Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: Tonsillitis; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (Tonsillitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis (Chronic plaque psoriasis) and Psoriatic arthritis.   In July 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Oct-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 24-Oct-2021, the patient experienced TONSILLITIS (Tonsillitis) (seriousness criterion medically significant). The patient was treated with AMOXICILLIN at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency; AZITHROMYCIN at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency. At the time of the report, TONSILLITIS (Tonsillitis) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  After she had her flu shot few weeks ago this Oct 2021, she waited a week before taking her next dose of Humira.  Severe Sore throat  (Oropharyngeal pain) was the reported symptom of Tonsillitis  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality of humira for the event(s) of severe sore throat and tonsillitis was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 67-year-old female patient, with concurrent medical history of chronic plaque psoriasis and psoriatic arthritis on Adalimumab, who experienced the unexpected serious (medically significant) event of Tonsillitis occurred 36 days after receiving the 3rd dose of mRNA-1273 vaccine. Patient had sore throat 33 days post vaccination, and three days later, patient had tonsillitis treated with Amoxicillin, Azithromycin and Acetaminophen. The outcome of event was reported as unknown. Patient received primary series of mRNA-1273 vaccine 28 days apart, and 3rd dose was given approximately 6 months apart. Concurrent chronic plaque psoriasis and psoriatic arthritis and co-suspect Adalimumab remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623433 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up receive that contains Non significant information.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient, with concurrent medical history of chronic plaque psoriasis and psoriatic arthritis on Adalimumab, who experienced the unexpected serious (medically significant) event of Tonsillitis occurred 36 days after receiving the 3rd dose of mRNA-1273 vaccine. Patient had sore throat 33 days post vaccination, and three days later, patient had tonsillitis treated with Amoxicillin, Azithromycin and Acetaminophen. The outcome of event was reported as unknown. Patient received primary series of mRNA-1273 vaccine 28 days apart, and 3rd dose was given approximately 6 months apart. Concurrent chronic plaque psoriasis and psoriatic arthritis and co-suspect Adalimumab remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.