Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Loss of personal independence in daily activities, Palatal disorder, Somnolence, Taste disorder
Clinical narrative: She had a bad taste in her mouth she couldn't get rid of; She felt tired but nothing bad/ she felt so exhausted; Off balance; Not a normal feeling at all/ She started to feel weird; Her mouth started to feel odd, and her palate went from pink to a strange color.; She didn't feel comfortable driving and that lasted a long time.; She also said that when she went to sleep she was very asleep; She usually turns her head upside down to brush her hair three times a day and she was unable to do that; This is a spontaneous report from a contactable consumer. This contactable 52-year-old female consumer (patient) reported for herself. This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 1 via an unspecified route of administration on 03May2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included vestibular disorder from an unknown date and unknown if ongoing She gets "vestibular" every so often. The patient's concomitant medications were not reported. The patient experienced she had a bad taste in her mouth she couldn't get rid of, she felt tired but nothing bad/ she felt so exhausted, off balance, not a normal feeling at all/ she started to feel weird, her mouth started to feel odd, and her palate went from pink to a strange color, she didn't feel comfortable driving and that lasted a long time, she also said that when she went to sleep she was very asleep, she usually turns her head upside down to brush her hair three times a day and she was unable to do that. Reporter enquired that how long does the vaccine last in your system and would it still last that long since there was a large gap in between my first and second dose and also enquired 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. The response included that on 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of Landmark COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) was effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the Centers for Disease Control and Prevention  and 95.3% effective in preventing severe disease as defined by the (FDA). Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage was prevalent. Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose. Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at: withheld: Please note that the "Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity" SRD has been updated to include the Press Release information. The caller enquired that the female, aged 52, received first dose of the Pfizer BioNTech Covid 19 vaccine on 03May2021. She gets "vestibular" every so often, and after the vaccine she felt tired but nothing bad. She said she doesn't do well with a lot of medication. She started to feel weird, off balance, not a normal feeling at all, her mouth started to feel odd, and her palate went from pink to a strange color. She also said she felt so exhausted that she didn't feel comfortable driving and that lasted a long time. She also said that when she went to sleep, she was very asleep, which was unusual for her because she's not typically a heavy sleeper. She had a bad taste in her mouth she couldn't get rid of. She usually turns her head upside down to brush her hair three times a day and she was unable to do that. She was concerned about her liver, but when she went to see the doctor her liver and blood work came back fine. In the past month she is starting to feel normal again, but why she delayed getting the second dose. She wants to know if it's okay to receive the second dose this long after the first dose or if she needs to restart the series. The patient underwent lab tests and procedures which included blood test was fine, liver function test was fine, on an unspecified date. The outcome of the events was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow u