Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus test, Lip erythema, Mouth ulceration, Oral discomfort, Oral herpes
Clinical narrative: cold sore; blister; canker; experienced sores in some parts of the tongue; lips felt like it got sun burned; mouth ulcers; Tested positive for HSV-1 antibody test./they can see if she has the HSV1 antibody/she took the test and she was positive, she does have the antibodies; Sometimes they feel kind of warm and some have been on her tongue too; little red areas and has had 24 different little red areas on lips; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm in the shoulder area on 22Apr2021 at 1200 or 12:15 in the afternoon, (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication was not reported. Patient had previously reported first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) on 01Apr2021 as a single dose for COVID-19 immunisation. No additional vaccines administered on same date of suspect. Patient did not receive other vaccine in four weeks of vaccination. As reported patient was taking COVID vaccine because she thinks that it was the right thing to do. On 02May2021, patient experienced little red areas and has had 24 different little red areas. Patient started getting red areas on lips (got in about 24 of this over the past few weeks). After getting second shot, started getting 3 spots in the morning, 2 spots in the evening, some spots go away after a few days, but some spots appear in some other areas of the mouth. It was as similar to blister, cold sore, and canker. Also experienced sores in some parts of the tongue and lips felt like it got sun burned. Her symptoms were pretty mild, but she did not know if mouth ulcers and things like that were being recorded or not. 10 days after her 2nd dose she started getting- she did not know what the correct word was for this part of the lip, but it was where you put lipstick on where your lip skin and the mouth skin meet but that area that lipstick did not stick to these little red areas and she had 24 different little red areas. Sometimes they feel kind of warm and some have been on her tongue too and some were like a tiny blister and then in the morning it was gone. None have cracked, scabbed or nothing like that but they keep coming and her doctor prescribed her valaciclovir hydrochloride (VALTREX) thinking that they were cold sores but that did not do anything. Sometimes she would have three and then by the end of the day she would have 2. She had 2 in different parts of her mouth and sometimes they were going all over the place. She had one on her tongue yesterday but her lips were looking good so she thought that it was getting better because of the valaciclovir hydrochloride (VALTREX) since her primary care doctor thought that it could be cold sores. So, patient thought well it must be cold sores and the valaciclovir hydrochloride (VALTREX) was working but then she had a new one and she thought, what the heck, and woke up with 4 others this morning. She was not had all 24 at the same time, but they change throughout the day. The only thing that was different in her life between that time was the second dose. She had been experiencing the sores for a few days, saw her primary care doctor. She did have the antibodies, but her doctor said that just because she had the antibodies did not mean that she had cold sores that were active.  On an unknown date, tested positive for HSV-1 antibody test. Patient took valaciclovir hydrochloride (VALTREX) 2 pills in the morning and 2 pills in the evening with the hoped to remedy the oral condition however the mouth sores still appeared. Product Complaint included reporting adverse event after her COVID vaccine and said that her doctor prescribed her valaciclovir hydrochloride (VALTREX) thinking that they were cold sores but that did not do anything. She took it for 1 day, 2 pills in the morning and 2 pills in the evening, to see if it would work itself out and she was hopeful it was working but then it did not, so she was seeing a dermatologist tomorrow for it. She thought at one point that the VALTREX was working when her lips had cleared up a bit, but then she had a new one and she thought, what the heck, and woke up with 4 others this morning. Probed for NDC, lot number and expiry date for the Valtrex and caller said that she threw it out so unable to provide any further information. Adverse events did not require a visit to emergency room. Patient visited physician office to see her primary care doctor and spoke to her dentist and they had referred her to an oral surgeon but they could not see her until Sep2021 but she did call the dentist to see if this had been reported to them before. She was going to see the dermatologist tomorrow. Patient most recent bloodwork looks phenomenal but was borderline anaemic a little bit. Reporter seriousness for little red areas and had 24 different little red areas was unspecified. The outcome for event little red areas and has had 24 different little red areas was not recovered and for other events was unknown.  No follow-up attempts are needed. No further information is expected.