Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product, Pain, Stool analysis, Weight decreased
Clinical narrative: moderate severe abdominal pain; partial contents of the Pfizer COVID vaccination back flowed onto my Rt ungloved hand while I was instilling  1.8 cc of diluent into the vaccine vial; became nauseous; anorexic; also lost 10 lbs in 7 days; acute abdominal pain that radiated to my back; blood amylase level was 17; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Apr2021 (Lot number: EP6955) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Relevant medical history included: "Moderate severe asthma" (unspecified if ongoing); "chronic Epstein Barre" (unspecified if ongoing); "Chronic vitamin D and Iodine deficiency" (unspecified if ongoing); "Chronic vitamin D and Iodine deficiency" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "MTRR gene mutation" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included (Other medications in two weeks): LEVOTHYROXINE; CYTOMEL; ADVAIR; ALBUTEROL HFA; CLONAZEPAM; SINGULAIR; MUCINEX; NASALCROM; ACYCLOVIR SODIUM; ZYRTEC ALLERGY; BUPROPION; PROZAC; PPI [OMEPRAZOLE]; NYSTATIN. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 18Mar2021, when the patient was 58 years old, for COVID-19 Immunization.  The following information was reported: ABDOMINAL PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "moderate severe abdominal pain"; OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 18Nov2021, outcome "recovering", described as "partial contents of the Pfizer COVID vaccination back flowed onto my Rt ungloved hand while I was instilling 1.8 cc of diluent into the vaccine vial"; NAUSEA (non-serious) with onset 18Nov2021, outcome "recovering", described as "became nauseous"; DECREASED APPETITE (non-serious) with onset 18Nov2021, outcome "recovering", described as "anorexic"; WEIGHT DECREASED (non-serious) with onset 18Nov2021, outcome "recovering", described as "also lost 10 lbs in 7 days"; PAIN (non-serious) with onset 18Nov2021, outcome "recovering", described as "acute abdominal pain that radiated to my back"; AMYLASE DECREASED (non-serious) with onset 18Nov2021, outcome "recovering", described as "blood amylase level was 17". The events "moderate severe abdominal pain", "partial contents of the pfizer covid vaccination back flowed onto my rt ungloved hand while i was instilling 1.8 cc of diluent into the vaccine vial", "became nauseous", "anorexic", "also lost 10 lbs in 7 days", "acute abdominal pain that radiated to my back" and "blood amylase level was 17" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: amylase: 17; stool analysis: unknown results. Therapeutic measures were taken as a result of abdominal pain, occupational exposure to product, nausea, decreased appetite, weight decreased, pain, amylase decreased.  Clinical course: Since the vaccination the patient had not been tested for COVID-19. The patient mixed a new vial of Pfizer vaccination & solvent and administered it to a customer, also a nurse, after letting the vaccine warm the appropriate length of time. Within several days, the patient became nauseous, anorexic, with moderate severe abdominal pain. The patient also lost 10 lbs in 7 days. The patient was treated at minor emergency for acute abdominal pain that radiated to back. The needle on the pre-packaged 3cc diluent syringe was faulty and not secured onto the syringe. Thus, when she diluted the vaccine vial, a mixture of solvent and vaccination back flowed onto her hand. The patient used hand sanitizer, notified the pharmacist on duty, and wasted the COVID vaccination vial. She mixed a new vial of Pfizer vaccination and solvent administered it to a customer, also a nurse, after letting the vaccine warm the appropriate length of time. The patient also lost 10 lbs in 7 days and was treated at minor emergency for acute abdominal pain that radiated to back. The patient had an appointment with FNP 2 get comprehensive stool analysis results.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event abdominal pain with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.