Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Headache, Metabolic function test
Clinical narrative: Pleurisy/chest discomfort/chest pain/dyspnoea; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of PLEURISY (Pleurisy/chest discomfort/chest pain/dyspnoea) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3039814) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None.  Previously administered products included for Product used for unknown indication: RSV VACCINE on 29-Sep-2023 and Flu vaccine on 12-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine and RSV VACCINE.    On 19-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced PLEURISY (Pleurisy/chest discomfort/chest pain/dyspnoea) (seriousness criterion medically significant) and HEADACHE (Splitting headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 19-Oct-2023 for Headache, at a dose of 2 dosage form, before bed; ACETAMINOPHEN on 20-Oct-2023 for Chest pain, at an unspecified dose and frequency and IBUPROFEN on 20-Oct-2023 for Headache, at an unspecified dose and frequency. On 11-Nov-2023, HEADACHE (Splitting headache) had resolved. At the time of the report, PLEURISY (Pleurisy/chest discomfort/chest pain/dyspnoea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Blood test: normal result. On 20-Oct-2023, Body temperature: 99. On 20-Oct-2023, Cardiac function test: normal result. On 20-Oct-2023, Chest X-ray: Not chest pain from pneumonia - no cough, lungs are clear. CXR negative for PTX or PNA.  normal result. On 20-Oct-2023, Computerised tomogram: normal result. On 20-Oct-2023, Electrocardiogram: no ischemia or signs of carditis >Does not have thoracic aortic dissection >Does not represent PE. normal result. On 20-Oct-2023, Fibrin D dimer: slightly elevated. On 20-Oct-2023, Full blood count: normal result. On 20-Oct-2023, Metabolic function test: normal result. On 20-Oct-2023, Physical examination: benign pain is not referred from the abdomen. On 20-Oct-2023, Scan with contrast: (Negative) negative pathology.  normal result. On 20-Oct-2023, Troponin T: normal result.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient's immunization history included Moderna vaccines (Dose: 1on 05-Apr-2021, lot number - 025B21A, Dose: 2 on 27-May-2021, lot number - 005C21A, Dose: 3 on 02-Dec-2021, lot number - 021H12B (doubtful), Dose: 4 on 19-Apr-2022, lot number 056A22A, Dose: 5 on 13-Oct-2022, lot number 027E22A. The patient had minimal side effects tiredness and sore arm after the vaccination.  On 19-Oct-2023, around 5:45PM, the patient took dose 6 Moderna vaccine. The patient had splitting headache upon reaching home. The patient took 2 Aspirins before going to bed and when she woke up around 5 hours later and had chest pains. The patient took Acetaminophen but the pain did not resolve so she went to the emergency room where she stayed all day of 20-Oct-2023. Complete workup was done including EKG, Cat Scan, Chest Xray (2 views), APL, and 6 kinds of blood exams (CMP panel, CBC, d dimer, troponin T among others) which were normal. The patient was given Ibuprofen in the hospital when she complained of headache. The next day, the chest pain resolved. It was reported that pleurisy - "fluid around the lungs" caused the pain. The etiology was unclear but likely some form of pleural irritation secondary to covid vaccine occurred. The patient had no myocardial edema and did not rule out cardiomyopathy, angina pectoris and painful respiration.   The patient took unspecified lungs treatment.   Company Comment: This is a spontaneous case concerning a 67 year-old, female patient with no reported medical history and previous vaccination with Flu vaccine 7 days prior, who experienced the serious (due to medically significant) unexpected, event of pleurisy, which occurred the same day after the Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula, received as the sixth dose of COVID-19 vaccination schedule. Patient reported chest pain, she took Acetaminophen, but the pain did not resolve so she went to the emergency room where she stayed all day. She was given Ibuprofen while in the hospital when she complained of headache. The next day, the chest pain resolved. She was told that she had pleurisy. Complete workup was done. The EKG showed no ischemia or signs of carditis. D-dimer was slightly elevated. CT Scan with contrast and chest x-ray were reported as negative. The outcome was reported as recovered. No further clinical information was available for medical review. The benefit-risk relationship of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula is not affected by this report.  This case was linked to MOD-2023-750226, MOD-2023-750230 (Patient Link).