Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Facial paralysis, General physical health deterioration, Hypophagia
Clinical narrative: CANCER SPOTS ON HEAD; TONGUE WAS NUMB/LEFT FACE WENT NUMB/LIPS DROOPED; POOR HEALTH AND A LOT OF HEALTH ISSUES; COULD NOT EAT REGULAR FOOD; AFTER EACH COLONOSCOPY MADE STOMACH SENSITIVE/DIARRHEA/STOMACH PAINS; AFTER EACH COLONOSCOPY MADE STOMACH SENSITIVE/DIARRHEA/STOMACH PAINS; under arms were swollen; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (CANCER SPOTS ON HEAD) and FACIAL PARALYSIS (TONGUE WAS NUMB/LEFT FACE WENT NUMB/LIPS DROOPED) in an adult female patient who received mRNA-1273 (Spikevax) 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 Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SKIN CANCER (CANCER SPOTS ON HEAD) (seriousness criterion medically significant), FACIAL PARALYSIS (TONGUE WAS NUMB/LEFT FACE WENT NUMB/LIPS DROOPED) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (POOR HEALTH AND A LOT OF HEALTH ISSUES), HYPOPHAGIA (COULD NOT EAT REGULAR FOOD), POST PROCEDURAL DIARRHOEA (AFTER EACH COLONOSCOPY MADE STOMACH SENSITIVE/DIARRHEA/STOMACH PAINS), ABDOMINAL DISCOMFORT (AFTER EACH COLONOSCOPY MADE STOMACH SENSITIVE/DIARRHEA/STOMACH PAINS), PERIPHERAL SWELLING (under arms were swollen) and DIZZINESS (Dizziness). At the time of the report, SKIN CANCER (CANCER SPOTS ON HEAD), FACIAL PARALYSIS (TONGUE WAS NUMB/LEFT FACE WENT NUMB/LIPS DROOPED), HYPOPHAGIA (COULD NOT EAT REGULAR FOOD), POST PROCEDURAL DIARRHOEA (AFTER EACH COLONOSCOPY MADE STOMACH SENSITIVE/DIARRHEA/STOMACH PAINS), ABDOMINAL DISCOMFORT (AFTER EACH COLONOSCOPY MADE STOMACH SENSITIVE/DIARRHEA/STOMACH PAINS), PERIPHERAL SWELLING (under arms were swollen) and DIZZINESS (Dizziness) outcome was unknown and GENERAL PHYSICAL HEALTH DETERIORATION (POOR HEALTH AND A LOT OF HEALTH ISSUES) had not resolved. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  It was reported that patient had a colonoscopy with unknown result, green tea and water only things that paient could drink. Cancer spot on head that had to be removed through two surgeries.  Reporters causality for event reduced general condition was not related and for all other events was not reported with respect to Humira drug.  The formulation for Humira was reported as Solution for injection in pre-filled pen.  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 reported by a consumer, concerning an adult female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Skin cancer (reported as cancer spots on head), and the expected and serious (due to medically significant) AESI of Facial paralysis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Ulcerative colitis. Cancer spot on head had to be removed through two surgeries. No information disclosed about diagnostic tests performed or clinical course. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Skin cancer (reported as cancer spots on head), and the expected and serious (due to medically significant) AESI of Facial paralysis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Ulcerative colitis. Cancer spot on head had to be removed through two surgeries. No information disclosed about diagnostic tests performed or clinical course. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.