Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10031066serious1Date Last Updated07/04/2014receiptdateformat102companynumbUS-BIOGENIDEC-2014BI024824occurcountryUSduplicate1Date Received24/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age37Unit of Onset AgeyearsWeight73SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionGait disturbanceOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionInjection site massOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionCryingOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionInjection site painOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionInfluenza like illnessOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionBladder disorderOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionChest painOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionMigraineOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductAVONEXdrugauthorizationnumb103628drugstructuredosagenumb30drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugadministrationroute030drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate01/02/1999drugenddateformat610drugenddate/02/1999actiondrug1

openFDA Info on Medication

Application NumberBLA103628Brand NameAVONEXGeneric NameINTERFERON BETA-1AManufacturersBiogen Inc.product_ndc59627-111, 59627-333, 59627-222, 59627-003, 59627-002Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARRXCUI153323, 153324, 727813, 727816, 797544, 1650899, 1650901spl_id2a66a68a-2391-4598-a662-d3c55b1547f7spl_set_idd70a39cc-de15-4c12-a1ec-8063b69ea0e1Package NDC 59627-333-04, 59627-222-05, 59627-111-04, 59627-111-03, 59627-003-01, 59627-003- ...

2)

drugcharacterization2medicinalproductZOLOFT

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductVALIUM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc.product_ndc0140-0004, 0140-0005, 0140-0006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMspl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14spl_set_id554baee5-b171-4452-a50a-41a0946f956cPackage NDC0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

4)

drugcharacterization2medicinalproductCOPAXONE

openFDA Info on Medication

Application NumberNDA020622Brand NameCOPAXONEGeneric NameGLATIRAMER ACETATEManufacturersTeva Neuroscience, Inc.product_ndc68546-317, 68546-325Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsGLATIRAMER ACETATERXCUI1111641, 1111642, 1487361, 1487363spl_idbea8ff63-1eaf-4d40-a913-dafabf9f0c63spl_set_idaa88f583-4f5f-433b-80b4-1f4c9fb28357Package NDC68546-317-00, 68546-317-30, 68546-325-06, 68546-325-12UNII5M691HL4BO

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI024824

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use