Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Electromyogram normal, Gastrooesophageal reflux disease, Head discomfort
Clinical narrative: Felt delirious; her ears felt full like it was gonna pop; swelling in throat and tongue which felt like an allergic reaction; swelling in throat and tongue which felt like an allergic reaction; allergic reaction; tingling all over her body, specifically in her arms, legs, back, face, head and tongue.; Pain at injection site, left arm; hives right after the injection/ she took off the band aid and had a big hive in that spot; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 31Jul2021 about 4:00 or 4:30 (Batch/Lot Number: FA7485) at the age of 48 years, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Jul2021 (evening), she took off the band aid and had a big hive in that spot which cleared up in a week. On 01Aug2021, a couple of hours after the shot, around 2 AM, her arms and legs were tingling all over. Later, her tongue was tingling. She had tingling all over her body, specifically in her arms, legs, back, face, head and tongue, changes from day to day, consistent with arms, legs and back. She also had pain at injection site, left arm which was off and on throughout the day on 01Aug2021. On 03Aug2021 at 9 PM, she experienced swelling in throat and tongue that felt like an allergic reaction, different sides of throat, off and on, for which she took antihistamines. On an unspecified date, she felt delirious, and it felt like her ears were full, like they were going to pop. She really just wanted some information, as she had been having symptoms on and off for 9 weeks. The patient asked if other people have had these symptoms and if can Pfizer provide recommendations for treatment. She tried antihistamines, steroids, and a lot of different things. Cetirizine (ZYRTEC) worked and it did not work at times, famotidine (PEPCID) caused her more tingling and headaches, prednisone made her tingling worse, loratadine (CLARITIN) and levocetirizine (XYZAL) did not work, fexofenadine (ALLEGRA) seemed to work well, but she took it for a day and had side effects (not specified), and paracetamol (TYLENOL) did not work and it made her tingling worse. She was feeling desperate and would like some support. It had been 9 or 10 weeks, and she was still having symptoms. She still had arm pain. She had been to multiple doctors and will be seeing specialists next week. Her doctors were not understanding her symptoms. She wanted to know if her symptoms will go away. She felt that there was a lot of help for people who have gotten COVID, but there was not help for people that have gotten a reaction to the vaccine. She did not have the second dose. The outcome of hives right after the injection was recovered on an unspecified date; of tingling all over her body, pain at injection site, left arm, and swelling in throat and tongue felt like an allergic reaction was not recovered; and of felt delirious, and ears were full, like they were going to pop was unknown.    Follow-up attempts are completed. No further information is expected.