Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated "could be ELO or ERO"), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that "I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated "No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine." Nurse added, "I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call." She was referring to the 'TCP'. "When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do." The outcome of the event "I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID" was not recovered and of the remaining events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.