Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Macroglossia, Throat tightness
Clinical narrative: Macroglossia / Tongue got big; Throat constriction/Throat closed up; Back pain; Slipped disc/Slipped disc in back; Skin cyst/cyst in back; COVID-19; 1st dose on 12-Mar-2020 and 2nd dose on 12-Dec-2020; This spontaneous case was reported by a consumer and describes the occurrence of MACROGLOSSIA (Macroglossia / Tongue got big), THROAT TIGHTNESS (Throat constriction/Throat closed up), BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (Slipped disc/Slipped disc in back) and DERMAL CYST (Skin cyst/cyst in back) in an elderly 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) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Mar-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Dec-2020, received second 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) Citrate Free. On an unknown date, the patient experienced MACROGLOSSIA (Macroglossia / Tongue got big), THROAT TIGHTNESS (Throat constriction/Throat closed up), BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (Slipped disc/Slipped disc in back), DERMAL CYST (Skin cyst/cyst in back), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12-Mar-2020 and 2nd dose on 12-Dec-2020). At the time of the report, MACROGLOSSIA (Macroglossia / Tongue got big), THROAT TIGHTNESS (Throat constriction/Throat closed up) and COVID-19 (COVID-19) outcome was unknown, BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (Slipped disc/Slipped disc in back) and DERMAL CYST (Skin cyst/cyst in back) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12-Mar-2020 and 2nd dose on 12-Dec-2020) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information provided. It was unknown if patient was enrolled in a COVID-19 clinical trial. Primary reporter contact for lot number information was unsuccessful.  Company Comment: This spontaneous case concerns an elderly female patient on the 6th decade of life with pre-existing condition of rheumatoid arthritis (RA) and was treated with Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest COVID-19, and non-serious events of macroglossia, throat tightness, intervertebral disc protrusion, back pain and dermal cyst on the back. Inappropriate schedule of product administration was reported as an additional event wherein vaccine interval was 9 months - outside recommended dosing period. The events occurred on unspecified dates after receiving mRNA-1273 as primary COVID-19 vaccine series. The patient mentioned that her throat closed and her tongue got big with Adalimumab. No further information was provided on the clinical course, diagnostic procedures conducted and medical intervention administered. The patient's elderly age and pre-existing RA remains a confounder for the back pain; while the co-suspect Adalimumab remains a confounder for all events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reporter's Comments: For the co-suspect Humira, reporter causality as Not Reported for the events of Slipped disc (PT: Intervertebral disc protrusion), Skin cyst (PT: Dermal cyst); Throat constriction (PT: Throat tightness); Macroglossia (PT: Macroglossia), Not Related for the events of COVID-19 (PT: COVID-19)a nd Probable for the events of Drug effect incomplete (PT: Therapeutic product effect incomplete).; Sender's Comments: This spontaneous case concerns an elderly female patient on the 6th decade of life with pre-existing condition of rheumatoid arthritis (RA) and was treated with Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest COVID-19, and non-serious events of macroglossia, throat tightness, intervertebral disc protrusion, back pain and dermal cyst on the back. Inappropriate schedule of product administration was reported as an additional event wherein vaccine interval was 9 months - outside recommended dosing period. The events occurred on unspecified dates after receiving mRNA-1273 as primary COVID-19 vaccine series. The patient mentioned that her throat closed and her tongue got big with Adalimumab. No further information was provided on the clinical course, diagnostic procedures conducted and medical intervention administered. The patient's elderly age and pre-existing RA remains a confounder for the back pain; while the co-suspect Adalimumab remains a confounder for all events. The benefit-risk relationship of mRNA-1273 is not affected by this report.