Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Haemorrhoids, Inappropriate schedule of product administration, Leukoplakia oral, Lip haemorrhage
Clinical narrative: Started to spill out clumps of blood; Mouth bleeding/Started to spill out clumps of blood; Lips and mouth were full of ulcers; Face was swollen; I was losing weight; Throat swollen; Lymph nodes Swollen; Throat red; Lip bleeding; Inappropriate schedule of vaccine administered (2nd dose administered after 41 days); Hemorrhoid; Gum started bleeding; Having a crazy sensation in my gums, like I needed to floss all the time.; The gum became black; Pemphigoid/pemphigus vulgaris; Bleeding through the rectum; Over the black something white, it was leucoplakia which is pre-cancerous; This spontaneous case was reported by a health care professional and describes the occurrence of HAEMATEMESIS (Started to spill out clumps of blood), PEMPHIGUS (Pemphigoid/pemphigus vulgaris) and LEUKOPLAKIA ORAL (Over the black something white, it was leucoplakia which is pre-cancerous) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Non-smoker.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced LEUKOPLAKIA ORAL (Over the black something white, it was leucoplakia which is pre-cancerous) (seriousness criterion medically significant). On 28-Feb-2021, the patient experienced PEMPHIGUS (Pemphigoid/pemphigus vulgaris) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (Bleeding through the rectum), GINGIVAL BLEEDING (Gum started bleeding), FEELING ABNORMAL (Having a crazy sensation in my gums, like I needed to floss all the time.) and GINGIVAL DISCOLOURATION (The gum became black). In April 2021, the patient experienced HAEMORRHOIDS (Hemorrhoid). On an unknown date, the patient experienced HAEMATEMESIS (Started to spill out clumps of blood) (seriousness criterion medically significant), MOUTH HAEMORRHAGE (Mouth bleeding/Started to spill out clumps of blood), LIP ULCERATION (Lips and mouth were full of ulcers), SWELLING FACE (Face was swollen), WEIGHT DECREASED (I was losing weight), PHARYNGEAL SWELLING (Throat swollen), LYMPHADENOPATHY (Lymph nodes Swollen), PHARYNGEAL ERYTHEMA (Throat red), LIP HAEMORRHAGE (Lip bleeding) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose administered after 41 days)). The patient was treated with IBUPROFEN for Mouth pain, at an unspecified dose and frequency. At the time of the report, HAEMATEMESIS (Started to spill out clumps of blood), PEMPHIGUS (Pemphigoid/pemphigus vulgaris), RECTAL HAEMORRHAGE (Bleeding through the rectum), LEUKOPLAKIA ORAL (Over the black something white, it was leucoplakia which is pre-cancerous), GINGIVAL BLEEDING (Gum started bleeding), FEELING ABNORMAL (Having a crazy sensation in my gums, like I needed to floss all the time.), LIP ULCERATION (Lips and mouth were full of ulcers), SWELLING FACE (Face was swollen), PHARYNGEAL SWELLING (Throat swollen), LYMPHADENOPATHY (Lymph nodes Swollen) and PHARYNGEAL ERYTHEMA (Throat red) had not resolved, HAEMORRHOIDS (Hemorrhoid), MOUTH HAEMORRHAGE (Mouth bleeding/Started to spill out clumps of blood), GINGIVAL DISCOLOURATION (The gum became black), WEIGHT DECREASED (I was losing weight) and LIP HAEMORRHAGE (Lip bleeding) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose administered after 41 days)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Colonoscopy: hemorrhoid (abnormal) hemorrhoid. On an unknown date, Biopsy: thought it was pemphigoid (abnormal) thought it was pemphigoid, pemphigus vulgaris.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had severe throat pain and difficulty in swallowing, lasted for 3 weeks then it went off for few hours and again came back on the right side. Had mouth ulcer for some days and weeks but came again. Colonoscopy was done in April and found hemorrhoid.  Patient was non-smoker, don't drink and not involved in nothing unhealthy. From October 6 patient could not take water in mouth, only could drink hot water. Patient throat became red, used anesthetic mouth wash. Patient saw a surgeon, did a biopsy and said he thought it was pemphigoid and prescribed narcotic pain killers,corticosteroid and BMX mouthwash. Surgeon wanted to do another biopsy but medications started to work after a day. It was a rare condition and patient read some articles about Moderna and Pfizer have caused pemphigus on people that did not have pemphigus. Patient said that never had this before in family. Patient was applied corticosteroid mouthwash in white area of mouth because it can be cancerous.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Pemphigus and the non serious events of Gingival bleeding, Mouth bleeding, Rectal haemorrhage, Haemorrhoids and other non serious events after mRNA- 1273 Moderna vaccine. Additionally, inappropriate schedule of vaccine administered was captured. The onset of the event Pemphigus occurred approximately 4 days after the second dose of mRNA- 1273 vaccine. Clinical manifestations included mouth ulceration, lip ulceration, tongue ulceration, odynophagia and dysphagia. Biopsy confirmed the diagnosis of Pemphigus vulgaris. Treatment with topical corticoids was prescribed. Gingival bleeding and Mouth bleeding were also reported, and could be in connection with oral ulcerations. On the other hand, rectal haemorrhage occurred at an unknown date after the second dose. Colonoscopy was performed  approximately 1 month and 6 days after vaccination and haemorrhoids were diagnosed. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Rectal haemorrhage was automatically upgraded as serious as per IME list. However, based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.