Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Dizziness
Clinical narrative: Massive stomach cramping; Extreme nausea/dizziness; Extreme nausea/dizziness; Could not get out of bed; Chills; Major vomiting/diarrhea; Major vomiting/diarrhea; 102 fever; This is a spontaneous report from a contactable other hcp (patient).   A 54-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Sep2021 18:30 (vaccination age was 54 years old) (Lot Number: 30145BA) as DOSE 2, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. Medical history included breast cancer from 2018 and no information about if ongoing , HASHIMOTO from 2006 and no information about if ongoing, BARRETT'S ESOPHOGUS from 2019 and no information about if ongoing.  No known allergy.Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Sep2021 11:30 AM (Lot Number: Ff2587) as DOSE 1, SINGLE for covid-19 immunisation. No other other vaccine in four weeks.Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; tamoxifen taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported and unspecified Flut.  On 30Sep2021 07:00 PM, the patient experienced massive stomach cramping for over 48 hours and recovered in Oct2021 (medical significant), 102 fever and recovered in 2021, chills and recovered in 2021, major vomiting/diarrhea for 18 hours and recovered on 01Oct2021 13:00, could not get out of bed for over 18 hours and recovered on 01Oct2021 13:00, extreme nausea/dizziness for over 24 hours and recovered in Oct2021 (medical significant), could not keep water down for 18hours.  The patient underwent lab tests and procedures which included body temperature: 102 on 30Sep2021.  No covid tested post vaccination.Therapeutic measures were taken as a result of massive stomach cramping, extreme nausea/dizziness, 102 fever, chills, major vomiting, diarrhea, could not get out of bed, as receiving Zofran and advised to get plenty of rest/fluids.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events abdominal pain upper, nausea, dizziness, and suspect drug BNT162B2 cannot be excluded.  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.