Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. 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 AE. 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.