Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Heart rate, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: She has not been feeling herself; Wheezing; Mild tachycardia; Oxygen saturation drop; This is a spontaneous report from a contactable nurse (patient's son) via Pfizer sponsored program. A 97-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 97 years of age), via an unspecified route of administration, administered in arm right on 18Mar2021 10:45 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included compression fracture (fell in the driveway) from Apr2010 to an unknown date, ongoing hypertension for a long time sine 1980s and has gotten less with age; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient has no known drug allergies and no known food allergies. Family history included cardiovascular, cholesterol, blood pressure, but nothing relevant to her situation. She was never a cigarette smoker and she had no history of smoking. Concomitant medication included atenolol taken for blood pressure from an unspecified start date and ongoing. The patient previously took atenolol for hypertension and experienced dizzy and sometimes her pulse will get a little on the higher side. She had no history of previous immunization with the Pfizer vaccine considered as suspect. She had no prior vaccinations within four weeks prior to the first administration date of the covid vaccine. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any recent vaccines for any other conditions prior to the event/s being reported. Patient received the first dose of the Pfizer COVID-19 vaccine 18Mar2021 and has yet to get the second dose. The patient experienced wheezing in the morning, mild tachycardia and Oxygen saturation drop on 15Apr2021. The patient got her first dose in Mar2021 and since then she had not been feeling herself so they waited on getting her second dose. The reporter asked if the patient can get her second dose or does she have to start all over. The patient is in a hospice, and she was at home; she can get out of the house rarely. The first dose was on 18Mar2021 and she tolerated it well. It was mentioned that she was kept in a tight bubble and anyone that comes into contact with her has to get the shot. She did about a month after her first dose experience wheezing. She never had wheezing before and she had to have oxygen, which she never had to use before. He said they had to do intermittent oxygen. She was doing ok now, and he was not sure if a month after the first dose was some kind of a reaction. The patient's first dose was on 18Mar2021 and has yet to get the second dose. He said a little less than a month later she had wheezing and that she never had wheezing and he never heard her wheezing. He said it was almost four weeks after the date of her vaccination. He said they put her on oxygen at home because her O2 saturation dropped. She was in the high 80's and she was usually in the high 90's. He said in mid Apr2021 she was in the 80's. He said the oxygen was intermittent now and they use 1L. He said he wanted to make sure her oxygen saturation stays good and that it was not life threatening. He said given her age she was dropping O2 saturations in the 80's and she was never in the 80's. She did not have her second dose and it was due 08Apr2021. He said she was doing ok, no wheezing at the time. He said with her age and hospice, he heard things on TV that there were lots of problems with the second dose any of the vaccines so they watch close. He said any contact with her is vaccinated and she stays in a tight bubble at home. He says they are being very conservative. He says she got the vaccine around 10:45am. It was mentioned that the patient was experiencing mild tachycardia. She was in the 90's or low 100's but was not sure if it was related to the wheezing or if it was the dose. He said he noticed it the first time on the same day he noticed the wheezing. He said that on 15Apr2021 her heart rate was 146 when checking oxygen saturation. He said that his mother's blood pressure was usually 115/75. He said her hypertension has gotten less with age. She has had no blood work done because of COVID or the pandemic. He says no pcp visits, only telemedicine visits. He said she has had no labs done in a long time but that they monitor every day and as long as she's eating, etc. Therapeutic measure was taken as a result of wheezing and Oxygen saturation drop wherein she was given intermittent oxygen 1L ordered by the hospice nurse. The caller says the used no inhaler or nebulizer because the oxygen brought her saturation up. He says they also gave her some cough medicine. He does not remember the name of the cough medicine. He says it was just some DM, dextromethorphan, from   . The events did not result from Emergency Department, patient was not hospitalized, not admitted to an Intensive Care Unit. The patient was recovering from the events as she was getting better.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug 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 drug 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 Committees, and Investigators, as appropriate.