Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: severe of a rash/2nd dose: Rash more severe over back, chest, stomach and arms; 02:00 early morning it woke him up because it was itching so bad; his doctor calls it dermatitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Aug2021 13:00 (Lot number: FC3183) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: cigarettes and mold is the worst. Ragweed is also bad; "asthma" (unspecified if ongoing), notes: diagnosed 35 -40 years ago. He has not had any problem in 9 years since he retired. Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease; ADVAIR taken for multiple allergies; FLUCONAZOLE taken for multiple allergies. Vaccination history included: Bnt162b2 (First dose 06Aug2021, Batch/lot number FA7485, Injected in left arm in the muscle.), administration date: 06Aug2021, for covid-19 immunisation, reaction(s): "mild rash". The following information was reported: RASH (non-serious) with onset 30Aug2021, outcome "recovering", described as "severe of a rash/2nd dose: Rash more severe over back, chest, stomach and arms"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "02:00 early morning it woke him up because it was itching so bad"; DERMATITIS (non-serious) with onset 2021, outcome "unknown", described as "his doctor calls it dermatitis". The event "02:00 early morning it woke him up because it was itching so bad" was 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 rash.  Additional information: The caller had his first dose of the vaccine on 06Aug2021 and second dose on 27Aug2021. Caller states he developed a mild rash after the first dose, then after the second dose had a severe rash that covered his entire trunk. Caller asks if it is normal to have this severe of a rash and how long would it last? Caller states that his doctor calls it dermatitis and says that in 4-6 weeks it should be gone and asks if that is true is that what it is? Caller states that on Tuesday last week his family doctor said they've had a lot of people come in with rashes but not as bad as his, and his doctor said it seems to be a correlation with people that have asthma, that something like a preservative that makes it last longer and whatever that was or the component seems like it causes persons with a history of asthma to get dermatitis. Caller states his doctor told him that it would take 4-6 weeks for it to go away after his second dose. Notified caller that Pfizer cannot provide treatment recommendations. No patient history.  When he got the second shot, it blew up all over again. When he got his physical last week, the doctor said people with history of asthma will have mild or bad cases of dermatitis after getting the vaccine and it usually takes 4 weeks to go away. He did not have information to report for any of the other people his doctor was referring to. He said the rash is getting better. When getting better in one spot, it pops up in another spot. He stated his doctor said they had people come in for all different types of reactions. They have had people for a rash but it is normally on arm or side of injection, but not to the point their chest, stomach back, and both of arms are affected. He again stated he did not have information on any of those people to complete a report for. He got the shot because of various reasons and because his loved ones wanted him to get it. Timing being 2 days after the vaccine shot, he thought it may be related. He went to Dermatologist and got Antibiotic ointment and steroid ointment and it started going away. On 27 Aug 2021, he got his second dose and he had to go back to his Dermatologist on 30 Aug 2021, because it was getting worse. He put him on a stronger Steroid ointment and it started going away. It is clearing up on left arm and is still on right arm and back and few patches on his stomach. He was itching real bad before. The 1st time, he gave her Triamcinolone acetonide ointment 0.025% and he put on for 10 days, twice daily. Lot 1FT0372, expiration Apr 2023. Total count size is 1 tube 15 grams. It was sealed and intact. The other medication he prescribed was Mupirocin 2% ointment apply to affected area twice daily for 10 days. Lot 433031, Expiration Sep 2022. Total size in 1 tube 22 grams. It was sealed and intact. The second time he went to his dermatologist, they gave him something stronger. It was Clobetasol Propionate 0.05% ointment apply to trunk and face twice daily. Lot K100131, Expiration 28 Feb 2023. That one has been making it go away. It is a strong steroid. He only used the other ones for 7 days. It was getting better, but not completely. Doctor said not to get anymore of the Pfizer COVID vaccine until he gets a definite answer that it is needed for booster. His doctor told him he can't even get Flu or Pneumonia vaccine until this clears up. Additional Vaccines Administered on Same Date of the Pfizer Suspect None. No Emergency Room visit required. Physician Office visit Yes. He saw a dermatologist. He tested him for both times. One for ringworm and one for a bacterial skin infection. Both came back negative. The patient was not hospitalized, how many days was the hospital stay. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) none. Patient's Medical History None or Unknown. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity Illness/AE: Seasonal Allergies diagnosed when he was working in a dusty environment making cigarettes and mold is the worst. Had yearly physical last week and did blood work and nothing on the lab work that was going on with this rash issue. blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI) Test: Date: Result: Units: Normal Range: Low: High: Comments: It could have be environmental but because of the time line being 2 days, he just wanted to check with Pfizer to see if it was related. His doctor said he had dermatitis and would take 4-6 weeks before it should be gone. Description of Product Complaint: The doctor prescribed a new stronger steroid for his rash. He only used the other ones for 7 days. It was getting better, but not completely. The doctor prescribed a new stronger steroid for his rash. He only used the other ones for 7 days. It was getting better, but not completely. The other medication prescribed was Mupirocin 2% ointment apply to affected area twice daily for 10 days. Product strength and count size dispensed: Total size in 1 tube 22 grams. Additional lot numbers: Lot 433031 Exp Sep 2022 Is a sample of the product available to be returned, if requested (Y/N): Yes. Advised to retain sample 3-10 business days in the event he received a Mailer for the return. Packaging sealed and intact yes.