Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Ear discomfort, Ear pain, Headache
Clinical narrative: REACTION TO BOTH COVID SHOTS; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; CRACKLING SOUND IN EAR; EAR PAIN/EAR FELT FULL LIKE SOMETHING WAS IN IT; EAR FELT FULL LIKE SOMETHING WAS IN IT; Diagnosed with COVID-19; FELT SLUGGISH; HEADACHES; CONGESTION/NASAL CONGESTION; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (REACTION TO BOTH COVID SHOTS), NASAL CONGESTION (CONGESTION/NASAL CONGESTION), TINNITUS (CRACKLING SOUND IN EAR), EAR PAIN (EAR PAIN/EAR FELT FULL LIKE SOMETHING WAS IN IT) and EAR DISCOMFORT (EAR FELT FULL LIKE SOMETHING WAS IN IT) in a 56-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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Patient did not have any known allergies.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 06-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 01-Jun-2022, the patient experienced COVID-19 (Diagnosed with COVID-19). In 2022, the patient experienced NASAL CONGESTION (CONGESTION/NASAL CONGESTION), SLUGGISHNESS (FELT SLUGGISH) and HEADACHE (HEADACHES). On 02-Sep-2022, the patient experienced TINNITUS (CRACKLING SOUND IN EAR), EAR PAIN (EAR PAIN/EAR FELT FULL LIKE SOMETHING WAS IN IT) and EAR DISCOMFORT (EAR FELT FULL LIKE SOMETHING WAS IN IT). On an unknown date, the patient experienced IMMUNISATION REACTION (REACTION TO BOTH COVID SHOTS), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 01-Jun-2022 for COVID-19, at an unspecified dose and frequency. In 2022, SLUGGISHNESS (FELT SLUGGISH), HEADACHE (HEADACHES) and COVID-19 (Diagnosed with COVID-19) had resolved. At the time of the report, IMMUNISATION REACTION (REACTION TO BOTH COVID SHOTS) was resolving, NASAL CONGESTION (CONGESTION/NASAL CONGESTION), TINNITUS (CRACKLING SOUND IN EAR), EAR PAIN (EAR PAIN/EAR FELT FULL LIKE SOMETHING WAS IN IT) and EAR DISCOMFORT (EAR FELT FULL LIKE SOMETHING WAS IN IT) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown. Not Provided          No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality with Humira for the events reaction to both COVID shots, congestion/nasal congestion, crackling sound in ear, ear pain/ear felt full like something was in it, diagnosed with COVID-19 was not provided and events felt sluggishness and headaches was reported as reasonable possibility.  The reporter's causality with PFIZER for the events congestion/nasal congestion, crackling sound in ear, ear pain/ear felt full like something was in it, diagnosed with COVID-19, felt sluggishness and headaches was not reported and reaction to both COVID shots was reported as probable.  Company Comment: This is a Spontaneous case concerning a 56-year-old female patient with concomitant treatment with Adalimumab (Humira) for Rheumatoid arthritis, who experienced the non-serious unexpected AESI of COVID-19. The event occurred approximately 4 months after the third dose of Covid-19 vaccine with mRNA-1273. The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid). The event had resolved. Interchange of vaccine products was noted in this case, the patient received doses 1 and 2 of Tozinameran ( Pfizer BioNTech Covid-19 vaccine). Immunosuppressive treatment with Adalimumab may remain a confounder risk factor. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 56-year-old female patient with concomitant treatment with Adalimumab (Humira) for Rheumatoid arthritis, who experienced the non-serious unexpected AESI of COVID-19. The event occurred approximately 4 months after the third dose of Covid-19 vaccine with mRNA-1273. The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid). The event had resolved. Interchange of vaccine products was noted in this case, the patient received doses 1 and 2 of Tozinameran ( Pfizer BioNTech Covid-19 vaccine). Immunosuppressive treatment with Adalimumab may remain a confounder risk factor. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.