Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Inappropriate schedule of product administration, Injection site joint pain, Magnetic resonance imaging
Clinical narrative: Skin cancer; Root canal infection; Sinus infection; Diarrhea; Allergy; Injection site joint pain; Cold; 3rd dose administered on 10-Jan-2022 and 2nd dose on 27-Apr-2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2022 and was forwarded to Moderna on 04-Mar-2022.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) and ROOT CANAL INFECTION (Root canal infection) in a 65-year-old male 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) solution for injection for Crohn's disease.    Concurrent medical conditions included Bowel resection (resected the small intestine to the large intestine and removed the valve that slows bowels.) since 2008.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, received third 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) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In March 2022, the patient experienced NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant), ROOT CANAL INFECTION (Root canal infection) (seriousness criterion medically significant), SINUSITIS (Sinus infection), SUNBURN (Sunburn), CRYOTHERAPY (Cryoablation), POST PROCEDURAL PRURITUS (Post procedural pruritus), BLISTER (Blister), SCAB (Scab), POST PROCEDURAL COMPLICATION (Post procedural complication), GASTROINTESTINAL SCARRING (Intestinal scarring), GASTROINTESTINAL HYPOMOTILITY (Bowel peristalsis decreased), DENTAL IMPLANTATION (Dental implantation), COUGH (Chronic cough), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergy) and INJECTION SITE JOINT PAIN (Injection site joint pain). At the time of the report, SKIN CANCER (Skin cancer), ROOT CANAL INFECTION (Root canal infection), SINUSITIS (Sinus infection), SUNBURN (Sunburn), CRYOTHERAPY (Cryoablation), POST PROCEDURAL PRURITUS (Post procedural pruritus), BLISTER (Blister), SCAB (Scab), POST PROCEDURAL COMPLICATION (Post procedural complication), GASTROINTESTINAL SCARRING (Intestinal scarring), GASTROINTESTINAL HYPOMOTILITY (Bowel peristalsis decreased), DENTAL IMPLANTATION (Dental implantation), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergy) and INJECTION SITE JOINT PAIN (Injection site joint pain) outcome was unknown and NASOPHARYNGITIS (Cold) and COUGH (Chronic cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: lower left sinus was full and had an infection. On an unknown date, Weight: increased.         No concomitant medications was reported.  on unknown dates, the patient experienced skin cancer on the face and upper part of ear from being sunburned/cancer spots on skins, bowel scar tissue, slows bowels, after being frozen cancer spots of face itch like crazy, blister up, and scab up, chronic cough, far back tooth that was replaced with an implant, shoulder hurts at injection site, allergies, lower left sinus infection, tooth was an old root canal that was infected, weight gain and diarrhea. In 2021, patient had bowel resection due to scar tissue. After COVID-19 vaccination injections, the patient experienced shoulder hurt at injection site, which was causing injection site pain for two weeks. Patient also had allergies. In Mar-2022, came down with a cold and then got better. Then he had a chronic cough. He had cancer spots on skins. Skin cancer on upper part of ear from being sunburned. Couple spots of face that had to be frozen. After being frozen they itch like crazy, blister up, and scab up. He had a cough for two years. Patient had a far back tooth that was replaced with an implant. The tooth in front of it was an old root canal that was infected and came out into the sinus cavity. Patient Had a tooth removed. Patient had daily diarrhea and had been gaining weight.  No treatment medications was reported.  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.  This spontaneous case concerns a 65-year-old male patient, with no relevant medical history, treated with co-suspect drug Adalimumab for Crohn's disease, who experienced the unexpected serious (medically significant) events of Skin cancer and Root canal infection that occurred on an unknown date after receiving mRNA-1273 vaccine along with other non-serious events. It was reported that post root canal front tooth was infected which involved the sinus cavity, and tooth was subsequently extracted. Patient received primary series of mRNA-1273 vaccine 28 days interval, and 3rd dose of mRNA-1273 vaccine was given 9 months later. Clinical course was not reported. The outcome of events was reported as unknown. The co-suspect Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live significant follow up-Events added On 06-May-2022: Live Significant Follow up received- The event 'after being frozen cancer spots on face itch like crazy, blister up and scab up' LLT was updated to post procedural complication. On 18-Jul-2022: Live Follow Up received : Patient age and events cold, chronic cough, after being frozen cancer spots on face itch like crazy, blister up and scab up were added.; Sender's Comments: This spontaneous case concerns a 65-year-old male patient, with no relevant medical history, treated with co-suspect drug Adalimumab for Crohn's disease, who experienced the unexpected serious (medically significant) events of Skin cancer and Root canal infection that occurred on an unknown date after receiving mRNA-1273 vaccine along with other non-serious events. It was reported that post root canal front tooth was infected which involved the sinus cavity, and tooth was subsequently extracted. Patient received primary series of mRNA-1273 vaccine 28 days interval, and 3rd dose of mRNA-1273 vaccine was given 9 months later. Clinical course was not reported. The outcome of events was reported as unknown. The co-suspect Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.