Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: lost a total of 4 pounds since getting the vaccine; decreased appetite; hot flashes; diarrhea/Loose stools; was near syncope twice; stomach, cramps/debilitating stomach cramps that were 9 out of 10 on the pain scale (felt like she was having a baby); sweaty; pale; light headed; fatigued/tired; nausea; body aches; chills; temperature of 100; headache; sore arm; This is a spontaneous report from a contactable other health carte professional (hcp).   A 33-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 15Sep2021 15:00 (Batch/Lot Number: EW0168) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) taken for an unspecified indication, start and stop date were not reported; multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) taken daily for an unspecified indication, start and stop date were not reported. On 15Sep2021 (Day 1) the patient experienced sore arm and headache.  On 16Sep2021 (Day 2) the patient experienced nausea, body aches, chills and temperature of 100. On 17Sep2021 (Day 3) the patient experienced  headache and fatigue. On 18Sep2021 (Day 4) the patient experienced  nausea stomach, cramps, felt sweaty and pale at work and was light headed, fatigued and near syncope twice while at work with a temperature of 99.4. On 19Sep2021 (Day 5) the patient experienced nausea, stomach cramps, hot flashes, diarrhea 6 times, fatigue, normal temperature.  On 20Sep2021 (Day 6) the patient experienced decreased appetite, debilitating stomach cramps 9/10, like having a baby, diarrhea 5 times, fatigue and headache.  On 21Sep2021 (Day 7) the patient experienced stomach cramps, diarrhea twice, fatigue. On 22Sep2021 (Day 8) the patient experienced looser stools, mild cramps. On 23Sep2021 (Day 9) the patient experienced severe stomach cramps, diarrhea 4 times, nauseated and sweat.  She states from unknown date she has lost 4 lbs since the vaccine. The doctors at work told her to go to urgent care and on 22Sep2021 she did and had a negative PCR test.  She states she s been around co-workers who had mostly Pfizer that only had 48 hours of feeling sick and body aches and then it went away. Her doctor looked up information from the clinical trials and said 11% had mild diarrhea and 1% had 6 or more cases.  She thinks she is one of those with severe diarrhea like in the trials. The doctor that suggested that she go to an Urgent care pulled up statistics of the side effects from the vaccine and it showed that 6% of people get diarrhea. So the doctor said that maybe she is just one of those 6%. She states that the Urgent care ruled out any other stomach related issues that could be causing the stomach cramps and the diarrhea. She did not to the Emergency Room for the events.The patient went to the Physician Office (urgent care) on 22Sep2021.This makes her not want to get the second dose.The patient underwent lab tests and procedures which included body temperature: 100 on 17Sep2021, body temperature: 99.4   on unknown date, body temperature: normal on unknown date, Covid swab in nose: negative on 22Sep2021, COVID-19 PCR test: negative on 22Sep2021, weight: she has lost 4 lbs since the vaccine on  unknown date. "Treatment of adverse event: Nurse stated I have Ibuprofen one time, 600 mg."  Outcome of the events were unknown.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.