Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Influenza like illness, Peripheral swelling, Therapeutic response shortened, Tinnitus
Clinical narrative: Flu like symptoms; Disorder equilibrium; Noises in head; Peripheral swelling; Wearing off effect; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BALANCE DISORDER (Disorder equilibrium), TINNITUS (Noises in head), PERIPHERAL SWELLING (Peripheral swelling) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BALANCE DISORDER (Disorder equilibrium), TINNITUS (Noises in head), PERIPHERAL SWELLING (Peripheral swelling) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and BALANCE DISORDER (Disorder equilibrium), TINNITUS (Noises in head), PERIPHERAL SWELLING (Peripheral swelling) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown.            No Concomitant medication was reported  Patient took booster dose It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the events of flu like symptoms, equilibrium issues and clicking sound in head  with humira was no reasonable possibility but for swelling in fingers and pads of feet when due for injection, it was unknown No Treatment medication was reported  Company Comment:  This is a spontaneous case concerning an elderly female patient with relevant concurrent medical condition of Psoriatic arthritis treated with co-suspect drug Adalimumab (Humira), who experienced the unexpected non-serious events of Influenza like illness, Balance disorder, Tinnitus, and Peripheral swelling in the context of the third/booster dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine on unknown dates, prior to the booster/third mRNA-1273 vaccination. Additionally, Therapeutic response shortened, described as wearing off effect, was also reported. The events were described as flu like symptoms, equilibrium issues, swelling in fingers and pads of feet when due for injection, and clicking sound in the head. No further details about the diagnostic procedures and treatments were provided. It was reported that the event Influenza like illness had resolved, while the outcome of the other events were unknown. The concurrent medical condition of Psoriatic arthritis remains as a confounder for the event Peripheral swelling, while the concomitant administration of the co-suspect drug Adalimumab (Humira) remains as a confounder for the event Influenza like illness. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning an elderly female patient with relevant concurrent medical condition of Psoriatic arthritis treated with co-suspect drug Adalimumab (Humira), who experienced the unexpected non-serious events of Influenza like illness, Balance disorder, Tinnitus, and Peripheral swelling in the context of the third/booster dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine on unknown dates, prior to the booster/third mRNA-1273 vaccination. Additionally, Therapeutic response shortened, described as wearing off effect, was also reported. The events were described as flu like symptoms, equilibrium issues, swelling in fingers and pads of feet when due for injection, and clicking sound in the head. No further details about the diagnostic procedures and treatments were provided. It was reported that the event Influenza like illness had resolved, while the outcome of the other events were unknown. The concurrent medical condition of Psoriatic arthritis remains as a confounder for the event Peripheral swelling, while the concomitant administration of the co-suspect drug Adalimumab (Humira) remains as a confounder for the event Influenza like illness. The benefit-risk relationship of mRNA-1273 is not affected by this report.