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VAERS ID: 1000409

AGE: 47| SEX: M|State: FR

Description

Antiepileptics toxicity; Drug level increased; Interaction between influenza virus vaccine, phenytoin and phenobarbital; Initial information regarding this unsolicited valid serious case downloaded from the Regulatory Authority, was received on 20-Jan-2021 from a other-health care professional via the health authority (under the reference number: IT-EMA-DD-20180611-faizanevprod-103715). The following narrative is based on the information retrieved from all other accessible data. This case involves a 47 year old male patient who had antiepileptics toxicity(toxicity to various agents), drug level increased and interaction between influenza virus vaccine, phenytoin and phenobarbital (drug interaction), while he received vaccine INFLUENZA VACCINE and PHENYTOIN and PHENOBARBITAL. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient started taking PHENYTOIN dosage unknown route unknown (with an unknown batch number) for drug use for unknown indication. On an unknown date, the patient started taking PHENOBARBITAL dosage unknown route unknown (with an unknown batch number) for drug use for unknown indication. On an unknown date, the patient developed a serious antiepileptics toxicity (toxicity to various agents), drug level increased and interaction between influenza virus vaccine, phenytoin and phenobarbital (drug interaction), unknown latency following administration of INFLUENZA VACCINE and PHENYTOIN and PHENOBARBITAL. The patient was hospitalized for all these events. No laboratory data was provided. It was not reported if the patient received a corrective treatment. Action with suspects PHENYTOIN and PHENOBARBITAL was unknown. At the time of reporting, the outcome of event was unknown. Information on lot number was requested for this case.; Reporter's Comments: Author comment: "According to DIPS algorithm, more than half of our validated AEFI reports were categorized as probable (1 report, 6.2%) and possible (7 reports, 43.8%), suggesting the hypothesis of a possible causal relationship between the occurrence of specific AEFI related to signs and symptoms of antiepileptics toxicity and vaccine-drugs interaction."; Sender's Comments: This case concerns 47 year old male patient who had toxicity to various agents, drug level increased and drug interaction after vaccination with INFLUENZA VACCINE produced by unknown manufacturer and treatment with PHENYTOIN and PHENOBARBITAL. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual the role of the vaccine cannot be assessed. IT-MYLANLABS-2018M1038378:

Symptoms

Drug interaction, Drug level increased, Toxicity to various agents

Vaccines

VAX DATE: | ONSET DATE: | DAYS TO ONSET:
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • FLUX
  • UNKNOWN MANUFACTURER
  • INFLUENZA (SEASONAL) (NO BRAND NAME)
  • UNK

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
U
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
PHENYTOIN; PHENOBARBITAL
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:
ITSA2021SA023803
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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