Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Blood cholesterol, Blood test, Dysphonia, Facial paralysis
Clinical narrative: Her voice was hoarse and raspy; She had about 10 canker sores in her mouth.; Facial paralysis; Her left calf felt numb; She said she saw more wrinkles on her face than she knew she had; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer product, lot: EP7534) in left arm on 23Mar2021 17:30 at a single dose for COVID-19 immunisation. Vaccination Facility Type was Hospital. Medical history included ongoing genital herpes. Concomitant medications included valaciclovir hydrochloride (VALACYCLOVIR HCL) 1gram tablet for genital herpes. Stated she had genital herpes for over 10 years, and had an outbreak about 2 weeks prior to getting her 1st COVID-19 Vaccine. She said she hadn't had a herpes outbreak in over 10 years. She said she stopped taking her Valtrex medication after the COVID-19 Virus Pandemic started. She said she restarted the Valtrex when she had the genital herpes outbreak a couple weeks before her 1st COVID-19 Vaccine. She said she had taken a 1/2 Valacyclovir 1gram tablet, off and on, to treat her recent. 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) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. Patient experienced her left calf felt numb on 23Mar2021 with outcome of recovered/resolved; the skin from under both her eyelids to her cheek bones felt like it was being pulled down on 23Mar2021 with outcome of recovered/resolved; her voice was hoarse and raspy on 24Mar2021 with outcome of not recovered/not resolved; she had about 10 canker sores in her mouth on 24Mar2021 with outcome of recovered/resolved; facial paralysis on 23Mar2021 with outcome of recovered/resolved; her skin felt tight on 23Mar2021 with outcome of recovered/resolved; She said she saw more wrinkles on her face than she knew she had on 23Mar2021 with outcome of unknown; cholesterol was high on an unspecified date in 2021 (either late Feb2021 or early Mar2021) with outcome of unknown. She is asking for a recommendation on receipt of second dose. Clinical course: patient reported she had her first COVID-19 Vaccine shot last Tuesday (23Mar2021), and she had some side effects that were not listed on the COVID-19 Vaccine information sheet she was given. She said she was concerned about getting the second COVID-19 Vaccine shot. She said she sat for 15 minutes after she received her COVID-19 Vaccine, and was completely fine. She said she then had about a 5 minute walk to her car. She said when she was walking to car, her left calf felt numb. She said at first she thought maybe she had been sitting too long, and her left leg fell asleep. She said once she got to her car, the skin from under both her eyelids to her cheek bones felt like it was being pulled down. She described the feeling as being in the sun for days, saying her skin felt tight. She said she looked in her car mirror. She said her face wasn't red, but her face definitely looked like it was being stretched. She said she saw more wrinkles on her face than she knew she had. She clarified her face being stretched as a facial paralysis, and said the facial paralysis only lasted about 4 hours, and then disappeared. She said the next day (24Mar2021), she woke up, and her voice was hoarse and raspy. She said her voice continued to be hoarse and raspy for 2 weeks now. She clarified the hoarseness had been on and off and had improved from last week, but in the evenings her voice gets raspy. She said she had about 10 canker sores in her mouth. She said she gargled with Scope, and the canker sores would come and go. She said the canker sores were not painful like canker sores, but were just sores. Reported she had blood work done in either late Feb2021 or early Mar2021, and everything was fine, except her cholesterol was high. No further details provided. Treatment: Reported she spoke to the on-call doctor at her doctor's office on 23Mar2021 first, and then called the (name) Hospital Emergency Room and spoke with someone about her side effects on 23Mar2021. She said the doctor on-call at her doctor's office told her to take a 1/2 tablet of Valtrex (clarified as generic Valacyclovir HCL 1gram tablet). She clarified she had been taking Valacyclovir HCL since she was diagnosed with genital herpes about 10 years ago. She said she stopped taking the Valacyclovir HCL when the COVID-19 Pandemic started last year. She said she restarted the Valacyclovir HCL, taking a half Valacyclovir HCL 1gram tablet (500mg) daily. She said she spoke with her gynecologist today (02Apr2021), and he told her to take the full Valacyclovir HCL 1gram tablet for 3 months and then go back to taking a half Valacyclovir HCL 1gram tablet (500mg). She said the Valacyclovir HCL 1gram tablet was dispensed in a pharmacy bottle, providing NDC Number: 1671469701. She did not have a Lot Number and Expiration Date. She said the generic Valacyclovir HCL 1gram tablet was manufactured by NorthStar Rx and had "(3/3)" after the manufacturer's name. Reported she gargled with Scope mouthwash for her canker sores in her mouth. She said she had finished the Scope mouthwash, and disposed of the product bottle, and didn't have the UPC, Lot and Expiration Date. Reported her gynecologist was the one who told her to call Pfizer to get further direction about getting her second COVID-19 Vaccine.  Follow-up attempts are completed. No further information is expected.