Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Peripheral swelling, Skin discolouration, Ultrasound scan normal
Clinical narrative: Legs are swollen; The skin on her leg has red blotches; her feet turned blueish/purple; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 23Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 13Feb2021 (age at vaccination was unknown) at a single dose for COVID-19 immunisation. The caller mentioned that she received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 23Jan2021 and the second dose on 13Feb2021. She explained, ever since 25Jan2021 her feet turned blueish/purple, her legs were swollen and the skin on her leg had red blotches. She specified she consulted doctors including her cardiologist, and she was waiting to speak with a neurosurgeon. She explained they through it was lipoedema, then a venous insufficiency. She stated the blood goes down to [her] feet but does not go back to [her] heart. She added her symptoms has started to dissipate: she said the purple had went away and was now like a pink and now she could sleep when before she could not. The caller asked whether these symptoms or symptoms affecting blood circulation were reported from the vaccine. She received the response stating that side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine included non-severe allergic reactions such as rash, itching, hives, or swelling of the face. The caller stated, if she decided to get a booster dose, could she get it from another brand of the COVID-19 vaccine. She received as response stating that there were no studies comparing the Pfizer-BioNTech COVID-19 Vaccine and how well it worked to other COVID-19 vaccines. The caller asked how low she would be protected after getting the Pfizer-BioNTech COVID-19 vaccine. The caller received the response stating that the results of that ongoing clinical trial have shown that, starting 7 days after the second dose of the vaccine, the Pfizer-BioNTech COVID-19 Vaccine was 95 percent effective in preventing COVID-19 infection in participants who did not previously have COVID-19 infection. Was the efficacy after one dose US. 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 percent vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose of Vaccine was 100 percent effective in preventing severe disease as defined by the Centers for Disease Control and Prevention (CDC) and 95.3percent effective in preventing severe disease as defined by the  Food and Drug Administration (FDA)o Vaccine was 100 percent effective in preventing COVID-19 cases in, where the B.1.351 lineage was prevalent from FAQ-Efficacy against COVID-19 up to 6 months following second dose. The caller asked whether the Pfizer-BioNTech COVID-19 vaccine was effective for the different COVID-19 strains like the one from India. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It was important to have a vaccine technology that allows them to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While they have not seen any evidence that the circulating variants result in a loss of protection provided by their vaccine in their laboratory studies, they are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine was not approved. Pfizer was unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, from FAQ-Pfizer statement regarding Covid-19 vaccine-booster dose. On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of Landmark COVID-19 Vaccine Study. Vaccine was 100 percent effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage was prevalent from FAQ-Efficacy against COVID-19 up to 6 months following second dose. The caller asked the CDCs phone number for the reporting of side effects. She received that response stating that report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number was [withheld] from CONS-what should they do about side effects. Used section No Information Found of the VR-Consumer Inquiry Management (Off-Label or No Info). The caller asked whether she could go out to dinner for Mother's Day and be exposed to unvaccinated individual. Could she get infected if exposed to someone with COVID-19 after being vaccinated with the Pfizer-BioNTech COVID-19 vaccine. She received that response stating that the Pfizer-BioNTech COVID-19 Vaccine may not protect everyone., per CDC People are considered fully vaccinated 2 weeks after their second dose in a 2-dose series, like the Pfizer or Moderna vaccines. and segment under what's changed. The caller asked whether the protection afforded from the Pfizer-BiONTech COVID-19 vaccine wean 5 months after being vaccinated. She received that response stating that no Information Found of the VR-Consumer Inquiry Management (Off-Label or No Info). The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained