Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Scratch, Somnolence, Urticaria
Clinical narrative: very uncomfortable; her legs were clearer; where she had hives on her legs, there was a small area with marks on her skin, but no longer hives. She said the marks on her skin may have been from her scratching; her lip was swollen; a strange thing happened on 26Mar2021, she said she noticed on the way to the store, her voice sounded strange; She said she took 2 Benadryl 25mg tablets on 24Mar2021, and the Benadryl 25mg made her sleepy; her ears started itching and were red; her ears started itching and were red; the hives were itchy and she had a little itching; She said the back of her neck & shoulders were covered with hives. She said the hives were on her arms & elbows, & parts of her back. She said the hives were on the side of her legs, & down her ankles; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Lot Number: EN6207 Expiration Date: Sep2022), via an unspecified route of administration, administered in Arm Right on 23Mar2021 16:30(at the age of 58-year) as DOSE 1, SINGLE for COVID-19 immunisation and diphenhydramine hydrochloride (BENADRYL, Batch/Lot Number: SSF051), oral from 24Mar2021 to an unspecified date, at 25mg tablet by mouth, 2 tablets initially, and then 1 tablet in morning and at night, as needed for pruritus.  Medical history included blood cholesterol increased (cholesterol was 184, and her LDL was a little elevated). She said both her parents had high cholesterol. Concomitant medication(s) included vitamin c, aspirin [acetylsalicylic acid] and vitamins nos (MULTIVITAMIN [VITAMINS NOS]).  Clinical course: She said everything was fine, and she did not think she had an allergy to the COVID-19 Vaccine. She said for 3-4 hours she was fine after getting the COVID-19 Vaccine, but then her ears started itching and were red. She said the back of her neck and shoulders were covered with hives. She said the hives were on her arms and elbows, and parts of her back. She said the hives were on the side of her legs, and down to her ankles. She said she was scratching and very uncomfortable. She clarified the hives were itchy. She said the next day (24Mar2021) she bought Benadryl 25mg tablets and took 2 Benadryl 25mg tablets. She said the Benadryl 25mg tablets made her sleepy. She said the hives and itching went down. She said she took another Benadryl 25mg tablet, clarifying she continued to take 1 Benadryl 25mg tablet (on 24Mar2021, 25Mar2021, and 26Mar2021) in the morning and 1 at night. She said she did not want to take too many of the Benadryl 25mg tablets, but just enough to manage her itching and hives. She said then a strange thing happened on 26Mar2021. She said she noticed on the way to the store, her voice sounded strange. She said when she got home from the store and looked in the mirror, her lip was swollen. She said she showered and then went to sleep. She said she woke up in the middle of the night and her lip looked fatter, so she took a Benadryl 25mg tablet, and then went back to sleep. She said when she had woke up the next morning, the swelling had gone down in her lip. She said the itching gradually stopped, and she did not have much left, only a little itching around her belly button, and on the back of her neck. She clarified her skin was not very raised in the areas that still itched a little. She said she was not concerned so much about the hives and itching. She added she had a little itching and hives on her forehead area, but it was not a big thing. She said the thing that concerned her was that she had a big fear of getting the second COVID-19 Vaccine and having a worse reaction than the first COVID-19 Vaccine dose. She said she wanted to make sure if she got the second COVID-19 Vaccine, her reaction would be nothing worse than what she had after the first COVID-19 Vaccine dose.  The events outcome for pruritus and urticaria was reported as recovering, ear pruritus and erythema was reported as recovered, lip swelling recovered on 27Mar2021, the event outcome for limb discomfort, voice sounded strange, made her sleepy and scratching were reported as unknown. The events were assessed as non-serious  No follow-up attempts are needed. No further information is expected.