Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Pruritus, Somnolence, Urticaria
Clinical narrative: sleepy and woozy; raging burning itching hives all over her body; raging burning itching hives all over her body; severe hives; arm hurt; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration (at the age of 42-years), administered in arm left on 23Feb2021 at 18:40 as dose 1, single for COVID-19 immunization and received diphenhydramine hydrochloride (BENADRYL, Formulation: Film-coated tablet), oral from an unspecified date (Lot number was not reported, Expiry date: May2022) to an unspecified date, at 25 mg received 1x/day 25 mg take 1 tablet by mouth for hives and also received methylprednisolone sodium succinate (SOLUMEDROL, Batch/Lot number was not reported), from 04Mar2021 at 125 mg, 1x/day as 125mg injection into buttock for hives. Medical history included PCOS and eczema both had for about 20 years, Hives in 2006, Peanut allergy, Lip swelled and Stress from an unknown date and unknown if ongoing. It was further stated that consumer also reports a long time ago maybe in 2006 she had an issue with hives. They thought it was peanut allergy because her lip swelled. They did a peanut allergy test and they did the other allergy test and determined it was caused by stress. She had deep tissue hives. She did have a high stress job and she hasn't had this issue since leaving that job several years ago. She stated maybe it was laying dormant and the vaccine made it come out. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken as 10mg one pill a day by mouth for seasonal allergy, plantago ovata (METAMUCIL CITRON) taken as takes 2-4 capsules a day and multivitamin 2 gummies a day by mouth taken for an unspecified indication from an unspecified start date and ongoing. The vaccination facility type was reported as gymnasium, pop up, old school. The patient did not receive any prior vaccination within four weeks and do not have any AE following prior vaccination. On 24Feb2021, the patient experienced arm hurt. On 25Feb2021, experienced severe hives. On 04Mar2021, experienced raging burning itching hives all over her body. On an unspecified date, experienced sleepy and woozy. The adverse events did not result in emergency room visit and physician office visit. It was further stated that the patient was taking Covid 19 Vaccine because she wanted to protect herself, mother in law, who has health issues and her son. Patient did not take multivitamins this morning 04MAR2021, she forgot. Consumer received the Covid 19 vaccine, the first one, she has been waiting an hour and a half, she needs to find out if she should take the second vaccine or not. She got her Covid 19 injection in the evening on 23Feb2021 at (institute name) and she stayed there for 15 minutes with no issues. Her arm hurt the next day. But the day after her injection, she developed hives and they are severe today. She still had hives so she went to her primary care doctor and was told she was having an allergic reaction and gave her a steroid, a 6 day dose, metha something was the name of the medication. She took the last dose on the morning of 02MAR2021. Yesterday on 03MAR2021 she has more hives, this time more severe than last time. Then last night she took Benadryl at 19:00 she took 1 tablet that didn't really save her, then she took 2 tab-lets of Benadryl at 12:00am, usually one make her loopy, two has her out, she woke up this morning and it was raging hives, like literally covering all over her body burning and itching. She went to an urgent care and received a steroid in her buttock and was prescribed another dose of steroid that was longer and more powerful and she wants to report this. She was scheduled for the second Covid 19 vaccine on 17MAR2021 vaccine. Today was the worst of it. Should she even pump herself with Benadryl. Between the steroid shot and the Benadryl she feels jittery and weird, normally Benadryl makes her feel weird, usually she's out, clarified Benadryl makes her sleepy and woozy. Usually one tablet of Benadryl will give her relief. She took 2 tablets and she experienced no relief. When she went to her primary care doctor, their first reaction, they thought it wasn't like an immediate reaction to the Covid 19 vaccine, they thought it was delayed and it wouldn't discount her from getting the second vaccine. She might just have to stay longer after receiving the second vaccine, longer than the 15 minutes you have to stay, maybe stay 30 minutes. The nurse at the urgent care told her she wouldn't get the second shot. The physicians assistant at the urgent care told her she should follow up with Pfizer to see if there was any information on getting the second shot. She reports trying to call her primary care physician twice yesterday and no one called her back, today she spoke with the receptionist who said she would give them the message. When querying indication for Covid 19 vaccine she states she wanted to help protect her mother in law who is older and has health issues and her son who has virus induced asthma, as well as herself. Methylprednisolone 4mg dose pack 6 day supply blister pack. NDC 72647-0331-04, lot, expiry unknown, as the packaging has been discarded. Last dose 02MAR2021. Solumedrol injection today 04MAR2021 125mg into buttock, NDC, Lot, Expiry unavailable, patient received injection in Urgent Care, Prednisone 20mg tablet, take 3 tablets on days 1-3, take 2 tablets on days 4-8, take 1 tablet on days 9-10. She was to begin this prescription tomorrow, 05MAR2021. NDC 70954-0060-20, expiry unknown. Lot number not provided by caller. Benadryl 25mg, she was told to take 2, tablets. John-son and Johnson consumer health care division, NDC 50580-226-52, expires May22. Stated she took the rest of the day off from work. Description of Product Complaint: Usually one tablet of Benadryl will give her relief. She took 2 tablets and she experienced no relief. Manufacturer: Johnson and Johnson, NDC 50580-226-52 Expiration MAY2022. Caller does not see lot number on package, Product strength and count size dispensed: 25 mg tablets. The clinical outcome for the event arm hurt was reported as recovered on 25Feb2021 while for the events severe hives, raging burning itching hives all over her body, sleepy and woozy was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.