Age: 46.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Blister, Feeding disorder, Feeling abnormal, Hyperhidrosis, Insomnia
Clinical narrative: Blisters; Excess sweating; Vaccination site pruritus; Vaccination site erythema; Vaccination site erythema; Vaccination site pruritus; RECURRENT UPPER ARM SWELLING; Weight loss; Unable to eat; Foggy feeling in head; Difficulty sleeping; Vomiting; RECURRENT UPPER ARM SWELLING; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), FEEDING DISORDER (Unable to eat), FEELING ABNORMAL (Foggy feeling in head), INSOMNIA (Difficulty sleeping) and BLISTER (Blisters) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 025D21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and Rheumatoid arthritis, ETANERCEPT  (HUMIRA)for Ankylosing spondylitis and Rheumatoid arthritis and GOLIMUMAB (SIMPONI) for Ankylosing spondylitis and Rheumatoid arthritis.    Concurrent medical conditions included Ankylosing spondylitis, Rheumatoid arthritis, Obesity and Smoker.   In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2019, the patient started ETANERCEPT (ENBREL) (unknown route) at an unspecified dose. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient started GOLIMUMAB (SIMPONI) (unknown route) at an unspecified dose. On 08-Oct-2021, the patient experienced the first episode of PERIPHERAL SWELLING (RECURRENT UPPER ARM SWELLING). On 11-Oct-2021, the patient experienced WEIGHT DECREASED (Weight loss), FEEDING DISORDER (Unable to eat), FEELING ABNORMAL (Foggy feeling in head), INSOMNIA (Difficulty sleeping) and VOMITING (Vomiting). In November 2021, the patient experienced the second episode of PERIPHERAL SWELLING (RECURRENT UPPER ARM SWELLING). On 15-Nov-2021, the patient experienced the first episode of VACCINATION SITE PRURITUS (Vaccination site pruritus) and the first episode of VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 30-Nov-2021, the patient experienced the second episode of VACCINATION SITE PRURITUS (Vaccination site pruritus) and the second episode of VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced BLISTER (Blisters) and HYPERHIDROSIS (Excess sweating). In 2021, FEEDING DISORDER (Unable to eat), FEELING ABNORMAL (Foggy feeling in head), INSOMNIA (Difficulty sleeping) and VOMITING (Vomiting) had resolved. In November 2021, last episode of PERIPHERAL SWELLING (RECURRENT UPPER ARM SWELLING) had resolved. At the time of the report, WEIGHT DECREASED (Weight loss), the last episode of VACCINATION SITE PRURITUS (Vaccination site pruritus) and the last episode of VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved, BLISTER (Blisters) had resolved and HYPERHIDROSIS (Excess sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2021, Weight: Lost 10 pounds of weight.         No concomitant medications were reported. On unknown dates simponi did not work in relieving the pain on spine, patient experienced blisters filled with water like or pus like fluid on the palm of hands and sweats a lot. Unknown date in 2019, enbrel did not work in relieving the pain on spine and spinal pain. Unknown date in 2021, the patient experienced reactions from moderna vaccine. Unknown date in October 2021 the patient did misuse/patient stopped humira of own accord. On 11-Oct-2021 the patient experienced lost 10 pounds of weight, could not eat, brain fog, not able to sleep and vomiting. No treatment medication details provided. 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 17-Dec-2021: Follow-up included event information updated.