Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Paralysis, Peroneal nerve palsy, Pharyngeal swelling, Poor quality sleep
Clinical narrative: rash was terrible/hot pink and looks like measles/bumpy and itchy/Second dose: Rash/big red, itchy, horrible, painful rash & then it gets blotchy off & on and it kind of gets bumpy and blotchy; made her nervous system worse; coughing; gagging; choking; not sleeping well; enough to be annoying and made it hard to swallow & eat; caller has a limp and draggy foot; I do have allergies/I have lot of underlying allergies; rash was terrible/hot pink pink and looks like measles/bumpy and itchy; rash was terrible/hot pink pink and looks like measles/bumpy and itchy; Headache; Nausea; Fever/had a much higher temperature than I did on the first dose by 4 points, it went up by 4 points; Dizziness; Tummy ache; swelling in my throat; wheezing; I am paralyzed; paralyzed right leg and nerve; she was going to faint; This is a spontaneous report from a contactable nurse (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FE3592, Expiration date: Not reported), via intramuscular route in left arm on 24Sep2021 at 10:00 (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. Medical history included heart surgery for a heart condition in Apr2021 and recovering from it where she is seeing petechiae and that maybe her blood vessels are getting affected, orthopedic bone stuff, bruit in her groin and had hip surgery on an unknown date resulted in right leg paralysis because of the hip surgery. The patient was allergic to dye and was also allergic to 30 unspecified medications. Concomitant medications included apixaban (ELIQUIS) 5mg, two times a day and had unspecified blood thinners for the heart medicine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3182, Expiration date: Unknown), via intramuscular route in left arm on 03Sep2021 at 11:00 (at the age of 75-years-old) as dose 1, single for COVID-19 immunization and experienced huge major rash/had it with number one also but not really as bad/caller also got the rash with the first shot/rash is huge on both legs but is more on the right leg, the vaccine is killing her paralysis, it is big red, itchy, horrible, painful rash & then it gets blotchy off & on and it kind of gets bumpy and it gets blotchy; first one swelled her arm up like an extra half of an inch and it was hot to touch; the second dose had a much higher temperature than she had on the first dose by 4 points; gagging; wheezing and coughing. The patient previously took flu vaccine and had high fever; pneumonia and Shingrix vaccine and had an allergy where the patient ends up in a ventilator. The patient experienced rash was terrible/hot pink and looks like measles/bumpy and itchy/second dose: rash/big red, itchy, horrible, painful rash & then it gets blotchy off and on and it kind of gets bumpy and it gets blotchy, and her nervous system was worse on 24Sep2021. The patient was paralyzed, paralyzed right leg and nerve damage; going to faint; rash was terrible/hot pink and looks like measles/bumpy and itchy; headache; nausea; fever/had a much higher temperature than she did on the first dose by 4 points, it went up by 4 points; dizziness; tummy ache; swelling in her throat; a little bit of wheezing; coughing; gagging; the choking thing; not sleeping well; had a lot of underlying allergies; enough to be annoying and made it hard to swallow and eat and had a lump and draggy foot in Sep2021. The patient used diphenhydramine (BENADRYL) ointment and it didn't help. She took Benadryl tablets for rashes and pruritus which didn't help either. The patient would like to use cortisone cream and wants to know what else she can use, or what other people have used to help relieve the rash. She drank liquids as night dinner which was a part of weight loss program. The patient's blood work in Sep2021 was reported as perfect with unknown results. It was reported that there was no investigation assessment. The patient was getting sick after every vaccination, she was considering not to get the booster because it's getting worse each time when she gets the next dose of this vaccine. The patient would like to know what else she can use or what other people have used to help relieve the rash. She also wanted to know how long this effect will last and also wanted to know what the reported cases of shingles rash look like. The outcome of the events rash and made her nervous system worse was not recovered while the outcome of the other events was unknown at the time of report. The nurse assessed the causality between the vaccine and the events rash, made her nervous system worse, wheezing, coughing and gagging, had a bad tummy ache and felt dizzy like she was going to faint to be related by global introspection method.; Sender's Comments: Based on the available information, a contributory role of the suspect drug cannot be excluded for the reported events. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.