Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Cataracts; Foot exostosis / Bone spur in foot; Rosacea; Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site warmth; Constipation/ Constipated; Sensation of pressure in eye / Eye pressure; Pain/Achy a lot; Loss of energy / Did not have energy; Paresthesia hand / Tingling in hands; Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site pruritus; Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site erythema; Joint pain; Feel a little tired after taking Humira/Tiredness; Possible Allergy; Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site swelling; Diarrhea/ Diarrhea with HUMIRA; Rash urticarial / Small rash or hives on up part of back/look like little pimples; Itching; Cough; Unusual Hoarseness/Hoarseness of voice; Mucus in throat/Throat secretion increased; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataracts) and DYSPHONIA (Unusual Hoarseness/Hoarseness of voice) in a 74-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and VEDOLIZUMAB (ENTYVIO) for an unknown indication.    The patient's past medical history included Scar, Bowel resection and Surgery (Ileum surgery). Concurrent medical conditions included Abstains from alcohol, Sulfonamide allergy (Sulfa allergy manifested by immune thrombocytopenia), Non-smoker and Crohn's disease. Concomitant products included MESALAZINE (CANASA) for an unknown indication.   In February 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. and VEDOLIZUMAB (ENTYVIO) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPHONIA (Unusual Hoarseness/Hoarseness of voice) (seriousness criterion medically significant), INCREASED UPPER AIRWAY SECRETION (Mucus in throat/Throat secretion increased), COUGH (Cough), PRURITUS (Itching) and URTICARIA (Rash urticarial / Small rash or hives on up part of back/look like little pimples). In June 2022, the patient experienced DIARRHOEA (Diarrhea/ Diarrhea with HUMIRA). On an unknown date, the patient experienced CATARACT (Cataracts) (seriousness criterion medically significant), EXOSTOSIS (Foot exostosis / Bone spur in foot), ROSACEA (Rosacea), VACCINATION SITE WARMTH (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site warmth), CONSTIPATION (Constipation/ Constipated), OCULAR DISCOMFORT (Sensation of pressure in eye / Eye pressure), PAIN (Pain/Achy a lot), ASTHENIA (Loss of energy / Did not have energy), PARAESTHESIA (Paresthesia hand / Tingling in hands), VACCINATION SITE PRURITUS (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site pruritus), VACCINATION SITE ERYTHEMA (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site erythema), ARTHRALGIA (Joint pain), FATIGUE (Feel a little tired after taking Humira/Tiredness), HYPERSENSITIVITY (Possible Allergy) and VACCINATION SITE SWELLING (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site swelling). The patient was treated with MACROGOL 3350 (MIRALAX) for Constipation, at an unspecified dose and frequency; LORATADINE (CLARITINE) at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, CATARACT (Cataracts), DYSPHONIA (Unusual Hoarseness/Hoarseness of voice), INCREASED UPPER AIRWAY SECRETION (Mucus in throat/Throat secretion increased), EXOSTOSIS (Foot exostosis / Bone spur in foot), COUGH (Cough), ROSACEA (Rosacea), PARAESTHESIA (Paresthesia hand / Tingling in hands) and ARTHRALGIA (Joint pain) had not resolved, VACCINATION SITE WARMTH (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site warmth), VACCINATION SITE PRURITUS (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site pruritus), VACCINATION SITE ERYTHEMA (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site erythema) and VACCINATION SITE SWELLING (Bad reaction to Moderna vaccination on arm felt like it was on fire/itchy/red/swollen,Vaccination site swelling) had resolved, CONSTIPATION (Constipation/ Constipated), OCULAR DISCOMFORT (Sensation of pressure in eye / Eye pressure), PAIN (Pain/Achy a lot), ASTHENIA (Loss of energy / Did not have energy), PRURITUS (Itching), DIARRHOEA (Diarrhea/ Diarrhea with HUMIRA), FATIGUE (Feel a little tired after taking Humira/Tiredness) and HYPERSENSITIVITY (Possible Allergy) outcome was unknown and URTICARIA (Rash urticarial / Small rash or hives on up part of back/look like little pimples) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: no active inflammation No active inflammation. On 23-Feb-2022, Computerised tomogram: no active inflammation No active inflammation. On an unknown date, Computerised tomogram: did not find anything Cat scan of lower right abdomen close to ilium: Did not find anything.         Patient went to ear, nose and throat physician because she had some unusual hoarseness. Patient got constipated with the HUMIRA and wanted to know if she could take HUMIRA in a month. She had pain in her lower right abdomen close to her ilium where she had surgery. In Aug 2021, she had the same pain and had CT scan with no abnormality. She was not feeling tip top. She had a bone spur in her foot that required surgery to remove but it would happen in the fall. She stopped taking Miralax on a daily basis because she had diarrhea in Jun 2022. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. For co-suspect Humira: Causality as per reporter was Probable for Hoarseness of voice, Cataracts, Rosacea, Foot exostosis,  and Reasonable possibility for Vaccination site erythema, Vaccination site warmth, Vaccination site pruritus, Vaccination site swelling and Not assessable for Itching, Rash urticarial and Not reported for Constipation, Tiredness, Throat secretion increased, Loss of energy, Sensation of pressure in eye, Cough, Paresthesia hand, Joint pain, Pain, Allergy, Diarrhea. Causality as per Mfr. was No reasonable possibility for Cataracts, Vaccination site erythema, Vaccination site warmth, Vaccination site pruritus, Vaccination site swelling, Foot exostosis, Joint pain, Pain, Diarrhea and Reasonable possibility for Tiredness, Itching, Rosacea, Rash urticarial and Not assessable for Throat secretion increased, Loss of energy, Sensation of pressure in eye, Cough, Paresthesia hand, Allergy. For co-suspect, Entyvio: Reporter cauality was provided as Probable for Hoarseness of voice, Rosacea and Not reported for Cataracts,Vaccination site erythema, Consipation, Vaccination site warmth,Vaccination site pruritus, Vaccination site swelling, Tiredness, Loss of energy, Foot exostosis, Sensation of pressure in eye, Paresthesia hand, Joint pain, Pain, Diarrhea and Not related for Throat secretion increased, Cough, Itching, Rash urticarial,Allergy.   Company comment:  This is a spontaneous case concerning a 74-year-old female patient with medical history of sulfonamide allergy and Crohn's disease, who experienced the unexpected, serious (medically significant) events of Cataract and Dysphonia, on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported that the hoarseness of voice started while taking Vedolizumab and worsened while on Adalimumab. The patient consulted with an ear, nose and throat physician and was given Loratadine, Fluticasone nasal spray and Guaifenesin with no relief. Medical history of sulfonamide allergy and concomitant medications of Vedolizumab and Adalimumab remain as confounders for the event of Dysphonia and medical history of Crohn's disease remains a risk factor for the event of Cataract. It should be noted that the patient received the first two doses of mRNA-1273 vaccine on 28-day interval and the third dose was administered approximately 8 months after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2021-581894 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with medical history of sulfonamide allergy and Crohn's disease, who experienced the unexpected, serious (medically significant) events of Cataract and Dysphonia, on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported that the hoarseness of voice started while taking Vedolizumab and worsened while on Adalimumab. The patient consulted with an ear, nose and throat physician and was given Loratadine, Fluticasone nasal spray and Guaifenesin with no relief. Medical history of sulfonamide allergy and concomitant medications of Vedolizumab and Adalimumab remain as confounders for the event of Dysphonia and medical history of Crohn's disease remains a risk factor for the event of Cataract. It should be noted that the patient received the first two doses of mRNA-1273 vaccine on 28-day interval and the third dose was administered approximately 8 months after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.