Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Ultrasound abdomen, Weight decreased, X-ray
Clinical narrative: acute and severe shortness of breath; typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea); lost 10lbs; This is a spontaneous report from a contactable nurse (patient).  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 08Jan2021, at  08:30 as the second single dose for COVID-19 immunization.  Medical history included  past history of migraines and colitis from unknown dates.  The patient's concomitant medications were not reported.  The patient previously took erythromycin and experienced allergy; the patient also has a vaccination history of BNT162B2 (lot number: EJ1685) as first dose on 18Dec2020 for COVID-19 immunization.  On 08Jan2021, at 20:00, the patient experienced acute and severe shortness of breath, typical flu-like symptoms (elaborated as fever 101.5, chills/shivering, body pain, headache, nausea), and lost 10lbs. The events were reported as life-threatening, elaborated by the reporting nurse as have been "essentially incapacitated for six weeks".  The patient underwent lab tests and procedures which included body temperature: 101.5 on 08Jan2021, Nasal Swab: negative on 12Jan2021, weight: lost 10lbs on an unspecified date. Clinical course was as follows:  patient noted that it felt as though she was having intractable diaphragm spasms that were forcing her exhales out at the end of her breath cycle. She lost 10lbs and was essentially incapacitated for 6 six weeks.  The patient has been evaluated by head and neck , with no noted vocal cord dysfunction, speech pathology (no swallowing difficulties were noted), pulmonology (no lung specific issues were noted) and was awaiting a neurology consult. Therapeutic measures were taken as a result of the events, and included unspecified treatments in the emergency department described as lots of medications.  There was no COVID infection prior to vaccination, and the patient has been tested post the vaccination, with negative results as aforementioned.  The clinical outcome of typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea) was recovered in Jan2021; the clinical outcome of acute and severe shortness of breath and lost 10lbs was not recovered.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between events severe shortness of breath and typical flu-like symptoms and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. the event lost weight is attributed to an intercurrent medical condition and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). 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.