Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin warm, Swelling, Urticaria, Vomiting
Clinical narrative: fever; redness; skin warm; Her skin continues to be warm and itching; purple blotch on her skin; She reports the hives are worse, they are spreading more and she thinks more are coming out.; rash like hives on her thighs, her arms and all over her body; rash is very thick and tight and it's giving her pain; cough; swollen lymph nodes; very bad headache; her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 with a very bad headache; armpit started to swell; felt like she couldn't eat; felt like she would throw up; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Batch/Lot Number: EW0170; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 22Apr2021 (at the age of 54-years-old) as dose 2, single for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included atorvastatin (ATORVASTATIN) and losartan (LOSARTAN) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Batch/Lot Number: ER8737), via unspecified route of administration, administered in Arm Left on 01Apr2021 as dose 1, single for COVID-19 immunisation. It was reported that patient received her second Pfizer COVID 19 Vaccine on 22April2021. Patient experienced fever, redness, skin warm, her skin continues to be warm and itching on an unspecified date, swollen lymph nodes, very bad headache, her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 with a very bad headache, armpit started to swell, cough, felt like she couldn't eat, felt like she would throw up on 23Apr2021, rash is very thick and tight and it's giving her pain on 24Apr2021 rash like hives on her thighs, her arms and all over her body, purple blotch on her skin, She reports the hives are worse, they are spreading more and she thinks more are coming out. on 25Apr2021. She experienced a fever, swollen lymph nodes under her arm and a very bad headache. On Friday 23April2021 her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 with a very bad headache. Her armpit started to swell on Friday 23April2021. On Sunday 25April2021 she developed a rash on her thighs that has spread at this time. The rash started as redness on her thighs with different size dots. The following day it was all together. There is a small area where no redness is present that has turned purple. She described the purple area as "looks like a bruise". She took Zyrtec the first night. It kind of helped with the itching. On Monday night 26April2021 she took Benadryl per her pharmacy recommendation, no relieve. Her skin continues to be warm & itching.`She can't sleep much during the night. Patient wants to know if the purple spot on her leg may be a blood clot and if so when should she seek for medical help. On Sunday, 25Apr2021, maybe at around 4:00PM-5:00PM she started to develop a rash like hives on her thighs and both her arms and then all over body. It looks like hives. Since then she's taken Zyrtec and tried Benadryl. The hives continue to spread and the hives are really painful. She called her doctor around 3:00AM in morning, 27Apr2021 because her hives were very itchy. On her thigh there is some kind of purple blotch on her skin. She was afraid that she had a blood clot. She sent pictures to the doctor and the doctor saw how bad the hives were and prescribed her Prednisone. Patient asking that if she can take the Prednisone that had been prescribed. She is calling to see if taking the Prednisone is going to void out her COVID 19 vaccine or interrupt the effectiveness of the vaccine. She reports she panicked early in the morning around 2:30AM because she noticed the purple blotches. She has more on her thigh. She reports the hives are worse, they are spreading more and she thinks more are coming out. The rash is very thick and tight and it's giving her pain. The Zyrtec and the Benadryl aren't helping at all. Well maybe the Zyrtec is helping a little bit with the itching. She does report she exercises regularly. She wants to point out that when she had the COVID 19 vaccine, within 24 hours she had a fever of 103.3 and her headache was terrible. She had a really bad headache. She took Tylenol probably at the 26th hour after she received her COVID 19 vaccine. She received her vaccine at 2:00PM and she took the Tylenol the following day at around 3:15PM because she couldn't stand the pain of her headache anymore. Her armpit was swollen and then maybe because of the fever she felt like she couldn't eat, she felt like she would throw up. She did not vomit. When she took the Tylenol, a couple hours after, her headache was better and the fever had gone down to 102 degrees Fahrenheit. She would say that she felt good, she felt better on Sunday morning, 25Apr2021. She still gets a headache if she coughs. But then in the afternoon on Sunday 25Apr2021 is when the hives came. She reports the swollen area under her arm was better on Sunday, 25Apr2021. Is no longer swollen. She did feel a little pain under her arm but she does not feel that anymore. She can tell it is better because she can put her arm down by her side and not feel the lump anymore. The patient underwent lab tests and procedures which included body temperature: 103.3 fahrenheit on 23Apr2021. Outcome of the events swollen lymph nodes, her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 , felt like she could not eat and felt like she would throw up was recovered on 25Apr2021, outcome of rash like hives on her thighs, her arms and all over her body, rash is very thick and tight and it's giving her pain and Hives was not recovered and outcome of very bad headache, armpit started to swell, redness, Her skin continues to be warm and itching, purple blotch on her skin and cough was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained