Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Condition aggravated, Genital pain, Inflammation, Lichen sclerosus
Clinical narrative: Activated her Lyme disease; Activated her Lyme disease; Lichen sclerosus; States that Lichen Sclerosis affects the genital area and is very painful.; Migraine headache; Nauseous; inflammation in the body; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 at 59-year-old, via an unspecified route of administration in arm left on 22Apr2021 16:00 (Batch/Lot Number: EP7533) at single dose for COVID-19 immunisation. Medical history included Lyme disease in late 1990s, and blood pressure high diagnosed 2 years before. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) for blood pressure high from 22Apr2021 and ongoing. Patient previously received flu vaccine and activated her Lyme disease about 10-12 years before. The patient had a bad reaction after receiving her first dose, but the situation had resolved and she was thinking about getting the second dose. Patient had Lyme disease and was fearful of getting the Covid-19 vaccine. She didn't normally even get a flu shot because it activated her Lyme disease. She decided to get the vaccine and after the first dose it did activate her Lyme disease, but it also activated a condition called Lichen Sclerosis, due to the inflammation in the body. It was an inflammatory skin condition that was treated with topical steroids called clobetasol ointment. It took a couple of months for it to resolve. She wanted to wait until it resolved before getting the second dose. There was so much conflicting information out there, so she wanted to go straight to the source and called Pfizer. She wanted to know how long she could go between the first and second dose before she would have to restart the series. The previous agent was able to answer to her question. She was on the fence about getting the second dose, but with the delta variant she was starting to consider it, she was just also concerned about the effects. She didn't remember exactly when her symptoms began after getting the Covid-19 Vaccine. She did remember that she went to the doctor several times in May2021 and Jun2021, and had a biopsy in Jun2021. Lichen Sclerosis affected the genital area and was very painful. She couldn't prove that the vaccine caused it, but she did think that the vaccine exasperated it; the timing was very coincidental. Lyme flare started within a week after getting the Covid-19 vaccine. She also had some normal side effects. She had a migraine headache and she was nauseous. Someone suggested taking Alka-Seltzer Gold for the nausea and it actually worked. Lichen Sclerosis had resolved, and she was better with the Lyme, but she was way past the 42 days, so she decided to call to ask about getting the second dose. MI agent told her that there was no restarting the series; if she wanted the second dose she could just go get it. There was just no data on the efficacy. That was why she was considering getting the second dose. Events required a visit to physician office. Biopsy done in Jun2021 diagnosed Lichen Sclerosis. Outcome of event Lichen sclerosus was resolved, and of other events was unknown.  Follow-up attempts are completed. No further information is expected.