Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: Arms got really hot and itched/Head got really hot; Arms got really hot and itched; Mouth swelled up; Tongue felt swollen; Really really dizzy; Shaky; Felt like I had hives; Injection site pain; maybe there was something in the vaccine that she's allergic to; still feeling pretty bad; she had fever; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01Apr2021 17:15 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization, at pharmacy. The patient medical history included Gastric bypass (12 years ago). The patient always got the flu shot. The patient had no family medical history relevant to adverse events. Concomitant medications included trazodone (TRAZODONE) started taking 3 years ago, does not take consistently but more as needed taken for sleep; nutritional supplements started on an unspecified date and was ongoing, taken because of her age, to be a better and healthy; folic acid (FOLIC ACID) taken to be a better and healthy; multivitamin to be a better and healthy; and colecalciferol (VITAMIN D 3) taken to be better and healthy. The patient was not administered with additional vaccine. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Mar2021 17:00 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization, at pharmacy. On 01Apr2021, after the second dose of the COVID-19 vaccine, the patient waited for 20 minutes after receiving the vaccination and then went to her car. Caller reported that by the time she got to her car and before she had started the ignition, "her arms got really hot and itched down" to her finger tips. Caller reported that her "mouth swelled up" (her lips were tingling and it felt like she had cayenne pepper on her lips) and her "tongue felt swollen" (it felt like the sides of her tongue on both sides were expanding). Caller reported that she was "really really dizzy" (she felt lightheaded and if she moved her head quickly it felt like a rush.) and that she did not go back into the facility because she started getting "shaky" .The shaky feeling lasted until she got home, the shakiness felt like the shaking when you have not eaten a lot and you feel like you have got to eat something, took about an hour for her to get home. Caller reported that she has felt the shakiness since when she first experienced on 01Apr2021. Caller reported that she did not know if the shakiness was related or not to the second dose of the Covid-19 vaccine. She could not say when she experienced the shakiness after 01Apr2021, but she knows she had experienced the shakiness since then. Caller reported that her "head got really hot" right away after receiving the second dose of the Covid-19 vaccine but she was unsure if she had a fever or not. The heat in her head may have gone away by time she got home, that she was not paying attention to it, but then it came back. Caller reported that she was laying in bed but could feel the hotness of her head. Caller reported that she did not check her temperature but knew "she had fever". She went home and was "still feeling pretty bad". She did not saw any hives, but she had hives before and it "felt like she had hives". Caller reported that she experienced these symptoms the entire day and through the rest of the night. Caller reported that she took some Benadryl when she got home, as a treatment to events. Caller reported that her reaction after the second dose of the Covid-19 vaccine was completely different, and she thought that "maybe there was something in the vaccine that she's allergic to". Caller reported that she could feel the injection site of the second dose of the Covid-19 vaccine if she pushes on it. The "injection site pain" following the second dose of the Covid-19 vaccine, but that it was not as bad as the first dose. No investigation assessment was performed. Caller stated that she was fine, but that it was interesting with the reaction as the pharmacist told her that it was not typical for people to get that sick if they have never had Covid-19. Caller reported that she had multiple Covid-19 tests and that her antibodies have been checked with negative results. Caller reported that she was dreading going to get her Covid-19 vaccine as she was afraid that she was going to be so sick. The event did not result into emergency room or physician office visit. No relevant tests were performed. The outcome of the events arms got really hot and itched/head got really hot, mouth swelled up, tongue felt swollen, really really dizzy, felt like I had hives, she had fever, and maybe there was something in the vaccine that she's allergic to was reported as resolved on 02Apr2021. The outcome of event shaky was reported as resolving. The outcome of events injection site pain and still feeling pretty bad was unknown. No follow-up attempts are needed. No further information is expected.