Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immune-mediated adverse reaction, Inappropriate schedule of product administration, Pain, Sleep disorder
Clinical narrative: lack of efficiency for dupilumab; She held off on completing her second and third dose of Moderna vaccine until she was on a break from Dupixent for about a 3-month period; Hiatal hernia; had symptoms of Allergies; mild asthma especially related to strong chemicals; hard time breathing; reaction from the covid injection while on Dupixent, her immune system; Arthritis; Pain; when she took vaccine she got really sick; had a poor immune system; not sleeping, when she did sleep she slept 10 to 14 hours; For the last 2 weekends in a row, the consumer began having a headache and she had headache even before and thought that it was not related to Dupixent; feels washed out (tired) the next day for the event; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (when she took vaccine she got really sick), IMMUNE SYSTEM DISORDER (had a poor immune system), IMMUNE-MEDIATED ADVERSE REACTION (reaction from the covid injection while on Dupixent, her immune system), ARTHRITIS (Arthritis) and PAIN (Pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Eczema.   On 30-Jul-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram once a day. On 13-Aug-2020, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 22-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2020, the patient experienced FATIGUE (feels washed out (tired) the next day for the event) and HEADACHE (For the last 2 weekends in a row, the consumer began having a headache and she had headache even before and thought that it was not related to Dupixent). In January 2021, the patient experienced ILLNESS (when she took vaccine she got really sick), IMMUNE SYSTEM DISORDER (had a poor immune system), PAIN (Pain) and SLEEP DISORDER (not sleeping, when she did sleep she slept 10 to 14 hours). In February 2021, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (reaction from the covid injection while on Dupixent, her immune system), ARTHRITIS (Arthritis), HIATUS HERNIA (Hiatal hernia), ASTHMA (mild asthma especially related to strong chemicals), DYSPNOEA (hard time breathing) and HYPERSENSITIVITY (had symptoms of Allergies). On an unknown date, the patient experienced DRUG INEFFECTIVE (lack of efficiency for dupilumab) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She held off on completing her second and third dose of Moderna vaccine until she was on a break from Dupixent for about a 3-month period). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency and BACLOFEN for Headache, at an unspecified dose and frequency. At the time of the report, ILLNESS (when she took vaccine she got really sick), IMMUNE SYSTEM DISORDER (had a poor immune system), DRUG INEFFECTIVE (lack of efficiency for dupilumab), ASTHMA (mild asthma especially related to strong chemicals), DYSPNOEA (hard time breathing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She held off on completing her second and third dose of Moderna vaccine until she was on a break from Dupixent for about a 3-month period) outcome was unknown, IMMUNE-MEDIATED ADVERSE REACTION (reaction from the covid injection while on Dupixent, her immune system), ARTHRITIS (Arthritis), PAIN (Pain), HIATUS HERNIA (Hiatal hernia), SLEEP DISORDER (not sleeping, when she did sleep she slept 10 to 14 hours) and HYPERSENSITIVITY (had symptoms of Allergies) had resolved and FATIGUE (feels washed out (tired) the next day for the event) and HEADACHE (For the last 2 weekends in a row, the consumer began having a headache and she had headache even before and thought that it was not related to Dupixent) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEADACHE (For the last 2 weekends in a row, the consumer began having a headache and she had headache even before and thought that it was not related to Dupixent) to be not related. No further causality assessments were provided for ILLNESS (when she took vaccine she got really sick), IMMUNE SYSTEM DISORDER (had a poor immune system), IMMUNE-MEDIATED ADVERSE REACTION (reaction from the covid injection while on Dupixent, her immune system), ARTHRITIS (Arthritis), PAIN (Pain), HIATUS HERNIA (Hiatal hernia), SLEEP DISORDER (not sleeping, when she did sleep she slept 10 to 14 hours), DRUG INEFFECTIVE (lack of efficiency for dupilumab), ASTHMA (mild asthma especially related to strong chemicals), DYSPNOEA (hard time breathing), FATIGUE (feels washed out (tired) the next day for the event), HYPERSENSITIVITY (had symptoms of Allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She held off on completing her second and third dose of Moderna vaccine until she was on a break from Dupixent for about a 3-month period).    No concomitant medication was reported. The patient had 5 shots so far and would be having the 6th one. Her next dose would be on 08-Oct-2020. Nurse reported that the patient had headache even before and thought that it was not related to dupilumab. She held off on completing her second and third dose of Moderna vaccine until she was on a break from Dupixent for about a 3-month period. 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   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Significant follow up- added secondary reporter and new events, updated dose information.