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Life Threatening? Yes
Write-up: Tumor "explodes"; pleural effusion; swollen lymph nodes; eczema in throat; This is a spontaneous report from a non-contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 74502], license party for COMIRNATY. A 55-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12May2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation; and pembrolizumab (KEYTRUDA), via an unspecified route of administration from 04Nov2020 (Batch/Lot number was not reported) to May2021, at 200 mg / 3 w, (Triple therapy scheme KN 189) for non-small cell lung cancer. Medical history included radiotherapy head, neurological rehabilitation, cough and dyspnoea in Jan2021 (Causality assessment to Keytruda: Yes). The patient''s concomitant medications were not reported. The patient previously took Comirnaty dose 1 on unspecified date for COVID-19 immunization. The patient experienced events such as tumor "explodes" after 2nd vaccination, pleural effusion, swollen lymph nodes, eczema in throat on 13May2021. The outcome of events was not recovered. The events were reported as serious per hospitalization and life-threatening. As reported, "After the 2nd vaccination with COMIRNATY, the patient''s condition has deteriorated drastically, tumor control has gotten out of control, tumor has "exploded". Causality assessment with pembrolizumab or COMIRNATY was not reported. The outcome of events was not recovered. The actin taken in response to PEMBROLIZUMAB for the events was temporarily withdrawn in May2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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