Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: An awful rash described as "a wild wild rash on my chest, bright red itchy angry"/Rash on mostly upper left part of back and right hand; itchy hurting mess//Every rash is painful and itching/ Rash is very itchy/ rash is a scratchy, hurty mess; itchy hurting mess/ Every rash is painful and itching/very painful/hurty mess; Tired and sleepy; Tired and sleepy; This is spontaneous report from contactable consumer (patient herself) via a medical information team. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 15Apr2021 at 12:10 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included fibromyalgia from an unspecified date in 2012, lupus psoriasis from an unspecified date in 2010, allergies, compromised immune status, genetic /chromosomal abnormalities, respiratory illness, endocrine abnormalities, diabetes from an unspecified date in 2015, chronic fatigue (chronic fatigue syndrome) from an unspecified date in 2012, obesity, psoriasis from an unspecified date in 2010, migraine, anxiety, and depression from an unspecified date in 1965. Concomitant medications included atenolol (Strength: 50 mg) from an unspecified date in 1988 at 50 mg, daily for migraine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), in left arm on 25Mar2021 (at the age of 59-year-old, Lot number: ER2613) as a single dose for COVID-19 immunisation and experienced left arm soreness and slept for 3 days on 25Mar2021. It was reported that the patient received first dose in left arm up very high in the muscle. The family history included glaucoma, anxiety, and depression from an unspecified date in 1965, diabetes from an unspecified date in 2015, heart disease. Prior vaccinations (within 4 weeks) was none. The patient did not develop adverse events prior vaccinations. Additional vaccines administered on same date of the Pfizer suspect was none. Caller was a consumer, enquired asking what she was supposed to do with this rash. Caller reports that she received her second vaccine dose on 15Apr2021 and 4 hours after getting her vaccination she became an "itchy hurting mess" on 19Apr2021. Her first vaccine dose was reportedly 3 weeks prior to her second. She reports that she was experiencing an awful rash described as "a wild rash on my chest, bright red itchy angry" on 19Apr2021. Caller reports that she has seen her healthcare professional twice her Dermatologist three times and her Psychiatrist twice with no improvement or guidance. Caller states "Pfizer was the one who made it they should know what do to about the side effects". Caller reports that she has tried numerous over the counter products and medicines to help with her rash, but nothing has helped. Caller reports that she has asked her doctor to give her a cortisone shot and was refused because it may interfere with the vaccine. Caller became audibly upset asking loudly, "what am I supposed to do?!" and "what happens to me" reporting that people get the shot, and they are "thrown to the wind" and no one knows what to do for me. Caller asks, "How many people total have had adverse reactions after getting the vaccine." During this call, caller threatened to go to the News and then stated, "I don't know what to do I may have to kill myself". Caller made no additional statements of harm to herself and no need to direct to suicide hotline was necessary. Caller was a consumer, asking "how do I get help to pay for the medicines I have had to use after getting the vaccine." Caller was a consumer, asking "what would be a contraindication to getting the vaccine." Caller was a consumer, asking, "did you have anyone with autoimmune problems get the vaccine". Caller reports that she has fibromyalgia, lupus Psoriasis and says, I have an autoimmune disease, I am not immunosuppressed. Received call from consumer regarding the Pfizer COVID vaccine. She has reported adverse events. There was no prescriber. The doctor's on site need more training. She should have never been allowed to have the vaccine. She had a swollen left eye and a rash around left eye when she went in and the doctor said it was ok. She wanted to know if there was any directive on who should not get the vaccine. Small rash around left eye started to spread. The rash was there before. It was hard to comb out what happened when. Rash was very itchy and very painful. Nobody knows what it was. She has been to 6 doctors. This was the second dose that she started having the issues with the rash. She later stated she had arm pain and slept for 3 days after the first dose. She has a growth that was there previous on the upper left arm and during the second injection, she thinks it was given a little higher in the shoulder, closer to where that growth was. She was not sure that one was given in the muscle. The Effexor was increased at first due to titration up to full capacity or dose. Then titration down because of side effects and then titration down due to rash. She stated it was the same rash that we are talking about. It was in a pharmacy vial with no lot or expiration. If she ever had a regular vial it was thrown away. There were different bottles with different doses and different lots and expirations. She no longer has any of the bottles to provide a lot or expiration. She has the 150mg, count size was 90 tablets. This was the one she was taking when she was taking the shot. It was in a Pharmacy vial. Her current dose was 75 mg once daily. That was in a pharmacy vial with no lot or expiration. She has pictures of the rash and it is bright red and very angry. They did a biopsy of chest on 27Apr2021, and the results are not back yet. She went to dermatologist for the third time on 27Apr2021. For the first one, she only slept for 3 days and only had arm pain. She later stated she might have slept for 3,4 or 5 days, she does not remember. ER or physician's office required. Physician visits 16Apr2021, saw a dermatologist at withheld Dermatology, that she doesn't remember his name. He was a 50-year-old male doctor. Creams, ointments and later stated Hydrocortisone 1%. She has a bag full of creams and ointments. and was lucky she remembers what goes on what parts. Some do not go on face or near eye. This was the only one that went near her eye. Then on 20Apr2021, she saw Dr. at the same group with the same address and phone as last one. She does not remember what was given when. Maybe 2.5% cream was given then, but then said no, that was not during that visit. She does not remember when was given what. They just keep having her buy more lotion and buy more stuff. They have helped a little bit. Something inside of her body was causing it. The rash just keeps getting worse and they are a band aid, and nothing was getting rid of it. She does not wish to provide the names of those creams and ointments and did not wish to provide dose, lot, or expiration for any. She said they are not the issue. She then saw the same 50-year-old bald male, not Dr. the other guy, on 27Apr2021, she got a biopsy on her chest and does not have results. He prescribed a new cream. She also saw Dr., primary care physician, 27Apr2021. She said she believes it was because of the vaccine but she did not want to give cortisone or prednisone because it might negate the vaccine. She directly faults Pfizer with her doctor not knowing what they could and could not use. She saw Dr. Psychiatrist, on 27Apr2021. She had already lowered her Effexor by phone. No additional treatment during that visit. She lowered the dosage on 22Apr2021 from 150 mg to 75 mg now. That doctor said she does not know if it was from the Effexor or the shot. The dermatologist does not know if it was from Psoriasis or the vaccine because the rash got worse in sun. Usually psoriasis gets better in the sun. Caller states she has done three reports so far and no one can help her. Says every idea they give her was one she has already done or can't do. States nobody knows why she has this rash, nor do they know what to do. She has been sleeping all day, every day, since 15Apr2021. She has lost 2 weeks of her life. She also wanted to know if Pfizer recommends giving the vaccine with autoimmune problems. She has not read anything about that. She lastly stated that the rash started in her upper arm and was now spreading to her lower right arm. This started 2 days ago (25Apr2021). Was there any clearing house for people with problems. She read there are like 400 people who have problems after the four hours. They did not count her and there are a probably a million other people. There was no specific information on those 400 people, and it was just a report. She did not have any further details to provide. Call handler asks caller if she was wanting to do a follow up report from the one this morning and if she has any new symptoms. The caller states that her rash has gotten worse. She states it was better in the morning, worse at night, better in the morning, worse at night. States her rash was a scratchy, hurty mess. She wants to know what to do about her rash. Caller says that the doctor won't give her steroid medications for the rash because she had the vaccine recently. Caller goes on about how she needs to speak with the people who developed the vaccine. States how can Pfizer just be out there telling everyone to get the vaccine, get the vaccine, get the vaccine; but then could not help them when they have a reaction. Caller randomly says that she has read about shingles after the vaccine. States why do they put polyethylene glycol in things if they know some people are allergic? Caller did not specify that this was in the vaccine, she just stated it as things. Call handler asks caller if she was allergic to polyethylene glycol? Caller yells she doesn't know. States her rash itches and hurts and was driving her nuts. Again says better in the morning, worse at night, better in the morning, worse at night. The patient was tired and sleepy on 15Apr2021. No investigation assessment. The patient underwent lab test and procedure which included biopsy: Results are not back yet on 27Apr2021. The outcome of the events tired and sleepy was not recovered, recovering for the event rash, itchy and unknown for the other event. Description of Product Complaint: Description of complaint: Unspecified creams and ointments that were prescribed that are not helping her rash get any better. They just keep having her buy more lotion and buy more stuff. They have helped a little bit. Something inside of her body was causing it. The rash just keeps getting worse and they are a band aid, and nothing was getting rid of it. She has a bag full of them and did not wish to provide the names, manufacturer's, doses, lots, or expirations. She only stated name of Hydrocortisone 1%. She later stated one was changed to 2.5% but did not wish to provide details about which one. She did not wish to provide lot or expiration for any of them. Product strength and count size dispensed: Unknown. Additional lot numbers: None was a sample of the product available to be returned.   Follow-up attempts are completed. No further information is expected.