VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1635204
Sex: F
Age: 24
State: OH

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Pressure in head; Muscle contractions in both arms; Tingling in arms and legs; Light headedness; This spontaneous case was reported by a medical assistant and describes the occurrence of HEAD DISCOMFORT (Pressure in head), MUSCLE TWITCHING (Muscle contractions in both arms), PARAESTHESIA (Tingling in arms and legs) and DIZZINESS (Light headedness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Pressure in head), MUSCLE TWITCHING (Muscle contractions in both arms), PARAESTHESIA (Tingling in arms and legs) and DIZZINESS (Light headedness). At the time of the report, HEAD DISCOMFORT (Pressure in head), MUSCLE TWITCHING (Muscle contractions in both arms), PARAESTHESIA (Tingling in arms and legs) and DIZZINESS (Light headedness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient's doctor ordered an MRI to look further into symptoms. no concomitant medication provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1635205
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: patient received dose from vial that experience temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose from vial that experience temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose from vial that experience temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose from vial that experience temperature excursion) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant medication was reported no treatment medication was reported

Other Meds:

Current Illness:

ID: 1635206
Sex: M
Age: 59
State: MD

Vax Date: 03/15/2021
Onset Date: 03/19/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Potential third dose administration; Possible dose administered outside of temperature range; soreness; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), HEADACHE (Headache), TEMPERATURE INTOLERANCE (Possible dose administered outside of temperature range) and DEVICE USE CONFUSION (Potential third dose administration) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031721A and 046A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN (soreness) and HEADACHE (Headache). On 12-Apr-2021, the patient experienced TEMPERATURE INTOLERANCE (Possible dose administered outside of temperature range). On 19-Apr-2021, the patient experienced DEVICE USE CONFUSION (Potential third dose administration). At the time of the report, PAIN (soreness) and HEADACHE (Headache) had resolved and TEMPERATURE INTOLERANCE (Possible dose administered outside of temperature range) and DEVICE USE CONFUSION (Potential third dose administration) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Tylenol. Concomitant medications were not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-080352 (E2B Linked Report).; Reporter's Comments: The consumer is taking Tylenol, as advised by their HCP to try to alleviate the symptoms.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080352:1st dose case

Other Meds:

Current Illness:

ID: 1635207
Sex: F
Age: 77
State: IL

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Swelling on injection site; Swelling several inches below injection site; Red inflammation; Red inflammation; Swellings were hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling on injection site), SWELLING (Swelling several inches below injection site), VACCINATION SITE ERYTHEMA (Red inflammation), INFLAMMATION (Red inflammation) and INDURATION (Swellings were hard) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included CALCIUM for an unknown indication, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID). On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling on injection site), SWELLING (Swelling several inches below injection site), VACCINATION SITE ERYTHEMA (Red inflammation), INFLAMMATION (Red inflammation) and INDURATION (Swellings were hard). At the time of the report, VACCINATION SITE SWELLING (Swelling on injection site), SWELLING (Swelling several inches below injection site), VACCINATION SITE ERYTHEMA (Red inflammation) and INFLAMMATION (Red inflammation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications includes:Blood pressure meds Heart meds Meds for restless leg syndrome Osteoporosis meds Antibiotics, there is no treatment povided Reporter did not allow further contact

Other Meds: CALCIUM; VITAMIN B12 & FOLIC ACID

Current Illness:

ID: 1635208
Sex: M
Age: 43
State: GA

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Smelling constant chemical smell; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smelling constant chemical smell) and HEADACHE (Headache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headache). On 14-Apr-2021, the patient experienced PAROSMIA (Smelling constant chemical smell). At the time of the report, PAROSMIA (Smelling constant chemical smell) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1635209
Sex: M
Age: 39
State: OR

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: vaccination was not entirely thawed to room temp; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (vaccination was not entirely thawed to room temp) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history). On 18-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021 at 8:00 AM, the patient experienced PRODUCT STORAGE ERROR (vaccination was not entirely thawed to room temp). On 18-Jan-2021 at 8:00 AM, PRODUCT STORAGE ERROR (vaccination was not entirely thawed to room temp) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided/unknown by the reporter. Treatment information was not provided/unknown.

Other Meds:

Current Illness:

ID: 1635210
Sex: F
Age:
State: FL

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Arm pain; Little headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and HEADACHE (Little headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and HEADACHE (Little headache). At the time of the report, PAIN IN EXTREMITY (Arm pain) and HEADACHE (Little headache) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient did not have any pre-existing medical condition. No concomitant mediations were reported. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-081274 (E2B Linked Report). This case was linked to MOD-2021-081274. Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-081274:

Other Meds:

Current Illness:

ID: 1635211
Sex: M
Age:
State: CA

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt really bad) and illness (sick) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038B21A) for COVID-19 immunization. No medical history reported. On Apr 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 18, 2021, patient experienced feeling abnormal (felt really bad) and illness (sick). On Apr 20, 2021, feeling abnormal (felt really bad) and illness (sick) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1635212
Sex: F
Age:
State:

Vax Date: 04/18/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Have two red blotches; Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Have two red blotches) and MYALGIA (Arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Have two red blotches) and MYALGIA (Arm is sore). At the time of the report, RASH MACULAR (Have two red blotches) and MYALGIA (Arm is sore) outcome was unknown. No medical history reported. No concomitant drugs reported. No treatment drugs reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635213
Sex: F
Age: 31
State: CA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: diarrhea; violent shaking chills/could not stop shaking; felt achy; Fever; chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TREMOR (violent shaking chills/could not stop shaking), PAIN (felt achy), PYREXIA (Fever) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038T5214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), TREMOR (violent shaking chills/could not stop shaking), PAIN (felt achy), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), TREMOR (violent shaking chills/could not stop shaking), PAIN (felt achy), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not reported. Treatment information as not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635214
Sex: F
Age: 59
State: AL

Vax Date: 03/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Breast Swelling; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast Swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No reported medical history. The patient's past medical history included No adverse event. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced BREAST SWELLING (Breast Swelling). At the time of the report, BREAST SWELLING (Breast Swelling) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1635215
Sex: M
Age: 55
State: MI

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: muscle pain was stated as making them breath shallower; muscle pain was stated as making them breath shallower because it hurt; Strange pain in left pectoral muscle; muscle aches; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of HYPOPNOEA (muscle pain was stated as making them breath shallower), MUSCLE DISCOMFORT (muscle pain was stated as making them breath shallower because it hurt), MYALGIA (Strange pain in left pectoral muscle), MYALGIA (muscle aches) and MYALGIA (muscle pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL and METFORMIN for an unknown indication. On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HYPOPNOEA (muscle pain was stated as making them breath shallower), MUSCLE DISCOMFORT (muscle pain was stated as making them breath shallower because it hurt), MYALGIA (Strange pain in left pectoral muscle), MYALGIA (muscle aches) and MYALGIA (muscle pain). At the time of the report, HYPOPNOEA (muscle pain was stated as making them breath shallower), MUSCLE DISCOMFORT (muscle pain was stated as making them breath shallower because it hurt), MYALGIA (Strange pain in left pectoral muscle), MYALGIA (muscle aches) and MYALGIA (muscle pain) outcome was unknown. Only medication taken for treatment was a generic Tylenol.

Other Meds: LISINOPRIL; METFORMIN.

Current Illness: Diabetes.

ID: 1635216
Sex: F
Age: 81
State:

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Hives; Became itchy; Sensation that wants to scratch as if it was an itch; A bump that appears in the skin, some big and some little, and is mainly on her arms; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Hives), PRURITUS (Became itchy), SCRATCH (Sensation that wants to scratch as if it was an itch) and SWELLING (A bump that appears in the skin, some big and some little, and is mainly on her arms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0D1A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]), MULTIVITAMIN [VITAMINS NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Became itchy), SCRATCH (Sensation that wants to scratch as if it was an itch) and SWELLING (A bump that appears in the skin, some big and some little, and is mainly on her arms). At the time of the report, URTICARIA (Hives), PRURITUS (Became itchy), SCRATCH (Sensation that wants to scratch as if it was an itch) and SWELLING (A bump that appears in the skin, some big and some little, and is mainly on her arms) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds: VITAMIN E [VITAMIN E NOS]; MULTIVITAMIN [VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1635217
Sex: F
Age: 73
State: IN

Vax Date: 03/24/2021
Onset Date: 04/19/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: urinary tract infection (UTI); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection (UTI)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination. No medical history was provided by the reporter. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection (UTI)). The patient was treated with NITROFURANTOIN at a dose of 100mg for 7 days. At the time of the report, URINARY TRACT INFECTION (urinary tract infection (UTI)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported

Other Meds:

Current Illness:

ID: 1635218
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: tired; pain on left arm from shoulder to elbow area; no energy; Slept 13-14 hrs; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), PAIN IN EXTREMITY (pain on left arm from shoulder to elbow area), FATIGUE (no energy) and SOMNOLENCE (Slept 13-14 hrs) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Mar-2021, the patient experienced FATIGUE (tired), PAIN IN EXTREMITY (pain on left arm from shoulder to elbow area), FATIGUE (no energy) and SOMNOLENCE (Slept 13-14 hrs). At the time of the report, FATIGUE (tired), PAIN IN EXTREMITY (pain on left arm from shoulder to elbow area), FATIGUE (no energy) and SOMNOLENCE (Slept 13-14 hrs) outcome was unknown. Not Provided This case was linked to US-MODERNATX, INC.-MOD-2021-081715 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-081715:cross link Dose 2

Other Meds:

Current Illness:

ID: 1635219
Sex: F
Age: 70
State: MD

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: fever; chills; body ache; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever), CHILLS (chills) and PAIN (body ache) in a 70-year-old female patient who received mRNA-1273 (batch no. 047A21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and PAIN (body ache). At the time of the report, PYREXIA (fever), CHILLS (chills) and PAIN (body ache) had resolved. Not Provided The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. At some point her husband tested positive for COVID-19. She didn't take the test and directly decided to stay home. Now she feels alright and recently tested negative for COVID-19. Treatment included ibuprofen, Nyquil and Dayquil. This case was linked to MOD21-079084 (E2B Linked Report).; Sender's Comments: MOD21-079084:cross linked

Other Meds: LEVOTHYROXINE; ATORVASTATIN

Current Illness:

ID: 1635220
Sex: F
Age: 72
State: CA

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Hematomas on the leg; Blood blisters that run down her legs; Rash all over her body which bleeds; Bad rash all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATOMA (Hematomas on the leg), BLOOD BLISTER (Blood blisters that run down her legs), SKIN HAEMORRHAGE (Rash all over her body which bleeds) and RASH (Bad rash all over her body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN HAEMORRHAGE (Rash all over her body which bleeds) and RASH (Bad rash all over her body). On an unknown date, the patient experienced HAEMATOMA (Hematomas on the leg) and BLOOD BLISTER (Blood blisters that run down her legs). At the time of the report, HAEMATOMA (Hematomas on the leg), BLOOD BLISTER (Blood blisters that run down her legs), SKIN HAEMORRHAGE (Rash all over her body which bleeds) and RASH (Bad rash all over her body) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant products are being used as per the reporter. Treatment for the events included betamethasone cream and a pill she was prescribed by her doctor, that has already run out, and she couldn't remember the name.

Other Meds:

Current Illness:

ID: 1635221
Sex: M
Age: 63
State: IL

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: fatigue; vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. The patient's past medical history included No adverse reaction (no medical History Reported ). On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds: HUMIRA

Current Illness:

ID: 1635222
Sex: F
Age: 17
State: CA

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: received 1st dose of Moderna vaccine under 18 Years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received 1st dose of Moderna vaccine under 18 Years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 033c21a) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received 1st dose of Moderna vaccine under 18 Years of age). On 17-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received 1st dose of Moderna vaccine under 18 Years of age) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment details were provided. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Non significant follow up received on 21-05-2021, patient ethnicity updated.

Other Meds:

Current Illness:

ID: 1635223
Sex: F
Age: 95
State: CA

Vax Date: 03/22/2021
Onset Date: 04/20/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: aches, and pains; large red raised area on the shot site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PAIN (aches, and pains) and VACCINATION SITE SWELLING (large red raised area on the shot site) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced PAIN (aches, and pains) and VACCINATION SITE SWELLING (large red raised area on the shot site). At the time of the report, NAUSEA (Nausea) and VACCINATION SITE SWELLING (large red raised area on the shot site) outcome was unknown. Not Provided This case was linked to US-MODERNATX, INC.-MOD-2021-082942, US-MODERNATX, INC.-MOD-2021-082892, MOD21-079883 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-082942:1st dose US-MODERNATX, INC.-MOD-2021-082892: MOD21-079883:

Other Meds:

Current Illness:

ID: 1635224
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Fatigue; Tired; Dragging herself; Distress; Going through a difficult time; headache; sleepless night; loud screaming sounds; Having just three and half hours of sleep; Vaccination site pain; tired; nightmares/Frightening dreams; Vaccination site pain; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams), HEADACHE (headache) and INSOMNIA (sleepless night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Skin cancer. Concurrent medical conditions included Blood pressure, Bipolar disorder (she do not have episodes), Depression (she do not have episodes), Allergy and Rotator cuff tear (right shoulder). Concomitant products included TRIAMTERENE for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams) and PAIN IN EXTREMITY (Arm hurts). On 14-Apr-2021, the patient experienced HEADACHE (headache), INSOMNIA (sleepless night), SLEEP TERROR (loud screaming sounds) and INSOMNIA (Having just three and half hours of sleep). On 21-Apr-2021, the patient experienced STRESS (Distress) and MALAISE (Going through a difficult time). On an unknown date, the patient experienced FATIGUE (Fatigue), FATIGUE (Tired) and GAIT INABILITY (Dragging herself). At the time of the report, PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams), HEADACHE (headache), INSOMNIA (sleepless night), SLEEP TERROR (loud screaming sounds), PAIN IN EXTREMITY (Arm hurts), INSOMNIA (Having just three and half hours of sleep), FATIGUE (Fatigue), FATIGUE (Tired), GAIT INABILITY (Dragging herself), STRESS (Distress) and MALAISE (Going through a difficult time) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: TRIAMTERENE

Current Illness: Allergy; Bipolar disorder (she do not have episodes); Blood pressure; Depression (she do not have episodes); Rotator cuff tear (right shoulder)

ID: 1635225
Sex: M
Age: 64
State: AL

Vax Date: 01/06/2021
Onset Date: 01/08/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210108; Test Name: covid-19; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Unevaluable event

Symptoms: intentional dose omission; Tested positive for COVID after first vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine) and INTENTIONAL DOSE OMISSION (intentional dose omission) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), ALPRAZOLAM (AZOR [ALPRAZOLAM]), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LORAZEPAM (ATIVAN), ALLOPURINOL, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentional dose omission). The patient was treated with Immunotherapy (BAMLAN monoclonal antibodies) for SARS-CoV-2 test positive. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine) outcome was unknown and INTENTIONAL DOSE OMISSION (intentional dose omission) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: positive (Positive) positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date. On 09-Jan-2021, the patient went to the hospital and received an antibody infusion and came home the same day after the treatment. Patient was instructed to wait 90 days and start the vaccination series all over again. Patient said the doctor told them their first dose must be repeated. This case was linked to US-MODERNATX, INC.-MOD-2021-083092, US-MODERNATX, INC.-MOD-2021-083133, US-MODERNATX, INC.-MOD-2021-083104 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Treatment information was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-083092:2nd dose US-MODERNATX, INC.-MOD-2021-083104:Wife's 1st dose US-MODERNATX, INC.-MOD-2021-083133:Wife's 2nd dose

Other Meds: TOPROL XL; AZOR [ALPRAZOLAM]; LIPITOR; PROTONIX [OMEPRAZOLE]; ATIVAN; ALLOPURINOL; ASPIRIN 81; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1635226
Sex: M
Age: 63
State: NY

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: itchiness to forearm; rippling to the skin- inside of right arm; pigmentation from wrist to elbow bright red; blotchy redness; stiff neck; headache; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness), MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain) had resolved. At the time of the report, PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red) and RASH MACULAR (blotchy redness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported Treatment drugs include Benadryl Topical Cream.

Other Meds:

Current Illness:

ID: 1635227
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Fever. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (very high fever). At the time of the report, PYREXIA (very high fever) outcome was unknown.

Other Meds:

Current Illness:

ID: 1635228
Sex: F
Age: 17
State: CA

Vax Date: 03/22/2021
Onset Date: 03/30/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: daughter is underage and received the first dose of the vaccine; sore arm; Minor headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is underage and received the first dose of the vaccine), PAIN IN EXTREMITY (sore arm) and HEADACHE (Minor headache) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is underage and received the first dose of the vaccine) and HEADACHE (Minor headache). 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is underage and received the first dose of the vaccine), PAIN IN EXTREMITY (sore arm) and HEADACHE (Minor headache) outcome was unknown. Not Provided No concomitant medications were reported. Treatment medications was mentioned. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: As per attached follow up document the drug start date has been corrected from 23- Mar- 2021 to 22--Mar-2021

Other Meds:

Current Illness:

ID: 1635229
Sex: U
Age:
State: MS

Vax Date: 03/21/2021
Onset Date: 04/19/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: breast milk; sore arms; fatigue; sore back; headache; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk), PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back) and HEADACHE (headache) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Migraine. On 21-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 19-Apr-2021, the patient was diagnosed with PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back) and HEADACHE (headache). On 20-Apr-2021, the patient was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk) and NO ADVERSE EVENT (son has not has side effects.). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk), PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back), HEADACHE (headache) and NO ADVERSE EVENT (son has not has side effects.) outcome was unknown.

Other Meds:

Current Illness:

ID: 1635230
Sex: M
Age: 21
State: DE

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210325; Test Name: Body temperature; Result Unstructured Data: ranging from 99F - 102F

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This morning he woke up around 2am shaking; muscles were hurting; severe joint pain; fever was 104.5degF; very hot to touch; was very wet and sweaty; he felt very nauseous; He was having trouble moving; constricted movements; we measured him again and it was 106degF within just next 15 mins; was having difficulty swallowing the ibuprofen pill; shaking; in the morning, his blood pressure was 112/60; pulse was 66; sore arm; Fever; achiness; achiness; fever ranging from 99degF-102degF for couple days; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MYALGIA (achiness), PYREXIA (fever ranging from 99degF-102degF for couple days), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and the second episode of MYALGIA (achiness) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced the first episode of MYALGIA (achiness) and PYREXIA (fever ranging from 99degF-102degF for couple days). On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and the second episode of MYALGIA (achiness). On an unknown date, the patient experienced TREMOR (This morning he woke up around 2am shaking), MYALGIA (muscles were hurting), ARTHRALGIA (severe joint pain), PYREXIA (fever was 104.5degF), FEELING HOT (very hot to touch), HYPERHIDROSIS (was very wet and sweaty), NAUSEA (he felt very nauseous), DYSKINESIA (He was having trouble moving), MOVEMENT DISORDER (constricted movements), PYREXIA (we measured him again and it was 106degF within just next 15 mins), DYSPHAGIA (was having difficulty swallowing the ibuprofen pill), TREMOR (shaking), BLOOD PRESSURE MEASUREMENT (in the morning, his blood pressure was 112/60) and PULSE ABNORMAL (pulse was 66). The patient was treated with IBUPROFEN at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever ranging from 99degF-102degF for couple days) had resolved and PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), the last episode of MYALGIA (achiness), TREMOR (This morning he woke up around 2am shaking), MYALGIA (muscles were hurting), ARTHRALGIA (severe joint pain), PYREXIA (fever was 104.5degF), FEELING HOT (very hot to touch), HYPERHIDROSIS (was very wet and sweaty), NAUSEA (he felt very nauseous), DYSKINESIA (He was having trouble moving), MOVEMENT DISORDER (constricted movements), PYREXIA (we measured him again and it was 106degF within just next 15 mins), DYSPHAGIA (was having difficulty swallowing the ibuprofen pill), TREMOR (shaking), BLOOD PRESSURE MEASUREMENT (in the morning, his blood pressure was 112/60) and PULSE ABNORMAL (pulse was 66) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: ranging from 99F - 102F. This case was linked to MODERNATX, INC.-MOD-2021-083418, MODERNATX, INC.-MOD-2021-083439 (E2B Linked Report). This case was linked to MOD-2021-084078 (Patient Link); Sender's Comments: MODERNATX, INC.-MOD-2021-083418:Mother case- dose 1 MODERNATX, INC.-MOD-2021-083439:Mother case- dose 2

Other Meds:

Current Illness:

ID: 1635231
Sex: F
Age: 25
State: IN

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: 2nd dose given early, 17 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided.

Other Meds:

Current Illness:

ID: 1635232
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: generalized aching; COVID-19; fatigue; headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (moderate to severe). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-05-2021 contains non-significant information.

Other Meds: HUMIRA

Current Illness: Rheumatoid arthritis (moderate to severe)

ID: 1635233
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (sore arm) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1635234
Sex: F
Age:
State: MI

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039E21A and 01421A) for COVID-19 vaccination. Concurrent medical conditions included Depression since 2010 and Diabetes. Concomitant products included ARIPIPRAZOLE (ABILIFY), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and ALPRAZOLAM (ZENAX) for Depression, METFORMIN for Diabetes. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. This case was linked to MOD-2021-085244 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR from follow up received and outcome of event was resolved

Other Meds: ABILIFY; TRINTELLIX; ZENAX; METFORMIN

Current Illness: Depression; Diabetes

ID: 1635235
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/21/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: sore arm; Depression have worsened; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pain in extremity and Depression. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened). At the time of the report, PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened) outcome was unknown. This case was linked to MOD-2021-085231 (Patient Link).

Other Meds:

Current Illness:

ID: 1635236
Sex: F
Age: 34
State: IN

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: wife is breastfeeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (wife is breastfeeding) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced EXPOSURE VIA BREAST MILK (wife is breastfeeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EXPOSURE VIA BREAST MILK (wife is breastfeeding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1635237
Sex: U
Age:
State:

Vax Date: 03/02/2021
Onset Date: 04/04/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 19-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. This case was linked to MOD21-080295, MOD-2021-085949 (Parent-Child Link). See case MOD21-080295,MOD-2021-085949 for details regarding the Parent case. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1635238
Sex: M
Age: 31
State: CO

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: vaccine from the batch effected by temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. Concomitant products included ALLOPURINOL for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medicines were not included Concomitant medicine include Allopurinol Action taken with mRNA-1273 in response to the event was unknown This case was linked to US-MODERNATX, INC.-MOD-2021-085726 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-085726:Husband case

Other Meds: ALLOPURINOL

Current Illness:

ID: 1635239
Sex: F
Age: 70
State: PA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Dizziness; Nausea; chills; headache; Muscle Pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache) and MYALGIA (Muscle Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain). On 15-Apr-2021, DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. Patient mentioned that she uses Herbal products for Diabetes and Hypertension.

Other Meds:

Current Illness:

ID: 1635240
Sex: F
Age: 35
State: ME

Vax Date: 04/15/2021
Onset Date: 04/22/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Irritated one side of the face; Swelling of the eyes; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL NEURALGIA (Irritated one side of the face) and EYE SWELLING (Swelling of the eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Eve primrose and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FACIAL NEURALGIA (Irritated one side of the face) and EYE SWELLING (Swelling of the eyes). At the time of the report, FACIAL NEURALGIA (Irritated one side of the face) and EYE SWELLING (Swelling of the eyes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: VITAMIN C & ROSEHIP; VITAMIN D 2000; PRIMROSE; VITAMIN B 1-6-12.

Current Illness:

ID: 1635241
Sex: F
Age:
State: LA

Vax Date: 03/02/2021
Onset Date: 03/31/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: outside of 42 day mark; Should have had her second vaccine on 31 Mar 2021; missed her appointment; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (outside of 42 day mark), PRODUCT DOSE OMISSION ISSUE (Should have had her second vaccine on 31 Mar 2021) and PRODUCT DOSE OMISSION ISSUE (missed her appointment) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her appointment). On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (outside of 42 day mark) and PRODUCT DOSE OMISSION ISSUE (Should have had her second vaccine on 31 Mar 2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (outside of 42 day mark), PRODUCT DOSE OMISSION ISSUE (Should have had her second vaccine on 31 Mar 2021) and PRODUCT DOSE OMISSION ISSUE (missed her appointment) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1635242
Sex: F
Age: 78
State: NV

Vax Date: 02/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: she got sick to her stomach; Did not feel good; Threw up once; Was really tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired). On 06-Mar-2021, ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired) had resolved. No Concomitant medications were provided by the reporter. No Treatment History was provided by the reporter. This case was linked to MOD-2021-031902 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information received on 24 May 2021 does not contain any new information

Other Meds:

Current Illness:

ID: 1635243
Sex: F
Age:
State: CO

Vax Date: 03/19/2021
Onset Date: 04/20/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: fever; mild headache; achy joints-especially hips; very fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips), FATIGUE (very fatigued) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips), FATIGUE (very fatigued) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips) and CHILLS (Chills) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1635244
Sex: M
Age: 58
State: PA

Vax Date: 04/13/2021
Onset Date: 04/17/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Migraine; top of shoulder hurting; Sore arm; Neck pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ARTHRALGIA (top of shoulder hurting) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0257321A) for COVID-19 vaccination. Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX), RIZATRIPTAN BENZOATE (MAXALT) and IBUPROFEN for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (top of shoulder hurting). On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ARTHRALGIA (top of shoulder hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication information was provided Patient said she is definitely not receiving second dose due to horrible migraines.

Other Meds: TOPAMAX; MAXALT; IBUPROFEN

Current Illness: Migraine

ID: 1635245
Sex: M
Age: 69
State: VA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Mixed dose series (first is pfizer, second shot is moderna); This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)). At the time of the report, WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided

Other Meds:

Current Illness:

ID: 1635246
Sex: F
Age:
State:

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: pelvic ultrasound

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Spotting; Bleeding; Cramping; My hips are hurting and difficult to walk; I have had multiple earaches; my fingers are inflamed in joints; I am exhausted and require more sleep than before; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk) and EAR PAIN (I have had multiple earaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDRALAZINE, LOSARTAN, DILTIAZEM and LEVOTHYROXINE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk), EAR PAIN (I have had multiple earaches), ARTHRITIS (my fingers are inflamed in joints) and FATIGUE (I am exhausted and require more sleep than before). At the time of the report, VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding) and MUSCLE SPASMS (Cramping) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: normal. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-087078. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received

Other Meds: HYDRALAZINE; LOSARTAN; DILTIAZEM; LEVOTHYROXINE

Current Illness:

ID: 1635247
Sex: F
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Tested Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested Positive for COVID-19). At the time of the report, COVID-19 (Tested Positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1635248
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported. Treatment medication was not provided. This case was linked to MOD-2021-089635 (Patient Link).

Other Meds:

Current Illness: Hypertension; Type 2 diabetes mellitus.

ID: 1635249
Sex: F
Age: 65
State: IL

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: feeling even worse; miserable right now; tired; dizzy; nauseated; short of breath; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included hydrochlorothiazide. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (soreness). On 22-Apr-2021, the patient experienced FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now). On 17-Apr-2021, PAIN (soreness) outcome was unknown. At the time of the report, FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated), DYSPNOEA (short of breath), FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now) outcome was unknown. Treatment was reported as tried some motion sickness pills.

Other Meds: hydrochlorothiazide

Current Illness:

ID: 1635250
Sex: F
Age:
State: CA

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 2013; Test Name: food allergy test; Test Result: Positive ; Result Unstructured Data: barley, rye; Test Date: 2015; Test Name: skin allergy test; Test Result: Positive ; Result Unstructured Data: native grasses, olive, Alternaria

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Developed bruise on the right side of skull.; Feels like something unusual; face swelling; Felt worse after the first night after vaccine; skull pain; Right upper skull swelling; few minor hives; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Developed bruise on the right side of skull.), FEELING ABNORMAL (Feels like something unusual), SWELLING FACE (face swelling), MALAISE (Felt worse after the first night after vaccine) and PAIN (skull pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 80777-273-10) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hives, Hives (scary stomach platform hives night after trimming underneath a Cryptomeria tree (Japanese cedar) - besides pollen, also dusty under this tree) in 2012 and Radiation therapy (ionizing radiation to the left breast) in 2011. Concurrent medical conditions included Hay fever, Edema face since 2011, Osteoarthritis since 2011, Tendinosis since 2011, Neck pain since 2011, Allergy since 2011, Rotator cuff tear since 2017, Pinched nerve (pinched nerve upper right side back near neck) since 2017, Allergic skin reaction (native grasses, olive, Alternaria) in 2015 and Food allergy (barley, rye) in 2015. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MAGNESIUM CHELATE, MELATONIN and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced CONTUSION (Developed bruise on the right side of skull.), FEELING ABNORMAL (Feels like something unusual), SWELLING FACE (face swelling), MALAISE (Felt worse after the first night after vaccine), PAIN (skull pain), SWELLING (Right upper skull swelling) and URTICARIA (few minor hives). At the time of the report, CONTUSION (Developed bruise on the right side of skull.), FEELING ABNORMAL (Feels like something unusual), SWELLING FACE (face swelling), MALAISE (Felt worse after the first night after vaccine), PAIN (skull pain), SWELLING (Right upper skull swelling) and URTICARIA (few minor hives) had resolved. Unknown DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2013, Allergy test: (Positive) barley, rye. In 2015, Skin test positive: (Positive) native grasses, olive, Alternaria. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient experienced a few minor hives late in the afternoon. The hives dissipated quickly, possibly within an hour. However, the next morning, woke with a tender, localized bruise-like swelling on the upper right part of the skull. This right upper skull pain and swelling lasted for 4 days. Patient connects the causality to electromagnetic fields. Patient live across from a newly beefed-up cell tower and near many 69 and 12kV overhead wires and a distribution substation. patient have stainless steel wires in both of the jaws from an old surgery. Cameras are installed which use invisible electromagnetic fields and patient suspects the radiations may be thermal. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up received on 3-Jun-2021, HCP information, patient ethnicity, medical history, lab tests, concomitant medications, events and event outcome were updated

Other Meds: VITAMIN D [COLECALCIFEROL]; MAGNESIUM CHELATE; MELATONIN; B COMPLEX [VITAMIN B COMPLEX]

Current Illness: Allergy; Edema face; Hay fever; Neck pain; Osteoarthritis; Pinched nerve (pinched nerve upper right side back near neck); Rotator cuff tear; Tendinosis

ID: 1635251
Sex: F
Age: 74
State: WY

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: itching from head to waist off and on.constant itching from head to waist.worsened itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching from head to waist off and on.constant itching from head to waist.worsened itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BD1A) for COVID-19 vaccination. Concomitant products included Aller-Tec pill once daily Allergy pill, OMEPRAZOLE, ATENOLOL, ESCITALOPRAM, ROSUVASTATIN and TRAMADOL for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRURITUS (itching from head to waist off and on.constant itching from head to waist.worsened itching). Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: Aller-Tec pill once daily Allergy pill; OMEPRAZOLE; ATENOLOL; ESCITALOPRAM; ROSUVASTATIN; TRAMADOL

Current Illness:

ID: 1635252
Sex: M
Age: 41
State: TX

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is calling in to find out if he can take an allergy test on the same day as receiving his second shot of the Covid-19 Moderna Vaccine. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1635253
Sex: F
Age: 26
State: OH

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: minor headache; minor fatigue; arm soreness lasted 3-4 days.; Has not got menstrual cycle since first dose was administered; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (minor headache), FATIGUE (minor fatigue), PAIN IN EXTREMITY (arm soreness lasted 3-4 days.) and MENSTRUAL DISORDER (Has not got menstrual cycle since first dose was administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (minor headache), FATIGUE (minor fatigue), PAIN IN EXTREMITY (arm soreness lasted 3-4 days.) and MENSTRUAL DISORDER (Has not got menstrual cycle since first dose was administered). On 06-Mar-2021, HEADACHE (minor headache) and FATIGUE (minor fatigue) had resolved. On 08-Mar-2021, PAIN IN EXTREMITY (arm soreness lasted 3-4 days.) had resolved. At the time of the report, MENSTRUAL DISORDER (Has not got menstrual cycle since first dose was administered) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided by reporter. This case was linked to MOD-2021-089544 (Patient Link).

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am