Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Folliculitis, Full blood count, Rash, Red blood cell sedimentation rate
Clinical narrative: Folliculitis; Bumps; Itchy rash in her scalp and the back of her neck and her in hairline; Itchy rash in her scalp and the back of her neck and her in hairline; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EW5313), dose 1 via an unspecified route of administration, administered in Deltoid Left on 27Jan2021 as 1ST DOSE, SINGLE DOSE and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EM9810), dose 2 via an unspecified route of administration, administered in Deltoid Left on 17Feb2021 as 2nd DOSE, SINGLE DOSE for covid-19 immunization. Medical history included ongoing cough diagnosed may be 6 years ago, had the cough for maybe 12 years, they thought it was asthma initially but it was not. Also included general health condition, cough, sleep disorder, Go to the bathroom and bone disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included nortriptyline (NORTRIPTYLINE) taken for cough from Dec2020 and ongoing; salbutamol (ALBUTEROL HFA) taken for cough from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D) taken for supplementation therapy from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for cough, sleep disorder, hypertonic bladder, muscle relaxant therapy from an unspecified start date and ongoing; calcium (CALCIUM) taken for bone disorder from an unspecified start date and ongoing.  She was on a similar medication from the same family (Amitriptyline) for years. They switched her because the Amitriptyline was not really working anymore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. A few days after the first dose of vaccine, she developed an itchy rash in her scalp, back of neck, and in her hairline. She didn't think it was related to the vaccine at the time. So she bought medicated shampoo and it did not get better. The rash started coming down her neck, but she didn't relate it to the shot so she went ahead and got the second shot, again not thinking it had anything to do with the vaccine because this is an atypical reaction, but the rash progressed and she went to urgent care on 04Mar2021. They prescribed her high doses of a steroid- started with 60 and went down to 10. She was doing everything to get rid of it herself. She was diagnosed with Folliculitis. They said she was scratching and then developed a bacterial infection. She received treatment with Steroid taper over 12 days, then 10 days of doxycycline over 10 days. She completed it a couple days ago. It was stated that initially everything was on the left side, but it wrapped around her neck to her left shoulder. It was described that the rash as patchy; there was a big patch on the left side of her lower back then down to her left upper buttock area; and there was a small patch on her left arm- antecube area. It was reported that now the rash had spread across her neck on the right side and chest stops at chin, nothing is on her face- clarified not yet. It was reported that the ones on the back of her head: the big bumps on the back of her scalp decreased in size, but she had new ones going up the top/occipital area. She explained that she went to urgent care and then went to her PCP to get tests to see if there was any underlying disease that presents with a rash. It was stated that everything came back negative; her bloodwork and labs were all normal for autoimmune disease. She had a CBC with diff- normal, ANA-normal, Sed rate was normal. After that, she went to a dermatologist because nothing improved, and it just continued increase. She stated, after the course of antibiotics and steroids, it did 0, nothing, and the rash continued to increase. Dermatology said that this is a reaction to the vaccine. She reported that everyone seemed to be in agreement that it was a reaction to the vaccine. She reiterated the rash was raised, patchy in location, and extremely itchy. She stated that everything was on the left side, but now it was bilateral, started going on both sides about four or five days ago. She clarified the rash started maybe 3 to 5 days after the first dose. She mentioned she went to the hairdressers on 28Jan2021, the day after the vaccine, and did not had any symptoms- she had her hair colored with no issues and then maybe 5 days after receiving the vaccine, she kind of noticed it. She reported that it was definitely spreading and she does not feel that it was getting much better. It was clearly visible to the naked eye and when you feel it, it was quite raised and red in color. The part that scares and concerned her was that she couldn't find anything about a rash except for rash at the injection site. She wanted to know what to do about it and when was it going to stop. It was also stated rash- woke up with it, noticed it in the morning, itching woke her up. Noticed itching before anything else. Exact time unknown. 4 or 5 days after, it could of been there but the itchiness made her notice it. Patient went to urgent care on 04Mar2021. She finished treatment from urgent care, then when it didn't get better went to PCP and went to dermatology on 16Mar2021. Her husband got the shot on the same day, no reaction at all. During concomitant medications, she mentioned she was on Nortriptyline. She was on a similar medication from the same family (Amitriptyline) for years. They switched her because the Amitriptyline was not really working anymore. Treatment was received for adverse events. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported events of Pruritic rash, rash and folliculitis   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.