Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Aspiration pleural cavity, Cerebrovascular accident, Chest X-ray, Computerised tomogram
Clinical narrative: Pleural effusion; Possible progression of her lung cancer/ new brain cancer; Stroke; Anxiety; Stress urinary incontinence; Enlarged lymph node; She had a little cough, it started to get a little worse; Could not take a deep breath and could not expand ribcage because there was immense pain; Pain in the right side under the ribcage muscle in the serratus anterior muscleshe thought she cracked her ribs; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right deltoid (arm) on 01Mar2021 (at the age of 39-year-old) (Lot Number: EN6201) as dose 2, single for COVID-19 immunization. Medical history included dyslipidemia due to taking LORBRENA, hypertension from 2007, lung cancer from 03Jul2017 and metastatic disease from lung cancer from Dec2018, all ongoing. Concomitant medication(s) included losartan taken for hypertension from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol from an unspecified start date and ongoing; lorlatinib (LORBRENA) taken for lung neoplasm malignant from 26Jun2019 and ongoing; vitamin D 3 taken for an unspecified indication from an unspecified start date and ongoing; ubidecarenone, vitamin e nos (COQ10 COMPLEX) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left deltoid (arm) on 08Feb2021 14:25 (at the age of 39-year-old) (Lot Number: EN6201) as dose 1, single for COVID-19 immunization and experienced bone pain and muscle pain. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient reported possible progression of her lung cancer. The patient stated that stated that there was severe pain after the second dose which started with a little cough, which progressively got worse. The patient had pain so bad that she thought she cracked her ribs. On 02Mar2021, patient had pain in the right side under the ribcage muscle in the serratus anterior muscle. On 06Mar2021, the patient could not take a deep breath and could not expand ribcage because there was immense pain. Patient stated she took some CBD and went to sleep and this lasted about 2 days and after that it got a little better. Patient stated it was improved but had slight lasting effects. The patient reported the whole next week the cough got worse, stated it was so bad and it was productive. She stated that by Thursday 11Mar2021, she started to have massive pain that started in the serratus anterior muscle, under her arm pit and around the rib cage. Patient stated that then over the weekend it precipitated towards extreme bone and muscle pain spanning over left upper torso and pain got so bad she thought she cracked her ribs and this lasted for 3 weeks. The patient's cough got worse and it was productive, had stress urinary incontinence. On 13Mar2021, patient had enlarged lymph node. On 18Mar2021, patient had a chest x-ray and it showed pleural effusion and fluid in her pleural space around her lungs. The patient had a thoracentesis 19Mar2021 to drain the fluid and they tested it and it was confirmed as cancer. The patient stated that it seemed to her there was a correlation with getting the COVID vaccine. The patient said that she knows that the immune system has to work very hard to combat COVID and she was wondering if it made her immune system fail and go haywire and wondering if it perpetrated, and stated if the immune system could have dealt with both. On 22Mar2021, the patient got CT scans which showed progression in her body and stated the pleural effusion had been drained and was less, but was still present. The patient reported thoracentesis caused her anxiety. On 23Mar2021, patient stated she felt weird and had neurological symptoms and thought she had a stroke or something because she has had that in the past. The patient was discharged on night of 24Mar2021. The patient received treatment with oral steroids. The outcome of the events was unknown. The patient said that it was all related to her lung cancer. On the same day, patient got hospitalized for getting more imaging. It was reported that new brain cancer was found and patient stated that all this was new worsening disease. The patient further stated that it her a little nervous all the side effects after she got it. The patient reported that she did not believe urinary incontinence was caused by the COVID 19 vaccine, she has had it for years. The patient stated that bone pain, not being able to take a deep breath, muscle pain, lymph node were in conjunction with the timing of the vaccine. The patient stated that anxiety was only in relation to psychological symptoms due to the stroke situation.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Pleural effusion, Lung cancer metastatic, Cerebrovascular accident and suspect drug BNT162B2 cannot be completely excluded. 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.