Drug:
Reaction: ACCIDENTAL EXPOSURE TO PRODUCT
20250101 - 20251231
No. 901 - 1000
No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
901 | 25027897 |
US |
22 | 2 |
Psoriasis, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
902 | 25028083 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
903 | 25028087 |
US |
74 | 2 |
Injection site swelling, Device use issue, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
904 | 25028095 |
US |
1 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
905 | 25028309 |
US |
65 | 2 |
Off label use, Accidental exposure to product, Exposure via skin contact, |
||||
INSULIN GLARGINE, |
||||
906 | 25028328 |
US |
18 | 2 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
907 | 25028358 |
US |
7 | 1 |
Exposure via skin contact, Accidental exposure to product, Product dose omission issue, Inappropriate schedule of product administration, |
||||
DUPILUMAB, DUPILUMAB, |
||||
908 | 25028360 |
US |
45 | 2 |
Injection site pain, Product preparation error, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
909 | 25021453 |
US |
69 | 2 |
Accidental exposure to product, Device difficult to use, Injection site indentation, |
||||
ADALIMUMAB-ATTO, |
||||
910 | 25021629 |
US |
69 | 2 |
Device difficult to use, Incorrect dose administered by device, Accidental exposure to product, Product preparation error, Injection site pain, Injection site bruising, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
911 | 25021842 |
US |
75 | 1 |
Device difficult to use, Accidental exposure to product, Injection site pain, Product preparation error, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
912 | 25022014 |
US |
2 | |
Migraine, Device difficult to use, Trigeminal nerve disorder, Accidental exposure to product, Facial pain, Headache, Paraesthesia, Drug dose omission by device, Hypoaesthesia, Asthenia, |
||||
ERENUMAB-AOOE, |
||||
913 | 25022860 |
US |
49 | 2 |
Injection site haemorrhage, Exposure via skin contact, Wrong technique in device usage process, Accidental exposure to product, Incorrect dose administered, Product complaint, |
||||
BELIMUMAB, |
||||
914 | 25022862 |
US |
2 | |
Incorrect dose administered by device, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, RIVAROXABAN, METOPROLOL TARTRATE, METOPROLOL, LEFLUNOMIDE, AMLODIPINE, CYCLOBENZAPRINE, ERGOCALCIFEROL, |
||||
915 | 25024531 |
US |
81 | 2 |
Device use error, Accidental exposure to product, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
916 | 25024656 |
US |
32 | 2 |
Wrong technique in product usage process, Product dose omission issue, Accidental exposure to product, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, NORTRIPTYLINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, FAMOTIDINE, |
||||
917 | 25024884 |
US |
2 | |
Device leakage, Exposure via skin contact, Accidental exposure to product, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
918 | 25025345 |
CN |
||
Needle issue, Accidental exposure to product, Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
919 | 25025525 |
US |
2 | |
Device malfunction, Accidental exposure to product, Incorrect dose administered by device, |
||||
GUSELKUMAB, |
||||
920 | 25015401 |
US |
1 | |
Accidental exposure to product, Device deployment issue, Device leakage, Exposure via skin contact, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
921 | 25015415 |
US |
2 | |
Syringe issue, Accidental exposure to product, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
922 | 25015434 |
US |
72 | 1 |
Device difficult to use, Drug dose omission by device, Injection site haemorrhage, Accidental exposure to product, Dyspnoea, Rubber sensitivity, Injection site erythema, Memory impairment, |
||||
EVOLOCUMAB, EVOLOCUMAB, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, |
||||
923 | 25015983 |
US |
7 | 2 |
Accidental exposure to product, Toxicity to various agents, |
||||
SOTALOL HYDROCHLORIDE, WARFARIN, SOTALOL HYDROCHLORIDE, WARFARIN, |
||||
924 | 25016486 |
US |
20 | 2 |
Accidental exposure to product, Injection site pain, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
925 | 25016490 |
US |
45 | 2 |
Device deployment issue, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
926 | 25016965 |
US |
1 | |
Accidental exposure to product, Device deployment issue, Exposure via skin contact, |
||||
SECUKINUMAB, |
||||
927 | 25017429 |
CA |
84 | 2 |
Haematochezia, Hot flush, Blood pressure systolic increased, Arthralgia, Skin swelling, Erythema, Heart rate increased, Dyspnoea, Joint swelling, Blood pressure increased, Oropharyngeal pain, Throat clearing, Accidental exposure to product, Exposure via skin contact, Wrong technique in product usage process, Incorrect dose administered, Musculoskeletal stiffness, Walking aid user, Fatigue, Blood pressure decreased, Throat irritation, |
||||
ETANERCEPT, PREDNISONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, CALCIUM, |
||||
928 | 25017499 |
US |
2 | |
Injection site pain, Accidental exposure to product, Drug dose omission by device, Device issue, |
||||
SECUKINUMAB, |
||||
929 | 25017777 |
US |
70 | 2 |
Device difficult to use, Accidental exposure to product, Incorrect dose administered by device, Injection site bruising, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
930 | 25018012 |
US |
71 | 2 |
Injection site pain, Exposure via skin contact, Wrong technique in device usage process, Accidental exposure to product, Underdose, |
||||
MEPOLIZUMAB, |
||||
931 | 25018036 |
US |
2 | |
Injection site pain, Accidental exposure to product, Device leakage, Drug delivery system malfunction, Exposure via skin contact, |
||||
SECUKINUMAB, |
||||
932 | 25018116 |
US |
2 | |
Device malfunction, Accidental exposure to product, Device leakage, Drug dose omission by device, Exposure via skin contact, |
||||
SECUKINUMAB, |
||||
933 | 25018261 |
US |
40 | 2 |
Device difficult to use, Drug dose omission by device, Injury associated with device, Accidental exposure to product, Wrong technique in product usage process, Therapeutic product effect incomplete, Injection site pain, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
934 | 25018588 |
US |
2 | |
Accidental exposure to product, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
935 | 25019139 |
US |
84 | 2 |
Accidental exposure to product, Injection site haemorrhage, Inappropriate schedule of product administration, |
||||
TOCILIZUMAB-AAZG, SITAGLIPTIN, LISINOPRIL, MEMANTINE, MEMANTINE HYDROCHLORIDE, OXYBUTYNIN, |
||||
936 | 25019537 |
CN |
||
Device issue, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
937 | 25020258 |
US |
2 | |
Exposure via skin contact, Accidental exposure to product, Device leakage, |
||||
SOMATROPIN, |
||||
938 | 25020814 |
US |
71 | 2 |
Injury associated with device, Accidental exposure to product, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
939 | 25020896 |
US |
||
Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, Device leakage, |
||||
SECUKINUMAB, |
||||
940 | 25020898 |
US |
40 | |
Panic reaction, Needle issue, Accidental exposure to product, Injection site nodule, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
941 | 25011151 |
US |
41 | 2 |
Injection site erythema, Accidental exposure to product, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
942 | 25011163 |
US |
1 | |
Device issue, Accidental exposure to product, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
943 | 25011451 |
US |
||
Injection site pain, Device use issue, Product dose omission issue, Accidental exposure to product, |
||||
TEZEPELUMAB-EKKO, |
||||
944 | 25011992 |
US |
25 | 2 |
Device malfunction, Accidental exposure to product, Inappropriate schedule of product administration, |
||||
SECUKINUMAB, VITAMIN C, |
||||
945 | 25012297 |
US |
61 | 1 |
Device difficult to use, Accidental exposure to product, Incorrect dose administered by device, Product communication issue, Injection site bruising, |
||||
EVOLOCUMAB, |
||||
946 | 25012487 |
US |
15 | 2 |
Accidental exposure to product, Product dose omission issue, No adverse event, Device leakage, |
||||
OMALIZUMAB, |
||||
947 | 25012522 |
US |
1 | |
Accidental exposure to product, Device deployment issue, Device leakage, Exposure via skin contact, |
||||
OFATUMUMAB, |
||||
948 | 25012541 |
US |
42 | 2 |
Rheumatoid arthritis, Drug dose omission by device, Device difficult to use, Accidental exposure to product, Wrong technique in product usage process, |
||||
ETANERCEPT, ETANERCEPT, |
||||
949 | 25013187 |
US |
2 | |
Device delivery system issue, Accidental exposure to product, Drug dose omission by device, Injection site pain, |
||||
SECUKINUMAB, |
||||
950 | 25013232 |
US |
74 | 2 |
Injury associated with device, Wrong technique in product usage process, Accidental exposure to product, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
951 | 25014401 |
US |
28 | 1 |
Device malfunction, Device mechanical issue, Device leakage, Accidental exposure to product, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
952 | 25014856 |
US |
52 | 2 |
Exposure via skin contact, Wrong technique in device usage process, Accidental exposure to product, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
953 | 25015210 |
US |
||
Accidental exposure to product, Device leakage, Device malfunction, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
954 | 25015233 |
US |
75 | 2 |
Accidental exposure to product, Product communication issue, Drug dose omission by device, Incorrect disposal of product, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
955 | 25015273 |
US |
65 | 2 |
Wrong technique in product usage process, Accidental exposure to product, Drug dose omission by device, Device use error, Therapy interrupted, |
||||
ETANERCEPT, ETANERCEPT, |
||||
956 | 25015314 |
US |
73 | 2 |
COVID-19, Accidental exposure to product, Product container issue, |
||||
SOMATROPIN, |
||||
957 | 25007769 |
US |
56 | 1 |
Accidental exposure to product, Wrong technique in product usage process, Injury associated with device, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
958 | 25007930 |
US |
54 | 2 |
Injection site pain, Device difficult to use, Accidental exposure to product, Incorrect dose administered by device, |
||||
ERENUMAB-AOOE, |
||||
959 | 25008061 |
US |
44 | 2 |
Injection site swelling, Injection site pain, Accidental exposure to product, Incorrect dose administered by device, |
||||
ETANERCEPT, |
||||
960 | 25008102 |
US |
||
Accidental exposure to product, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
961 | 25008647 |
US |
36 | 2 |
Burning sensation, Device malfunction, Accidental exposure to product, |
||||
FREMANEZUMAB-VFRM, |
||||
962 | 25008801 |
US |
40 | 2 |
Accidental exposure to product, Needle issue, Device leakage, Drug dose omission by device, |
||||
SECUKINUMAB, IRON, NIFEDIPINE, HYDROCHLOROTHIAZIDE, SPIRONOLACTONE, |
||||
963 | 25008912 |
US |
55 | 1 |
Accidental exposure to product, Device difficult to use, Therapy interrupted, Device use error, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
964 | 25009668 |
US |
27 | 2 |
Device use error, Accidental exposure to product, Drug dose omission by device, Device difficult to use, Therapy interrupted, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
965 | 25009755 |
US |
74 | 1 |
Unintentional medical device removal, Accidental exposure to product, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
966 | 25010018 |
US |
64 | 2 |
Injection site haemorrhage, Exposure via skin contact, Accidental exposure to product, |
||||
MEPOLIZUMAB, MEPOLIZUMAB, |
||||
967 | 25010051 |
US |
2 | |
Accidental exposure to product, Drug delivery system malfunction, Drug dose omission by device, Exposure via skin contact, |
||||
SECUKINUMAB, |
||||
968 | 25010080 |
US |
67 | 1 |
Product dose omission issue, Device issue, Accidental exposure to product, Injection site haemorrhage, |
||||
GUSELKUMAB, |
||||
969 | 25010740 |
US |
45 | 2 |
Device malfunction, Accidental exposure to product, Needle issue, Device leakage, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
970 | 25010857 |
US |
53 | 1 |
Device placement issue, Accidental exposure to product, Device leakage, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
971 | 25010890 |
US |
85 | 2 |
Visual impairment, Eye disorder, Exposure via skin contact, Accidental exposure to product, Product delivery mechanism issue, Circumstance or information capable of leading to medication error, Product prescribing issue, Product container issue, Product complaint, Product physical consistency issue, Product use complaint, Poor quality product administered, |
||||
PERFLUOROHEXYLOCTANE, WHITE PETROLATUM MINERAL OIL, |
||||
972 | 25010978 |
US |
75 | 2 |
Eye irritation, Drug dose omission by device, Accidental exposure to product, |
||||
EVOLOCUMAB, |
||||
973 | 25001743 |
US |
22 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
974 | 25001754 |
US |
14 | 2 |
Injury associated with device, Accidental exposure to product, Exposure via skin contact, Needle issue, |
||||
DUPILUMAB, |
||||
975 | 25001813 |
US |
||
Accidental exposure to product, Product dose omission issue, Needle issue, |
||||
GUSELKUMAB, |
||||
976 | 25001820 |
US |
9 | 2 |
Accidental exposure to product, Exposure via skin contact, Off label use, |
||||
DUPILUMAB, |
||||
977 | 25001870 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
978 | 25002104 |
US |
65 | 2 |
Product quality issue, Device defective, Accidental exposure to product, Wrong technique in product usage process, Device defective, Inappropriate schedule of product administration, Circumstance or information capable of leading to device use error, No adverse event, |
||||
TOCILIZUMAB, HYDROXYCHLOROQUINE SULFATE, PREGABALIN, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL, |
||||
979 | 25002114 |
US |
1 | |
Accidental exposure to product, Exposure via skin contact, Device deployment issue, Device leakage, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
980 | 25002311 |
US |
40 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
981 | 25002366 |
US |
36 | 2 |
Device use issue, Product dose omission issue, Exposure via skin contact, Accidental exposure to product, Device malfunction, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
982 | 25002488 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
983 | 25002557 |
US |
42 | 2 |
Retching, Odynophagia, Injection site urticaria, Injection site rash, Injection site pain, Injection site swelling, Eosinophilic oesophagitis, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
984 | 25002645 |
US |
69 | 2 |
Therapy non-responder, Fatigue, Accidental exposure to product, Wrong technique in product usage process, Injury associated with device, Drug dose omission by device, |
||||
EVOLOCUMAB, ROSUVASTATIN, |
||||
985 | 25002784 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
INSULIN GLARGINE, |
||||
986 | 25002927 |
GB |
||
Pneumothorax, Ocular hyperaemia, Adverse event, Exposure via skin contact, Accidental exposure to product, Wrong technique in product usage process, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
987 | 25003063 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
988 | 25003268 |
US |
44 | 2 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
989 | 25003304 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
990 | 25003438 |
US |
39 | 2 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
991 | 25003465 |
US |
68 | 1 |
Exposure via skin contact, Accidental exposure to product, Device use error, Accidental underdose, Product use in unapproved indication, Product use issue, Product complaint, |
||||
MEPOLIZUMAB, MEPOLIZUMAB, |
||||
992 | 25003796 |
US |
30 | 1 |
Choking, Abdominal discomfort, Vomiting, Accidental exposure to product, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, ALBUTEROL SULFATE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LEVOTHYROXINE, NAPROXEN, NAPROXEN SODIUM, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, VALSARTAN, QUETIAPINE, NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE, METHOCARBAMOL, METHOCARBAMOL TABLETS, |
||||
993 | 25003853 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, Device leakage, |
||||
SOMATROPIN, |
||||
994 | 25003927 |
US |
80 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
INSULIN GLARGINE, |
||||
995 | 25005415 |
US |
70 | 1 |
Respiratory distress, Ageusia, Anosmia, Insomnia, Injection site pain, Asthma, Secretion discharge, Cough, Oropharyngeal pain, Hypersensitivity, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
996 | 25005625 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, Product knowledge deficit, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
997 | 25006160 |
US |
2 | |
Abdominal pain upper, Burning sensation, Device malfunction, Device leakage, Muscle strain, Abdominal discomfort, Accidental exposure to product, |
||||
SECUKINUMAB, ERGOCALCIFEROL, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, FAMOTIDINE, LEVOTHYROXINE, |
||||
998 | 25006206 |
US |
65 | 2 |
Vulvovaginal burning sensation, Accidental exposure to product, |
||||
FREMANEZUMAB-VFRM, |
||||
999 | 25006464 |
US |
69 | 1 |
Injection site discomfort, Injection site haemorrhage, Accidental exposure to product, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
1000 | 25001222 |
US |
73 | |
Injection site haemorrhage, Throat irritation, Drug dose omission by device, Incorrect dose administered by device, Device delivery system issue, Device leakage, Accidental exposure to product, |
||||
EXENATIDE, |
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2025-04-28