Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Autoimmune disorder, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EN6199) injected intramuscularly in left shoulder (left arm) on 09Mar2021 13:30 at age of 51 years old at single dose for COVID-19 immunisation. Medical history included hypertension (HTN), Ehlers-Danlos syndrome (EDS), neurosarcoidosis (diagnosied 1997 with remission since 2002), high cholesterol, depression, gastrooesophageal reflux disease (GERD), osteoarthritis. Allergies to penicillin (no specific manufacturer, lot or expiration) in 1990. Obesity through all her life. No relevant test. Diagnosed allergies, compromised immune status, respiratory illness. There was no family medical history. Patient was not pregnant. There were no additional vaccines administered on same date of the Pfizer Suspect. There were other medications in two weeks. There was not covid prior vaccination. There was no other vaccine in four weeks prior vaccinations. The adverse event patient experienced: lose of voice with shortness of breath with communication and chest tightening, fatigue. This similar to her neurosarcoidosis diagnosied 1997 with remission since 2002. The events started on 10Mar2021 11:30 AM. Received call from consumer regarding the Pfizer COVID vaccine 1st dose.  She was losing her voice.  She was a pediatric Occupational Therapist. She was eligible on Tuesday for the first dose and went and got it.  Her main concern was the symptoms she was having was the same thing that comes out when her autoimmune was exacerbated.  She would like to know if it was safe to get next dose. When providing her weight, she said she was not a small girl. There was no prescriber. She was waiting to see if it would disappear before calling Pfizer to report it and it did not.  It started yesterday about 24 hours after the vaccine. She received it for prevention and for the population she works with. A lot of her kids she worked with were autoimmune compromised. The majority of her medications she had been on for over two years, so she did not feel they were relevant. No further details provided. No Emergency Room (ER) or physician's office required. She called her physicians' office and they suggested she contact Pfizer. Patient received covid tested post vaccination: nasal Swab/Antigen on 09Feb2021: negative. Outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.