Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye swelling, Eyelid exfoliation, Ocular hyperaemia, Pneumonia, Psoriasis
Clinical narrative: Eyelid exfoliation/Dead skin on the lid and made it difficult to see; Psoriasis flare-up/Plaque psoriasis outbreak on eyelid/back of legs and arms; Eyes swollen; Eyes red; Visual impairment; Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 51-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 Plaque psoriasis.    No known allergies.  Concurrent medical conditions included Plaque psoriasis.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, 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) UNK, citrate free. In August 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced EYELID EXFOLIATION (Eyelid exfoliation/Dead skin on the lid and made it difficult to see), PSORIASIS (Psoriasis flare-up/Plaque psoriasis outbreak on eyelid/back of legs and arms), EYE SWELLING (Eyes swollen), OCULAR HYPERAEMIA (Eyes red) and VISUAL IMPAIRMENT (Visual impairment). The patient was treated with PREDNISONE at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. In September 2021, PNEUMONIA (Pneumonia) had resolved. At the time of the report, EYELID EXFOLIATION (Eyelid exfoliation/Dead skin on the lid and made it difficult to see), PSORIASIS (Psoriasis flare-up/Plaque psoriasis outbreak on eyelid/back of legs and arms), EYE SWELLING (Eyes swollen), OCULAR HYPERAEMIA (Eyes red) and VISUAL IMPAIRMENT (Visual impairment) had not resolved.            No concomitant drugs were taken.  On unknown dates, the patient experienced dead skin on the lid and made it difficult to see, eyes swollen, red eyes, difficulty to see and plaque psoriasis outbreak on eyelid/back of legs and arms. In August 2021, the patient experienced pneumonia. In September 2021, the pneumonia resolved. Moderna vaccine was also considered suspect. The patient had plaque psoriasis outbreak on her eyelids and on the back of legs and arms. It was not clearing up even thought her doctor gave her prednisone and cortisone. The eyes were swollen and red and had dead skin on the lid and it made difficult to see. She got first Moderna shot in Aug 2021 and developed pneumonia due to which she was deathly ill from Aug 2021 through Sep 2021.  Formulation of Humira was reported as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   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 is a spontaneous case concerning a 51-year-old female patient with Plaque psoriasis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Pneumonia, that occurred on the same month after receiving the first dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. It was reported patient was seriously ill due to the event for approximately one month. Psoriasis flare-up, eyelid exfoliation and eye swelling were also reported as non-serious events. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Live-significant follow-up received included vaccination date updated.; Sender's Comments: This is a spontaneous case concerning a 51-year-old female patient with Plaque psoriasis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Pneumonia, that occurred on the same month after receiving the first dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. It was reported patient was seriously ill due to the event for approximately one month. Psoriasis flare-up, eyelid exfoliation and eye swelling were also reported as non-serious events. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.