Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Inappropriate schedule of product administration
Clinical narrative: She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021.; my daughter slept for 12-13 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200015970 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01), administration date: 03Sep2021, for Covid-19 Immunization, reaction(s): "slept for almost two days", "experienced tiredness", "she missed her menstrual cycle". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021."; HYPERSOMNIA (non-serious) with onset Dec2021, outcome "unknown", described as "my daughter slept for 12-13 hours".  Clinical information: E-transmitting duplicate AE info. She already spoke with facility. She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021. After the daughter received the first dose of the Pfizer covid-19 vaccine, 3 weeks later, she experienced tiredness and slept for almost two days and she missed her menstrual cycle. After the 2nd dose, my daughter slept for 12-13 hours. After my 2nd dose, I had a pain in my left side. I took Advil and felt better. Response: No specific info, since it was dosed outside of how it was studied, but spoke to Pfizer.com: For participants without evidence of SARS-CoV-2 infection prior to 7 days after Dose 2, vaccine efficacy against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0%. Response:  Comirnaty is FDA-approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under EUA to provide a two-dose primary series in individuals 12 through 15 years. Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a two-dose primary series in individuals 12 years of age and older. Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine have received EUA from FDA to provide a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and as a single booster dose in individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY. The vaccines are also authorized as a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination. Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a two-dose primary series to individuals 5 through 11 years of age. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD and amp;C Act unless the declaration is terminated or authorization revoked sooner. To understand how variants work, the Centres for Disease Control and Prevention (CDC) states the following:(3) If you think about a virus like a tree growing and branching out; each branch on the tree is slightly different than the others. By comparing the branches, scientists can label them according to the differences. These small differences, or variants, have been studied and identified since the beginning of the pandemic. Some variations allow the virus to spread more easily or make it resistant to treatments or vaccines. Those variants must be monitored more carefully.  The CDC states that viruses constantly change through mutation. Some variants emerge and disappear while others may emerge and persist. New variants will continue to emerge. CDC and other public health organizations monitor all variants of the virus that causes COVID-19 and globally. (4)  DOES THE VACCINE PROTECT AGAINST THE ALPHA, BETA, GAMMA, OR DELTA VARIANTS? The vaccine has been shown to prevent COVID-19. The duration of protection against COVID-19 is currently unknown. The vaccine may not protect everyone. (1,2) The CDC states that the Delta variant is currently the predominant variant of the virus. It is highly contagious, more than 2 times as contagious as previous variants. Some data suggest the Delta variant might cause more severe illness than previous variants in unvaccinated people. (5) Although this is not specific to Comirnaty or the Pfizer-BioNTech COVID-19 vaccine, the CDC also states the following about vaccine efficacy against variants:(6). Available evidence suggests the currently approved or authorized COVID-19 vaccines are highly effective against hospitalization and death for a variety of strains, including Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2). Data suggest lower effectiveness against confirmed infection and symptomatic disease caused by the Beta, Gamma, and Delta variants compared with the ancestral strain and Alpha variant. Ongoing monitoring of vaccine effectiveness against variants is needed. Please call your vaccination provider or your healthcare provider if you have any questions about this topic or the safety or efficacy of the vaccine. DOES THE VACCINE PROTECT AGAINST THE OMICRON VARIANT? The vaccine has been shown to prevent COVID-19. The duration of protection against COVID-19 is currently unknown. The vaccine may not protect everyone. (1,2) Pfizer and BioNTech are remaining vigilant and constantly conducting surveillance efforts focused on monitoring for emerging variants that potentially escape protection from our vaccine. We are beginning to run tests on the new Omicron variant of concern to see how the vaccine may protect against this variant. We expect to have initial data in the coming weeks. (7) Pfizer and BioNTech will continue to follow the science as we examine the best approaches to protecting people against COVID-19.(7)In a November 30 statement regarding the omicron variant, the FDA said: "Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends."(8) Please call your vaccination provider or your healthcare provider if you have any questions about this topic or the safety or efficacy of the vaccine.  REFERENCES: See in the attached document.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.