Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Product administered at inappropriate site, Red blood cell count, Red blood cell count decreased, Weight
Clinical narrative: Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't move/tiredness; weakness; bleeding; Test: Iron; Result: Critically low; red blood cell was below 5; administered at the left upper forearm; This is a spontaneous report from a contactable nurse (patient) via Pfizer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left upper forearm on 01Mar2021 at the age of 75-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy (in a grocery store). The patient had no prior vaccinations (within 4 weeks). The patient's medical history included retired (retired registered nurse), ongoing depression (has had this condition for probably 20 years), ongoing lung cancer (has had this condition for probably 3 years), ongoing bipolar (has had this condition for about 4 years), ongoing emphysema (has been severe for about 4 or 5 years), and ongoing chronic obstructive pulmonary disease (COPD) (has been severe for about 4 or 5 years). Concomitant medications included duloxetine taken for depression from an unspecified start date and ongoing (been taking this probably for 15 years); and arformoterol tartrate (BROVANA) (started taking this probably 5 years ago), budesonide (started taking this probably 5 years ago), tiotropium bromide (SPIRIVA) (has been taking this for probably about 4-5 years), oxygen (has been using this full time for 3 years), and Trilogy machine (she sleeps with this, it is an invasive intubation. She puts a big mask on and it pumps air in, pulls air out, letting her lungs rest. Her oxygen hooks up to it), all taken for emphysema and COPD from an unspecified start date and ongoing. The patient reported that she received the vaccine on 01Mar2021 and sometime in Apr2021 around Easter, she went to the hospital for COPD exacerbation, tiredness and weakness. The patient required a visit to the emergency room due to the events and reported that she went by ambulance to the hospital. The patient stated that she has these events often and it has nothing to do with the COVID vaccine. She went to the hospital with exacerbation of COPD and missed her date to get her last shot. She wanted to know whether she can get the 2nd dose of the vaccine with her experience after the 1st dose. The patient reported that she now weighs 177 after she has been pumped full of cortisone. The patient reported that her lung doctor was really the one that manages her medical. The patient reported that she thinks she came home from the hospital the day before Easter and she was in the hospital for 5 days (in Apr2021). She was sick before that, at home, and she finally had to call # to come and get her. She believes she had to call # the 5th day before Easter, but she was not positive. When asked to clarify what she meant by sick, the patient explained she was extremely tired, she couldn't get out of bed and couldn't move. She was having trouble breathing. She was on oxygen 24/7 and sleeps with a trilogy machine so she was having a lot of trouble, it was awful. She said she then found out at the hospital her red blood cell was below 5 and her iron was critically low. They had to give her 2 units of blood and an infusion. Then she went back yesterday and got another infusion and she has to go back next week for another infusion. The patient confirmed that she was hospitalized for COPD. She then stated she didn't know the exact date of when she was discharged from the hospital, but she was thinking it was the day she was scheduled for her second shot. She then clarified she came home Easter. The patient reported that she can't do much without having to sit down, catch her breath, and rest a little bit. She was improving but not as fast as she'd like to. While reading the vaccine record card, the patient stated "my eyes aren't as good as they used to be". Her pulmonologist stated she was going to die if she doesn't take the vaccine. If she catches COVID she was not going to make it, so her pulmonologist thinks her chances are better with the vaccine than without it. The patient said she goes all the time to the hospital; therefore, she doesn't think the events were related to the vaccine. She had been sick several times. They can't do anything about the bleeding, they can't go in to do anything because of her lungs, her lungs were so bad. No further details were provided regarding the bleeding she was speaking of. The patient reported that duloxetine doesn't come as 90 mg so she takes a 30 mg and 60 mg tablet; she mixes the Brovana and Budesoind and takes them at the same time, twice a day. She was given an albuterol solution, 0.5mg PRN (as needed), for her emphysema/COPD. She says she just started taking this from her last hospital stay. The patient reported that she did not remember her iron count, just that it was critically low. She did remember asking the nurse what could happen, and the nurse said a lot of things such as infection. She confirmed tests were done in regards to the lung cancer. Her lungs were too critical for any kind of invasive tests. It was reported that the events Exacerbation of COPD and "extremely tired, couldn't get out of bed, couldn't move" were assessed by the patient as unrelated to BNT162B2. The outcome of the events "Exacerbation of COPD/having trouble breathing" and " extremely tired, couldn't get out of bed, couldn't move/tiredness" was recovering, while the outcome of the other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, the reported events Chronic Obstructive Pulmonary Disease, Fatigue, Asthenia, Blood iron decreased, Red blood cell count decreased and Asthenia are assessed as intercurrent medical conditions and unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection). 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 RAs, Ethics Committees, and Investigators, as appropriate.