Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary congestion, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the  community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection.   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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.