Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Pleurisy; This is a spontaneous report received from a Pharmacist from medical information team.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ1620) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Really sick", start date: Jan2020 (unspecified if ongoing), notes: In Mar2020 everyone was notified about Covid, but it was in Jan2020 when caller got really sick.; "Blood clotting disorder", start date: 06Dec2022 (unspecified if ongoing); "Tendonitis" (unspecified if ongoing); "pulmonary embolism" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for coagulopathy (ongoing). The patient also took other concomitant therapy. Vaccination history included: Moderna covid vaccines, administration date: Feb2021, for Immunization; Moderna covid vaccines, administration date: Mar2021, for Immunization; Flucelvax (In Sept or Oct and would have Flucelvax. it wasn't high dose. ,  Lot Number/ Expiry Date: unknown ,  Route, Anatomical Location: intramuscularly, left upper arm. She always gets everything on left side.), for Immunization. The following information was reported: PLEURISY (disability) with onset 06Jan2024, outcome "recovering". The event "pleurisy" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Normal, notes: everything is normal; Computerised tomogram: Normal, notes: everything is normal; Electrocardiogram: Normal, notes: everything is normal; Antibodies: Negative; SARS-CoV-2 test: Negative, notes: got tested for Covid 3 to 4 times during the pandemic and was always negative; Ultrasound scan: she had DVT. Therapeutic measures were taken as a result of pleurisy. The caller asks if there is any information regarding Pfizer Biontech COVID-19 vaccine, that she got back in 2021, and pleurisy. The caller states she developed pleurisy on Saturday and wants to check every box on why she got it. Pleurisy was reported as disabling/incapacitating. Caller states she is a pharmacist and also a patient. Caller received two Moderna Covid Vaccines, one in Feb2021 and one in Mar2021. Caller has called them. On 01Dec2021 caller received the Pfizer Covid vaccine. Those are the only 3 Covid vaccines she has received. Two days ago caller developed pleurisy. Went to Emergency Room. She had bad chest pain and thought it was a heart attack. They tested heart and for pulmonary embolism. She had CT, EKG, and blood work and everything is normal. Caller doesn't know how she developed pleurisy or why she got it. She has looked up that pleurisy is due to bacterial infection, or viral infection, or being on Methotrexate, or having sickle cell, but caller doesn't have any of those things. Caller's friends said maybe it was due to the vaccine. It is has been 2 years, but maybe long haul. As far as caller knows she hasn't had Covid infection at all. Caller thought maybe she had Covid when Covid first came out in 2020. In Mar2020 everyone was notified about Covid, but it was in Jan2020 when caller got really sick. Covid was out in Nov, but wasn't aware to public until March. Caller thought she had Covid in Jan2020 based on the description, but she had negative antibodies when she got tested. Caller got tested for Covid 3 to 4 times during the pandemic and was always negative. Caller clarified that she is calling to ask if pleurisy has been documented with the Pfizer Covid vaccine. Treatment:  At the Emergency Room right before leaving they gave her IV Dexamethasone to relieve inflammation and wheezing pain. She was given a prescription to get filled of Prednisone 20mg once a day for 4 days. Today is second day of taking Prednisone. Concomitant Medications: takes Xarelto. Caller has a blood clotting disorder and thought this was related to a Pulmonary Embolism. Caller had a Pulmonary Embolism 13 months ago. Caller doesn't have Pulmonary Embolism now because she is on Xarelto. Caller has blood clotting disorder that was diagnosed on 06Dec2022. She had Chest X-ray, EKG, CT scan, and blood work. She has no new Pulmonary Embolism and had no heart attack. The CT scan showed pleurisy which is inflammation of lining of lungs and that was causing chest pain. Prior Vaccinations (within 4 weeks):  In Sept or Oct and would have Flucelvax. it wasn't high dose.  She would not have been on medication when she got Pfizer Covid Vaccine. Started Xarelto 13 months ago.  Specific Relevant Test: For Thromboembolic events with Thrombocytopenia: She got PRP in left ankle because she had tendonitis. Had two doses of PRP.  First dose was around 05Nov2022 or the first week of Nov2022. 29Nov2022 she got second dose and 3 days later she got DVT and then three days later she got pulmonary embolism. They did ultrasound on left shin area. Caller clarified she couldn't think of the anatomical area, when she said left shin, but it was the left calf area where they did the ultrasound. Did calf ultrasound and worked up to thigh area and said she had DVT. She went to emergency room and they did Chest X-ray and CT scan and she had pulmonary embolism and was started on Xarelto. Then she went to hematologist who said it was hereditary. Caller clarified that PRP is not a drug where she could provide NDC/LOT/EXP. PRP is administer into her, but they take out 4oz of blood from her then put her blood in a machine to centrifuge and take out the plasma and protein. Then that is injected into the area. PRP works, but it isn't covered by insurance. It was 1000 a treatment, so she paid 2,000 (withheld). AE required visit to Emergency Room and Physician Office: she is going to family doctor, Dr. (Name), today for follow up. No Intensive Care Unit.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pleurisy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.