Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Dysphonia, Dyspnoea, Wheezing
Clinical narrative: suffers from asthma but never had the symptoms she's had now; shortness of breath; hoarse/ hoarseness; audible wheezing; doesn't have the energy; This is a spontaneous report from a contactable nurse (patient). This 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 (Batch/Lot Number: EN6208) as 0.3 ml, single for COVID-19 immunization. Medical history included asthma from 2019 and ongoing, when she would sleep her oxygen would drop, and shrunk from 5 feet 5 1/4 inches to now 5 feet 2 inches. She never found out why her oxygen saturations dropped at night but she does not have sleep apnea. Her saturations would drop down to the 80s and she would still be sleeping. Concomitant medications included ongoing albuterol [salbutamol] taken for asthma and oxygen taken for "when she would sleep her oxygen would drop" from 2012 and ongoing. Patient previously took Anoro and Qvar in Aug2019. Patient received the first dose of BNT162B2 on 25Feb2021 (lot number: EN6206, NDC:59267-1000-01, Expiry date unknown) in the left arm. With the first vaccine she did not have any symptoms, she thought she got saline. Only symptoms she felt were when they told her to wait 15 minutes and she sat there and when she got up and she was driving and had her window down her nose felt like it was swelling. She lost her sense of smell due to an injury and she had an acute sense of smell of tobacco from the car next to her. That is the only symptom she had. The acute sense of smell was about 30 minutes after she got her injection, about 5-7 minutes after that. She left about 10:30 am and it happened around 10:35-10:37 am. The acute sense of smell was short lived, it happened for a minute or two. Several years ago she had shoulder surgery and had her great granddaughter and she was playing with her and her foot got caught in the coffee table and she fell and her nose got cut and lost her sense of smell. When asked for seriousness criteria, patient stated it was significant because she had not been able to smell since 2011 and she had the sensation of her nose swelling. She felt like that but she was driving and could not look at her nose. She didn't have the feeling 15 minutes after the vaccine, she had been driving for 5-7 minutes and had the feeling and it was exactly when she got in the car. It was significant because she was able to smell something. Patient had her second dose of the Pfizer Covid-19 vaccine on 18Mar2021 and had shortness of breath. She suffers from asthma but never had the symptoms she's had now. She did not seem to be getting better and the slightest movement, she's short of breath. She is taking the medicine that she normally takes but never had to take it this much. She was short of breath and not paying that much attention to it, when she goes out she wears a mask, since last year, and she went to put the trash out and had shortness of breath stepping out the back door. She was talking to a friend long distance and she told her she was so short of breath. To get out of bed and turn in bed she's more short of breath. The shortness of breath may have started before Friday 26Mar2021 but that's when she noticed it. She would have her mask on, park her car and go to the post office and when she would walk to her PO box, which is the first of the boxes, she was exhausted and not getting enough air and she noticed it. But then when she went outside to put the trash out, just a step outside she was short of breath, that's when she began to notice. She has never been this short of breath and her breathing and exchange of air has never been this bad. She thought she would maybe get her smell back and in all the years she's been diagnosed with asthma she's never had the wheezing and shortness of breath that she's had now. She's never heard herself wheeze. Monday night she was up at 3 am and got up to go to the bathroom and she was so short of breath. She had to take it at 3:30 am and that had never happened to her. She never had wheezing until the second vaccine. She doesn't need a stethoscope to hear the wheezing and that most people have asthma with wheezing but she did not. Patient was not taking the Qvar until after the second dose of the vaccine and was only using the albuterol before. She would take two puffs in her car and then put two masks before getting out. No additional vaccines administered on same date of the Pfizer suspect. No AE required a visit to emergency room or physician office. She was scheduled to see her primary doctor on 13Apr2021 but could not get in earlier and attempted to see her pulmonary doctor and the earliest she can is 07Apr2021 and she has that appointment. Patient was also very hoarse. From time to time medications like her inhaler for her asthma sometimes makes her hoarse. This time she has the hoarseness even when she doesn't take her inhaler. She has audible wheezing. She would not consider the shortness of breath life threatening but it is concerning because she is not able to do what she needs to do because she doesn't have the energy. Hoarseness is worsening because she is taking more of the medications she's normally taking and now she is taking the inhaler twice a day because she is more short of breath. The one inhaler she is using is Qvar. She has been taking the albuterol more also. Hoarseness is not life threatening, it is effective but it is not disabling. The more she talks, the more hoarse she gets. Relatedness of drug to reactions shortness of breath, very hoarse, by primary source reporter (Method of assessment: Global Introspection) was related. Outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Asthma aggravated and Shortness of breath cannot be excluded. Medical history of asthma may provide a plausible alternative explanation for the events.  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.