Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Gastrointestinal haemorrhage, Inflammatory marker test, Rectal haemorrhage
Clinical narrative: diagnosed with CDiff; rectal bleeding; she was experiencing recurring GI bleeding; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in arm left, administration date 06Jun2021 (Lot number: EW0187) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sensitivity to milk" (unspecified if ongoing). No covid prior vaccination. It was unknown if covid tested post vaccination. Concomitant medications included: PROBIOTICS NOS (possibly); VITAMINS NOS. The patient did not receive other vaccine in four weeks of vaccination. Vaccination history included: Bnt162b2 (Lot number: EW0170, Administration route: Intramuscular, Vaccine location: Left arm), administration date: 16May2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant) with onset 2021, outcome "unknown", described as "diagnosed with CDiff"; RECTAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "rectal bleeding"; GASTROINTESTINAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "she was experiencing recurring GI bleeding". The events "diagnosed with cdiff", "rectal bleeding" and "she was experiencing recurring gi bleeding" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: GI inflammatory markers: high. Therapeutic measures were taken as a result of clostridium difficile infection, rectal haemorrhage, gastrointestinal haemorrhage and included treatment with vancomycin antibiotic. Clinical course: Reporter's daughter started experiencing rectal bleeding over the summer. Her GI inflammatory markers were high and she was diagnosed with CDiff despite not being on recent antibiotics or being in a hospital or nursing home. Because this happened over 2 months after the vaccine administration, it did not occur to reporter that this was a potential adverse event. However, given that she was experiencing recurring GI bleeding and a friend just texted about her mom dying with heart and lung inflammation (separate record report), reporter was wondering if she was having a long term inflammatory reaction due to the vaccine.; Sender's Comments: As there is limited information in the case provided, the causal association between the event clostridium difficile infection, rectal haemorrhage, gastrointestinal haemorrhage and the suspect vaccine COMIRNATY 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.