Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Prothrombin time, Respiratory disorder, Speech disorder, Ventricular extrasystoles
Clinical narrative: she is throwing PVC's; nose felt like it was swollen shut; eyes watered; lips were tingly and itchy; lips were tingly and itchy; She then got really hoarse; coughing; couldn't breath; could hardly talk; her oxygen dropped; her blood pressure increased; When first admitted she couldn't get up and move a lot; respiratory compromise; mouth started to itch; Chest pain; dizziness; her nose felt like it was swollen shut with nasal congestion; she is bleeding and brusing really bad; she is bleeding and brusing really bad; Her anion gap was kind of playing around; she feels drunk; nauseated; She just didn't feel right; bloody discharge shot out of her nose.; her white count has been climb steadily. It was 9.69 on 19Jan2021; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) received second dose of BNT162B2 (Batch/lot number FL3249) on 19Jan2021 03:30 PM at single dose for covid-19 immunization. Medical history was Allergies: latex which is an anaphylactic reaction and gave her angioedema, pseudotumor cerebri (a conditions where she makes too much spinal fluid and is why she takes the Lasix), reflux. Concomitant drug was furosemide (LASIX), topiramate (TOPAMAX), acetazolamide (DIAMOX), levothyroxine sodium (SYNTHROID), dexamethasone (DEXALONE) for reflux, and isosorbide mononitrate (IMDUR). She is also allergic to morphine, penicillin's, sulfa and Imitrex. Caller states it is not an anaphylactic reaction for the medication. Historical Vaccine was the first dose was on 30Dec2020 around 1:30pm in the left deltoid, Lot number: GH9899. She reports she didn't even have a headache after this shot, it was like getting a shot of water. She got her second dose on 19Jan2021 at the local health department and has had lots of problems and was hospitalized twice secondary to the reactions experienced. She wants to make sure this was reported. After getting the shot she experienced chest pain within 4-5 minutes of injection, then her nose felt like it was swollen shut with nasal congestion, her eyes watered, mouth started to itch and lips were tingly and itchy. She went and told someone and she was taking to the back and given Benadryl IM. She then got really hoarse, was coughing, and couldn't breath. She was given Epi. The facility called # after giving IM Benadryl and 2 rounds of Epi and she still couldn't catch her breath and could hardly talk; they wanted her transferred to another facility. When EMS arrived they couldn't get an IV, her oxygen dropped and her blood pressure increased. She was admitted at this point to the PCU department. She was admitted on 19Jan2021 and discharged on 21Jan2021. On 23Jan2021 had to go back to the emergency room with chest pain, dizziness, and feeling nauseated. She just didn't feel right and couldn't get it together. She went to sit down and a thin bloody discharge shot out of her nose. A CT scan was done of her head, she was given IV fluids, steroids and medication to get her pain under control. They treated and released her that day with follow up with neurology due to not knowing what is causing the dizziness. She was also to follow up with cardiology to figure out why the chest pain is still present and she is throwing PVC's. On 25Jan2021 she was admitted again with chest pain, dizziness, and because she was throwing PVC's. When she stand, she feels drunk and dizzy. Caller remarks it is like she missed a party but got all the side effects. The severe chest pain has been the big thing and that was the first thing she had after getting the injection. Any time she tries to get up and walk she has chest pain. She was discharged yesterday 26Jan2021 and is to follow up with cardiology tomorrow and placed on medication. The caller mentions she has noticed she is bleeding and brusing really bad. Everywhere she has been stuck she is black, blue and purple. She was given Lovenox and that spot bled for 2 day; she has no NDC, Lot, or expiry for the Lovenox administered. Her PT and INR are fine. When first admitted she couldn't get up and move a lot, the didn't even want her to talk because of the respiratory compromise she was experiencing. At the location she was stuck for the Lovenox shot, blood oozed out of her belly for 2 days. Simple IV sticks that should just leave a dot have left her black and blue. The caller report that her white count has been climb steadily. It was 9.69 on 19Jan2021 and now it is 14.56. It is weird but has been on a steady climb. Emergency Room visited. She is still out work at this point, she might can go back next Monday. Her anion gap was kind of playing around. She explains that it was not outside normal barriers but would fluctuate between 4 and 13 like it was riding a wave. When in the hospital she was on Racemic epinephrine, which is epi mixed with atropine and lidocaine and so she was out of it for a few days and so she doesn't know what her labs were at that time. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported serious events cannot be completely excluded based on temporal relation. Other contributing factor includes the use of isosorbide mononitrate for the reported bleeding and PVCs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.