Document text
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
BNT162b1 18-55 10 μg C4591001
1001
10011006 1 22 SKIN PAPULES ON RIGHT BASE OF THUMB AND WRIST TO
FOREARM, AND DERMATITIS ON THE RIGHT HAND.
C4591001
1001
10011006 2 7 SKIN BILATERAL ANTERIOR ARM / WRITSTS FAIRLY
ERYTHEMATOUS RASH, SCALY NOW, NON PRURITIC,
IMPROVED FROM PREVIOUS VISIT STILL ONGOING SINCE
16MAY2020
C4591001
1001
10011008 1 2 MUSCULOSKELETAL MINIMAL TENDERNESS AT INJECTION SITE
C4591001
1001
10011 008 2 13 ABDOMEN LEFT LOWER QUADRANT TENDERNESS
C4591001
1001
10011009 1 2 MUSCULOSKELETAL MILD TENDERNESS AT VACCINATION SITE
C4591001
1001
10011009 2 14 EYES L LATERAL ASPECT OF EYE - SLIGHT SWELLING AND
PROMINENT VESSELS
C4591001
1002
10021009 2 7 EXTREMITIES MINIMAL ECCHYMOSIS AT LEFT UPPER EXTREMITY
INJECTION SITE
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 1
FDA-CBER-2021-5683-0019398
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1002
10021013 2 7 EXTREMITIES MILD TENDERNESS AT INJECTION SITE. LEFT ARM
20 μg C4591001
1001
10011067 1 22 THROAT MILD POSTERIOR PHARYNGEAL ERYTHEMA WITH
COBBLESTONING
C4591001
1001
10011070
-8 EXTREMITIES LEFT LEG SWOLLEN COMPARED TO RIGHT WITHOUT
PITTING
C4591001
1001
10011076 1 21 SKIN LIGHT DESQUAMATION
C4591001
1002
10021081 1 2 MUSCULOSKELETAL MILD TENDERNESS TO PALPATION
C4591001
1002
10021081 1 2 SKIN NO ERYTHEMA OR SWELLING AT LEFT ARM INJECTION
SITE
30 μg C4591001
1001
10011011 1 2 EXTREMITIES LUE TENDERNESS, SWELLING, HYPERSENSITIVITY
C4591001
1001
10011011 1 2 SKIN LEFT UPPER ARM MILDLY HYPERSENSITIVE AND MILD
SOFT, TENDER SWELLING: 3CM AREA AROUND INJECTION
SITE; NO REDNESS; IT IS TENDER
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 2
FDA-CBER-2021-5683-0019399
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1001
10011011 2 8 MUSCULOSKELETAL .5CM ECHYMOSIS AT THE INJECTION SITE IN LEFT
DELTOID
C4591001
1001
10011015 1 2 HEART TACHYCARDIC
C4591001
1001
10011015 1 2 MUSCULOSKELETAL 5CM INDURATION AT SITE OF INJECTION (LUE - DELTOID
AREA)
C4591001
1001
10011020 1 2 SKIN SKIN: NO RASH NOTED. REDNESS MEASURING 18 UNITS ON
THE MEASURING DEVICE, WITH ERYTHEMA AT INJECTION
SITE IN LEFT DELTOID, MILD TENDERNESS TO PALPATION
OF INJECTION SITE. (PLEASE SEE AE NOTE)
C4591001
1002
10021014 1 2 EXTREMITIES RIGHT ARM WITH TEND ERNESS AT SITE OF INJECTION. NO
ERYTHEMA OR SWELLING. FULL RANGE OF MOTION
RIGHT SHOULDER
C4591001
1002
10021014 2 7 EXTREMITIES 5MM (0.5CM) RESOLVING ECCHYMOSIS RIGHT DELTOID
C4591001
1002
10021017 1 2 EXTREMITIES LEFT SHOULDER WITH MILD DECREASED RANGE OF
MOTION. NO ERYTHEMA/SWELLING
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 3
FDA-CBER-2021-5683-0019400
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1002
10021017 2 7 EXTREMITIES 1CM ECCHYMOSIS ARM AT LEFT DELTOID. NO
TENDERNESS OR REDNESS
C4591001
1002
10021020 1 2 EXTREMITIES TENDERNESS AT INJECTION SITE UP PER LEFT ARM. FULL
RANGE OF MOTION LEFT SHOULDER. NO ERYTHEMA OR
SWELLING
C4591001
1002
10021020 1 21 LYMPH NODES SHOTTY ANTERIOR CERVICAL LYMPHADENOPATHY
Placebo 18-55 Placebo C4591001
1002
10021022 2 7 SKIN BRUISING LEFT ARM AT INJECTION SITE
C4591001
1002
10021083 1 8 EXTREMITIES NO SWELLING
C4591001
1002
10021083 1 8 SKIN FAINT BRUISES, NON TENDER, NO NODULARY EDEMA
BNT162b1 65-85 10 μg C4591001
1001
10011037 1 2 EXTREMITIES MILD TENDERNESS TO PALPITATION OVER INJECTION SITE
C4591001
1001
10011039
-6 SKIN PAPULES ON BACK
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 4
FDA-CBER-2021-5683-0019401
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1001
10011039 1 1 SKIN RASH
C4591001
1001
10011040 2 8 MUSCULOSKELETAL LEFT WRIST EXCORIATION FROM WEARING GLOVES AND
WORKING
C4591001
1001
10011044 1 2 HEART IRREGULAR HR PART OF HIS MEDICAL HX
C4591001
1001
10011045
-6 MUSCULOSKELETAL ABLE TO LIFT ARMS AT SHOULDERS TO SLIGHTLY
BEYOND 90 DEGREES UNABLE TO BRING ARMS BEHIND
BACK, SLIGHT DEFORMITY OF RIGHT 2ND FINGER, MILDLY
ENLARGED FINGER JOINTS
C4591001
1001
10011045
-6 SKIN RAISED, RED, NON -BLANCHING, NON -SCALING PATCH
APPROXIM ATELY 2 CM IN DIAMETER BEHIND LEFT EAR
ON SCALP, NO OTHER RASHES
C4591001
1001
10011045 1 1 MUSCULOSKELETAL LIMITED ROM IN UPPER SHOULDER
C4591001
1001
10011045 2 15 MUSCULOSKELETAL 1 CM ECCHYMOSIS TO LEFT DELTOID
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 5
FDA-CBER-2021-5683-0019402
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1002
10021043 1 8 EXTREMITIES RIGHT THUMB BANDAGED/ STITCHES NO EDEMA
C4591001
1002
10021045 1 2 EXTREMITIES SMALL BRUISE AT INJECTION SITE LEFT ARM
20 μg C4591001
1001
10011050 1 2 EXTREMITIES MILD TENDERNESS WITH
C4591001
1001
10011055
-5 EXTREMITIES R 4TH MCP WITH SOME LIMITATION OF ROM
C4591001
1001
10011055 1 2 MUSCULOSKELETAL TENDERNESS AT INJECTION SITE, GUARDED ROM LUE
C4591001
1001
10011059 1 2 MUSCULOSKELETAL TENDERNESS PRESENT, MILD TENDERNESS TO
PALPATION, GUARDED ROM OF LUE
C4591001
1001
10011059 1 22 EXTREMITIES RIGHT LOWER LEG BELOW KNEE MILDLY SWOLLEN
COMPARED TO LEFT WITHOUT PITTING EDEMA, MILD
INDURATION OVER RIGHT UPPER LATERAL PORTION OF
THE LOWER LEG. ALL RELATED TO FRACTURE AS NOTED
IN AE
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 6
FDA-CBER-2021-5683-0019403
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1002
10021054 1 2 MUSCULOSKELETAL LEFT UPPER EXTREMI TY- TENDONS PALPATION
C4591001
1002
10021060 1 2 MUSCULOSKELETAL TENDER LEFT UPPER ARM TO PALPATION NO EDEMA NO
ERYTHEMA
C4591001
1002
10021060 1 8 SKIN RESOLVED DERMATOMAL RASH
C4591001
1002
10021068 2 9 EXTREMITIES RIGHT INJECTION SITE TENDERNESS TO PALPATION
C4591001
1002
10021071 1 2 EXTREMITIES TENDERNESS TO PALPATION LEFT ARM AT VACCINATION
SITE
30 μg C4591001
1001
10011046
-13 HEART MILD BRADYCARDIA
C4591001
1001
10011046
-13 MUSCULOSKELETAL OCCASIONAL PAIN IN RIGHT KNEE
C4591001
1001
10011046 2 15 EXTREMITIES RIGHT ELBOW WITH LARGE ERYTHEMA, EXCORIATION
COVERED WITH DRESSING, B/L PALMS WITH RESOLVING
EXCORIATIONS, R KNEE BRUISE AND R THIGH EDEMA
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 7
FDA-CBER-2021-5683-0019404
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1001
10011046 2 15 SKIN RIGHT ELBOW WITH LARGE ERYTHEMA, EXCORIATION
COVERED WITH DRESSING, B/L PALMS WITH RESOLVING
EXCORIATIONS, R KNEE BRUISE AND R THIGH EDEMA
C4591001
1001
10011048 1 2 MUSCULOSKELETAL MILD TENDERNESS
C4591001
1001
10011048 1 8 MUSCULOSKELETAL MILD BRUISING OF DELTOID, MILD DISCOLORATION, 1 CM
IN DIAMETER, CIRCULAR, NONTENDER
C4591001
1001
10011048 1 8 SKIN FAINT OUTLINE OF BANDAID VISIBLE
C4591001
1001
10011058 1 1 SKIN ECHYMOSIS IN IN MEDIAL LEFT ANTECUBITAL FOSSA
C4591001
1001
10011063 1 20 LYMPH NODES LEFT AXILLARY SUBCENTIMETER LYMPH NODE
C4591001
1001
10011063 2 7 EXTREMITIES LEFT ARM EXAM - SMALL SWELLING, NO ERYTHEMA,
MILD TENDERNESS ON PALPATION, 4X2CM, NO BLISTERS,
ABLE TO USE ARM WITHOUT ANY LIMITATIO N OF
MOVEMENT
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 8
FDA-CBER-2021-5683-0019405
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1002
10021062 2 9 SKIN FAINT ERYTHEMA NO SWELLING
C4591001
1002
10021074 1 2 EXTREMITIES MILD TENDERNESS AT INJECTION SITE, LEFT ARM
C4591001
1002
10021075 1 2 EXTREMITIES MILD INJECTION SITE TENDERNESS LEFT ARM
C4591001
1002
10021077 1 2 MUSCULOSKELETAL PAIN RAISING LEFT ARM
Placebo 65-85 Placebo C4591001
1001
10011042 1 2 SKIN LIGHT RED, NON -SCALY, NON -EXCORIATED RASH
AROUND THE EDGE OF THE BANDAGE SITE
C4591001
1001
10011053
-5 EXTREMITIES RIGHT HAND 5TH DIP (DISTAL INTERPHALANGEAL JOINT)
ABNORMAL RANGE OF MOTION
C4591001
1001
10011053 1 2 SKIN 3MM VESICULAR LESION ON LEFT LOWER LIP WITH NO
ASSOCIATED CELLULITIS
C4591001
1001
10011053 1 8 SKIN LEFT LOWER LIP WITH TWO LESIONS, CRUSTED CENTER
VESICLE WITH SURROUNDING ERYTHEMATOUS BASE
2MM IN SIZE, NON TENDER
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 9
FDA-CBER-2021-5683-0019406
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1001
10011057
-5 EARS TINNITUS
C4591001
1001
10011057
-5 MUSCULOSKELETAL MINIMAL CREPITUS AT FULL ROM L KNEE
C4591001
1001
10011064
-2 HEART BRADYCARDIA
BNT162b2 18-55 10 μg C4591001
1003
10031019 1 2 EXTREMITIES 10MM INDIRATION AT INJECTION SITE NO REDNESS
C4591001
1003
10031021 1 2 EXTREMITIES LEFT ARM SLIGHTLY WARM NO REDNESS
C4591001
1007
10071019 2 8 NOSE BILATERAL NASAL MUCOSAL ERYTHEMA; BILATERAL
CLEAR NASAL DRAINAGE
C4591001
1007
10071019 2 8 THROAT MILD ERYTHEMA; CLEAR DRAINAGE NOTED POSTERIOR
PHARYNX
20 μg C4591001
1003
10031028
-11 EXTREMITIES BRUISE ON LEFT LEG
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 10
FDA-CBER-2021-5683-0019407
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1003
10031028
-11 SKIN RESOLVING SUNBURN
C4591001
1003
10031028 2 8 SKIN HAS A LARGE FLAT RED RASH ON RIGHT
SUPRACLAVICULA ALSO ON UPPER BACK.
C4591001
1007
10071026 2 8 SKIN SCATTERED, MILDLY ERYTHEMATOUS PAPULAR RASH
OVER THE RIGHT UPPER CHEST, APPROXIMATELY 3 -4 CM
IN DIAMETER. SIMILAR, PATCHY, MILDLY
ERYTHEMATOUS PAPULAR RASH TO THE RIGHT SIDE OF
HER FOREHEAD, TEMPLE
C4591001
1007
10071027 1 2 EXTREMITIES INJECTION SI TE WITH MODERATE TENDERNESS
30 μg C4591001
1003
10031061 1 2 SKIN SWEATY
C4591001
1003
10031072
-5 EYES CONGENITAL NYSTAGMUS
C4591001
1003
10031072
-5 NEUROLOGICAL CONGENITAL NYSTAGMUS
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 11
FDA-CBER-2021-5683-0019408
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
C4591001
1003
10031072 1 2 EXTREMITIES FAINT AREA 5CM OF REDDNESS OVER VACCINE SITE
C4591001
1007
10071050 2 4 LYMPH NODES HAS 1X2 CM NON -TENDER, MOBILE NODE IN RIGHT
AXILLAE
C4591001
1007
10071064
-9 SKIN MILD ROSACEA BILATERAL CHEEKS
Placebo 18-55 Placebo C4591001
1007
10071020
-7 EXTREMITIES RIGHT ANKLE WITH PAIN ON INVERSION STARTED
02JUN2020 AFTER NEW YOGA ROUTINE; MILD TINGLING IN
RIGHT GREAT TOE; RESOLVING TODAY; EXAM NORMAL.
C4591001
1007
10071025 1 22 SKIN RIGHT LOWER VERMILION BORDER WITH A 4MM AND
6MM NONERYTHEMATOUS, ROUND LESI ON WITH CLEAR
BORDER AND THIN CRUST
C4591001
1007
10071065
-9 SKIN 2 BY 2 INCH PATCH OF POISON IVY LEFT UPPER INNER
ARM.
C4591001
1007
10071065 1 1 SKIN 3CM AREA ON LEFT MEDIAL THIGH WITH LIGHT GREENISH
ECCHYMOSIS AND SCATTERED ERYTHEMATOUS PAPULES
WITHIN A 6CM AREA
BNT162b2 65-85 10 μg C4591001
1003
10031076 2 8 LYMPH NODES SINGLE LEFT AXILLARY NODE - NOT TENDER
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 12
FDA-CBER-2021-5683-0019409
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
20 μg C4591001
1003
10031035 2 15 LYMPH NODES LEFT AUXILIARY NODE 1 CM - NOT TENDER
C4591001
1003
10031063 1 3 EXTREMITIES BRUISES ON LEFT ARM FROM WORKING ON LAWN MOWER
C4591001
1007
10071052 1 2 MUSCULOSKELETAL RUQ MILD ABDOMINAL TENDERNESS
30 μg C4591001
1003
10031058 1 1 THROAT LEFT LOWER GUM MILD SWELLING
C4591001
1007
10071043 1 22 MUSCULOSKELETAL PAIN IN LEFT HIP WITH STANDING AND TRUNCAL
ROTATION
C4591001
1007
10071043 1 22 EXTREMITIES PAIN RADIATING DOWN LEFT LATERAL THIGH
Placebo 65-85 Placebo C4591001
1003
10031036 1 22 LYMPH NODES VERY SMALL LEFT AXILLARY NODE NOT TENDER
C4591001
1003
10031083 1 7 MUSCULOSKELETAL TENDER AT THE ANTERIOR OUTER RIGHT MID THORACIC
RIBS
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 13
FDA-CBER-2021-5683-0019410
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
System Descriptio n
a. Relative Day (Rel Day) = date of physical examination - date of last vaccination + 1. For a physical examination that occurred before the date of the
first study vaccination, + 1 was not added to compute relative day.
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:33) Source Data: adpe Table Generation: 02SEP2020 (12:06)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001_IA_P1/adpe_l001_abn_p1
090177e194d78553\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 14
FDA-CBER-2021-5683-0019411
16.2.5.2.1.1 Listing of Physical Examination With Abnormal Finding Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
Syste m Description
BNT162b1 18-55 100 μg C4591001
1001
10011028 1 38 SKIN MACULAR RASH ON EXPOSED BILATERAL ARMS, UPPER
CHEST
C4591001
1001
10011030 1 2 MUSCULOSKELETAL MILD TENDERNESS TO PALPATION
C4591001
1001
10011032 1 2 EXTREMITIES L ARM: 3X5CM TENDER SWELLING
C4591001
1001
10011034 1 2 MUSCULOSKELETAL TENDERNESS IS PRESENT WITH PALPITATION OF
INJECTION SITE IN LEFT DELTOID. NO REDNESS OR
SWELLING. THIS IS ABNORMAL AND NOT CLINICALLY
SIGN IFICANT
C4591001
1002
10021023 1 1 EXTREMITIES LEFT UPPER ARM HEMANGIOMA
C4591001
1002
10021023 1 2 EXTREMITIES TENDERNESS TO DIRECT PALPATION AT INJECTION SITE
C4591001
1002
10021024 1 2 EXTREMITIES TENDERNESS TO LEFT ARM WITH PALPATION
090177e194fbc503\Final\Final On: 22-Sep-2020 14:25 (GMT)
Page 15
FDA-CBER-2021-5683-0019412
16.2.5.2.1.1 Listing of Physical Examination With Abnormal Finding Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Dose
No. Rel
Daya Body
Syste m Description
C4591001
1002
10021027 1 2 EXTREMITIES TENDERNESS UPON PALPATION AT LEFT ARM
C4591001
1002
10021034 1 2 EXTREMITIES SORENESS/TENDERNESS AT INJECTION SITE LEFT ARM
C4591001
1002
10021035 1 2 EXTREMITIES TENDERNESS TO PALPATION AT LEFT ARM
C4591001
1002
10021036 1 2 EXTREMITIES TENDER TO PALPATION AT LEFT ARM
C4591001
1002
10021036 1 28 HEAD TENDERNESS OVER MAXILLARY SINUS
Placebo 18-55 Placebo C4591001
1001
10011013
-13 SKIN POSITIVE FOR RASHES
a. Relative Day (Rel Day) = date of physical examination - date of last vaccination + 1. For a physical examination that occurred before the date of the
first study vaccination, + 1 was not added to compute relative day.
PFIZER CONFIDENTIAL SDTM Creation: 28A UG2020 (16:33) Source Data: adpe Table Generation: 18SEP2020 (19:42)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001 IA P1 100/adpe l001 abn 100 p1
090177e194fbc503\Final\Final On: 22-Sep-2020 14:25 (GMT)
Page 16
FDA-CBER-2021-5683-0019413
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
16-55 C4591001
1012
10121103 2 22SEP2020 Product
administration
error DOSE NOT
CHANGED N N 22SEP2020 Y N
C4591001
1024
10241002 1 12AUG2020 Product storage
error DOSE NOT
CHANGED N N 12AUG2020 N N
2 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241004 1 12AUG2020 Product storage
error DOSE NOT
CHANGED N N 12AUG2020 N N
2 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1024
10241006 1 12AUG2020 Product storage
error DOSE NOT
CHANGED N N 12AUG2020 N N
2 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1024
10241009 1 13AUG2020 Product storage
error DOSE NOT
CHANGED N N 13AUG2020 N N
C4591001
1024
10241014 1 13AUG2020 Product storage
error DOSE NOT
CHANGED N N 13AUG2020 N N
2 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241015 1 13AUG2020 Product storage
error DOSE NOT
CHANGED N N 13AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 17
FDA-CBER-2021-5683-0019414
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1024
10241021 1 14AUG2020 Product storage
error DOSE NOT
CHANGED N N 14AUG2020 N N
C4591001
1024
10241023 1 14AUG2020 Product storage
error DOSE NOT
CHANGED N N 14AUG2020 N N
2 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1024
10241032 1 17AUG2020 Product storage
error DOSE NOT
CHANGED N N 17AUG2020 N N
C4591001
1024
10241033 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241039 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241040 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241042 1 19AUG2020 Product storage
error DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1024
10241044 1 19AUG2020 Product storage
error DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1024
10241046 1 19AUG2020 Product storage
error DOSE NOT
CHANGED N N 19AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 18
FDA-CBER-2021-5683-0019415
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1024
10241054 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1024
10241055 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1024
10241061 1 21AUG2020 Product storage
error DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1024
10241066 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241067 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241071 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241072 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1024
10241074 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1024
10241078 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1024
10241084 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 19
FDA-CBER-2021-5683-0019416
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1024
10241085 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1024
10241091 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1024
10241094 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1024
10241100 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1024
10241102 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1024
10241104 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241108 1 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441001 2 02SEP2020 Product
temperature
excursion issue DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441015 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441028
24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 20
FDA-CBER-2021-5683-0019417
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1044
10441029 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1044
10441031 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1044
10441034 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441037 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441045 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441048
27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441050 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441052 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1044
10441054 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1044
10441060 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 21
FDA-CBER-2021-5683-0019418
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1044
10441063 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1044
10441068 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1044
10441071 1 02SEP2020 Product storage
error DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441076 1 03SEP2020 Product storage
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1044
10441079 1 04SEP2020 Product storage
error DOSE NOT
CHANGED N N 04SEP2020 N N
C4591001
1044
10441088 1 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1044
10441089 1 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1068
10681002 1 18AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1068
10681003 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681006 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 22
FDA-CBER-2021-5683-0019419
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681010 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681011 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681012 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681013 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681016 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681017 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681018 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681021 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681024 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681025 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 23
FDA-CBER-2021-5683-0019420
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681026 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681027 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681028 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681031 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681034 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681035 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681036 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681037 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681038 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681042 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 24
FDA-CBER-2021-5683-0019421
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681046 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681047 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681052 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681053 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681058 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681060 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681061 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681064 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681066 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681071 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 25
FDA-CBER-2021-5683-0019422
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681072 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681073 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681074 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681076 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681077 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681080 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681081 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681083 1 01SEP2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1079
10791130 1 17AUG2020 Wrong product
administered DRUG
WITHDRAWN N N 17AUG2020 N N
C4591001
1088
10881077 2 11SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 11SEP2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 26
FDA-CBER-2021-5683-0019423
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1090
10901334 1 03SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1091
10911005 1 30JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 30JUL2020 N N
C4591001
1091
10911008 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1091
10911014 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1091
10911015 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1116
11161226 1 11SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 11SEP2020 N N
C4591001
1126
11261053 1 20AUG2020 Expired product
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1141
11411011 2 21AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1141
11411014 1 03AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1141
11411023 2 25AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 25AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 27
FDA-CBER-2021-5683-0019424
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1141
11411065 1 12AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 12AUG2020 N N
C4591001
1141
11411068 1 12AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 12AUG2020 N N
C4591001
1141
11411080 1 14AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 14AUG2020 N N
C4591001
1141
11411093 1 18AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1141
11411139 1 27AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1146
11461196 1 03SEP2020 Product
administration
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1161
11611015 1 01AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 01AUG2020 N N
C4591001
1163
11631006 1 31JUL2020 Product
administration
error DRUG
WITHDRAWN N N 31JUL2020 N N
C4591001
1163
11631039 1 06AUG2020 Expired product
administered DOSE NOT
CHANGED N N 06AUG2020 N N
C4591001
1163
11631096 1 12AUG2020 Expired product
administered DOSE NOT
CHANGED N N 12AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 28
FDA-CBER-2021-5683-0019425
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1163
11631117 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631121 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1163
11631124 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631127 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631136 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631142 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1163
11631145 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1231
12313428 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313429 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313449 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 29
FDA-CBER-2021-5683-0019426
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1231
12313456 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313459 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313467 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313469 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313479 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313483 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313486 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313487 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313492 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313497 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 30
FDA-CBER-2021-5683-0019427
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1231
12313498 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313501 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313505 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313506 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313508 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313509 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313512 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313514 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313515 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313517 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 31
FDA-CBER-2021-5683-0019428
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1231
12313518 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313519 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313528 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313533 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313534 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313537 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313541 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313542 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313546 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313551 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 32
FDA-CBER-2021-5683-0019429
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1231
12313553 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313554 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313556 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313564 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313567 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1254
12541005 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1254
12541008 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1254
12541023 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541027 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1254
12541029 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 33
FDA-CBER-2021-5683-0019430
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1254
12541030 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1254
12541033 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1254
12541035 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1254
12541038 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1254
12541040 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1260
12601002 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1260
12601005 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1260
12601006 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1260
12601009 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1260
12601013 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 34
FDA-CBER-2021-5683-0019431
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1260
12601014 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1260
12601016 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1260
12601017 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1260
12601029 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1260
12601032 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1260
12601036 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
>55 C4591001
1003
10031120 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1024
10241003 1 12AUG2020 Product storage
error DOSE NOT
CHANGED N N 12AUG2020 N N
2 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1024
10241010 1 13AUG2020 Product storage
error DOSE NOT
CHANGED N N 13AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 35
FDA-CBER-2021-5683-0019432
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1024
10241018 1 14AUG2020 Product storage
error DOSE NOT
CHANGED N N 14AUG2020 N N
C4591001
1024
10241019 1 14AUG2020 Product storage
error DOSE NOT
CHANGED N N 14AUG2020 N N
C4591001
1024
10241031 1 17AUG2020 Product storage
error DOSE NOT
CHANGED N N 17AUG2020 N N
C4591001
1024
10241037 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241041 1 18AUG2020 Product storage
error DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1024
10241049 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1024
10241057 1 21AUG2020 Product storage
error DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1024
10241059 1 21AUG2020 Product storage
error DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1024
10241065 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1024
10241068 1 24AUG2020 Product storage
error DOSE NOT
CHANGED N N 24AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 36
FDA-CBER-2021-5683-0019433
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1024
10241077 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1024
10241081 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1024
10241083 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1024
10241087 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1024
10241096 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1024
10241097 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1037
10371356 2 12NOV2020 Expired product
administered DOSE NOT
CHANGED N N 12NOV2020 N N
C4591001
1044
10441002 2 02SEP2020 Product
temperature
excursion issue DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441004 2 02SEP2020 Product
temperature
excursion issue DOSE NOT
CHANGED N N 02SEP2020 N N
C4591001
1044
10441007 2 05SEP2020 Product storage
error DOSE NOT
CHANGED N N 05SEP2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 37
FDA-CBER-2021-5683-0019434
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1044
10441010 2 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1044
10441016 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441018 1 20AUG2020 Product storage
error DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1044
10441032 1 25AUG2020 Product storage
error DOSE NOT
CHANGED N N 25AUG2020 N N
C4591001
1044
10441036 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441041 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1044
10441047 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441049 1 27AUG2020 Product storage
error DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1044
10441055 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1044
10441062 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 38
FDA-CBER-2021-5683-0019435
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1044
10441067 1 01SEP2020 Product storage
error DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1044
10441073 1 03SEP2020 Product storage
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1044
10441075 1 03SEP2020 Product storage
error DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1044
10441080 1 04SEP2020 Product storage
error DOSE NOT
CHANGED N N 04SEP2020 N N
C4591001
1044
10441083 1 04SEP2020 Product storage
error DOSE NOT
CHANGED N N 04SEP2020 N N
C4591001
1044
10441085 1 05SEP2020 Product storage
error DOSE NOT
CHANGED N N 05SEP2020 N N
C4591001
1044
10441090 1 06SEP2020 Product storage
error DOSE NOT
CHANGED N N 06SEP2020 N N
C4591001
1044
10441092 1 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441093 1 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1044
10441094 1 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 39
FDA-CBER-2021-5683-0019436
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1054
10541024 2 10OCT2020 Wrong product
administered DOSE NOT
CHANGED N N 10OCT2020 N N
C4591001
1068
10681001 1 18AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 18AUG2020 N N
C4591001
1068
10681004 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681005 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681007 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681008 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681009 1 19AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 19AUG2020 N N
C4591001
1068
10681014 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681015 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
C4591001
1068
10681019 1 20AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 20AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 40
FDA-CBER-2021-5683-0019437
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681020 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681022 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681023 1 21AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 21AUG2020 N N
C4591001
1068
10681029 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681030 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681032 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681033 1 24AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 24AUG2020 N N
C4591001
1068
10681039 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681040 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681041 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 41
FDA-CBER-2021-5683-0019438
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681043 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681044 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681045 1 26AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1068
10681050 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681051 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681054 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681055 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681056 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681057 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
C4591001
1068
10681059 1 27AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 27AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 42
FDA-CBER-2021-5683-0019439
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1068
10681062 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681063 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681065 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681068 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681069 1 28AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1068
10681075 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681078 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681079 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681082 1 31AUG2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1068
10681084 1 01SEP2020 Incorrect dosage
administered DOSE NOT
CHANGED N N 01SEP2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 43
FDA-CBER-2021-5683-0019440
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1081
10811053 2 09SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1091
10911001 1 30JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 30JUL2020 N N
C4591001
1091
10911004 1 30JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 30JUL2020 N N
C4591001
1091
10911010 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1091
10911012 1 31JUL2020 Incorrect dose
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1121
11211071 1 03SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 03SEP2020 N N
C4591001
1129
11291091 2 01SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 01SEP2020 N N
C4591001
1141
11411066 1 12AUG2020 Incorrect dose
administered DOSE NOT
CHANGED N N 12AUG2020 N N
C4591001
1163
11631003 1 31JUL2020 Expired product
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1163
11631005 1 31JUL2020 Product
administration
error DRUG
WITHDRAWN N N 31JUL2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 44
FDA-CBER-2021-5683-0019441
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1163
11631007 1 31JUL2020 Expired product
administered DOSE NOT
CHANGED N N 31JUL2020 N N
C4591001
1163
11631008 1 31JUL2020 Product
administration
error DRUG
WITHDRAWN N N 31JUL2020 N N
C4591001
1163
11631010 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1163
11631011 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1163
11631013 1 03AUG2020 Product
administration
error DOSE NOT
CHANGED N N 03AUG2020 N N
C4591001
1163
11631126 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631131 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631132 2 08SEP2020 Product storage
error DOSE NOT
CHANGED N N 08SEP2020 N N
C4591001
1163
11631133 2 10SEP2020 Product storage
error DOSE NOT
CHANGED N N 10SEP2020 N N
C4591001
1163
11631144 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 45
FDA-CBER-2021-5683-0019442
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1163
11631149 2 09SEP2020 Product storage
error DOSE NOT
CHANGED N N 09SEP2020 N N
C4591001
1177
11771089 2 09SEP2020 Wrong product
administered DOSE NOT
CHANGED N N 09SEP2020 N Y
C4591001
1231
12311057 1 11AUG2020 Product
dispensing error DOSE NOT
CHANGED N N 11AUG2020 N N
C4591001
1231
12313446 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313461 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313468 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313478 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313480 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313496 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313503 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0019443
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1231
12313511 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313524 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313530 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313536 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313538 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313549 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1231
12313562 1 23AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 23AUG2020 N N
C4591001
1254
12541002 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1254
12541004 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1254
12541010 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0019444
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1254
12541011 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1254
12541014 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541016 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541018 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541019 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541025 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541026 1 28AUG2020 Product storage
error DOSE NOT
CHANGED N N 28AUG2020 N N
C4591001
1254
12541037 1 29AUG2020 Product storage
error DOSE NOT
CHANGED N N 29AUG2020 N N
C4591001
1260
12601003 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
C4591001
1260
12601008 1 26AUG2020 Product storage
error DOSE NOT
CHANGED N N 26AUG2020 N N
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 48
FDA-CBER-2021-5683-0019445
16.2.5.4 Listing of Medication Errors – All Subject s
Age
Group
(Years) Subject Dose
No.a Start
Date Type of
Medication
Error Action Taken Was a
Concomitant
Medication
Given
(Yes/No) Was the
Non-Drug
Treatment
Given
(Yes/No) Stop
Date Discontinued
From Study
(Yes/No) Medication Error
Associated AE
(Yes/No)
C4591001
1260
12601025 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1260
12601026 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1260
12601027 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1260
12601033 1 31AUG2020 Product storage
error DOSE NOT
CHANGED N N 31AUG2020 N N
C4591001
1265
12651026 1 31AUG2020 Wrong product
administered DOSE NOT
CHANGED N N 31AUG2020 N N
Note: Data for subjects randomized on or after 10OCT2020 are included to comprehensively show all data reported but are subje ct to change with
additional follow -up.
Note: † = HIV -positive subject.
a. Dose No. = the vaccination visit at which the medica tion error occurred.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (09:48) Source Data: adae Table Generation: 18NOV2020 (10:07)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_IA_P3_2MPD2/adae_l002_me_all_p3
090177e1959b0fdf\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 49
FDA-CBER-2021-5683-0019446