Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise, Myalgia, Pain, Vaccination site pain
Clinical narrative: Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown.  No follow-up attempts are possible. No further information is expected.