Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Chest pain, Oxygen saturation, Pain in extremity
Clinical narrative: pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; pain in her chest whenever she would take a deep breathe; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318, Expiration date unknown) at 10 AM via an unspecified route of administration on 04Feb2021 at 10:00 as single for covid-19 immunization. Medical history included ongoing Psoriatic arthritis and first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EL8982, Expiration date unknown) via an unspecified route of administration on 14Jan2021 for Covid-19 immunization and minimally sore arm. Concomitant medication included methotrexate (Injection) at 0.4 mL, weekly taken for Psoriatic arthritis. It was reported that, pain in her chest whenever she would take a deep breathe and described the symptoms as pleurisy symptoms on an unspecified date in 2021. Stated that the pain has "definitely subsided and it was gone within a week. Reports that her oxygen saturations were lower than normal, and stayed around 94%. With her second injection she had what she thought was some interesting side effects from the vaccine. She says the first one she got she only had a minimally sore arm, she got that first one on the 14Jan2021 and then got the second vaccine on 04Feb2021 and the first 24 hours her arm was really sore on an unspecified date in 2021, but she thought that was nothing to worry about. She got the second dose at 10 am and the next day after 10 AM at about 1 or 2PM she noticed that it was sore for her to take a breath and she thought hmm okay. That night she had a low grade fever which she expected and she took Tylenol. On an unspecified date in 2021, the next morning she woke up Saturday at 5 AM in severe she pain couldn't turn over, she couldn't take a deep breath, she had fever of 102, she managed to get up and she took Tylenol and she had to sit in a chair, she couldn't take a deep breath. She was not short of breath, she just couldn't expand her lungs and she went to a clinic at about 3PM because she was scared she had a pulmonary embolism, they did a chest x-ray and didn't see anything, and they said it sounds like pleurisy, she has never had that in her life ever and they just gave Toradol and said if it gets worse come back the next day or if it does not go away come back Monday. She says it did not end up getting better she was the same way the next morning. Her O2 sats were staying around 94 which was not bad but for a healthy person they should be a little but higher than that, but she couldn't take a deep breath. She says that Monday she thought maybe she got Corona and didn't know it so she went back to the Clinic and asked for a test and she tested negative for the corona virus and they just said they did not feel like it was vaccine related. They sent her home and did not do anything else. It took her until Friday of the week after the vaccine. She says she got the vaccine on a Thursday and on Friday she started feeling bad and it took until the following Friday and Saturday to be fever free and feeling like a human being. She has been on hold for 2 hours so she can answer some questions. She confirm it was the second dose that she was calling about. She got the second dose 04Feb2021 and she had minimal slight soreness when she took a deep breath starting the next day. She says it did not present it self as sever until 5 AM the next morning after she had been asleep all night. She says initially it was pain in both sides of her chest but it wound up setting on the right side, the right lung, she says she keeps saying lung but it she would say right chest. She takes Methotrexate injection once per week for psoriatic arthritis and she contacted her rheumatologist and he okayed her to get the vaccine. She says it was a small dose. It comes in bottle of 50 mg per 2ml and she only takes 0.4 ml once weekly. She has been on it for about a year and half. She would says it was medically significant because she doesn't normally get ill with anything hardly. She does not even go to the doctor but once per year to get a check up. She asks has anyone else reported symptoms like this, pleurisy like symptoms. She asks if it was not long she would be interested to see. The outcome of the events was unknown and Causality was reported as related.    Follow-up activities completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pleurisy and the suspect drug.  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.