Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: she got extremely sick and is still not feeling well; she got extremely sick and is still not feeling well; This is a spontaneous report from a contactable consumer (patient). A female patient of (Age: 46 unit: unknown) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Apr2021, as DOSE 1, SINGLE for COVID-19 immunization and incorrect storage of drug was reported for first dose. The patient received the first dose of the Pfizer covid vaccine in the beginning of Apr2021. However, within a week or so, there was an investigation where they could not validate the correct storage there. The recommendation from the state was to start the process again. She got her 2nd first dose on Sunday and felt she had a pretty severe reaction yesterday and still feeling it on an unspecified date. She was in a state where some of the vaccines were not stored correctly. She was one on the people who was vaccinated with the bad vaccine. The state  said everyone that was vaccinated, needed to be re vaccinated. She received her second first dose on Sunday and she got extremely sick and was still not feeling well on an unspecified date. She was wondering if she really needs the third dose. Response received: 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 February25, 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 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. Pfizer was unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described. The patient would like to validate the guidance provided to her by the state department of health on the invalid dose she received. She was a little concerned that there was not any research around getting 3 shots in a short period of time. Outcome of the events she got extremely sick and was still not feeling well were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be required. No further information is expected.