Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Severe heartburn; abdominal pain; Agita; swelling; chest tightness; generalized redness; itching; sore throat; severe weakness; fatigue; headache; muscle pain; nausea; malaise/feeling unwell; increased temp but not febrile; This is a spontaneous report from a contactable nurse, the patient.  A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the left arm on 18Dec2020 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included chronic pain, hypertension, diabetes, depression, and broken vertebra. The patient was allergic to many antibiotics and benzodiazepines which caused dystonia. The patient also had an allergy to all anti-emetics except ondansetron (ZOFRAN) in the form of dystonia.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Ongoing concomitant medications included diclofenac (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication, esomeprazole magnesium (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication, fentanyl (MANUFACTURER UNKNOWN) for a broken vertebra from an unknown date, gabapentin (MANUFACTURER UNKNOWN) from 2019 for an unknown indication, misoprostol (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication, oxycodone hydrochloride/paracetamol (PERCOCET) from an unknown date for an unknown indication, and fentanyl (FENTANYL PATCH) from an unknown date for an unknown indication.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020 at 14:30, the patient experienced generalized redness, itching, swelling, and chest tightness; which required her to go the emergency room for 6 hours and was treated with epinephrine (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL), and fluids. On an unknown date in Dec2020 (reported as later), the patient had sore throat, severe weakness, fatigue, headache, muscle pain, nausea, malaise/feeling unwell, and increased temperature but not febrile. On 22Dec2020, the patient had severe heartburn, abdominal pain, and agita.  Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of generalized redness, itching, swelling, chest tightness, sore throat, severe weakness, fatigue, muscle pain, nausea, malaise/feeling unwell, and increased temperature but not febrile were recovering; while that of the headache, severe heartburn, abdominal pain, and agita were not recovered. The events were reported as non-serious and assessed as possibly related to the vaccine.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The patient was allergic to many antibiotics and benzodiazepines and had an allergy to all anti-emetics except ondansetron (ZOFRAN) in the form of dystonia.  Based on information available, the reported chest tightness and swelling together with generalized redness and itching were possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and clinical course.  This case will be reassessed should additional information become 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.