Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat/throat pain; diarrhea; Dizziness; fatigue; headache; Muscle ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/throat pain), DIARRHOEA (diarrhea), DIZZINESS (Dizziness), FATIGUE (fatigue) and HEADACHE (headache) in a 63-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 Crohn's disease and Rheumatoid arthritis.    The patient's past medical history included Polycystic ovary (Polycystic ovary syndrome) in 1987, Non-tobacco user, Abstains from alcohol, Throat swelling, Hives (hives in mouth), Coronary occlusion on 07-Apr-2021, Atypical angina from November 2020 to 07-Apr-2021, Shortness of breath from November 2020 to 07-Apr-2021, Coronary occlusion on 29-Jan-2021 and Cardiac catheterization. Previously administered products included for Drug use for unknown indication: CLINDAMYCIN and PENICILLIN [BENZYLPENICILLIN]. Past adverse reactions to the above products included Skin rash with CLINDAMYCIN and PENICILLIN [BENZYLPENICILLIN]. Concurrent medical conditions included Fruit allergy (Watermelon allergy manifestated by throat swelling, hives in mouth), Vegetable allergy (Cucumber allergy manifestated by throat swelling, hives in mouth), Food allergy (Honeydew allergy manifestated by throat swelling, hives in mouth), Fruit allergy (Cantaloupe allergy manifestated by throat swelling, hives in mouth), Crohn's disease, Rheumatoid arthritis, Gastritis, Nausea, Gastroparesis, Pancreatic insufficiency, Type 2 diabetes mellitus, Hypertension, Joint pain, Nerve compression, Penicillin allergy (MANIFESTATED BY SKIN RASH) and Allergy to antibiotic (MANIFESTATED BY SKIN RASH). Concomitant products included BUDESONIDE for Crohn's disease, OMEPRAZOLE for Gastritis, DOMPERIDONE for Gastroparesis, LISINOPRIL, HYDROCHLOROTHIAZIDE and FUROSEMIDE for Hypertension, HYDROCODONE and TRAMADOL for Joint pain, ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, GABAPENTIN for Nerve compression, PANCREATIN (CREON) for Pancreatic insufficiency, METHOTREXATE for Rheumatoid arthritis, MAGNESIUM for Supplementation therapy, FOLIC ACID for Supplementation therapy and Drug effect decreased, METFORMIN for Type 2 diabetes mellitus.   In November 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, (1 in 2 wk). On 06-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat/throat pain), DIARRHOEA (diarrhea), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (Muscle ache) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat/throat pain), DIARRHOEA (diarrhea), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (Muscle ache) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Cardiac stress test: Severe coronary blockages. On an unknown date, Blood test: The patient's blood work showed HUMIRA level was low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's blood work showed HUMIRA level was low and physician increased the dosage to weekly from bi-weekly. On 07 Apr 2021, she had coronary bypass surgery due to severe coronary blockages. She was in-patient for seven days. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality and manufacturer's opinion for the events coronary blockages, atypical angina, shortness of breath, dizziness, fatigue, headache, diarrhea, muscle ache, fever and sore throat/throat pain pertaining to Humira were reported as no reasonable possibility.  Action taken w.r.t Humira for the events coronary blockages, atypical angina and shortness of breath were reported as drug discontinued.  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.