Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Rash, Urticaria
Clinical narrative: brain fog; itching; hives; Rash; This is a spontaneous report from a contactable consumer (the patient, reported for self)  A 46-year-old male patient received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in arm left on 03Mar2021 10:15 (At 46-year-old) as single dose, for COVID-19 immunization. The patient medical history included ongoing anxiety, blood cholesterol, cardiac disorder from an unknown date.  Patient reported that he was diagnosed with anxiety like 8 years ago. Patient reported that he started to have issues with his cholesterol maybe 5 or 10 years ago. Patient reported that his cholesterol had been going up and down. Patient reported that couldn't keep it down so he started taking medication, Atorvastatin. Patient reported that he has heart problems, with his bicuspid aortic valve. Patient reported that the problems with his heart valve were diagnosed when he was 14 years old. Additional Administered Vaccines were None. No Family Medical History Relevant to adverse event. Concomitant medications included sertraline hydrochloride (ZOLOFT) 100 mg, by mouth, once daily taken for Anxiety, atorvastatin 20 mg, by mouth, once daily taken for blood cholesterol for all start and stop date were not reported. Additional Information for Concomitant Products Zoloft included: Patient reported that he took the after market off brand of Zoloft. No further details provided regarding this statement. Patient stated that he began taking Zoloft like 8 years ago. Patient reported that he began taking Atorvastatin about a year ago, maybe in 2019 or 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient reported that he doesn't normally take the flu shot and hasn't had a vaccine in 10 or 15 years.  Patient reported that on 04Mar2021 he had the first shot of the Pfizer vaccine for Covid-19, a week and a half into it, he developed a rash all over his body. Patient stated that the rash came up at night and was gone the next morning. Patient reported that 2 days later, the rash came up again and went away and then came up again, the rash is currently present, that he has a little bit all over in certain spots.  Patient reported that he is due for the second dose of the Covid-19 vaccine on Wednesday, 24Mar2021. Patient stated that the report said if you develop a rash all over your body it is listed as a serious side effect. Patient reported that he didn't have any issues other than the rash/itching and that he is looking for some advice as to whether he is at risk and if he should take the second dose of the Covid-19 vaccine or not.  Patient reported that he went to see his physician regarding the rash that developed after the first dose of the Covid-19 vaccine. Patient reported that his physician stated that it was a side effect and didn't really say much as to whether he should worry or not. Patient reported that he went to see his physician the following day after the rash disappeared, patient showed his physician pictures of the rash as he didn't have the rash at the time. Patient was unable to provide NDC number, lot number, or expiration date of the Pfizer Covid-19 vaccine as he does not have his vaccine card with him and was in his car and that he would be able to provide that information at a later date if he was contacted by Pfizer for a follow-up.  Patient reported that he didn't want to end up in the ICU or anything like that and that he wants to be protected. Patient reported that he was looking at the Covid-19 vaccine fact sheet from Pfizer provided to him by CVS. Patient stated that it says there's risks and they're all listed- listed under signs of severe allergic reactions is a bad rash all over your body. Patient reported that he doesn't know if his rash would be considered severe, it was just itchy and a little scary, but he felt fine besides that. That is why he is seeking guidance on what to do for the second dose. Rash: Patient reported that in the beginning when the rash first developed it was itchy, now he doesn't feel the rash and there is very little of the rash now. Patient doesn't know if the rash is getting better but it seems like it has improved.  Therapeutic measures were taken as a result of the adverse event, Treatment: Patient reported that he just took allergy medicine to treat the rash, he tried Benadryl at first and then Claritin. Patient reported that the Claritin seemed to work a little better. Patient reported that Benadryl didn't really do anything for the rash. Lot: 1800414; Expiration date: Aug2022; NDC: 50580-228-24; Strength: 25 mg; Package size: 24 capsules. Relevant tests: Patient reported that his physician looked at pictures of rash and looked at information about the Pfizer Covid-19 vaccine. No Emergency Room visit, but patient had visited the Physician Office. Outcome of the event rash was reported as recovering, outcome of other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.