Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dermatitis contact, Fatigue, Hypersensitivity, Mycotic allergy, Neuropathy peripheral
Clinical narrative: Neuropathy; Contact dermatitis; Allergy to molds; Environmental allergy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 63-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) solution for injection for Hidradenitis suppurativa and Plaque psoriasis.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to sever Hidradenitis suppurativa), Plaque psoriasis (Moderate to sever Chronic Plaque psoriasis) and Rheumatoid arthritis. Concomitant products included BACLOFEN for Rheumatoid arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, received fourth 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) 1 dosage form. In June 2022, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), DERMATITIS CONTACT (Contact dermatitis), MYCOTIC ALLERGY (Allergy to molds) and HYPERSENSITIVITY (Environmental allergy). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), DERMATITIS CONTACT (Contact dermatitis), MYCOTIC ALLERGY (Allergy to molds) and HYPERSENSITIVITY (Environmental allergy) had not resolved and FATIGUE (Tiredness) had resolved.            Reported that it was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 63-year-old female patient with relevant concurrent medical conditions of Hidradenitis suppurativa and Plaque psoriasis treated with co-suspect drug Adalimumab (Humira), who experienced the unexpected serious (medically significant) event of Neuropathy peripheral, in the context of the second booster/fourth dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule, approximately 8 months prior to third mRNA-1273 vaccination and 13 months prior to the  second booster/fourth dose of mRNA-1273 vaccine. Patient also experienced contact dermatitis, allergies from change in weather and molds, and tiredness. No further details about the clinical course, diagnostic procedures and treatments were provided. The concurrent medical conditions of Hidradenitis suppurativa and Plaque psoriasis could be the risk factors for the event contact dermatitis, and the co-suspect drug Adalimumab (Humira) remains as a confounder for the event Neuropathy peripheral. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 63-year-old female patient with relevant concurrent medical conditions of Hidradenitis suppurativa and Plaque psoriasis treated with co-suspect drug Adalimumab (Humira), who experienced the unexpected serious (medically significant) event of Neuropathy peripheral, in the context of the second booster/fourth dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule, approximately 8 months prior to third mRNA-1273 vaccination and 13 months prior to the  second booster/fourth dose of mRNA-1273 vaccine. Patient also experienced contact dermatitis, allergies from change in weather and molds, and tiredness. No further details about the clinical course, diagnostic procedures and treatments were provided. The concurrent medical conditions of Hidradenitis suppurativa and Plaque psoriasis could be the risk factors for the event contact dermatitis, and the co-suspect drug Adalimumab (Humira) remains as a confounder for the event Neuropathy peripheral. The benefit-risk relationship of mRNA-1273 is not affected by this report.