Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Listless, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Cannot carry out my normal activities without feeling like I need to lie back down; Soft stools; Diarrhea; Listless; Feeling worn out, listless, and uneasy 5 days after; Feeling worn out/Severely fatigued; Experienced GI issues; body aches; sore right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:00 (Batch/Lot Number: ER87290) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included Allergies: Penicillin, Allergies: sulfa; (Allergies to medications, food, or other products: Penicillin, sulfa), breast cancer remission (Had breast cancer 3 years ago but am in remission). Age at vaccination: 57 Years. Patient was not pregnant: No. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Other. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Concomitant medication(s) included gabapentin taken for an unspecified indication, start and stop date were not reported; desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. List of any other medications the patient received within 2 weeks of vaccination: Gabapentin, Pristiq Reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Historical Vaccine included BNT162B2 for COVID-19 immunization (Start Date/Time: 24Mar2021 01:00 PM, Right arm, dose number: 1, Lot number: EP7534) (Age at vaccination: 57-year-old). The patient experienced soft stools (non-serious) on 14Apr2021 15:00, diarrhea (non-serious) on 14Apr2021 15:00, listless (non-serious) on 14Apr2021 15:00, feeling worn out, listless, and uneasy 5 days after (non-serious) on 14Apr2021 15:00, feeling worn out/severely fatigued  (non-serious) on 14Apr2021 15:00, experienced GI issues (non-serious) on 14Apr2021, body aches (non-serious) on 14Apr2021, sore right arm (non-serious) on 14Apr2021, cannot carry out my normal activities without feeling like i need to lie back down (non-serious) on an unspecified date. Adverse event: Soft stools within 2 hours of vaccine, then Diarrhea for 1 day, then soft stools for 2 more days. Feeling worn out, listless, and uneasy 5 days after. Adverse event country: US. if patient recovered: Recovering. Was treatment received for the adverse event: No. Vaccine Facility information available. Ethnicity information is available. Race information is available. Does Pfizer have permission to contact your/the patient's healthcare provider about this report: Yes. Event: Experienced GI issues within a couple of hours following the 2nd vaccine on 14Apr2021; soft stools, then body aches and sore right arm the evening of the 2nd vaccine; Had diarrhoea the following day for 24 hours, then back to soft stools for a couple of days following that. Stools back to normal my 14Apr2021. Severely fatigued 15Apr2021, then felt a little less fatigued over the weekend. Then became extremely fatigued again on 20Apr2021 and continued on until today, 22Apr2021. Cannot carry out my normal activities without feeling like I need to lie back down. Have contacted my primary care physician and am waiting for a call back, but not sure what can be done. Have submitted a previous report of these symptoms as well. I also had blood work done 1 month prior to the 1st vaccine and all was good. This issue seems to be a direct effect from the vaccine itself. Would appreciate a call back to discuss due to the fact I do not see any of these types of long term adverse effects on your site. if patient recovered: Not recovered. For events, soft stools, outcome was recovered on unspecified date in 2021, Diarrhea, outcome was recovering, Listless, outcome was recovering, feeling worn out, listless, and uneasy 5 days after, outcome was recovering, feeling worn out/severely fatigued, outcome was not recovered, experienced GI issues, outcome was not recovered, body aches, outcome was not recovered, sore right arm, outcome was not recovered, cannot carry out my normal activities without feeling like i need to lie back down, outcome was not recovered. The patient underwent lab tests and procedures which included blood work: all was good in 2021.    Information about Lot/Batch number is obtained. Additional information has been requested