Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: she got really sick after second COVID-19 vaccine; feeling cold; shaking inside; her whole body was aching; nauseous; dizzy; slept in bed all day; feel warm; bad headache; shortness of breath; her heart skips a beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: ER8731) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fatty liver" (unspecified if ongoing), notes: Fatty liver; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "allergy" (unspecified if ongoing), notes: allergy pill. Concomitant medication(s) included: AMLODIPINE taken for hypertension; ROSUVASTATIN taken for hepatic steatosis; LEVOCETIRIZINE taken for hypersensitivity. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EP7534 (populated lot number), Location: Left arm), administration date: 20Mar2021, when the patient was 64 years old, for Covid-19 Immunization; Shingles vaccine (first shingles shot last Jan2021 she had an adverse event.), administration date: 15Jan2021, when the patient was 64 years old, for Immunization, reaction(s): "she was laying in bed", "wasn't feeling well"; Shingles vaccine (the second Shingles vaccine in Jul2021 and had no reactions.), administration date: Jul2021, when the patient was 64 years old, for Immunization, reaction(s): "had no reactions". The following information was reported: ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "she got really sick after second COVID-19 vaccine"; FEELING COLD (non-serious) with onset Apr2021, outcome "unknown", described as "feeling cold"; NERVOUSNESS (non-serious) with onset Apr2021, outcome "unknown", described as "shaking inside"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "her whole body was aching"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nauseous"; DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "dizzy"; SOMNOLENCE (non-serious) with onset Apr2021, outcome "unknown", described as "slept in bed all day"; FEELING HOT (non-serious) with onset Apr2021, outcome "unknown", described as "feel warm"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "bad headache"; DYSPNOEA (non-serious) with onset 2021, outcome "recovering", described as "shortness of breath"; EXTRASYSTOLES (non-serious) with onset 2021, outcome "unknown", described as "her heart skips a beat". The event "shortness of breath" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea.  Additional information: The patient had not received any other vaccination within 4 weeks prior to Covid-19 vaccine.  Warm transfer from (withheld) with regulatory authority, CEP:159558. Agents states she has a caller on the line that declined to provide information on her name or number. Caller reported to the agent after getting the Pfizer COVID-19 vaccine she got a mild case of COVID- 19 virus. Agent reports the caller didn't know anything until she got sick. Caller states she was so afraid to get COVID-19 booster because she got really sick after second COVID-19 vaccine. After the booster shot her reaction was not as severe as after the second shot. Caller states she can't remember how many days later after the COVID-19 booster dose she developed shortness of breath, when climbing up the stairs. Caller states the shortness of breath gradually builds up more and more and it then it was getting severe until Jan when she went to the Emergency Room. She states she requested to get a blood test of COVID-19. Caller reports the blood test came back as IgM was positive and IgG was negative. Caller states she had a CAT scan done and there were no signs of pneumonia or embolism. Caller states she just talked to agency and agency had a study program that she was not qualified for because the CAT scan showed nothing. Agency told the caller that her IgM could have been a false positive. She states that her doctor said she may have had a very mild case of COVID-19 since she never felt sick with covid. She didn't even know herself. She reports that at first she thought got COVID-19 from the Pfizer COVID-19 vaccine. She assumes Pfizer would like to gather this data but nobody thinks she has COVID-19. Caller states the shortness of breath began a few days later. Caller confirmed the shortness of breath started a few days later. Caller states the shortness of breath is slightly better maybe. She states maybe she was to fast running up the stairs. Caller states the shortness of breath was gradually getting heavier and heavier and was getting more severe. This was signaling to her that this is a pattern. Outcome of shortness of breath: Caller states the shortness of breath was going on persistently and gradually and then it worsened and then this week she started feeling better. Caller states that means there is hope that she can get well. Caller states when she lays on the table she gets lightheaded and dizziness as well as, headaches and insomnia. Caller states the insomnia is not consistent. She reports  when her body wants to catch some sleep, she is able to sleep. Caller states this is weakness of her legs. Now its improving but she gets tired easily. She reports she can't do daily activities one day and will have a setback the next day and be very tired. Caller states if she can rest, it improves. Caller states the shortness of breath still exist. Caller states the lightheadedness has improved but seldom it will come back. Headaches: Caller states she now experiences more frequency of headaches and the headaches started a few days ago. Caller states the headaches are ongoing and come along periodically. Caller states she is tired more easily. Outcome of Headaches: Caller states the headaches are not worsening but maybe persisting. Dizziness: Caller states the dizziness began the beginning of Jan. She reports that maybe after Jan they can come back rarely or seldomly. Caller states that the dizziness could come back and then goes away. She reports that the dizziness does not bother her as the dizziness comes back and then goes away quickly. Tired more easily: Caller states the getting tired more easily started last week and is ongoing.  Caller states that lack of exercise may have caused her to be tired more easily. She reports she played pickleball and has not been able to in these months. Caller states she got sick and hasn't been able to do anything these last 4 months because of the shortness of breath. Caller clarifies that her Emergency Room visit was an outpatient visit. Caller states 12 hours after her 2nd dose of the COVID-19 vaccine she started feeling cold and was shaking inside. She states she felt so cold and her whole body was aching. Caller states she was so cold even under a blanket. Caller states she was nauseous. She states she was afraid to take Tylenol because she was nauseous and did not want to vomit. Caller reports that she laid in bed all day. She even moaned in the bed since the achiness was so bad. Caller reports on the next day she was dizzy and slept in bed all day. Caller reports starting to feel warm and she developed a bad headache that felt like inside her head was to burst, it was so painful. Clarifies that her head felt like it was going to explode. She has never had a headache like this in the past. She reports she was dizzy and slept in bed all day. She reports that night she had a low temperature and took some Tylenol because she wasn't nauseous. Caller reports she perspired a lot and the fever broke. Caller states the dizziness stayed with her until the 4th day and by day 5 she was able to go out. Caller reports this is why she was so hesitant about the COVID-19 vaccine booster. Treatment for Shortness of Breath: Reports diclofenac didn't help. The doctors couldn't find out anything and that she must have inflammation in her body. She reports they found IgM was positive and she was placed on prednisone and that didn't help. Caller reports albuterol sulfate inhalation aerosol 90mcg 2 puffs every 4 hours as needed and the inhaler didn't help , she was also prescribed budesonide formoterol fumarate dihydrate inhalation aerosol 160/4.5mcg 2 puffs 2 times a day. Caller reports no treatment for the lightheadedness, headache, dizziness, tired more easily, or weakness of legs. Caller states when she has shortness of breath she has to lay in bed not moving for 3 hours to feel better. Caller reports now they find out when she has shortness of breath her heart skips a beat. Caller wanted to know if other people are calling Pfizer and reporting events after the COVID-19 vaccine. She states is she the only one who is calling and reporting this to Pfizer. Caller reports that she hasn't eaten lunch yet and have been on the phone for an hour and she needs to go. Caller asks so what will Pfizer do with her information. Caller reports if she had known she wouldn't have provided her information. She was hoping this information was going to scientist so that it can help people. Caller asks why would the information be needed if the information wasn't going to scientists. Caller states that we don't know if the answer is a reaction to the COVID-19 vaccine or from the COVID-19 virus. She is hoping this information would help so one we will know how to treat COVID-19. Caller states where is your office based. She wants to know what center she is disclosing her information to. Caller asks why she is disclosing her location and address when Pfizer cannot provide theirs when she is willing to provide her information. Caller states why would she provide all this information about her personal history when it could be accessed by any authority in the industry. Caller states she is not very confident on how Pfizer is working. Caller states she doesn't want anything shared. Caller states Pfizer's company is so concealing. Callers states to destroy all her information she has provided. Caller states if she had knew the outcome she wouldn't have stayed on the phone for an hour and wasted her time and Pfizer's. Caller asks if she can be confident that Pfizer will delete all the information she has shared. She does not want her information shared with Pfizer. Caller asks again to have her information deleted now. Caller asks why we are circumventing an answer to her. Caller states she is really regretful she has released all her information if she had known this was how the call would end. Caller states she would advise no one to call Pfizer and to delete her information. Caller states so that her information can't be saved. Caller states please do not forward this report to anyone or any department. Caller states to tell your authority that she never even called Pfizer. Caller asks if Pfizer can send her an email that her information will be removed. Caller states she has made a mistake and that there is no reason she should have to stay on the line for over an hour. Caller states she was very unhappy and trying to help. There is a product complaint to report. After getting the Pfizer COVID-19 vaccine booster dose, she got a mild case of COVID- 19 virus. Requested to get a blood test of COVID-19. Reports the blood test came back as IgM was positive and IgG was negative. Confirmed that the blood work for her IgM was how they told her she was positive for the COVID-19 virus but she doesn't know when she had it. Reports diclofenac didn't help.  She was placed on prednisone and that didn't help. Caller reports albuterol sulfate inhalation aerosol 90mcg 2 puffs every 4 hours as needed and the inhaler didn't help , she was also prescribed budesonide formoterol fumarate dihydrate inhalation aerosol 160/4.5mcg 2 puffs 2 times a day.  No follow-up attempts are possible. No further information is expected.