Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: ACOUSTIC NEUROMA IN LEFT EAR; Allergic reaction to antibiotics; Diverticulitis; ARM PAIN DUE TO COVID BOOSTER VACCINE; Vaccination site erythema; Vaccination site warmth; SWELLING DUE TO COVID BOOSTER VACCINE; ARM RASH DUE TO COVID BOOSTER VACCINE; SHINGLES; Sinus infection; DOUBLE EAR INFECTION; Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of ACOUSTIC NEUROMA (ACOUSTIC NEUROMA IN LEFT EAR) and DIVERTICULITIS (Diverticulitis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Acoustic neuroma in 2006 and COVID-19 in December 2020. Concurrent medical conditions included Psoriatic arthritis and Ankylosing spondylitis.   On 01-May-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HERPES ZOSTER (SHINGLES), SINUSITIS (Sinus infection), EAR INFECTION (DOUBLE EAR INFECTION), BRONCHITIS (Bronchitis), VACCINATION SITE SWELLING (SWELLING DUE TO COVID BOOSTER VACCINE) and VACCINATION SITE RASH (ARM RASH DUE TO COVID BOOSTER VACCINE). In September 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (ARM PAIN DUE TO COVID BOOSTER VACCINE) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 20-Oct-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant). On an unknown date, the patient experienced ACOUSTIC NEUROMA (ACOUSTIC NEUROMA IN LEFT EAR) (seriousness criterion medically significant) and DRUG HYPERSENSITIVITY (Allergic reaction to antibiotics). In 2021, DIVERTICULITIS (Diverticulitis), HERPES ZOSTER (SHINGLES), VACCINATION SITE SWELLING (SWELLING DUE TO COVID BOOSTER VACCINE) and VACCINATION SITE RASH (ARM RASH DUE TO COVID BOOSTER VACCINE) had resolved. In September 2021, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (ARM PAIN DUE TO COVID BOOSTER VACCINE) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. At the time of the report, ACOUSTIC NEUROMA (ACOUSTIC NEUROMA IN LEFT EAR) and DRUG HYPERSENSITIVITY (Allergic reaction to antibiotics) had not resolved and SINUSITIS (Sinus infection), EAR INFECTION (DOUBLE EAR INFECTION) and BRONCHITIS (Bronchitis) outcome was unknown.            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. No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This is a spontaneous case concerning a 59-year-old female patient with psoriatic arthritis and  ankylosing spondylitis treated with Adalimumab and past medical history of acoustic neuroma in left ear in 2006, who experienced the serious (medically significant) unexpected events acoustic neuroma in left ear and diverticulitis. Acoustic neurinoma was reported on an unknown date and diverticulitis was reported 26 days after the booster dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Other non-serious reported adverse events include herpes zoster, sinusitis, ear infection, bronchitis, allergic reaction to antibiotics and expected vaccination site reactions. Patient medical history of acoustic neuroma remains a confounder to event acoustic neuroma.  Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2021: Significant FU: Event added.; Sender's Comments: Company comment: This is a spontaneous case concerning a 59-year-old female patient with psoriatic arthritis and  ankylosing spondylitis treated with Adalimumab and past medical history of acoustic neuroma in left ear in 2006, who experienced the serious (medically significant) unexpected events acoustic neuroma in left ear and diverticulitis. Acoustic neurinoma was reported on an unknown date and diverticulitis was reported 26 days after the booster dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Other non-serious reported adverse events include herpes zoster, sinusitis, ear infection, bronchitis, allergic reaction to antibiotics and expected vaccination site reactions. Patient medical history of acoustic neuroma remains a confounder to event acoustic neuroma.  Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.