Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling abnormal, Malaise, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I am not feeling well/ I was already not feeling very well when I got the first vaccination; I received the first one, I was feeling little lousy; Felt like type of little weird; I was tired after that the usual pain that was sore arm; I was tired after that the usual pain that was sore arm; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733, Expiry date was not reported), via an unspecified route of administration on 31Mar2021 (at the age of 48-years-old) in Arm Left as single dose for COVID-19 immunization. Patient received tetracycline hydrochloride (TETRACYCLIN), route of administration, start and stop date, batch/lot number and dose were not reported for urinary tract infection. The Patient Medical history included type 1 diabetes mellitus, gastrooesophageal reflux disease, attention deficit hyperactivity disorder, cardiac disorder, ongoing urinary tract infection. Concomitant medications included insulin taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; pantoprazole sodium sesquihydrate (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient received other products. Consumer stated, she was calling because, On unspecified date she was not feeling well and she have some underlying issues (history). She just got the second COVID vaccination shot last Wednesday and she do have underlying issues like she was a diabetic and also a heart patient (clarified as history). She was on antibiotic for UTI infection when she received the first vaccination, so she was on Tetracycline at that time and she do think, she still have the UTI infection going on. So, she was already not feeling very well when she got the first vaccination but then she felt better, she was feeling better and she was told to go ahead for the vaccination. When she received the first one, she was feeling little lousy like she don't know maybe an hour later just felt like type of little weird but it was not a big deal but may be it was from the vaccination. So, she just went home and felt better and she was tired after that the usual pain that was sore arm and all that but it was not a big deal. Consumer further stated, The same thing had happened immediately with the first one and she was there for quite a while and she went to shopping at (Withheld) so it was probably like an hour and half but before she felt that weird, crazy and lightheaded feeling that wasn't until hours or two hours later. Consumer further stated, So she do want to report it because it helping more people to do share what is going through otherwise how will we know. She was keen to report it but she didn't do anything until this time and then she was waiting for the things to go away before she reported anything that is how is going on. Event start date: Consumer stated, All these started right after the shot actually like the lousiness and fatigue that started after the shot and it got little bit better after first shot and it came back after the second shot and increased immensely. Actually, the lousiness stated after couple of hours later but the rest of the symptoms started the next day or the day after like couple of days later. So, after the first shot on 04/02, I started the side effects and they were like worse after couple of days later and with the second one it was like the same thing. (not clarified further). Consumer stated, she have a heart condition and she believe she was 16 years old when she was diagnosed with Type 1 diabetes and she take two types of insulin. Consumer stated, she had two COVID tests and she took one in March and they tried to give me one for my UTI infection but they couldn't get any blood because she was dehydrated, she was always dehydrated. (not clarified further). Still experiencing event consumer stated, Yes they are much worse. (event not appropriately paraphrased and clarified further, hence ongoing not checked for events). Treatment: Consumer stated, "No, she haven't done anything yet because she was expecting it go away and instead it is getting worse. She didn't had that much after the first one but from the second on everyday it is getting worse. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on, sars-cov-2 test: negative on Mar2021. The outcome for the events was unknown.    No follow-up attempts are needed. No further information is expected.