Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Body temperature, Bone densitometry, Chills, Feeding disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 (Lot Number: EN6202) as 1st dose, single for covid-19 immunisation. Medical history included Mild hyperparathyroid (mild hyperparathyroid), Autoimmune disease from 2019/autoimmune flared up (Diagnosed 2 years ago, and the minor things that go along with autoimmune disease. This is the major disease she sees doctors for), colon cancer, Graves disease, Thyroid replacement since 1981, hypothyroidism, Mild asthma, Osteoporosis in right hip. Concomitant medication included levothyroxine taken for Hyperthyroid, Graves disease, Thyroid replacement, hypothyroidism from 1980 to an unspecified stop date (patient started back in 1980. She had hyper thyroid and it turned to graves then in 81 she was given radioactive iodine drink and when hypo. since 1981, she has had thyroid replacement); formoterol fumarate, mometasone furoate (DULERA) taken for Mild asthma, start and stop date were not reported (she also has mild scarring on lungs from autoimmune disease.  no additional details provided. her doctors are afraid of her getting Covid); vitamin d3 taken for Osteoporosis in right hip, Autoimmune flared up, start and stop date were not reported (for quite few years she has been on, doctors suggested.  Her because autoimmune flared up 2019 so she uses this instead of prolia); cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for Supplement/ she is on because of her age, start and stop date were not reported (She has been on for maybe 2 years or a year and a half). The patient previously took second dose of Hepatitis B vaccine in 1980 for immunisation and experienced Difficulty breathing, caller states her understanding is that she was an employee and they filed a report on this for her. They had not ever had a reaction. She was in the hospital with difficulty breathing after her second Hepatitis B Vaccine shot. They told her the third shot would kill her. Caller does not have manufacturer or any additional information regarding this vaccine. She was just told she can not have the third shot; hydroxychloroquine phosphate (PLAQUENIL) from 1987 (reported since 1987-1988) to 2013 (but she is not sure) for Systemic Lupus and experienced Retinopathy/bad eyes/ dead spots on her retina and trouble seeing. caller states she cannot see this information because she has bad eyes because of a medication she was on for a disease. She reacted to a drug. This occurred while she was on Plaquneil, caller confirms spelling, and states that her original diagnosis was Systemic Lupus and it built up in the central portion of her retina so she had retinopathy due to drug toxicity from the medication she was on for her disease.  She has dead spots on her retina and trouble seeing unless she gets direct sunlight. She states it is spelled Plaquneil or iel, she does not know. She had the generic brand which caller states is hydroxychloroquine. She states the problem is with her eye doctor they gave her a safe dose of 400 mg and because of her size, they felt like she was getting the same dose of a man that was 300 pounds would have gotten. She had been on it since 1987-1988 and then she was thinking she was taken off of it in 2013 but she is not sure because she is still getting routine checks to see how much damage the drug did.  She has been off of it for so long she does not know any additional product details. Caller adds she just knows she went to a male doctor and complained about her vision issues and they did tests that they were going to run. He told her to accept the fact that she is getting old.  She switched from him to a female doctor.  She failed every test, so they instantly removed her from it.  caller has no additional details to provide about the hydroxychloroquine or Hepatitis B Vaccine.  She states her rheumatologist handles all of this. she confirms she was on hydroxychloroquine but refers to as Plaquneil.  She confirms her spelling; prednisone; denosumab (PROLIA); shingles shot for immunization, shingles shot bruising and hot where they put it but did not last long. Additional vaccines same day was none. Prior vaccinations 4 weeks was none. patient has an autoimmune disease  and when she got her first vaccine 25Feb2021 she had to wait a half hour because she has had a reaction to the second Hepatitis Vaccine which they stopped back in the 80s. Caller had Pfizer Covid-19 Vaccine, and started a fever before she left. Caller adds she had a sore throat and she felt like lymph nodes were enlarged (25Feb2021). She adds that this all occurred over the weekend. Lymph nodes enlarged: the lymph nodes in her neck swelled so bad mostly largest on the right side that she could hardly open her mouth. She could not get her thyroid pill, it was difficult to eat or drink. The doctor determined that it was the Hepatitis B vaccine that it was from, and it was hard for them to examine her. caller clarifies that she meant it was the Pfizer Covid-19 Vaccine it was from, and that she misspoke. Caller adds that she had a previous reaction to the Hepatitis B vaccine and that is what she meant. Everything she is reporting is on the Pfizer Covid-19 Vaccine.  She does not provide any additional information regarding her thyroid pill. She clarifies that is was hard for them to examine her, because she could not open her mouth hardly at all to get anything in and that.  She adds she has health problems. She called the clinic because of how her first vaccine went and spoke with the head of education department. She checked things out for her and from what she told her what happened she did not know if she contacted Pfizer or not, but the woman said she should follow up with her doctor orders and get the second shot. Sore throat, fever, lymph nodes enlarged: started the evening after the first vaccine, it started with a fever and a sore throat.  She is not still having a sore throat. She does have an autoimmune disease and does run fevers on and off.  She was not concerned about her fever until it got much worse, it went as high as 102 (her normal temperature is 97.4-97.9).  It went up to 102. And then her lymph nodes got excessively large.  Caller does not know if she had a fever when she went to her doctor.  Her doctor just said her lymph nodes were excessively large. She states that all events occurred after her first vaccine, but she also had them again after her second vaccine. That night she felt her neck was tender and the morning after, the lymph nodes were sore and it was the vaccine on a Thursday so that may have been on a Sunday morning.  She woke up with them so enlarged and painful that she did not want to go to the ER. That is when she could barely open her mouth from the pain. She adds it was right sided. It really is a lot better, there might be just a small area where the lymph nodes are still a problem. She states she wonders if anyone else experienced this because of an autoimmune disease. Caller adds that her main doctor is not aware of this, but she has an appointment with her routine doctor. Lymph nodes enlarged: on her jaw nothing on the inside but on the outside, broke up, and she had drainage.  She happened to have a routine cancer check appointment with her dermatologist. The dermatologist did a biopsy and they sent what was into pathology and it showed no cancer or no infection. She adds they have never seen anything like that, her skin was like a burn victim where it broke open. It must have been lymph nodes that were large and broke. She does not provide a start date but states she is still having trouble with this. It is not completely healed.  There is a little bit of swelling, a small amount of swelling, in her lymph nodes.  It was her jaw on the right side and in the neck.  It mostly effected her jaw. Chills, lost weight: she had chills and obviously lost weight because she could not eat or do anything  She had chills with no fevers or anything now, the only thing she is having is this area that broke through is taking a long time to heal and she still has to cover it and there is still an area that is draining and finally stopped but is still raw in some areas. She feels a lot better, she looks better. Caller adds that she lost four pounds, and verifies she corresponds this to the issues she was having.  She had colon cancer so she is already low body weight, where her colon was removed some people will have malabsorption.  Her body weight will always be low.  It is not a good thing. first vaccine EN6202, that is the only thing the card says.  It was given at hospital on 25Feb2021, and states it was the Pfizer. The second one caller interrupts sentence and states she was on antibiotics 10 days and started to improve and could eat.  She had trouble eating and then the second shot the same thing happened. No additional information is on the card.  Both were given in her left upper right below shoulder, in upper arm. Fever, chills, sore throat: By the time she got home, when she waited the half hour, she felt like she was starting to get a fever because her face was starting to fever.  She also had chills and sore throat. Indication: because of the fact that she has autoimmune disease and was concerned, she did not want to get Covid. Her doctor and her had a discussion about it and he convinced her she needed to have it because if she were to get it, her system is so weak and to get covid she would be extremely sick. He thought she would be hospitalized.  He said not to think about the Hepatitis vaccine and what happened to get the vaccine, and that if she felt side effects later not to worry because if anything happened she would be rushed to the ER like they would do with the Hepatitis vaccine. He said do not let this make her afraid to get the second vaccine. Fever, headache: caller adds that her headaches started the problem because of her autoimmune disease.  Sometimes she has headache and fevers and swollen lymph glands and not to this extent that she had.  Caller adds that they realized it was from the Covid vaccine.  She probably had headaches at the same time of the fevers and that.  She was sick enough that there were three days after the first round of Covid that she slept and stayed down. Her jaw was so swollen it was hard to hold her head up.  She does not know when the headaches were and all that. caller adds she is on no other medications for her diseases after the Plaquneil, her side effects come on quicker and it effects problems. She adds she was on prednisone so she did not get her Prolia shots because she got prednisone instead. She would get Prolia shots every 6 months. Caller confirms that prednisone and Prolia were not taken within the weeks leading up to the vaccine. Caller adds that her endocrinologist took her off of Prolia because they stopped the shots when she saw them sometime in April and was taken off shots because her bone density was normal, and she has not been back on it.  Caller states that she went to her dentist, they felt it was going to take longer for her lymph nodes to go down. The dentist said do not let it go long because her face was red and large and he was shocked. Treatment: 03Mar2021 first round of antibiotics, she believes was Ciprofloxacin. There were concerns she had too many antibiotics, it was 200 mg twice a day for 10 days. The second antibiotic was from a different doctor, on 19MAR2021. Then 20Mar2021 levofloxacin 500 mg once a day for seven days. Caller adds she also had headaches too in the beginning and with the second vaccine so she took Tylenol 500 mg. AE was not require trip to ER. Require Physician office. The last outcome of fever was recovered, and the last outcome of the other events was unknown.   Information on the lot/batch number has been requested.