Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Escherichia sepsis, Rash
Clinical narrative: Occurrence of E.coli Sepsis and ended up in hospital; Developed a body rash; This is a spontaneous report from a contactable Other-HCP.  A  85-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration on the right shoulder (unsure) on 01Apr2021 as a single dose for COVID-19 immunization. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6701), via an unspecified route of administration on the left shoulder (unsure) on 20Feb2021 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's  concomitant medications included Rocephin, Keflex, IV.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller stated that she developed a body rash. The caller states that the body rash looked like  round, and approximately, probably, maybe of different sizes. Some of the rashes  were just like at the follicle end of the hair, caller lost all the hair. Then there was rounder rashes and bigger rashes. The rash was two shades darker than the skin. The caller stated that the rashes become sort of with slight dome across that dries up and that part of the epidermis slips off and then it was bright red. The caller stated that the rash doesn't itch, but at first it was just a little bit of rash and now it was all over the caller's arms. The caller had some rash on top of thighs, inside of thighs and a few on the caller's back. Caller stated that the rash developed after the second vaccine dose. The body rash began after 01Apr2021 and they stayed the same number for quite a while.  The caller didn't' have any on the inside of the arms, just on the outside of the arms, then about two weeks ago, the caller looked. The caller turned her arms over and now the rash was on the inside of the arm. The caller noticed this and thought something else was probably going on. The caller stated that she was in hospital for Occurrence of E.coli Sepsis and between 15Mar2021 to 02Apr2021. The caller stated that originally her first dose Pfizer Covid Vaccine appointment was cancelled because the caller was in the hospital for her first occurrence of E.coli Sepsis. The caller confirmed that she had E.coli Sepsis twice. The case was assessed as Serious (prolonged hospitalization). The caller used 1% cortisone cream on the rash as treatment medication and the rash had gotten less pronounced.  The caller stated that the rash didnot seem to be multiplying anymore. The caller was treated with Rocephin for of E.coli Sepsis. The outcome of the events for rash was resolving and unknown for E.coli Sepsis  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported E.Coli Sepsis. 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.