Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear infection, Fatigue, Feeling abnormal, Headache
Clinical narrative: Ear infection; headache; fatigue/tried; weak; felt off couple of days/not myself; This is a spontaneous report received from a contactable consumer (Patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL0140) via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. Medical history included Lyme's disease (I got it from a tick) from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL3302) via an unspecified route of administration on 26Jan2021 as dose 1, single for COVID-19 immunization. On an unspecified date of 2021 patient experienced Ear infection, headache, felt off couple of days, fatigue, not myself, tired and weak. Reporter stated she was fine on the day. Reporter seriousness for Ear infection was Unspecified. Reporter stated she was calling with questions that she said she felt like she could not get answered by her health care professionals. She had already been vaccinated. She was seven months out from the second shot. She would be getting the booster. On that time, she was on an antibiotic, Z-Pac due to an ear infection. She was wondering if she could still get the COVID Vaccine while on an antibiotic or does she had to wait for it to run its course. She was going to go and get the booster on the day, but she did not want to because of being on the antibiotic. She had spoken with her doctor. One doctor said to go ahead and get it while another said to wait. When asked about the vaccination site whether the vaccine given in the deltoid muscle, reporter queried that Where was the deltoid muscle, Response was Pfizer COVID-19 vaccine is given in the upper arm muscle which is the deltoid muscle. Patient queried that What was the efficacy of a booster dose and What was the protection after seven months of vaccination. Reporter sated she heard on the new and your doctor said after 6 months the efficacy starts waning off. it's also scary nobody was able to provide us information. Response was 1. Section 11.5 P.I Use in Immunocompromised From an independent report (PRIVACY, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients., safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. Spoke from the attached document CONS-how long will she be protected. Advised to visit our website cvdvaccine.com for more information. Therapeutic measures were taken as a result of the event ear infection that was Z-Pac. Outcome of the event Ear infection was unknown, and Outcome of other events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.