Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Throat tightness, Wheezing
Clinical narrative: Sore throat; Cough; Tightness in throat; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), THROAT TIGHTNESS (Tightness in throat) and WHEEZING (Wheezing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB for Atopic dermatitis.    The patient's past medical history included Musculoskeletal discomfort (On 05-Mar-2020, she had scheduled left shoulder surgery, she was hospitalized overnight.). Concurrent medical conditions included Cardiac disorder (had cardiac issues for several years and while there's no change with that since she's been on Dupixent,), Palpitations, Asthma, Pruritus, Psoriasis and Itch. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and PROCATEROL HYDROCHLORIDE (PRO-AIR) for Asthma, BENZETHONIUM CHLORIDE, BENZOCAINE (LANACAINA) for Itch, UREA for Psoriasis.   In November 2019, the patient DUPILUMAB (Subcutaneous) dosage was changed to 600 milligram. On 01-Jan-2020, DUPILUMAB (Subcutaneous) dosage was changed to 600 milligram. In January 2020, DUPILUMAB (Subcutaneous) dosage was changed to 600 milligram. In 2020, DUPILUMAB (Subcutaneous) dosage was changed to 600 milligram. On 27-Sep-2021, DUPILUMAB (Subcutaneous) dosage was changed to 600 milligram. On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (Subcutaneous) 300 milligram. On an unknown date, DUPILUMAB (Subcutaneous) dosage was changed to 300 milligram. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), THROAT TIGHTNESS (Tightness in throat) and WHEEZING (Wheezing). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), THROAT TIGHTNESS (Tightness in throat) and WHEEZING (Wheezing) had not resolved.      On an unknown date of Dec-2019, patient had bronchitis and sinus infection (sinusitis). Patient would have a shoulder replacement scheduled on 05-Mar-2020 for shoulder problems. After the surgery, her tongue swelled, and it was bigger than big (swollen tongue, onset date: mar-2020, latency: few months). She could not eat for a week (feeding disorder, onset date: mar-2020, latency: few months) and she talked with a lift (speech disorder, onset date: mar-2020, latency: few months). She was first diagnosed with trench mouth, but the swelling did not subside, she went to the ear, nose, throat unit (ENT) and said she probably bit her tongue during the surgery (tongue biting, mar-2020, latency: few months). The nurse reported that the patient has not had a dose since mid-Feb-2020 (product dose omission issue, latency: few months), but she planned on going back on dupilumab. Last dose of dupilumab was one to two weeks prior to surgery. She had not gone back on it because she thought her doctor office was closed due to COVID-19 and even though she knew how to give herself the injection, she refused to do it. Upon follow-up, it was reported that the patient had asthma (concurrent condition) and she was supposed to go to the doctor's office for another dose but was cancelled (product dose omission issue) because she said, "a guy's wife was in labor". On 27-Jan-2021, patient went to her general practitioner and told her that there was blood in her stool (haematochezia, onset date and latency: unknown). She would follow up with her gastro-intestinal (GI) doctor. The nurse said that the patient's last dose was on 24-Dec-2020 and she thought that she still had 2 doses she could take at the doctor's office. The nurse also stated that the patient denied any GI symptom. It was reported that in 3 months, the patient had not had her dose because of financial and insurance issues. Since 02-Jun-2021, she had her 6th cardiac ablation. Since unknown date, her heart was working at 45 percent (cardiac dysfunction). It was reported that patient had not had her dose because of financial and insurance issues. On 27-Sep-2021, patient received two 300 mg injections (Product use issue). The nurse also reported she had not received her Dupilumab since Mar-2021 due to insurance issues. The patient was using her inhalers for her symptoms.    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.