VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1626786
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: feel bad after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel bad after second shot) in a patient of an unknown age and gender 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 FEELING ABNORMAL (feel bad after second shot). At the time of the report, FEELING ABNORMAL (feel bad after second shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were mentioned. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1626787
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Difficulty breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown. concomitant medicines was not reported by reporter treatment information was not provided

Other Meds:

Current Illness:

ID: 1626788
Sex: F
Age: 60
State: TX

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 08/24/2021
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: "tight muscles in my neck"; "terrible diarrhea"; "was sick as a dog"; "really bad leg cramps"; "zero appetite like when I had COVID-19"; lost 2 pounds; "I feel like I have to urinate all the time"; "my bladder is very uncomfortable since getting the vaccine"; I can't eat; "a little itchy"; abdomen hurting; backside hurting; "violent chills"; "super bad headache"; "it hurt really bad"; "I am scared"; "real hot"; "started feeling really bad"; This spontaneous case was reported by an other health care professional and describes the occurrence of FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), MUSCLE TIGHTNESS ("tight muscles in my neck") and DIARRHOEA ("terrible diarrhea") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST SODIUM (SINGULAIR), Flomax, Breo Inhaler, ESTROGENS CONJUGATED (PREMARIN), Celexa, CLONAZEPAM (KLONOPIN) and Flexeril for an unknown indication. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), CHILLS ("violent chills"), HEADACHE ("super bad headache") and MYALGIA ("it hurt really bad"). On 01-Jun-2021, the patient experienced MUSCLE TIGHTNESS ("tight muscles in my neck"), DIARRHOEA ("terrible diarrhea"), ILLNESS ("was sick as a dog"), MUSCLE SPASMS ("really bad leg cramps"), DECREASED APPETITE ("zero appetite like when I had COVID-19"), WEIGHT DECREASED (lost 2 pounds), POLLAKIURIA ("I feel like I have to urinate all the time"), BLADDER DISCOMFORT ("my bladder is very uncomfortable since getting the vaccine"), FEEDING DISORDER (I can't eat), PRURITUS ("a little itchy"), ABDOMINAL PAIN UPPER (abdomen hurting) and BACK PAIN (backside hurting). At the time of the report, FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), MUSCLE TIGHTNESS ("tight muscles in my neck"), DIARRHOEA ("terrible diarrhea"), ILLNESS ("was sick as a dog"), MUSCLE SPASMS ("really bad leg cramps"), DECREASED APPETITE ("zero appetite like when I had COVID-19"), WEIGHT DECREASED (lost 2 pounds), POLLAKIURIA ("I feel like I have to urinate all the time"), BLADDER DISCOMFORT ("my bladder is very uncomfortable since getting the vaccine"), FEEDING DISORDER (I can't eat), PRURITUS ("a little itchy"), ABDOMINAL PAIN UPPER (abdomen hurting), BACK PAIN (backside hurting), CHILLS ("violent chills"), HEADACHE ("super bad headache") and MYALGIA ("it hurt really bad") 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: SYNTHROID; SINGULAIR; Flomax; Breo Inhaler; PREMARIN; Celexa; KLONOPIN; Flexeril

Current Illness:

ID: 1626789
Sex: M
Age: 73
State: AZ

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/24/2021
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: soreness; Bump at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and VACCINATION SITE MASS (Bump at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011A21A) for COVID-19 vaccination. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication. On 02-Mar-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 02-Mar-2021, the patient experienced VACCINATION SITE MASS (Bump at injection site). On an unknown date, the patient experienced PAIN (soreness). The patient was treated with WARFARIN SODIUM (COUMADIN) at a dose of 1 dosage form. At the time of the report, PAIN (soreness) and VACCINATION SITE MASS (Bump at injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable This case was linked to MOD-2021-033458 (Patient Link).

Other Meds: COUMADIN

Current Illness:

ID: 1626790
Sex: F
Age: 66
State: TX

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/24/2021
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: 20210305; Test Name: Body temperature; Result Unstructured Data: fever 102-103F

Allergies:

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

Symptoms: shortness of breath; Dizzy; Tachycardia; fever 102-103F; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vitrectomy in 2018. Concurrent medical conditions included Stroke (Stroke through eye and loss her vision). 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 DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 16-Apr-2021, TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown and DIZZINESS (Dizzy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102-103f (High) fever 102-103F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported. This case was linked to MOD-2021-209164 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information received on 2/7/2021 contains significant information. The previously reported adverse event related to second dose i.e., vision had not resolved. On 13-Aug-2021: Follow up received on 13/8/2021 contains No new information

Other Meds:

Current Illness: Stroke (Stroke through eye and loss her vision)

ID: 1626791
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: urinary tract infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.

Other Meds:

Current Illness:

ID: 1626792
Sex: F
Age: 68
State: PR

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 08/24/2021
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: Itching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZIRTEC) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her body) 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 relevant concomitant medications reported.

Other Meds:

Current Illness:

ID: 1626793
Sex: F
Age: 39
State:

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 08/24/2021
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: I developed a really bad Dermatographia; Just a slight scratch like someone wrote in my arms all the time; Sometimes its really itchy; Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (I developed a really bad Dermatographia), SCRATCH (Just a slight scratch like someone wrote in my arms all the time), PRURITUS (Sometimes its really itchy) and ERYTHEMA (Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025O20A) for COVID-19 vaccination. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced MECHANICAL URTICARIA (I developed a really bad Dermatographia), SCRATCH (Just a slight scratch like someone wrote in my arms all the time), PRURITUS (Sometimes its really itchy) and ERYTHEMA (Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, at a dose of UNK, bid and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Allergy, at a dose of UNK, bid. At the time of the report, MECHANICAL URTICARIA (I developed a really bad Dermatographia), SCRATCH (Just a slight scratch like someone wrote in my arms all the time), PRURITUS (Sometimes its really itchy) and ERYTHEMA (Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No medical history was provided by reporter. Concomitant medicine include Vitamin D Treatment Took Zyrtec, Benadryl or Claritin but still doesn't help

Other Meds: VITAMIN D 2000

Current Illness:

ID: 1626794
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Arm Sore two weeks after shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Sore two weeks after shot) in a patient of an unknown age and gender 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 PAIN IN EXTREMITY (Arm Sore two weeks after shot). At the time of the report, PAIN IN EXTREMITY (Arm Sore two weeks after shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1626795
Sex: M
Age: 47
State: IL

Vax Date: 03/22/2021
Onset Date: 05/01/2021
Rec V Date: 08/24/2021
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: psoriasis aggravated; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIASIS (psoriasis aggravated) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication. No Medical History information was reported. On 22-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PSORIASIS (psoriasis aggravated). At the time of the report, PSORIASIS (psoriasis aggravated) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drugs were reported. No treatment drugs were reported.

Other Meds:

Current Illness:

ID: 1626796
Sex: M
Age: 42
State: OH

Vax Date: 05/17/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 100.2; Test Date: 20210101; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: temp 100.2 oral; body aches; chills; fatigue; headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature:. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 100.2 (High) 100.2. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable. No Concomitant medication was provided. No Treatment medication was provided. This case was linked to MOD-2021-006050 (Patient Link).

Other Meds:

Current Illness:

ID: 1626797
Sex: U
Age:
State:

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/24/2021
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: Shortness of Breath; Asthma; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma). At the time of the report, DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626798
Sex: F
Age: 66
State: IL

Vax Date: 04/06/2021
Onset Date: 05/04/2021
Rec V Date: 08/24/2021
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: lot of pain in the arm of the injection site; Warm; Can't lift arm; Muscle spasms; Doesn't let her sleep; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep) and PAIN IN EXTREMITY (Pain in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm) and INSOMNIA (Doesn't let her sleep). 04-May-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced INJECTION SITE PAIN (lot of pain in the arm of the injection site). The patient was treated with NAPROXEN at a dose of 500 mg. At the time of the report, FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep), PAIN IN EXTREMITY (Pain in the arm) and INJECTION SITE PAIN (lot of pain in the arm of the injection site) outcome was unknown. Treatment included Warm compresses Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-JUN-2021 contains NNI

Other Meds: EUTHYROX

Current Illness:

ID: 1626799
Sex: U
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 08/24/2021
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: Test Name: Covid test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: no taste or smell; no taste or smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Apr-2021 at 11:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 6:00 PM, the patient experienced AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell). At the time of the report, AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1626800
Sex: M
Age: 49
State: DC

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

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

Lab Data: Test Name: COVID; Test Result: Positive ; Result Unstructured Data: Had COVID in 2020

Allergies:

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

Symptoms: Pain in the lungs or kidney; Pain in the lungs or kidney; without strength; tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in the lungs or kidney), RENAL PAIN (Pain in the lungs or kidney), ASTHENIA (without strength) and FATIGUE (tired) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 038A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Had COVID in 2020). On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-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 PULMONARY PAIN (Pain in the lungs or kidney), RENAL PAIN (Pain in the lungs or kidney), ASTHENIA (without strength) and FATIGUE (tired). At the time of the report, PULMONARY PAIN (Pain in the lungs or kidney), RENAL PAIN (Pain in the lungs or kidney), ASTHENIA (without strength) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Had COVID in 2020. No concomitant medications were mentioned. The patient's symptoms started a week after the second dose and. The patient mentioned that after the first dose felt something on the arm, but that was all. No treatment details were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments This case was linked to MOD-2021-213314 (Patient Link).

Other Meds:

Current Illness:

ID: 1626801
Sex: F
Age: 68
State: CA

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/24/2021
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: Hives/The hives mostly stayed on my chest, my breast had terrible rash too; I still have blotchiness on my legs; I had that rash all over my stomach, back, arms, groin, all over the place; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/The hives mostly stayed on my chest, my breast had terrible rash too), RASH MACULAR (I still have blotchiness on my legs) and RASH (I had that rash all over my stomach, back, arms, groin, all over the place) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 027A21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included ENALAPRIL, METFORMIN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (LEVOXYL), GEMFIBROZIL, IBUPROFEN, ASCORBIC ACID (VITAMIN C ACID), ZINC, FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM 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 02-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 URTICARIA (Hives/The hives mostly stayed on my chest, my breast had terrible rash too), RASH MACULAR (I still have blotchiness on my legs) and RASH (I had that rash all over my stomach, back, arms, groin, all over the place). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and HYDROCORTISONE ACETATE (HYDROCORTISONE [HYDROCORTISONE ACETATE]) at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives/The hives mostly stayed on my chest, my breast had terrible rash too) and RASH (I had that rash all over my stomach, back, arms, groin, all over the place) had resolved and RASH MACULAR (I still have blotchiness on my legs) had not resolved. Treatment information was not provided by reported. This case was linked to MOD-2021-213312 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up received and contained No New Information.

Other Meds: ENALAPRIL; METFORMIN; NEURONTIN; LEVOXYL; GEMFIBROZIL; IBUPROFEN; VITAMIN C ACID; ZINC; FISH OIL; VITAMIN D [COLECALCIFEROL]; CALCIUM

Current Illness:

ID: 1626802
Sex: U
Age:
State:

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 08/24/2021
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: first vaccine on April 10 can I still get my second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine on April 10 can I still get my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine on April 10 can I still get my second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine on April 10 can I still get my second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not reported. Treatment information as not reported.

Other Meds:

Current Illness:

ID: 1626803
Sex: F
Age: 71
State: PA

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 08/24/2021
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: She is terrified of the side effects/Terrified of the Second Shot; Injection Site Hurt a little if touched; Extremely Tired; Dull Headache; Not feeling like her usual self; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Hurt a little if touched), FATIGUE (Extremely Tired), HEADACHE (Dull Headache), FEELING ABNORMAL (Not feeling like her usual self) and ANXIETY (She is terrified of the side effects/Terrified of the Second Shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer and Radiation therapy in March 2021. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (Injection Site Hurt a little if touched), FATIGUE (Extremely Tired), HEADACHE (Dull Headache) and FEELING ABNORMAL (Not feeling like her usual self). On 08-Jun-2021, the patient experienced ANXIETY (She is terrified of the side effects/Terrified of the Second Shot). On 15-May-2021, VACCINATION SITE PAIN (Injection Site Hurt a little if touched) had resolved. On 18-May-2021, FATIGUE (Extremely Tired), HEADACHE (Dull Headache) and FEELING ABNORMAL (Not feeling like her usual self) had resolved. At the time of the report, ANXIETY (She is terrified of the side effects/Terrified of the Second Shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1626804
Sex: F
Age:
State: CA

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 08/24/2021
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: Warm in the injection site; Swelling in the injection site; Redness in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Warm in the injection site), VACCINATION SITE SWELLING (Swelling in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included METFORMIN for Diabetes, ESZOPICLONE (LUNESTA) for Sleeping sickness. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm in the injection site), VACCINATION SITE SWELLING (Swelling in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm in the injection site), VACCINATION SITE SWELLING (Swelling in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds: METFORMIN; LUNESTA

Current Illness:

ID: 1626805
Sex: F
Age: 36
State: SC

Vax Date: 06/08/2021
Onset Date:
Rec V Date: 08/24/2021
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: chills a thousand times worse than normal; Chills with shakes that are uncontrollable; I got my shot the following day I had fevers; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are uncontrollable) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. NO MEDICAL HISTORY WAS REPORTED BY REPORTER. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are uncontrollable). At the time of the report, CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are uncontrollable) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient experienced with chills a thousand times worse than normal, and chills with shakes that are uncontrollable. no medical history was reported. no concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1626806
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products and treatment medication were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626807
Sex: M
Age: 46
State: NJ

Vax Date: 06/06/2021
Onset Date:
Rec V Date: 08/24/2021
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: Unevaluable event

Symptoms: Received 2nd dose less than 25 days after receiving 1st dose; Received 1st dose of Pfizer and 2nd dose of moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jun-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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Nurse reported that a patient received 1st dose of Pfizer vaccine on 23May2021 and 2nd dose of moderna vaccine on 6Jun2021 on his left arm and the patient had no any adverse effects. The lot number of the 2nd dose of moderna vaccine is "022C21A". She gave the consent for follow up by safety. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626808
Sex: M
Age: 66
State: NJ

Vax Date: 06/06/2021
Onset Date:
Rec V Date: 08/24/2021
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: Received 1st dose of J&J and 2nd dose of moderna vaccine; Received 2nd dose more than 35 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1626809
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Shakes; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported.

Other Meds:

Current Illness:

ID: 1626810
Sex: M
Age: 40
State: TX

Vax Date: 05/19/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 in response to the events were not applicable. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09-JUN-2021 included non-significant information

Other Meds:

Current Illness:

ID: 1626811
Sex: F
Age: 25
State: AZ

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 08/24/2021
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: A patient received her first Moderna Covid-19 vaccine from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial) 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 mentioned. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1626812
Sex: F
Age: 76
State: WI

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/24/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: Coughing started; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing started) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Bronchiectasis (Patient has a history of bronchiectasis without Cystic Fibrosis.) since 07-Jan-2017, Fibrillation atrial since 01-Jan-2020, Penicillin allergy (Hives as a reaction.), Sulfonamide allergy (Hives as a reaction.) and Drug allergy (Allergic to Ceclor . Hives as a reaction.). Concomitant products included ALBUTEROL [SALBUTAMOL] from 07-Jan-2017 to an unknown date for Bronchiectasis, ALLOPURINOL, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication. On 10-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 10:30 AM, 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 COUGH (Coughing started). At the time of the report, COUGH (Coughing started) had not resolved. No treatment medications were provide by reporter. Patient started coughing about 2-3 months after receiving the Moderna covid-19 vaccine. She reportedly had a persistent cough secondary to non-cystic fibrosis bronchiectasis. Per report, the patient had a period of relief from coughing between the first and second doses of the vaccine. However, her cough progressively worsened to its pre-vaccination intensity within 3 months of receiving her second dose vaccination. The patient is concomitantly taking other unspecified medications. Patient has a history of hives as a reaction to drug allergies including penicillin, sulfonamides, and cefaclor. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up included updated information regarding patient demographics, facility type, medical history, suspect product details like batch number, route of administration, anatomical location, added concomitant medications, outcome of the event cough updated to recovered. On 09-Jul-2021: Follow-up information received to include updates on reaction for allergies, outcome of the event cough was update from recovered to not recovered.

Other Meds: ALBUTEROL [SALBUTAMOL]; ALLOPURINOL; ELIQUIS; AMLODIPINE

Current Illness: Bronchiectasis (Patient has a history of bronchiectasis without Cystic Fibrosis.); Drug allergy (Allergic to Ceclor . Hives as a reaction.); Fibrillation atrial; Penicillin allergy (Hives as a reaction.); Sulfonamide allergy (Hives as a reaction.)

ID: 1626813
Sex: F
Age: 43
State: LA

Vax Date: 05/01/2021
Onset Date: 06/07/2021
Rec V Date: 08/24/2021
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: A hemorrhage in the right eye; This spontaneous case was reported by a physician and describes the occurrence of EYE HAEMORRHAGE (A hemorrhage in the right eye) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN for an unknown indication. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE HAEMORRHAGE (A hemorrhage in the right eye). The patient was treated with CARBOMER (TEAR DROPS) at an unspecified dose and frequency. At the time of the report, EYE HAEMORRHAGE (A hemorrhage in the right eye) 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. Treatment include hydration. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds: METFORMIN

Current Illness:

ID: 1626814
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Physician states patient experienced localized reaction following 1st dose of Moderna COVID 19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Physician states patient experienced localized reaction following 1st dose of Moderna COVID 19 vaccine) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (Physician states patient experienced localized reaction following 1st dose of Moderna COVID 19 vaccine). At the time of the report, VACCINATION COMPLICATION (Physician states patient experienced localized reaction following 1st dose of Moderna COVID 19 vaccine) 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. Concomitant medications were not reported. Physician advised patient not to have 2nd dose of Moderna COVID19 vaccine. Treatment details were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626815
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: arm was sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore after the 1st dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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 PAIN IN EXTREMITY (arm was sore after the 1st dose). At the time of the report, PAIN IN EXTREMITY (arm was sore after the 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication provided. No concomitant medication provided. This case was linked to MOD-2021-214787 (Patient Link).

Other Meds:

Current Illness:

ID: 1626816
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: muscle soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle soreness) in a patient of an unknown age and gender 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 MYALGIA (muscle soreness). At the time of the report, MYALGIA (muscle soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626817
Sex: M
Age: 57
State: FL

Vax Date: 01/02/2021
Onset Date:
Rec V Date: 08/24/2021
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: Fever; Soreness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1626818
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: High fever and took about 2weeks to recover.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (High fever and took about 2weeks to recover.) in a patient of an unknown age and gender 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 PYREXIA (High fever and took about 2weeks to recover.). At the time of the report, PYREXIA (High fever and took about 2weeks to recover.) 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. patient was immunocompromised and received the Moderna COVID-19 vaccine developed high fever and took about 2weeks to recover. No concomitant medications and treatment medications was provided.

Other Meds:

Current Illness:

ID: 1626819
Sex: F
Age: 57
State: MD

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 08/24/2021
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: Weakness; Dizziness; Cannot work/Struggles to function throughout the day; Struggles to lift her limbs; Muscle ache; Severe fatigue/feels exhaustion; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work/Struggles to function throughout the day), LIMB IMMOBILISATION (Struggles to lift her limbs) and MYALGIA (Muscle ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 23-Feb-2021. Concurrent medical conditions included Grass allergy, Allergic asthma, Dust allergy and Allergy NOS (Trees). Concomitant products included ALBUTEROL [SALBUTAMOL] from 01-Jan-2000 to an unknown date for Allergic asthma, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 01-Jan-2000 to an unknown date and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) from 01-Jan-2000 to an unknown date for Allergy, ELDERBERRY [SAMBUCUS NIGRA] from 25-Feb-2021 to an unknown date for Zinc, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ZINC, ONE A DAY WOMEN'S from 01-Jan-2000 to an unknown date and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 04-Jun-2021 at 9:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work/Struggles to function throughout the day), LIMB IMMOBILISATION (Struggles to lift her limbs), MYALGIA (Muscle ache), FATIGUE (Severe fatigue/feels exhaustion) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 07-Jun-2021, HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work/Struggles to function throughout the day), LIMB IMMOBILISATION (Struggles to lift her limbs), MYALGIA (Muscle ache) and FATIGUE (Severe fatigue/feels exhaustion) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 25-Feb-2021, the patient received monoclonal antibodies. Patient went to urgent care on unknown date and was prescribed to drink lots of water, sleep along with acetaminophen. Patient was test for Covid on unknown date and same was negative. On unknown date, patient visited with Family Physician and diagnosed patient with Long Haulers due to Vaccine. This case was linked to MOD-2021-278380 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Additional follow up information included: Patient details updated, Medically confirm, Events (severe fatigue/feels exhaustion, weakness, dizziness, muscle ache, cannot work/struggles to function throughout the day and struggles to lift her limbs) outcome updated to not recovered/resolved, action taken updated, iNarrative information updated with physician visit information.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]; XYZAL; ZINC; ALBUTEROL [SALBUTAMOL]; ONE A DAY WOMEN'S; ELDERBERRY [SAMBUCUS NIGRA]; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Allergic asthma; Allergy NOS (Trees); Grass allergy

ID: 1626820
Sex: M
Age: 36
State: NJ

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 08/24/2021
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: Inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.

Other Meds:

Current Illness:

ID: 1626821
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 06/08/2021
Rec V Date: 08/24/2021
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: splitting headache; chills; nausea; muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. No medical history was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain). At the time of the report, HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported , No treatment medication was reported . This case was linked to MOD-2021-214773 (Patient Link).

Other Meds:

Current Illness:

ID: 1626822
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1626823
Sex: F
Age: 70
State: CA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/24/2021
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: arthritis is improving,no pain,theumbs no longer recovered,she is happy; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. Concomitant products included PANTOPRAZOLE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy) outcome was unknown. Caller reports that prior to getting the vaccine she had arthritis in both her thumbs. Patient reports that arthritis is improving since receiving the vaccines. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable

Other Meds: PANTOPRAZOLE

Current Illness: Arthritis

ID: 1626824
Sex: F
Age: 49
State: NJ

Vax Date: 04/20/2021
Onset Date: 05/29/2021
Rec V Date: 08/24/2021
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: both breast are severely soar,; pain on the right side of the face over the forehead spot; patient did not felt better/ still not ok."; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok.") in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 024C21A.) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Gabapentin 100mg bid, Lexapro 10 mg OD and Zen ax TID for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-May-2021, the patient experienced BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok."). At the time of the report, BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok.") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.

Other Meds: Gabapentin 100mg bid; Lexapro 10 mg OD; Zen ax TID

Current Illness:

ID: 1626825
Sex: U
Age:
State:

Vax Date: 06/03/2021
Onset Date:
Rec V Date: 08/24/2021
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: Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-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 an unknown date, the patient experienced ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA is not applicable.

Other Meds:

Current Illness:

ID: 1626826
Sex: F
Age: 53
State: MN

Vax Date: 05/08/2021
Onset Date: 06/05/2021
Rec V Date: 08/24/2021
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: she drank four glasses of water that day and four bubbly water cans that were 12 ounces each; any movement was painful; muscles in arms and legs began cramping/spasms and cramping; higher than normal blood sugar ranged between 200-300; able to sleep 20-30 mins at a time/wake up due to cold/shaking and body pain; her muscles and joints would not work; she could feel blood running through her body, it was pulsating and thought blood was going to burst through her head. She felt like her blood pressure was so high; a new pain in her legs that she would get hot spots,her legs would seize in a convulsive pain; felt like she was dying/feel blood rushing through body; stiffness then turned to pain that moving was excruciating all over even her wrist hurt, her elbow hurt to bend/body sore; felt like a truck hit her as she was exhausted/exhausted; major chill,shivering/shivering/shaking of limbs from being so cold; headache/pulsating and pounding in head/felt like top of head would explode off; very stiff,she felt like she was an 80-85 year old in how she was going down the steps because she was so stiff/body began to feel stiff; overwhelmingly cold feeling,shivering visibly/extremely cold; can feel her body like it is not wanting to continue to move,could hardly change from her street clothes to her pajamas/very difficult to get up and move around/could barely move legs to get out of vehicle; her muscles and joints would not work; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (very stiff,she felt like she was an 80-85 year old in how she was going down the steps because she was so stiff/body began to feel stiff), FEELING COLD (overwhelmingly cold feeling,shivering visibly/extremely cold), MOBILITY DECREASED (can feel her body like it is not wanting to continue to move,could hardly change from her street clothes to her pajamas/very difficult to get up and move around/could barely move legs to get out of vehicle), MUSCLE DISCOMFORT (her muscles and joints would not work) and HYPERTENSION (she could feel blood running through her body, it was pulsating and thought blood was going to burst through her head. She felt like her blood pressure was so high) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type I diabetes mellitus since 09-May-1976, Cholesterol, Hypothyroidism and Drug allergy (codeine). Concomitant products included SIMVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid atrophy, INSULIN LISPRO (HUMALOG), INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 10R), INSULIN GLARGINE (LANTUS), MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (very stiff,she felt like she was an 80-85 year old in how she was going down the steps because she was so stiff/body began to feel stiff), FEELING COLD (overwhelmingly cold feeling,shivering visibly/extremely cold), MOBILITY DECREASED (can feel her body like it is not wanting to continue to move,could hardly change from her street clothes to her pajamas/very difficult to get up and move around/could barely move legs to get out of vehicle), MUSCLE DISCOMFORT (her muscles and joints would not work), CHILLS (major chill,shivering/shivering/shaking of limbs from being so cold) and HEADACHE (headache/pulsating and pounding in head/felt like top of head would explode off). On 06-Jun-2021, the patient experienced HYPERTENSION (she could feel blood running through her body, it was pulsating and thought blood was going to burst through her head. She felt like her blood pressure was so high), PAIN IN EXTREMITY (a new pain in her legs that she would get hot spots,her legs would seize in a convulsive pain), FEELING ABNORMAL (felt like she was dying/feel blood rushing through body), MYALGIA (stiffness then turned to pain that moving was excruciating all over even her wrist hurt, her elbow hurt to bend/body sore) and FATIGUE (felt like a truck hit her as she was exhausted/exhausted). On an unknown date, the patient experienced THIRST (she drank four glasses of water that day and four bubbly water cans that were 12 ounces each), PAIN (any movement was painful), MUSCLE SPASMS (muscles in arms and legs began cramping/spasms and cramping), BLOOD GLUCOSE INCREASED (higher than normal blood sugar ranged between 200-300), SLEEP DISORDER (able to sleep 20-30 mins at a time/wake up due to cold/shaking and body pain) and ARTHRALGIA (her muscles and joints would not work). On 07-Jun-2021, MUSCULOSKELETAL STIFFNESS (very stiff,she felt like she was an 80-85 year old in how she was going down the steps because she was so stiff/body began to feel stiff), FEELING COLD (overwhelmingly cold feeling,shivering visibly/extremely cold), MOBILITY DECREASED (can feel her body like it is not wanting to continue to move,could hardly change from her street clothes to her pajamas/very difficult to get up and move around/could barely move legs to get out of vehicle), MUSCLE DISCOMFORT (her muscles and joints would not work), HYPERTENSION (she could feel blood running through her body, it was pulsating and thought blood was going to burst through her head. She felt like her blood pressure was so high), PAIN IN EXTREMITY (a new pain in her legs that she would get hot spots,her legs would seize in a convulsive pain), FEELING ABNORMAL (felt like she was dying/feel blood rushing through body), CHILLS (major chill,shivering/shivering/shaking of limbs from being so cold), HEADACHE (headache/pulsating and pounding in head/felt like top of head would explode off), MYALGIA (stiffness then turned to pain that moving was excruciating all over even her wrist hurt, her elbow hurt to bend/body sore) and FATIGUE (felt like a truck hit her as she was exhausted/exhausted) had resolved. At the time of the report, THIRST (she drank four glasses of water that day and four bubbly water cans that were 12 ounces each), PAIN (any movement was painful), MUSCLE SPASMS (muscles in arms and legs began cramping/spasms and cramping), BLOOD GLUCOSE INCREASED (higher than normal blood sugar ranged between 200-300), SLEEP DISORDER (able to sleep 20-30 mins at a time/wake up due to cold/shaking and body pain) and ARTHRALGIA (her muscles and joints would not work) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up received contains patient demographic information, race and ethnic information, non serious events, allergy to codeine, concomitant drug.

Other Meds: HUMALOG; NOVOLIN 10R; LANTUS; MELOXICAM; LEVOTHYROXINE; SIMVASTATIN; ASPIRIN (E.C.)

Current Illness: Cholesterol; Drug allergy (codeine); Hypothyroidism; Type I diabetes mellitus

ID: 1626827
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (missed the second dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (missed the second dose). At the time of the report, product dose omission issue (missed the second dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication and treatment information not reported.

Other Meds:

Current Illness:

ID: 1626828
Sex: U
Age:
State:

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 08/24/2021
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: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Large red rash around injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Large red rash around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) 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 an unknown date, the patient experienced VACCINATION SITE RASH (Large red rash around injection site). At the time of the report, VACCINATION SITE RASH (Large red rash around injection site) outcome was unknown. Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided. Action taken with the drug in response to events was not applicable.

Other Meds:

Current Illness:

ID: 1626829
Sex: U
Age:
State:

Vax Date: 06/02/2021
Onset Date: 06/08/2021
Rec V Date: 08/24/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Small redness on the arm; Little Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-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 08-Jun-2021, the patient experienced ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish). At the time of the report, ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish) outcome was unknown. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1626830
Sex: M
Age: 58
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 08/24/2021
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: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. No medication history information was reported. Concomitant products included AMOXICILLIN for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication were provided This case was linked to MOD-2021-214827 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information was received and reporter information was updated. On 04-Aug-2021: Follow Up received- No new information for dose-1 related event.

Other Meds: AMOXICILLIN

Current Illness:

ID: 1626831
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Fibromyalgia flare; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia flare) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia flare). At the time of the report, FIBROMYALGIA (Fibromyalgia flare) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626832
Sex: M
Age: 58
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 08/24/2021
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: 2021; Test Name: Body temperature; Result Unstructured Data: Abnormal

Allergies:

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

Symptoms: felt like they had tonsillitis; still weak; stomach is sort of out of sorts; I'm constantly having floaters, referring to bowel movements; Arm pain; ongoing fatigue the past two or three weeks/ tired all of the time; fever; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (felt like they had tonsillitis), ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements) and PAIN IN EXTREMITY (Arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Tooth repair. Concomitant products included AMOXICILLIN for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-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 TONSILLITIS (felt like they had tonsillitis), ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements), PAIN IN EXTREMITY (Arm pain), FATIGUE (ongoing fatigue the past two or three weeks/ tired all of the time) and PYREXIA (fever). At the time of the report, TONSILLITIS (felt like they had tonsillitis), PAIN IN EXTREMITY (Arm pain) and PYREXIA (fever) outcome was unknown and ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements) and FATIGUE (ongoing fatigue the past two or three weeks/ tired all of the time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) Abnormal. Treatment medications were not provided This case was linked to MOD-2021-214821 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up received on 30-JUN-2021. Reporter phone number, salutation, email address were updated and Events like stomach discomfort, floaters/Gas, Tired and weakness were updated

Other Meds: AMOXICILLIN

Current Illness:

ID: 1626833
Sex: U
Age:
State:

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 08/24/2021
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: After my 2nd dose I was able to lift my arm unlike after my first dose; large red rash around injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE RASH (large red rash around injection site) and LIMB DISCOMFORT (After my 2nd dose I was able to lift my arm unlike after my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (large red rash around injection site) and LIMB DISCOMFORT (After my 2nd dose I was able to lift my arm unlike after my first dose). At the time of the report, INJECTION SITE RASH (large red rash around injection site) had resolved and LIMB DISCOMFORT (After my 2nd dose I was able to lift my arm unlike after my first dose) outcome was unknown. Concomitant drugs are not provided Treatment information not provided. This case was linked to MOD-2021-214817 (Patient Link).

Other Meds:

Current Illness:

ID: 1626834
Sex: F
Age: 49
State: NJ

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 08/24/2021
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 arm at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm at the injection arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 024C21A) for COVID-19 vaccination. The patient's past medical history included Shingles (Shingles attack few years back). Concomitant products included GABAPENTIN for Rheumatoid arthritis, ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (ZENAX) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm at the injection arm). At the time of the report, PAIN IN EXTREMITY (Sore arm at the injection arm) outcome was unknown. Not Provided Patient received no treatment for events that occurred due to first dose. Action taken with the drug in response to events was not applicable.

Other Meds: GABAPENTIN; LEXAPRO; ZENAX

Current Illness:

ID: 1626835
Sex: M
Age:
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/25/2021
Rec V Date: 08/24/2021
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: More than 45 days to get second dose; Fatigue; Mild fever; Mild weakness, limited activity; Itching; Blister appeared next day on my arm on the same spot where the vaccine was injected; Minor bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Minor bleeding), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 45 days to get second dose), VACCINATION SITE VESICLES (Blister appeared next day on my arm on the same spot where the vaccine was injected), ASTHENIA (Mild weakness, limited activity) and VACCINATION SITE PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure since 15-Aug-2011. Concomitant products included ESOMEPRAZOLE from 15-Aug-2020 to an unknown date for Acid reflux (esophageal), LOSARTAN POTASSIUM from 07-Feb-2021 to an unknown date and NEBIVOLOL from 07-Feb-2021 to an unknown date for Hypertension. On 15-Apr-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced ASTHENIA (Mild weakness, limited activity) and PYREXIA (Mild fever). On 27-Apr-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Minor bleeding), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 45 days to get second dose), VACCINATION SITE VESICLES (Blister appeared next day on my arm on the same spot where the vaccine was injected) and VACCINATION SITE PRURITUS (Itching). The patient was treated with FUSIDATE SODIUM (FUCIDIN [FUSIDATE SODIUM]) (topical) for Blister, at a dose of 1 UNK. At the time of the report, VACCINATION SITE HAEMORRHAGE (Minor bleeding), VACCINATION SITE VESICLES (Blister appeared next day on my arm on the same spot where the vaccine was injected) and VACCINATION SITE PRURITUS (Itching) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 45 days to get second dose), ASTHENIA (Mild weakness, limited activity), FATIGUE (Fatigue) and PYREXIA (Mild fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. PCR Covid Test- Saliva was done but no results were mentioned Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05 JUL 2021: Updated patient demographics, Past medical history, Concomitant and treatment medications and Events and Event outcome. On 19-Jul-2021: Follow up received on 19 JUL 2021 and contains no new information On 20-Jul-2021: Follow up additional 2 report received and contains no new information On 20-Jul-2021: Follow up additional information received and contains no new information On 23-Jul-2021: Follow up additional information 3 received containing No New Information On 30-Jul-2021: Follow-up received on 30-Jul-2021 included no new information.

Other Meds: LOSARTAN POTASSIUM; NEBIVOLOL; ESOMEPRAZOLE

Current Illness: Blood pressure

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am