Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Muscle spasms, Myalgia
Clinical narrative: because my medicine (Unspecified Medication) seem to be diminished after taking my first vaccine shot; Breathing not as effective; rapid heartbeat/Waking up in the night feeling like heart beating fast; dry mouth/Dryer mouth worsening; More cramping; Slight headache; Funny feeling out of character than what she was normally feeling; Aching in muscle after injection given; She is feeling fatigue; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose BNT162B2 (Pfizer-biontech COVID-19 vaccine, Solution for injection) via Intramuscular at left arm on 22Jan2021 at single dose for Prevention and prednisone acetate (PREDNISONE, Tablet, 10 mg) via an unspecified route of administration from an unspecified date at 10 mg, daily for improve breathing and budesonide; formoterol fumarate; glycopyrronium bromide (BREZTRI, lot number: 6100107E00, expiry date: Jun2022) via oral from Nov2020 to an unspecified date at twice a day [180 mg 9mcg 4.8mcg/inhalation 2 puffs twice daily by mouth] for help improve breathing. Patient medical history included out of character, survivor of Lung cancer (She is starting into her 5th year of stage 3 lung cancer. She gets CT scans every 6 months. There has not been any sign of cancer anymore. She just has lots of scar tissue) and shortness of breath and limited breathing capacity. Concomitant medications included sulfamethoxazole (Tablet) via oral at 1 DF, thrice a day [800/160 mg. One tablet 3 times weekly by mouth], azithromycin via oral at 250 mg, daily and umeclidinium bromide, vilanterol trifenatate (ANORO, lot number: FW8J, expiry date: Dec2021). States that in the mean time she am on inhaler that has steroids in it and she take prednisone 10mg daily. States she has experienced a "dry mouth" from her inhaler since the 1st vaccine dose. She was no longer using the inhaler, after speaking to her PCP. She was continuing to take her daily prednisone pill. Was it ok for her to take the prednisone and get the Pfizer vaccine? She took the vaccine on 22Jan2021. She was getting ready for 2nd dose 10Feb2021. She first stated she takes 20 mg of Prednisone every day and later stated it was 10mg. She was also on Breztri inhaler for 2 months and was on it at the time of her shot. She stopped the Breztri 2 days ago. For some reason, a couple of days later, the side effects listed for the Breztri were worse. She was having more cramping and a dryer mouth on 25Jan2021. On 25Jan2021, the small things, like slight headache, waking up in the night feeling like her heart was beating faster, having a funny feeling, out of character than she had experienced for 2 months prior. On 23Jan2021, Aching in muscle after injection given. On 01Feb2021, breathing not as effective. She began to wonder if there was some interaction between the steroids, inhaler and the vaccine. Two days ago, she stopped taking Breztri inhaler, Astra Zeneca lot 6100107E00, Exp Jun2022. She was taking 2 puffs twice daily, morning and night 8-12 hours apart. She said after she got the vaccine, it was not as effective and was not working as well on an unspecified date in Jan2021. She then stated she was not having any problem. She was wondering if it was ok to take second shot next week. Would it be ineffective and was there a correlation between the effectiveness of the shot and what she was taking and was it just a coincidence that they all transpired after she got the shot. Patient was taking Steroid type of Inhaler before-November and up until 2days ago. She stopped taking this because Caller was experiencing rapid heartbeat on 30Jan2021 and dry mouth. On an unspecified date in Jan2021, it got worse because of the Covid 19 Vaccine that she took before, the 22nd of January 1st dose and her 2nd dose was on the 10th of Feb. Caller asks if there's a reaction of having these 2? the Steroid type of inhaler and the Covid 19 Vaccine. She was feeling fatigue on an unspecified date in Jan2021 and feels the inhaler was less effective. Slowly she noticed her breathing was not as good. It was not helping as much. The cramping quit after she stopped taking the inhaler 2 days ago. She was a survivor of Lung cancer for 5 years and has shortness of breath and limited breathing capacity. Her breathing has worsened since getting the vaccine. She was doing well with her breathing and then it was not as effective. It has not changed a lot because shewais not using the inhaler. The Breztri was a replacement for the Anoro. The Anoro inhaler was not as effective. She has been using it for probably 2 years and it was possible she built up a tolerance to it. She provided Lot FW8J, Expiration Dec2021, 1 container of 30 doses. She has been taking Prednisone 10 mg for 2 years and was on higher doses previously during times when she was having more problems with her cancer. She does not have a lot or expiration for any previous doses. She was starting into her 5th year of stage 3 lung cancer. She gets CT scans every 6 months. There has not been any sign of cancer anymore. She just has lots of scar tissue. It was mentioned she contacted Pfizer 6 weeks ago because after receiving the Pfizer-BioNTech COVID- 19 Vaccine first dose, she experienced a "diminished effect of the inhaler" then had increasing side effects (Caller did not specify what). Upon receiving the second dose, Caller mentioned that "everything was the same". She mentioned she was now using another inhaler without steroids but there was very little change with the effect in the inhaler. Had her second shot and she have had the body blood work test and the test came back non-responsive or non-reactive, it came back non-reactive. Stated, she was calling about a letter that she have received from Pfizer (further clarification unknown, hence report type checked as initial report). SHe called about six weeks ago because her medicine (Unspecified Medication) seem to be diminished after taking her first vaccine shot on an unspecified date in Jan2021. Action taken in response to the events with prednisone was unknown and BREZTRI was Permanently Withdrawn on an unspecified date. Outcome of event Heartbeats increased, Dry mouth, More cramping, Slight headache, Muscle pain was recovering, while event Feeling abnormal, Breathing not as effective was not recovered and with other events was unknown.   Information on the Lot/Batch number has been requested