Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cerebrovascular accident, Chest discomfort, Eyelid ptosis, Mass
Clinical narrative: She was advise to go to the ER because it could be a stroke.; Tingling in her arms post vaccination/ tingling started in her face and then spread; Her right eye lid was drooping a little.; She noticed a pressure on her chest including panic attacks and anxiety.; She noticed a pressure on her chest including panic attacks and anxiety.; She noticed a pressure on her chest including panic attacks and anxiety.; Soreness in arm; Lump; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional from Pfizer sponsored program. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN6207 ), dose 1 via an unspecified route of administration, administered in top of the Arm Left on 17Mar2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in top of the Arm Right on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Prior vaccinations within 4 weeks were None. Reporter then stated she did not receive any of the vaccines and she thinks she just had the tests to confirm you had it. Medical history included pain in extremity and visual impairment. There were no concomitant medications. The patient experienced she was advise to go to the ER because it could be a stroke on an unspecified date, tingling in her arms post vaccination/ tingling started in her face and then spread ( It was within 48 to 72 hours of receiving the vaccine). it initially started at the jaw bone and down into her arm midway to forearm then continued to left side of hip and down leg and stopped right above her knee, her right eye lid was drooping a little, she noticed a pressure on her chest including panic attacks and anxiety, soreness in arm, lump. It was reported that reporter has asked certain questions Has Pfizer provided a statement on the need for a booster dose (3rd dose)? Is Pfizer investigating the need for a booster dose. My pediatrician told me the vaccine is only 95 % effective against the variant. Response: The emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine has been expanded to include individuals 12 to 15 years of age. In the Phase 3 pivotal trial, there were 2,260 individuals in this age group who received either the vaccine or placebo. The dose in 12 to 15 years of age is the same dose as currently available for adults (30 mcg per 0.3 mL dose as a series of two doses). Topline results showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and the vaccine was also generally well-tolerated. These individuals will continue to be monitored for an additional two years after their second dose. Also, Pfizer has submitted this information for publication in a scientific journal for peer-review and potential publication. Pfizer and BioNTech started a Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in children aged 5 to 11 years. This is part of the Phase 1/2/3 dose-escalation study in healthy children 6 months to 11 years was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:o 5 to 11 yearso 2 to 5 yearso  6 months to 2 yearsAdditional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04816643. The Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals less than 12 years of age. References:Pfizer-BioNTech COVID-19 Vaccine EUA Prescribing Information Pfizer-BioNTech COVID-19 Vaccine Authorized Product Monograph. Pfizer Press Pelease. withheld 10May2021.Pfizer-BioNTech COVID-19 Vaccine. Data on file (155). Pfizer. 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 is important to have a vaccine technology that allows us 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 we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we 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 is not approved. She had asked her doctor confirmed the vaccine can cause demyelination in adults post vaccination. Response: There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech. She asked What are the ingredients of the vaccine. Response: Informed caller to retrieve the list of ingredients on the following website. Sending the attached document via e-mail for reference. She was sure she does not have a stroke . Response was sent tot her to speak to her HCP. Reporter stated she had the adverse events after both the first and second doses. The outcome of she was advise to go to the ER because it could be a stroke on an unspecified date, tingling in her arms post vaccination/ tingling started in her face and then spread. it initially started at the jaw bone and down into her arm midway to forearm then continued to left side of hip and down leg and stopped right above her knee, She noticed a pressure on her chest including panic attacks and anxiety , Soreness in arm and Lump was unknown. The outcome of Her right eye lid was drooping a little was not recovered. She has to see when she goes to the doctor next week.