Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Migraine, Off label use, Oropharyngeal discomfort
Clinical narrative: fatigue.. more tired; coughing and clearing her throat; anxiety; felt achy; lost a lot of weight; clearing her throat.. Sounded like she had junk in throat; fever; The patient reported the following symptoms after recived her 3rd Covid-19 vaccination: swollen lymph nodesin her neck and under her arms and flu like symptoms; The patient reported the following symptoms after recived her 3rd Covid-19 vaccination: swollen lymph nodesin her neck and under her arms and flu like symptoms; swollen lymph nodes in her neck and under her arms; flu like symptoms/flu type of experience; very hot/chills; very hot/chills; Low energy/don't have all the energy; frog in my throat; cytokine storm; migraine.. headache; emotional- sobbing, crying, laughing during the infusion; This is a solicited report based on the information received by Pfizer (Mfr Control No. #2021-0520432) from a contactable consumer (patient).   A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (1 dosage form; 3 total doses) for Covid-19 prevention (prophylaxis); axicabtagene ciloleucel, intravenous from 29May2018 (Batch/Lot number was not reported) to 29May2018, at unspecified dose for non-hodgkin's lymphoma. Medical history included ongoing non-hodgkin's lymphoma. The patient's concomitant medications were not reported. On 29May2018, the patient experienced emotional- sobbing, crying, laughing during the infusion [emotional reaction]. In Jun2018, the patient experienced cytokine storm and migraine headache (also noted as for 3 days). On an unspecified date, the patient experienced the onset of fatigued, fever, anxiety, felt achy, flu type of experience, lost a lot of weight, don't have all the energy like she used to, fatigue more tired now, coughing, and clearing her throat sounded like she had junk in her throat [throat secretion increased]. On 05Mar2021, the patient experienced frog in her throat [pharynx discomfort]. On an unspecified date, the patient reported the following symptoms after received her 3rd Covid-19 vaccination: swollen lymph nodes in her neck and under her arms, low energy, and flu like symptoms- very hot/chills; the patient did not have a fever. No Laboratory/ diagnostic tests were reported. The action taken in response to the events for axicabtagene ciloleucel was unknown. The outcome of events flu like symptoms/flu type of experience, low energy/don't have all the energy, migraine headache, anxiety, felt achy was recovered on an unspecified date, frog in her throat, fatigue more tired, coughing and clearing her throat, clearing her throat sounded like she had junk in throat was not recovered, outcome of other events was unknown.   regulatory authority assessment: The assessment of the event of cytokine storm as serious (medically significant per assessment; no serious criterion provided by the reporter), the assessment of the rest events were non-serious, causality of all events were not reported for Axicabtagene.   Case comment: cytokine release syndrome has been associated with Axicabtagene Ciloleucel; however the event was reported as cytokine storm. Lack of information limits causality assessment of pharynx discomfort, emotional reaction, migraine, headache, fatigue, coughing, fever, anxiety, felt achy, flu type of experience, weight loss, asthenia, swollen lymph nodes, low energy, flu like symptoms- very hot/chills and throat secretion increased in this case.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    Information on the lot/batch number for the vaccine has been requested.; Sender's Comments: Based on known mechanism of action of the drugs, the event of cytokine storm  is assessed as not related to BNT162B2 , and more likely due to concomitant medication Axicabtagene Ciloleucel  and Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of  other reported events  cannot be totally 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.