Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Aspiration pleural cavity, Cerebrovascular accident, Chest X-ray, Computerised tomogram
Clinical narrative: Brain cancer; thought she had a stroke; Possible progression of her lung cancer; Pain in the right side under the ribcage muscle in the serratus anterior muscle; Pain in the right side under the ribcage muscle in the serratus anterior muscle; Cough got worse and it was productive; Stress urinary incontinence; Extreme bone and muscle pain spanning over left upper torso; Pain in the right side under the ribcage muscle in the serratus anterior muscle; Felt weird; Anxiety; Pleural effusion; Enlarged lymph node; Started with a little cough, which progressively got worse; Could not take a deep breath; This is a spontaneous report received from a contactable physician (patient herself). A 39 year old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201,Expiry date: Unknown) via intramuscular in right deltoid on 01Mar2021 as a single dose for COVID-19 immunization. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201, Expiry date: Unknown) via intramuscular in left deltoid on 01Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included ongoing lung cancer from 03Jul2017, metastatic disease from lung cancer from: Dec 2018 and hypertension from: 2007. Concomitant medication included Losartan at 100 mg once a day tablet for blood pressure, Atorvastatin at 80 mg a day tablet for cholesterol, Lorbrena from 26Jun2019 at 100 mg once a day tablet for lung cancer, vitamin D3 at 3000 IU once a day gel cap and coq10 supplement at 100mg and all the drugs were ongoing. The patient did not receive any vaccination 4 weeks prior to the vaccination. No AEs (adverse events) following prior vaccination. The patient started feeling better around 27Feb2021. The patient was a cancer patient, and took marijuana and CBD which helps her sleep. The patient had pain in the serratus anterior the next morning 08Feb2021 and by the 11Feb2021 she had the massive bone and muscle pain spanning over left upper torso and lasted for about 3 weeks. The patient medicated herself with CBD and marijuana tincture and she would occasionally take Ibuprofen. The patient was thinking COVID vaccine can cause a variety of things. The patient got the second dose on 01Mar2021 in her right arm. The morning after the patient got her vaccine, experienced pain in the right side under the ribcage muscle in the serratus anterior muscle. As a treatment drug the patient received Tylenol and felt it masked the pain and was fine and still a little sore in the muscular distribution which was on and off mildly sore, not bad and states that the patient recovered with lasting effects. The patient started to have a slight cough, that the patient not had a cough in over a year and a half due to lung cancer and did not think it was lung cancer. The cough first time started to get a little worse, and that day was very cold and when the patient tried to walk around her boyfriends house and started jogging, the patient could not take a deep breath and could not expand ribcage because there was immense pain on 06Mar2021. As a treatment therapy the patient received some CBD and went to sleep, and this lasted about 2 days and after that it got a little better. The patient was improved but had slight lasting effects. The patient experienced cough the whole next week which got worse and was so bad and it was productive. The patient had stress urinary incontinence and was back on her pee pads that she had not been on for years. The patient palpated her left arm pit and felt an enlarged lymph node on Saturday 13Mar2021. On 15Mar2021 the patient would be two weeks since the patient was fully vaccinated and have seen reports that the vaccine causes lymphadenopathy. The patient found the lymph node and called her oncologist because she was worried about the worsening cough. The patient also reached to a Nurse Practitioner and the only thing that worried her was the cough, that she has not seen this in the data so far. The Nurse Practitioner sent her to have a chest x-ray on 18Mar2021 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 cancer. The patient seems to her there was a correlation with getting the COVID vaccine. On 22Mar2021, the patient got CT Scans of progression in her body and states the pleural effusion had been drained and was less but was still there. The patient felt weird all weekend and thought it was the thoracentesis that caused her anxiety and on 23Mar2021 and had neurological symptoms and thought that the patient had a stroke or something because she has had that in the past. The patient was all related to her lung cancer. The patient called her neuro oncologist and they said to go to ER (emergency room) on 23Mar2021. The patient had newfound brain cancer, and it was worsening, that it was only found Tuesday. The patient underwent brain MRI on 23Mar2021. This was new worsening disease, before it was stable and not getting worse or better, it was not active in the brain and felt a little nervous all the side effects after she got it. The outcome of the event Extreme bone and muscle pain spanning over left upper torso, Pain in the right side under the ribcage muscle in the serratus anterior muscle was recovering and the outcome of all the other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to BNT162b2 and can be attributed to intercurrent conditions in this patient with underlying lung cancer, metastatic disease from lung cancer and other comorbidities. 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.