHADENOPATHY (The lymph nodes under my chin hurt and swell), LYMPH NODE PAIN (The lymph nodes under my chin hurt and swell) and CHILLS (Had crazy chills a few hours after third dose the patient was freezing, had chills that made me shake like a leaf, my teeth were chattering). On 29-Sep-2021, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The Pharmacist who administered the vaccine hit a vein or a capillary when administering to the patient and there was blood everywhere.The patient was concerned that she may not have received full dose of the Moderna). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Fatigue/Pyrexia/Arthralgia) (seriousness criterion medically significant). In 2021, VACCINATION SITE ERYTHEMA (The area was a little bit red and hung around for at least a couple of days maybe 3 or more days) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Fatigue/Pyrexia/Arthralgia) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The Pharmacist who administered the vaccine hit a vein or a capillary when administering to the patient and there was blood everywhere.The patient was concerned that she may not have received full dose of the Moderna) outcome was unknown and VACCINATION SITE REACTION (Had Covid Arm, the area was like a half circular dome), ASTHENIA (Did not have the energy to do anything/I was so dead), HEADACHE (Headache), VACCINATION SITE MASS (The area where I got the shot on my left arm turned into this huge lump immediately after getting the shot), LYMPHADENOPATHY (The lymph nodes under my chin hurt and swell), LYMPH NODE PAIN (The lymph nodes under my chin hurt and swell) and CHILLS (Had crazy chills a few hours after third dose the patient was freezing, had chills that made me shake like a leaf, my teeth were chattering) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient reported that since patient had Rheumatoid Arthritis hence had bad joint pains after receiving first Moderna Covid-19 vaccine. The lymph nodes under chin hurt and swell. This happens after Simponi dose starts to wear off and after each dose of the vaccine. Patient always space Simponi shot 2 weeks from COVID-19 vaccine. It was reported that patient probably had other side effects also but cannot remember them as it was 2 years ago. Patient was freezing and chattering so badly that patient could not sleep. The Pharmacist who administered the vaccine hit a vein or a capillary when administering vaccine and there was blood everywhere. The patient had a concern that may not have received the full dose of the Moderna Covid-19 vaccine. The Pharmacist assured that the patient was ok. The patient told doctor about it and the doctor said that patient was probably fine. No treatment medication was provided.  Company Comment This spontaneous case concerns a 68-years-old-female patient, with medical history of Co-suspect product included non-company product GOLIMUMAB, Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised who experienced the unexpected seriousness criterion medically significant AESI of rheumatoid arthritis, the unexpected events of vaccination site reaction, asthenia, lymphadenopathy, circumstance or information capable of leading to medication error and other expected events in the context of the 4th. dose of  mRNA- 1273 vaccine administrated on June 2022. The medical history is a contributor for the events. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   Reporter did not allow further contact