Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin irritation, Tinnitus, Urticaria
Clinical narrative: ringing in her ears; rashes all over her body; hives and blotches in her back and torso; hives and blotches in her back and torso; it's burning in her skin.; The rash started out kind of mild then progressed to more itchy; its irritating and uncomfortable; its irritating and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 (Lot number: FL3209) at the age of 73 years as dose 3 (booster), single and administration date 29Apr2021 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL. Vaccination history included: Bnt162b2 (Dose: 1, Batch/Lot Number: EW0153, Anatomical Location: Left arm), administration date: 08Apr2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "flushing face". The following information was reported: TINNITUS (non-serious), outcome "recovering", described as "ringing in her ears"; RASH (non-serious), outcome "not recovered", described as "rashes all over her body"; URTICARIA (non-serious), RASH MACULAR (non-serious), outcome "unknown" and all described as "hives and blotches in her back and torso"; BURNING SENSATION (non-serious), outcome "unknown", described as "it's burning in her skin."; PRURITUS (non-serious), outcome "unknown", described as "The rash started out kind of mild then progressed to more itchy"; SKIN IRRITATION (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "its irritating and uncomfortable". The events "ringing in her ears", "rashes all over her body", "hives and blotches in her back and torso", "hives and blotches in her back and torso", "it's burning in her skin.", "the rash started out kind of mild then progressed to more itchy", "its irritating and uncomfortable" and "its irritating and uncomfortable" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, rash, urticaria, rash macular, burning sensation, pruritus, skin irritation, discomfort.  Additional information: Patient has received 3 doses of the vaccine and she has been experiencing a flushing face, ringing in her ears and rashes all over her body; stating also to have hives and blotches in her back and torso. She mentioned that everytime she puts her clothes on it feels like it is burning in her skin. She went to the dermatologist and she had a biopsy and they told her that this side effects might be due to a medication. She is taking Benadryl and a medication for her blood pressure but they verified if the manufacturer changed the formulation for this medicines and at the end they see most probable that the side effects are due to the vaccine. The patient experienced ringing in the ears and rash after the vaccines. The patient got the first dose on 08Apr2021, and she immediately had flushing in her face. The patient stayed there for 15 -20 minutes until it subsided. Then the patient had ringing in her ears, mostly in her left ear but it went down until 29Apr2021, when she got the second dose, then it increased and she had more ringing. On 12Jan2022, the patient got the booster dose and the ringing of the ears got a little worse, it got better then worse. At first the patient had a rash that was not too prominent but over the last couple of months, since January it was most noticeable. The rash started out kind of mild then progressed to more itchy and has not gone away. The patient has seen a dermatologist and an allergist who prescribed low doses of benadryl and allegra- fexofenadine. At night the patient takes one benadryl and she takes on allegra in the morning. The rash is still there and been there for a couple of months. The rash is aggravated by heat, its irritating, and it bothers the patient when her clothes touch her. The patient has an appointment next week with her allergist. The rash showed up mild at the beginning- it was after the second one or the third dose, it got more prominent after the third. The rash is not responsive to the antihistamines. The patient's symptoms serious criteria is mild to moderate, they are more of a nuisance. After each shot the ringing of the ears got worse and then got better. The rash is the main concern because its irritating and uncomfortable. The patient also now has hives with the rash. The dermatologist did a biopsy and at first she thought it was rosacea pityriasis but it was not. The patient had the biopsy done at and it showed it represents a medicine and medication reaction. This has been going on for a long time. The patient was only taking a blood pressure pill and vitamins when she got her vaccines and stopped them to see if it was and it was not. The dermatologist said it was from the blood pressure pill and she had been on that for years and they hadn't changed the formulation in it in over 10 years and she takes that brand for over 20 years. The patient stopped taking her blood pressure pill about 2 weeks ago.  Follow-up attempts are completed. No further information is expected.