Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Dyspepsia, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: burning in stomach and throat; burning in stomach and throat; Weakness; Headache; Shoulder pain; sweating from shoulders up; today tried to go to walking had to stop felt heavy in her chest; she was really hurt; had to spit and she threw up foam; From her breast up to herribs and up all the way back to her head and her ears were blocked; her head was so heavy; tiredness; red cells are a little bit higher; after her second dose she was fine but the 4th day felt sick; rash on hands like little pimples; she doesn't feel good; felt so bad; she is just laying in bed, has no energy; This is a spontaneous report from a contactable consumer (patient) reported in response to telephonic follow-up activity. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0179, Expiration Date: 31Aug2021), via an unspecified route of administration, administered in right arm on 12May2021 at 13:20 or 13:40 (at the age of 75 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing hypothyroidism almost 30 years, the patient stomach and her heart rate went up and she threw up, the patient was allergic to a lot of medicine. She had hyperthyroid, when her granddaughter was 4 or 5 years old but she is not 28 years old, so was about 25 years ago. She had hyperthyroid, now she is being treated for low thyroid. The patient stated she never takes a flu shot, she doesn't know. The patient never had the flu or cold and she doesn't take the flu shot and was allergic to a lot of medicine and was afraid to get the vaccine but her doctor said to go ahead and get the shot. Family medical history relevant to adverse event includes family all healthy, father died at 98, mom died by 86. She broke her hip and doctor gave her pain killer. She took the pain killer and it killed her. She took the pain killer the doctor gave her for years or months, she went to the pharmacy and they gave it to her for six months that strong pain killer, then her liver and kidneys gave up. She was a healthy person, she never took no medication, had no surgery, only a gall surgery. Concomitant medication included levothyroxine sodium (SYNTHROID) taken at 88 mg, once a day, once in the morning by mouth on empty stomach via oral for hypothyroidism, start and stop date were not reported. The patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 Vaccine, LOT number: EW0169, Expiry date: 31Aug2021, NDC number; unknown) administered in right arm on 21Apr2021 (Age at Immunization was 75-years-old) for covid-19 immunisation. Vaccination facility type was at clinic. The patient has previously called to Pfizer before regarding her first vaccine of the Pfizer BioNTech Covid 19 vaccine. Confirmed with caller that this was the second time that she has called and her first call was in regards to her getting the first vaccine. The patient called the first time to report burning in her stomach and throat. The patient called her family doctor because she was afraid to get her second shot. The family doctor told her to take pepcid 3 days before her second dose and 3 days after. On an unspecified date the patient has had burning in her stomach and throat after the first and second shot. The patient weakness and headache from second dose of Pfizer BioNTech Covid 19 vaccine. On an unspecified date the patient shoulder did not hurt the first time but hurt on the second dose. The patient could not lay on that right shoulder, after the third day that went away. Weakness will not go away, the patient cannot do anything. States yesterday the patient was laying in bed all day and so weak and tired and worried about her head. States sweating constantly and has heat from her chest. The patient would never had done it if she was given time and had read all the paperwork before getting the shot. The patient called the doctor and was advised to take tylenol and pepcid and that was what she has done. The patient was afraid to take it, called her doctor again and they said to go ahead and take the pepcid. The patient said the pepcid has helped. The patient took the pepcid after the first shot after talking to her doctor and the burning went away. Her family doctor told her to go ahead and to take pepcid 3 days before and 3 days after her next vaccine. The patient told her husband why she should take pepcid if she doesn't have burning so she just started taking it the day she got her second shot instead of three days before. The patient doesn't feel good and doesn't think she should have gotten the second shot. The patient was just laying in bed, has no energy and states pain on the right side of her head and neck. This is her headache pain. The patient has only seen this doctor once and was told to take tylenol, advil, and pepcid and the doctor told her what to do but didn't feel good so called the number on the paper. The patient only goes once a year to her family doctor. Made an appointment for a blood test in July but when she had the burning and felt so bad she was thinking it was due to her thyroid medication being recalled. States she was switched to synthroid but took the blood test early and the blood test came back normal. States she then thought she was feeling bad due to her second dose of the Pfizer BioNTech Vaccine. The burning in her stomach was bad for 4 days and the pepcid helped. Then weakness, tiredness, and headache. The patient states unsure of start date of headache, has been taking advil, doesn't want to take too much because of the burning in her stomach. The headache with the second shot was not as bad as the headache with the first shot. The headache with the first shot was very bad and now it is not so bad, maybe the medication is helping, no fever but sweating. The patient sweating started from the shoulder up, it is from under her breasts and all the way around and the heat comes up. She doesn't remember what day it started. It comes and goes. The patient states in the time we have been talking it went away three or four times. With the first shot it only happened once. She wanted to do some work on a Saturday and had to lay down, suddenly she felt like fire from her stomach up, like three times but that was it. With the second shot she has the sweating and the heat comes up. The patient has a rash on hands like little pimples but states they didn't bother her. The patient went to get the second shot the burning was gone but she was just weak. The burning began again after the second dose and began taking pepcid twice a day, in the morning and in the evening. States 3 days after her second dose she was fine but the 4th day felt sick. The patient after the first shot she didn't have the sweating but with the second one she is steady wet, all wet right now. The patient does not have shoulder pain now. The patient had pain in the shoulder two or three days very bad. There was no swelling, not red, or pain on her arm where she had the shot. Lasted two or three days and then it was fine and she could sleep on that shoulder, had the shoulder pain right away, the evening of the second shot. States today the patient tried to go to walk but had to stop because felt heavy in her chest. The patient had to stop and asks is it from the shot is it not? States that she was an active person. The patient states she works hard, she was 75 and could work like a person 30 years younger working next to her. This shot made her go down. She doesn't have strength anymore and hope it will get better. The patient goes once a year for lab test for her thyroid and they do the cholesterol and everything and patient was told everything was fine or better than last year. Made patient appointment earlier than usual and her appointment was supposed to be in July. The patient thought the burning was from her thyroid but her labs were normal so she thinks it was from the shot. The patient stated everything was fine the only thing patient had was her red cells are a little bit higher on an unknown date, so they told her to come back in one month to check to see how the blood cells are then, if they are the same, or they come down. The patient was taking Synthroid 88mg, clarified with caller that she was taking 88MCG not 88MG. The patient takes this because she was rushed to the hospital 40 or 30 years ago, they went to check her stomach and her heart rate went up and she threw up. She was rushed to the hospital by ambulance twice. The patient was treated 4 years for a heart problem, but then doctor stated it was her thyroid. Said this all happened when her granddaughter was 4 or 5 years old but she was not 28 years old, so was about 25 years ago. The patient had hyperthyroid, now patient was being treated for low thyroid. When patient was in the hospital with hyperthyroid, they gave patient medication in the hospital, gave big pills, chemo pills to take. Then they gave her another kind of medication. The patient got so sick from this medication and patient doesn't know which one so from that time doctor told her to take synthroid. The patient thinks patient got sick from the thyroid medication that was recalled. Doesn't know why it was recalled. States the medication is NP thyroid 90mg. The patient was told to take it for 6 days then one day to skip it. Provides RX number. Caller states she does not see NDC/LOT/expiry date. States she took one in the morning on an empty stomach and quantity is 90. The patient was flying on Tuesday the 25th. She will be coming back 15Jun2021. The patient never had this problem and never had a headache and has never had a headache in her life. The patient never had a problem with that medication that was why patient cannot understand why it was recalled. The patient just bought the Pepcid and her throat was starting to hurt from talking and she was getting tired. The patient woke up Saturday and had to spit and she threw up foam and never had anything like this, she was a healthy person. No one ever said on the news that people shouldn't get the vaccine, she was told the vaccine was safe. The only thing she ever heard about on the news was about the Johnson and Johnson Covid 19 vaccine. She still doesn't feel good and she hopes she feels better. The patient goes once a year to see her doctor and get her blood drawn. The patient had her blood drawn and everything was normal. The patient felt good taking her normal medications. Therapeutic measures were taken as a result of event headache with Tylenol PM (expiry Apr2021), 500 mg extra strength: takes in pm for sleeping and pain, takes 1 sometimes 2 at night, Advil ibuprofen 200mg (expiry Apr2023), takes after lunch and takes 2, for burning in stomach and throat took Pepcid 20mg takes just in the morning and in the evening, as the doctor told her. Outcome of the event Shoulder pain was resolved on an unspecified date; for event chest heaviness was recovering and remaining events were unknown.  Follow-up attempts are completed. No further information is expected.