Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Red blood cell sedimentation rate
Clinical narrative: the rash progressed and it started spreading, it's not on her face but is everywhere else, it's on her neck, her shoulder, her back; diagnosed with folliculitis; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as 2nddose, single for covid-19 immunisation (age at vaccination was 65year). Historical vaccine was A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EW5313), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing cough diagnosed may be 6 years ago, had the neurogenic cough for 10 years, they thought it was asthma initially, but it was not, pertinent Details: W/U and ruled out over past 10 years asthma, Reflux. ongoing seasonal allergies, pertinent Details: Treated with allegra or clacton flonase. Also included general health condition, cough, sleep disorder, Go to the bathroom and bone disorder from an unknown date and unknown if ongoing. No relevant family medical history was reported. Concomitant medication(s) included nortriptyline (NORTRIPTYLINE) taken for cough from Dec2020 to 25Feb2021; 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 previously 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 did not 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 did not 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-ante cube 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, Sedimentation 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 coloured 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 colour. The part that scares and concerned her was that she could not 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 have 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 did not get better went to PCP and went to dermatology on 16Mar2021. Her husband got the shot on the same day, no reaction at all. Treatment was received for adverse events. Upon follow up received on 17Mar2021 is a follow-up spontaneous report from a contactable Nurse.  This nurse reported about patient characteristics (Age at time of onset of reaction, sex, relevant medical history and concurrent conditions, patient medical comments verbatim neurogenic cough, outcome of the events was not recovered, results of tests and procedures for investigation of the patient. Drug information of 1st and 2nd dose (Pfizer Covid Vaccine, lot number, date), reaction related to drug, concomitant drugs, additional information for concomitant products nortriptyline, Investigation assessment, history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. Physician office visit was yes from 15Mar2021 went to urgent care on 04Mar2021. Description of product complaint Upon follow up received on 14Jun2021, it was reported that Onset date: On 01Feb2021 at 3 "a" the patient had rash extreme itch, raised rash scalp back of head seriousness criteria was reported as persistent/ significant disability/ Incapacity. On 18Feb2021, had Rash- Hives, seriousness criteria were persistent/ significant disability/ Incapacity. Main reason for reporting was that if she had known after her first vaccine that an atypical rash (scalp in my case) with extreme itching was possibly a reaction to vaccine she may have waited longer for second dose or asked for dose or passed all together. She was not antivaccine now- encourage all to become vaccinated. This was a miserable experience her skin was hypersensitive (still was) she had hives and rash every-where skin bruised and open from scratching- did not sleep more than 2 hours at a time for 4 months- taking 10 antihistamines daily topical steroids- the only thing that stopped it was Xolair which she was very hesitant to take given that there was no history of giving this med for a reaction post vaccine. Her 'w/n' for other possible causes rule out any other possibilities she reported this to Pfizer-CDC-Mass general. She had sent pics of Rash/ Hives. This was the first time anyone has for followed up although not life-threatening this was a life altering experience, she was misdiagnosed with folliculitis no way was this from vaccine. She said very strange, but timeline was hard to overlook this was dis-missed. She felt until work up and labs proved otherwise (because it was unusual) no one wanted to say this was vaccine related she was retired Registered nurse (RN) "with very little PMH4 except weird neurogenic cough I have had for 15 srst". After first vaccine she felt fine 48 degree developed extremely itchy raised rash scalp above neck persisted did not affiliated with vaccine after 2nd vaccine itching rash spread to left neck up-per back extreme itch treated Hydrocent/Epson salt but by 3/4 rash spread back urgent care diagnosed with folliculitis Bacterial infection treated with prednisone 60 mg taper diclonacillin rash hives spread no relief PCP labs ANA etc WAL Derm punch biopsy inflammation asthma allergy further labs skin testing all normal hives and rash trunk Plus extremities scalp forehead taking 10 antihistamine per day topical steroids, cold shower, ice all ORS hyper inflammatory response to vaccine persisted for 4 months- no improvement consult with doctor (withheld) Xolair started relief from hives. The patient consider the Pfizer product had a casual effect to the adverse events. The patient gave consent to contact. The outcome of events Itchy rash, Scalp rash, Bacterial folliculitis was not recovered and outcome of events papule, Hypersensitive skin, Bruise and Sleep difficult was reported as unknown.  No follow up attempts are possible. No further information is expected. Follow up (17Mar2021): This is a follow-up spontaneous report from a contactable Nurse.  This nurse reported about patient characteristics (Age at time of onset of reaction, sex, relevant medical history and concurrent conditions, patient medical comments verbatim neurogenic cough, outcome of the events was not recovered, results of tests and procedures for investigation of the patient. Drug information of 1st and 2nd dose (Pfizer Covid Vaccine, lot number, date), reaction related to drug, concomitant drugs, additional information for concomitant products nortriptyline, Investigation assessment, history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. Physician office visit was yes from 15Mar2021 went to urgent care on 04Mar2021. Description of product complaint. Follow-up (14Jun2021): New information was received from a contactable other healthcare professional (patient) in response to healthcare professional letter sent via follow-up letter which included: New events Hives, Hypersensitive skin, Bruise and Sleep difficult were added. Seriousness was updated for Itchy rash, Scalp rash and Bacterial folliculitis. Suspect vaccine dose 1 and dose 2 details: anatomical location was updated, and route, time and facility of administration was added. Concomitant medication nortriptyline stop date was added. Patient's Medical history family history and clinical course was added. Lab data added.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.