Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Periostitis, Pyrexia
Clinical narrative: periostitis; In January patient saw her Primary care Physician who thought that the caller had a cyst; reactive inflammatory disease; The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022; The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022; The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022; The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022; The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022; The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRITIS REACTIVE (reactive inflammatory disease) in a 52-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (dose 1) and Pfizer (dose 2). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   In April 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 09-Dec-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced the first episode of CHILLS (The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022), the first episode of PYREXIA (The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022) and the first episode of MYALGIA (The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022). In December 2022, the patient experienced the second episode of CHILLS (The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022), the second episode of PYREXIA (The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022) and the second episode of MYALGIA (The pharmacist also had chills, fever, and body pain after her second Moderna Covid-19 vaccine in December 2022). In January 2023, the patient experienced CYST (In January patient saw her Primary care Physician who thought that the caller had a cyst). In 2023, the patient experienced ARTHRITIS REACTIVE (reactive inflammatory disease) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIOSTITIS (periostitis). The patient was treated with PARACETAMOL (TYLENOL) in December 2022 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in April 2022 at an unspecified dose and frequency. In April 2023, CYST (In January patient saw her Primary care Physician who thought that the caller had a cyst) had resolved. At the time of the report, ARTHRITIS REACTIVE (reactive inflammatory disease) outcome was unknown and PERIOSTITIS (periostitis), the last episode of CHILLS (The pharmacist also had chills, fever, and body pain after her last Moderna Covid-19 vaccine in December 2022), the last episode of PYREXIA (The pharmacist also had chills, fever, and body pain after her last Moderna Covid-19 vaccine in December 2022) and the last episode of MYALGIA (The pharmacist also had chills, fever, and body pain after her last Moderna Covid-19 vaccine in December 2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Patient was diagnosed with a reactive inflammatory disease of unknown Origin.. On an unknown date, Magnetic resonance imaging: Inconclusive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient received her last Moderna COVID-19 vaccine on 09-DEC-2022. Four or five days later she developed an itch on her left index finger there was also a red spot on the lateral side of my index finger towards the thumb. She thought that it was a mosquito bite. The spot started to get larger and developed all the inflammatory symptoms ''full blown" warm to the touch, redness, swelling, itching, throbbing.  As the weeks and months went by the spot was getting larger. Around Christmas 2022 the spot was getting larger. In January patient saw her Primary care Physician who thought that the caller had a cyst. The patient was referred to an Orthopedic hand surgeon. The Surgeon wanted to take the cyst out.  The patient had the cyst removed in Mid-April 2023. Since the cyst was removed the patient felt better. The patient wanted Moderna to contact her Physician. The patient said her entire life was put on hold for 6 months. She will never get another Covid-19 vaccine again forever. The vaccine was nonsense, and we don't need it at this point. The patient received the Pfizer vaccines for her first two vaccines. The patient received the Moderna Covid 19 vaccine for her booster doses with her first dose in April 2022 and her second dose in December 2022. The patient had chills and fever, body pain for 48 hours after her first Moderna COVID-19 vaccine in April 2022.  The patient also had chills, fever, and body pain after her second booster Moderna COVID-19 vaccine in December 2022. The patient used Tylenol in both April and December to treat the symptoms.  Company Comment: This is a spontaneous case concerning a 52-year-old, female patient previously vaccinated with two doses of Tozinameran vaccine, and no other medical history reported, who experienced the unexpected serious (medically significant) AESI of Arthritis reactive~and non-serious events of Periostitis, Cyst, Chills, Pyrexia and Myalgia. About 5 days after the administration of the second dose of SPIKEVAX COVID-19 VACCINE NOS vaccine, the patient developed an itchy spot on her index finger which became with inflammatory symptoms. During the next month of start date, the patient went through different tests such as MRI, biopsy and genetics tests and it was diagnosed as a reactive inflammatory disease of unknown Origin. She was also diagnosed with Periostitis. The cyst was removed 4 months after vaccination. Non-serious events of Chills, Pyrexia and Myalgia occurred after the third and fourth dose in the COVID-19 schedule. Both done with SPIKEVAX COVID-19 VACCINE NOS The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-753455 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753455:Same Reporter Different Patient