Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Hypersensitivity, Pneumonia, Rhinorrhoea
Clinical narrative: Pneumonia; Allergy; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), HYPERSENSITIVITY (Allergy) and RHINORRHOEA (Runny nose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Oak tree allergy manifested by pressure behind eyes, headache, runny nose Red dye on laboratory tests allergy manifested by turn red, flushed face and skin Unspecified yellow flowers allergy manifested by pressure behind eyes, headache, runny nose Doxycycline allergy manifested by red veins showing through entire body Rocephin allergy manifested by legs swell up, shortness of breath, felt like a needle prick pain on both hands Clindamycin allergy manifested by legs swell up, shortness of breath, felt like a needle prick pain on both hands.  The patient's past medical history included Alcohol use (MIMOSAS OCCASIONALLY) from 1982 to 25-Dec-2020, Cellulitis and Phlebitis. Previously administered products included for Arthritis: CELEBREX; for Diabetes: INVOKAMET; for Product used for unknown indication: DOXYCYCLINE, ROCEPHIN and CLINDAMYCIN. Past adverse reactions to the above products included No adverse event with CELEBREX, CLINDAMYCIN, DOXYCYCLINE, INVOKAMET and ROCEPHIN. Concurrent medical conditions included Allergy to antibiotic (DOXYCYCLINE, ROCEPHIN and CLINDAMYCIN allergy), Allergy to NSAIDs (CELEBREX), Rheumatoid arthritis, Ankylosing spondylitis, Type 2 diabetes mellitus, Dust allergy (MANIFESTED BY PRESSURE BEHIND EYES, HEADACHE, RUNNY NOSE), Pollen allergy (MANIFESTED BY PRESSURE BEHIND EYES, HEADACHE, RUNNY NOSE) and Grass allergy (MANIFESTED BY PRESSURE BEHIND EYES, HEADACHE, RUNNY NOSE). Concomitant products included TRAMADOL for Arthritis, INSULIN DEGLUDEC, LIRAGLUTIDE (XULTOPHY), EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) and PIOGLITAZONE for Diabetes, LEVOTHYROXINE for Thyroid disorder, FUROSEMIDE for an unknown indication.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. On 05-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergy) (seriousness criteria hospitalization and medically significant) and RHINORRHOEA (Runny nose) (seriousness criteria hospitalization and medically significant). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). On 05-Apr-2021, HYPERSENSITIVITY (Allergy) and RHINORRHOEA (Runny nose) had resolved. In April 2021, PNEUMONIA (Pneumonia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Chest X-ray: Pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant also included VITAMIN D and VITAMIN B supplement. The patient thought had an allergic reaction such as runny nose and difficulty of breathing a day after taking first dose of Covid-19 Vaccine. It was unknown if she was enrolled in a Covid-19 Vaccine Trial. On 12 Apr 2021, she was rushed in the emergency room due to shortness of breath, She was admitted to the hospital due to full blown pneumonia on both lungs for two weeks and stayed another two weeks when moved to the intensive care unit. She did not take humira for two weeks as prescribed due to having pneumonia. Covid-19 antibodies while being admitted even though she was not diagnosed with Covid-19.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 No treatment medication was provided. Company comment: This spontaneous case concerns a 57 year old female patient with an underlying allergic predisposition; ongoing conditions of diabetes mellitus, rheumatoid arthritis and ankylosing spondylitis, who experienced the unexpected serious (hospitalization, medically significant) events of Hypersensitivity and Rhinorrhoea on the same day; Pneumonia-about 7 days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient thought she had an allergic reaction such as runny nose and difficulty in breathing after taking the first dose of COVID-19 vaccine. About 7 days later, she was rushed to the emergency room due to shortness of breath. She was admitted to the hospital for two weeks due to full blown pneumonia in both lungs which was confirmed on chest x-ray and stayed for another two weeks when moved to the intensive care unit. The events resolved. Underlying allergic predisposition, diabetes mellitus and concomitant adalimumab could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57 year old female patient with an underlying allergic predisposition; ongoing conditions of diabetes mellitus, rheumatoid arthritis and ankylosing spondylitis, who experienced the unexpected serious (hospitalization, medically significant) events of Hypersensitivity and Rhinorrhoea on the same day; Pneumonia-about 7 days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient thought she had an allergic reaction such as runny nose and difficulty in breathing after taking the first dose of COVID-19 vaccine. About 7 days later, she was rushed to the emergency room due to shortness of breath. She was admitted to the hospital for two weeks due to full blown pneumonia in both lungs which was confirmed on chest x-ray and stayed for another two weeks when moved to the intensive care unit. The events resolved. Underlying allergic predisposition, diabetes mellitus and concomitant adalimumab could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.