Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: HERNIATED DISK; BRAIN FOG; Increased joint pain as well as achiness in hips knees; INCREASED MUSCLE PAIN/ACHINESS; Skin Breakout; INCREASED HEADACHE; Nausea; FATIGUE; Vaccination failure; Cancer; exacerbate flare ups; Achiness in spine; SLIGHT SWELLING; Eye Infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 47-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 and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic) and Psoriatic arthritis.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-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) CF, Solution for injection in pre-filled pen. On 31-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), CONDITION AGGRAVATED (exacerbate flare ups), SPINAL PAIN (Achiness in spine), SWELLING (SLIGHT SWELLING), EYE INFECTION (Eye Infection), INTERVERTEBRAL DISC PROTRUSION (HERNIATED DISK), FEELING ABNORMAL (BRAIN FOG), ARTHRALGIA (Increased joint pain as well as achiness in hips knees), MYALGIA (INCREASED MUSCLE PAIN/ACHINESS), RASH (Skin Breakout), HEADACHE (INCREASED HEADACHE), NAUSEA (Nausea), FATIGUE (FATIGUE) and VACCINATION FAILURE (Vaccination failure). At the time of the report, NEOPLASM MALIGNANT (Cancer), CONDITION AGGRAVATED (exacerbate flare ups), SPINAL PAIN (Achiness in spine), SWELLING (SLIGHT SWELLING), EYE INFECTION (Eye Infection), COVID-19 (COVID-19), HEADACHE (INCREASED HEADACHE), NAUSEA (Nausea) and VACCINATION FAILURE (Vaccination failure) outcome was unknown and INTERVERTEBRAL DISC PROTRUSION (HERNIATED DISK), FEELING ABNORMAL (BRAIN FOG), ARTHRALGIA (Increased joint pain as well as achiness in hips knees), MYALGIA (INCREASED MUSCLE PAIN/ACHINESS), RASH (Skin Breakout) and FATIGUE (FATIGUE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: (Positive) positive.    Unknown cancer medication was considered as co suspect. No concomitant medications was reported.  The patient stated that, she was still experiencing increased muscle and joint pain as well as achiness in hips, knees, knuckle joints, spine and throughout back. Patient was taking a medication for cancer treatment to prevent recurrences of cancer cells and she felt it might have exacerbate her flare ups. On 31 Dec 2021, patient tested positive for covid-19. Patient experienced fevers, chills, sore throat, fatigue, light headedness and patient had eye infection which her physician thought was related to Covid-19. Patient was not fully recovered yet. As of 14-Apr-2022, patient was still experiencing joint pain, her skin was breaking out. Patient had slight swelling. Currently in 2022, patient had been undergoing cancer treatment and was experienced nausea, increased headache and increased joint pain as well.  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 spontaneous case concerns a 47-year-old female patient on Adalimumab medication for Plaque psoriasis and Psoriatic arthritis, who experienced the unexpected, serious  (medically significant) event of Neoplasm malignant (reported as Cancer), and unexpected, non-serious adverse event of special interest COVID-19.  Neoplasm malignant occurred on an unknown date (Onset latency could not be determined), while the event COVID-19 occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine. There were no further details with respect to Neoplasm malignant except that patient received cancer treatments which may have exacerbated her flare ups. Patient tested positive for SARS-CoV-2 test  for which she presented with fevers, chills, sore throat, fatigue, light headedness along with an eye infection.  Additionally, Vaccination failure was noted since patient previously received mRNA-1273 vaccine as first dose 31 days prior to current mRNA-1273 vaccine. Adalimumab medication, an immunosuppressant, and the cancer treatment could be considered as predisposing risk factors as these may increase the susceptibility of patient to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Significant follow-up received: Swelling, COVID-19, Eye Infection, Skin Breakout, Headache and Nausea added. On 06-Sep-2022: Follow up received wherein new events were added, the event of increased muscle pain was  amended to increased muscle pain/achiness and the event of achiness in throughout back was removed.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient on Adalimumab medication for Plaque psoriasis and Psoriatic arthritis, who experienced the unexpected, serious  (medically significant) event of Neoplasm malignant (reported as Cancer), and unexpected, non-serious adverse event of special interest COVID-19.  Neoplasm malignant occurred on an unknown date (Onset latency could not be determined), while the event COVID-19 occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine. There were no further details with respect to Neoplasm malignant except that patient received cancer treatments which may have exacerbated her flare ups. Patient tested positive for SARS-CoV-2 test  for which she presented with fevers, chills, sore throat, fatigue, light headedness along with an eye infection.  Additionally, Vaccination failure was noted since patient previously received mRNA-1273 vaccine as first dose 31 days prior to current mRNA-1273 vaccine. Adalimumab medication, an immunosuppressant, and the cancer treatment could be considered as predisposing risk factors as these may increase the susceptibility of patient to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.