Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchiectasis, Hepatic pain, Hypersensitivity, Off label use, Traumatic lung injury
Clinical narrative: Bronchiectasis/Damaged right lung; Damaged right lung; Pain in liver; Allergy with Humira; Off label use; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHIECTASIS (Bronchiectasis/Damaged right lung) in an adult female patient who received mRNA-1273 (Spikevax) 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 Spondylosis and Radiculopathy.    Previously administered products included for Product used for unknown indication: MELOXICAM, IODINE, ASPIRIN [ACETYLSALICYLIC ACID], HYDROCODONE BITARTRATE and EPINEPHRINE. Past adverse reactions to the above products included No adverse event with ASPIRIN [ACETYLSALICYLIC ACID], EPINEPHRINE, HYDROCODONE BITARTRATE, IODINE and MELOXICAM. Concurrent medical conditions included Diabetes, Food allergy, Latex allergy, Peanut allergy, Allergy to animal (Standardized cat hair allergy) and Shellfish allergy (Shrimp allergy). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA) and PRAVASTATIN SODIUM for an unknown indication.   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHIECTASIS (Bronchiectasis/Damaged right lung) (seriousness criterion medically significant), TRAUMATIC LUNG INJURY (Damaged right lung), HEPATIC PAIN (Pain in liver), HYPERSENSITIVITY (Allergy with Humira) and OFF LABEL USE (Off label use). At the time of the report, BRONCHIECTASIS (Bronchiectasis/Damaged right lung), TRAUMATIC LUNG INJURY (Damaged right lung), HEPATIC PAIN (Pain in liver), HYPERSENSITIVITY (Allergy with Humira) and OFF LABEL USE (Off label use) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in COVID-19 vaccine trial.   On an unknown date, the patient experienced Damaged right lung, Off label use, pain in liver, bronchiectasis and allergy.  On an unknown date, the patient also experienced Pain in liver.  Treatment medications were not reported.  Company comment: This is a spontaneous case concerning a adult female patient of unknown age with relevant concurrent medical condition of diabetes and with concomitant medication of Pravastatin sodium for unspecified indication. Patient had co-suspect medication of Adalimumab (Humira) for spondylosis without myelopathy/radiculopathy unspecified. Patient experienced the unexpected serious (medically significant) event of bronchiectasis, the unexpected non-serious events of hepatic pain and hypersensitivity (allergy with Humira). Off label use was also reported. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The co-suspect medication of Adalimumab (Humira) remain confounder for the events hypersensitivity (allergy with Humira) and hepatic pain. The concurrent medical condition of diabetes and concomitant medication of Pravastatin sodium remain confounders for the event hepatic pain. The unspecified indication for the concomitant medication of Pravastatin sodium may remain confounder for the event hepatic pain. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2022: Significant live follow-up received on 15-Jun-2022, New Event was added as Liver pain, reporter opinion of causality and narrative description. Action taken of co suspect was added.; Sender's Comments: This is a spontaneous case concerning a adult female patient of unknown age with relevant concurrent medical condition of diabetes and with concomitant medication of Pravastatin sodium for unspecified indication. Patient had co-suspect medication of Adalimumab (Humira) for spondylosis without myelopathy/radiculopathy unspecified. Patient experienced the unexpected serious (medically significant) event of bronchiectasis, the unexpected non-serious events of hepatic pain and hypersensitivity (allergy with Humira). Off label use was also reported. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The co-suspect medication of Adalimumab (Humira) remain confounder for the events hypersensitivity (allergy with Humira) and hepatic pain. The concurrent medical condition of diabetes and concomitant medication of Pravastatin sodium remain confounders for the event hepatic pain. The unspecified indication for the concomitant medication of Pravastatin sodium may remain confounder for the event hepatic pain. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.