Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: His second shot was in Feb and his upper torso had a rash that started as hives and transferred to several different rashes and climbing to his face.; His second shot was in Feb and his upper torso had a rash that started as hives and transferred to several different rashes and climbing to his face.; rash was getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2022 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: he has asthma; "allergic to penicillin" (unspecified if ongoing), notes: He is allergic to penicillin and sulfa; "allergic to sulfa" (unspecified if ongoing), notes: He is allergic to penicillin and sulfa; "eczema" (unspecified if ongoing), notes: He has eczema. Concomitant medication(s) included: FLU VACCINE VII taken for asthma. Vaccination history included: BNT162b2 (first dose, Date given: 25Jan2022, NDC: Unknown, Lot: Unknown, Expiration: Unknown, Dose given: Unknown, Anatomical location. arm, Time given: 3:00 pm), administration date: 25Jan2022, when the patient was 23-year-old, for Covid-19 Immunization, reaction(s): "He got a patch in the creases of his arm".  The following information was reported: RASH (non-serious), URTICARIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "His second shot was in Feb and his upper torso had a rash that started as hives and transferred to several different rashes and climbing to his face."; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "not recovered", described as "rash was getting worse". The events "his second shot was in feb and his upper torso had a rash that started as hives and transferred to several different rashes and climbing to his face." and "rash was getting worse" required physician office visit. Therapeutic measures were taken as a result of rash, urticaria, condition aggravated. Additional information: Caller was cons/caregiver who states her 23-year-old son received the Covid 19 Vaccine on 21Feb2022. This was his 2nd dose. Since then he has developed a rash. She states the rash is mutating to different scenarios and now is spreading to his face and he is getting depressed because of the rash. They have been to an allergist and a dermatologist about the rash and the dermatologist took a biopsy on their last visit. She is asking if this has been reported as a side effect, and what treatment recommendations we would give. DSU e-transmitting for possible duplicate A/E- More information. Question: Caller stated Providers wre brainwashed by the government and are drinking the Kool-Aid that everyone should get the vaccine. I thought it was BS that the manufacturer cannot give me advice on what to do. Caller said she was calling for her son (Name withheld). Calling about the Covid-19 vaccine.  He got his first dose in Jan and (withheld) has eczema and has had it his whole life and he is 23.  He got a patch in the creases of his arm and the college made him get the vaccine. His second shot was in Feb and his upper torso had a rash that started as hives and transferred to several different rashes and climbing to his face. He went to the Dermatologist and given medications that are not working. Asking if Pfizer has come across this or is there a remedy?  She said she thinks Pfizer has a lot of problems with vaccines.  Asking if Pfizer is trying to do anything about it?  She said she is so upset but did not want to be rude.  She didn't want him to get the shot. She said she would like to get the rash gone and he is a 23-year-old male starting his first new job. She said she has been on the phone all morning trying to get an answer. Event date: 27Jan2022 right after his first shot on 25Jan2022 and rash is all over his upper torso. Caller confirmed son has received a total of two vaccines. She was looking at his medial file and looking for information. Indication: College demanded he have the vaccine. She said she just has generic paperwork for vaccines and no information for NDC, Lot, and expiration. She said he had the card and asking if the information would be on there. Treatment/Medical intervention: He has been to the Allergist and the Dermatologist since Mar2022 and after the second shot and she noticed rash was getting worse and he had to wait to get in and he was new patient.  He has been to the Dermatologist for the third time and they took a biopsy of the big bump on his neck and he has tried all kinds of medications and pills to take rash away and has the rash has gotten worse. She provided medications that he has currently tired that didn't work. Dosage today Ketoconazole 2 percent cream; two times daily; 45 grams, NDC: 00093-3219-15, Lot: 299101, Expiration: Oct2023. She said there is a lot of information from the pharmacy. Asking if information is on the bottle. She said they put everything so small on this stuff.  She has got to get a magnifying glass.  She said there is a crimp in the tube.  This is a tube of cream from the pharmacy. This was a pill he just finished. Fluconazole 150mg, NDC 707101139-08; one tablet by mouth every day, Lot: Z200020, Expiration: Dec2023. Prednisolone 10mg tablets; 6 days for 5 days, 4 tabs for 5 days, 2 tablets for 5 days, 1 daily for 5 days; 65 tablets, NDC: 70954005920, Lot: Unknown, Expiration: Mar2023. Clindamycin CH 1 percent solution; apply at bedtime to face, NDC: 21922000201, Lot: Unknown, Expiration: Apr2023. She said this must be the typical dermatologist medication that they prescribe to everybody.Clobetasol .05 percent ointment, NDC: 43386009662, Lot: Unknown, Expiration: Apr2023 She said she was looking at the pharmacy records.  She is surprised they don't have the Lot number on here. Triamcinolone. 1 percent ointment; Apply twice a day to body, NDC: 45802005505, Lot: Unknown, Expiration: Apr2023. She said the expiration might just be with prescription as all are Apr2023.  She said there are a bunch of number but no lot.  Asking if that is not important. Hydroxyzine HCL 25 mg tablet; take one tablet at bedtime; quantity 30 and with refills. NDC 42806016005, Lot: Unknown; she said she would look on the bottle. Expiration: Mar2023. Doxycycline Hyclate 50 mg capsules; Take one capsule by mouth twice a day with food, NDC: 54389011802, Lot: Unknown, Expiration: Apr2023.   6. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No; She said wasn't the same day and he was mandated to get the flu shot and at a different pharmacy and he was asthmatic and has had the flu shots before.  NDC, Lot and expiration are unknown.  The rash didn't start after the flu shot and was after the Covid vaccine.  She thought the rash was a flare up of his eczema.  She said was a couple days before the flu vaccine and he couldn't get at the pharmacy and he had to have before college.   7. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: He got a patch in the creases of his arm. Adverse Event: His second shot was in Feb and his upper torso had a rash that started as hives and transferred to several different rashes and climbing to his face.  8. Additional Information Did any AE(s) require a visit to: Emergency Room? No; Physician Office? Yes; If Yes, which AE(s)? If the patient was hospitalized, how many days was the hospital stay? Hospital Name: City, State: Went to the physical office and to on 16Mar went to Allergist and thought this was an allergic reaction for hives and he went to the Dermatologist and not to the emergency room because he wasn't having difficulty breathing and she said she should have taken him to the emergency room and she thought the rash could be taken care of right away.  9. 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): Vaccine Name: Flu vaccine Manufacturer: Unknown Lot Number: Unknown Route, Anatomical Location: Not provided No. of Previous Doses: Date: Not provided  10. AE(s) following prior vaccinations: None or Unknown Adverse Event: Onset Age: Vaccine/Brand Name: Vaccination Date: No, he has never had any.  She was going to fight it and his doctor told him if he has never had a problem then he should be alight and he would not give him a letter to be excluded.  He nerve had it this bad and he has asthma and allergies.  He is allergic to penicillin and sulfa and he has had flu shot due to asthma and never anything like this.  He has eczema and this is not eczema and this looked like measles to her.  She said she wants to send pictures to show what they did to her son.  11. Patient's Medical History (including any illness at time of vaccination)? 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: Onset Date: Stop Date: If no Stop Date, check box if ongoing at time of last observation during or at end of event(s) Pertinent Details: Include surgical procedures and dates: No, this isn't her only child and she has three and no allergies and skin conditions.   12. Family Medical History Relevant to AE(s): No 13. Relevant Tests: None or Unknown List other relevant diagnostic and confirmatory test results for event(s), for example, from 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: No  14. For Lack of Efficacy, request the following information if not included in the initial report what is the primary infection site? Unknown; Known If known, please specify: N/A Asking if Pfizer Drug Safety number is the same as the CDC number?  Description of Product Complaint: Description of complaint: Caller provided list of medications that did not work. Ketoconazole 2 percent cream; two times daily; 45 grams NDC: 00093-3219-15 Lot: 299101 Expiration: Oct2023 She said there is a lot of information from the pharmacy. Asking if information is on the bottle?  She said they put everything so small on this stuff.  She has got to get a magnifying glass.  Fluconazole 150mg NDC 707101139-08; one tablet by mouth every day Lot: Z200020 Expiration: Dec2023 Prednisolone 10mg tablets; 6 days for 5 days, 4 tabs for 5 days, 2 tablets for 5 days, 1 daily for 5 days; 65 tablets NDC: 70954005920 Lot: Unknown Expiration: Mar2023  Clindamycin CH 1 percent solution; apply at bedtime to face NDC: 21922000201 Lot: Unknown Expiration: Apr2023  Clobetasol .05 percent ointment NDC: 43386009662 Lot: Unknown Expiration: Apr2023  Triamcinolone .1 percent ointment; apply twice a day to body NDC: 45802005505 Lot: Unknown Expiration: Apr2023  Hydroxyzine HCL 25 mg tablet; take one tablet at bedtime; quantity 30 and with refills. NDC 42806016005 Lot: Unknown Expiration: Mar2023  Doxycycline Hyclate 50 mg capsules; take one capsule by mouth twice a day with food NDC: 54389011802 Lot: Unknown Expiration: Apr2023 Product strength and count size dispensed: Listed with medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.