Sex: F
Vaccine: PPV
Symptoms: Insomnia, Intentional product misuse, Neuralgia, Pyrexia, Rash
Clinical narrative: Cellulitis; cannot sleep; cannot relax; rheumatoid arthritis flare up; low grade fever; INFLAMMATION on hand; nerve pain; autoimmune disorder; intentional misuse in product use duration; rash; shingles; This spontaneous report has been received from a 43 years old female consumer via other company letter (manufacture control number#21K-163-3984635-00) (It was also reported as a solicited report, conflict information). The patient was a non-smoker, abstains from alcohol. She had stomach problems, lupus markers, preeclampsia, autoimmune condition, dilantin allergy manifested by hives, sulfa drugs allergy manifested by hives, cefdinir allergy manifested by hives, phenytoin allergy manifested by hives (it was also reported the patient had no known allergies and no relevant medical history, conflict information).   On unspecified date, the patient started suspect therapy with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, unit, frequency, strength, lot# expiration date were not reported) for prophylaxis. From unspecified date in 2020, the patient started with upadacitinib (RINVOQ) 15 mg orally daily (lot#1138391) for rheumatoid arthritis.  On an unknown date, the patient experienced cellulitis. In unspecified date in 2020, the patient experienced rashes and shingles. It was unknown if the patient was enrolled in a covid-19 vaccine trial. In February 2021, the patient received 1st dose of covid-19 vaccine tozinameran manufactured by Pfizer. In March 2021, the patient received the 2nd dose tozinameran. In March 2021, the patient experienced misuse/ stopped taking upadacitinib (RINVOQ) because of autoimmune condition and it was not advised by physician. The patient had taken a break from upadacitinib (RINVOQ) treatment started in March 2021 and turning at the end of June 2021. In June 2021, the patient experienced nerve pain. In June 2021, the rashes resolved. On 01-JUN-2021, the patient experienced inflammation on hands. On 30-JUN-2021, the patient experienced rheumatoid arthritis flare ups and low grade fever. In July 2021, the patient experienced cannot sleep and cannot relax. On 01-JUL-2021, the low grade fever resolved. Upadacitinib (RINVOQ) did help with her rheumatoid arthritis and with that she had returned back to treatment and was prescribed with a month long steroid pack. She was stopped taking upadacitinib (RINVOQ) because of her autoimmune condition and it was not advised by her physician. She stated she saw her physician last on 06-JUL-2021 and restarted upadacitinib (RINVOQ) again. It was also reported as intentional misuse in product use duration and autoimmune was stopped on the same day (outcome for both events was reported as unknown, conflict information). The patient was treated with fexofenadine hydrochloride (ALLEGRA), prednisone and gabapentin. Outcome of inflammation localized, difficulty sleeping, feeling anxious, nerve pain, rheumatoid arthritis flare up, shingles was reported as improved at the reporting time. Outcome of intentional misuse in product use duration, cellulitis, autoimmune disorder was reported as unknown. Action taken with upadacitinib (RINVOQ) regarding all of the events were reported as dose not changed. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding all of the events were reported as unknown.  The reporter's causality for the event (s) of inflammation on hands, cannot sleep, cannot relax and rheumatoid arthritis flare ups with upadacitinib (RINVOQ) was a reasonable possibility. The reporter's causality for the event(s) of misuse/stopped taking upadacitinib (RINVOQ) because of autoimmune condition and it was not advised by physician onset in March 2021, rashes, nerve pain, cellulitis, low grade fever, shingles and misuse/stopped taking upadacitinib (RINVOQ) because of autoimmune condition and it was not advised by physician onset in March 2021 was not provided. Alternate etiology for cellulitis was reported as pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). Causality with other events with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) were not reported.   Upon internal review, cellulitis, rheumatoid arthritis flare up and autoimmune disorder were determined to be medically significant events.