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: 1644544
Sex: F
Age:
State: NJ

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Mammogram; Result Unstructured Data: Suspicion of malignancy; Test Name: Ultrasound; Result Unstructured Data: 95% likelihood of breast cancer

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: breast cancer; Retracted nipple; breast lump; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a female patient of an unknown age 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-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 BREAST CANCER (breast cancer) (seriousness criterion medically significant), RETRACTED NIPPLE (Retracted nipple) and BREAST MASS (breast lump). At the time of the report, BREAST CANCER (breast cancer), RETRACTED NIPPLE (Retracted nipple) and BREAST MASS (breast lump) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: suspicion of malignancy (abnormal) Suspicion of malignancy. On an unknown date, Ultrasound breast: abnormal (abnormal) 95% likelihood of breast cancer. Concomitant products were not provided. Treatment medication were not reported. After vaccine the patient developed retracted nipple. Later patient developed a small lump and went for an immediate mammography and its results stated suspicion of malignancy, ultrasound results shown 5 on scale indicating 95% likelihood of breast cancer. Doctor confirmed it as breast cancer and mentioned they need biopsy to go for the treatment option. Also stated that patient developed this mass after 4 months of vaccination. Company Comment : Very limited information regarding these events has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Additional information required.

Other Meds:

Current Illness:

ID: 1644545
Sex: F
Age: 64
State: WA

Vax Date: 03/10/2021
Onset Date: 04/08/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Blood Pressure; Result Unstructured Data: High; Test Name: Blood test; Result Unstructured Data: all blood tests were normal.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Can not walk right; Eyes can not focus; Sweating/drenched clothes; Memory Problems; Hateful behavior; Vaccine is eating me inside and out after second dose/It crippled me/does not feel well; Trouble sleeping; High Blood Pressure; No energy; Agitated; Too much pain; Pain on the injection site after second dose; Muscles are out; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can not walk right) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 661 003B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Brain injuries (Had brain injuries since the accident), Motor vehicle accident and Drug allergy (Allergic to an injection during surgery about 50 years ago.). Concurrent medical conditions included Disability. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced GAIT DISTURBANCE (Can not walk right) (seriousness criterion medically significant), VISION BLURRED (Eyes can not focus), HYPERHIDROSIS (Sweating/drenched clothes), MEMORY IMPAIRMENT (Memory Problems), ABNORMAL BEHAVIOUR (Hateful behavior), VACCINATION COMPLICATION (Vaccine is eating me inside and out after second dose/It crippled me/does not feel well), SLEEP DISORDER (Trouble sleeping), HYPERTENSION (High Blood Pressure), ASTHENIA (No energy), AGITATION (Agitated), PAIN (Too much pain), VACCINATION SITE PAIN (Pain on the injection site after second dose), MUSCULAR WEAKNESS (Muscles are out) and CHILLS (Chills). On 10-Apr-2021, HYPERHIDROSIS (Sweating/drenched clothes), VACCINATION SITE PAIN (Pain on the injection site after second dose) and CHILLS (Chills) had resolved. At the time of the report, GAIT DISTURBANCE (Can not walk right), VISION BLURRED (Eyes can not focus), MEMORY IMPAIRMENT (Memory Problems), ABNORMAL BEHAVIOUR (Hateful behavior), SLEEP DISORDER (Trouble sleeping), HYPERTENSION (High Blood Pressure), ASTHENIA (No energy), AGITATION (Agitated), PAIN (Too much pain) and MUSCULAR WEAKNESS (Muscles are out) outcome was unknown and VACCINATION COMPLICATION (Vaccine is eating me inside and out after second dose/It crippled me/does not feel well) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood test: normal (normal) all blood tests were normal.. Concomitant medications were not reported. No treatment details were provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-281242 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644546
Sex: F
Age: 120
State: CA

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/28/2021
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: Caller states she just had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller states she just had a sore arm) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma (She takes Asthma inhalers) and GERD. Concomitant products included CLONAZEPAM (KLONOPIN), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Caller states she just had a sore arm). At the time of the report, PAIN IN EXTREMITY (Caller states she just had a sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient was taking a tranquilizer very seldom along with other concomitant drugs. This case was linked to MOD-2021-281133 (Patient Link). Reporter did not allow further contact

Other Meds: KLONOPIN; PROTONIX [OMEPRAZOLE]; CYMBALTA

Current Illness: Asthma (She takes Asthma inhalers); GERD

ID: 1644547
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: his various vein in his leg started bleeding; bleeding from his shot site; This spontaneous case was reported by a consumer and describes the occurrence of VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) in a male patient of an unknown age 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 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 VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) (seriousness criterion medically significant) and VACCINATION SITE HAEMORRHAGE (bleeding from his shot site). At the time of the report, VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) and VACCINATION SITE HAEMORRHAGE (bleeding from his shot site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644548
Sex: F
Age: 69
State: NJ

Vax Date: 03/02/2021
Onset Date: 03/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Depression on her eardrum; Pressure on her left ear increased; Hearing loss in left ear; High pitched screeching sound; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in left ear) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (High pitched screeching sound). On 02-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss in left ear) (seriousness criterion medically significant) and EAR DISCOMFORT (Pressure on her left ear increased). On an unknown date, the patient experienced TYMPANIC MEMBRANE DISORDER (Depression on her eardrum). The patient was treated with XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) on 02-Apr-2021 for Hearing loss, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 02-Apr-2021 for Hearing loss, at a dose of 1 dosage form and BUDESONIDE (RHINOCORT [BUDESONIDE]) on 03-Apr-2021 for Adverse event, at a dose of 1 dosage form. On 03-Apr-2021, DEAFNESS UNILATERAL (Hearing loss in left ear) had resolved. At the time of the report, TINNITUS (High pitched screeching sound) and EAR DISCOMFORT (Pressure on her left ear increased) had not resolved and TYMPANIC MEMBRANE DISORDER (Depression on her eardrum) outcome was unknown. Concomitant products were not provided. The pressure on patient left ear remains. Also states that the high pitched screeching would still come and go. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's old age, may be a confounding factor to the event tinnitus. This case was linked to MOD-2021-281254 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's old age, may be a confounding factor to the event tinnitus.

Other Meds:

Current Illness:

ID: 1644549
Sex: F
Age:
State: MD

Vax Date: 02/06/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Test Date: 20210723; Test Name: Magnetic resonance imaging (MRI); Result Unstructured Data: blood clot was still there

Allergies:

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

Symptoms: lost consciousness; diagnosed with Venous Sinus Thrombosis; very bad vertigo since receiving the Moderna vaccine/it has been serious; Headache; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL VENOUS SINUS THROMBOSIS (diagnosed with Venous Sinus Thrombosis), LOSS OF CONSCIOUSNESS (lost consciousness) and THROMBOSIS (Blood clot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 610M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (had breast cancer 17 years ago but had not had any problems since then). Concurrent medical conditions included Myelodysplasia and Osteopenia. Concomitant products included EPOETIN ALFA (PROCRIT) and CITALOPRAM for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (diagnosed with Venous Sinus Thrombosis) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (very bad vertigo since receiving the Moderna vaccine/it has been serious) and HEADACHE (Headache). The patient was hospitalized on 10-May-2021 due to CEREBRAL VENOUS SINUS THROMBOSIS and LOSS OF CONSCIOUSNESS. The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at an unspecified dose and frequency; ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for Clot blood, at a dose of UNK, qwk and APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, CEREBRAL VENOUS SINUS THROMBOSIS (diagnosed with Venous Sinus Thrombosis), LOSS OF CONSCIOUSNESS (lost consciousness), THROMBOSIS (Blood clot), VERTIGO (very bad vertigo since receiving the Moderna vaccine/it has been serious) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Magnetic resonance imaging: abnormal (abnormal) blood clot was still there. The patient turned 70 years of age on 08-JUL-2021. On 23-JUL-2021, magnetic resonance venography (MRV) showed that the blood clot was still there. When she was on Xarelto, there was no change in the clot hence it was stopped. then she was given Lovenox for a week. After this Eliquis was started. Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the event of headache.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the event of headache.

Other Meds: PROCRIT; CITALOPRAM

Current Illness: Myelodysplasia; Osteopenia

ID: 1644550
Sex: M
Age: 24
State: MA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/28/2021
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: Consumer is beyond 42 days for second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.) 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.

Other Meds:

Current Illness:

ID: 1644551
Sex: M
Age: 74
State:

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 08/28/2021
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: her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021; fever of 104 degrees Fahrenheit; deep redness from wrist to shoulder on injection arm; Chest Pain; deep redness from wrist to shoulder on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021). At the time of the report, CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm) had resolved and PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant medication provided. On an unknown date, Body temperature: 104 (Inconclusive) 104 degrees Fahrenheit. No treatment medication provided. The patient did not receive second dose at all.

Other Meds:

Current Illness:

ID: 1644552
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: dementia; cannot walk; COVID-brain; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) in a male patient of an unknown age 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 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 DEMENTIA (dementia) (seriousness criterion medically significant), GAIT DISTURBANCE (cannot walk) and COVID-19 (COVID-brain). At the time of the report, DEMENTIA (dementia), GAIT DISTURBANCE (cannot walk) and COVID-19 (COVID-brain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product was reported. On an unspecified date, SARS-CoV-2 test was positive. No treatment information was reported. Very limited information regarding these events has been provided at this time. Patient declined further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient declined further contact

Other Meds:

Current Illness:

ID: 1644553
Sex: F
Age: 74
State:

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20200317; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive for the COVID-19

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Never received her second administration of the vaccine and is far outside the allowed time window to do so; Fever of 102 degrees Fahrenheit; Fatigue; Hallucinations; Bones aching; loss of appetite; Foggy feeling in head; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included WARFARIN, METOPROLOL SUCCINATE (TOPROL) and DIGOXIN for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), BONE PAIN (Bones aching), DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (Foggy feeling in head), PYREXIA (Fever of 102 degrees Fahrenheit) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received her second administration of the vaccine and is far outside the allowed time window to do so). At the time of the report, HALLUCINATION (Hallucinations), BONE PAIN (Bones aching), PRODUCT DOSE OMISSION ISSUE (Never received her second administration of the vaccine and is far outside the allowed time window to do so), PYREXIA (Fever of 102 degrees Fahrenheit) and FATIGUE (Fatigue) had resolved and DECREASED APPETITE (loss of appetite) and FEELING ABNORMAL (Foggy feeling in head) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2020, SARS-CoV-2 test: positive (Positive) positive for the COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product includes chlorizide. Treatment information was not provided. Expiry date reported as unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: WARFARIN; TOPROL; DIGOXIN

Current Illness:

ID: 1644554
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: He passed out; Injection site was bleeding; Learn about severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (He passed out) in a male patient of an unknown age 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 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 LOSS OF CONSCIOUSNESS (He passed out) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Injection site was bleeding) and HYPERSENSITIVITY (Learn about severe allergic reaction). At the time of the report, LOSS OF CONSCIOUSNESS (He passed out), VACCINATION SITE HAEMORRHAGE (Injection site was bleeding) and HYPERSENSITIVITY (Learn about severe allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644555
Sex: F
Age: 55
State:

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: felt out of breath; body pain was so severe; had a fever (didn't take it); feeling very tired; tightness in the chest; diarrhea; chills; muscle pain; head ache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST DISCOMFORT (tightness in the chest), DYSPNOEA (felt out of breath), PAIN (body pain was so severe) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) 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 BUPROPION for an unknown indication. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (head ache) and ARTHRALGIA (joint pain). On 04-Aug-2021, the patient experienced CHEST DISCOMFORT (tightness in the chest) and FATIGUE (feeling very tired). On an unknown date, the patient experienced DYSPNOEA (felt out of breath), PAIN (body pain was so severe) and PYREXIA (had a fever (didn't take it)). At the time of the report, DIARRHOEA (diarrhea), DYSPNOEA (felt out of breath), PAIN (body pain was so severe), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (head ache), ARTHRALGIA (joint pain), FATIGUE (feeling very tired) and PYREXIA (had a fever (didn't take it)) had resolved and CHEST DISCOMFORT (tightness in the chest) had not resolved. NO Treatment drug reported. This case was linked to MOD-2021-281341 (Patient Link).

Other Meds: BUPROPION

Current Illness:

ID: 1644556
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: side effects of moderna vaccine on preganant ladies; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies). At the time of the report, VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medications were reported no treatment medications were reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644557
Sex: F
Age: 41
State: NJ

Vax Date: 04/05/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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: blood work; Result Unstructured Data: couldn't find anything; Test Date: 20210513; Test Name: MRI of my cervical spine; Result Unstructured Data: Abnormal Diagnosed with Acute Transverse Myelitis. Spine was inflamed from C2 - C7; Test Name: urine; Result Unstructured Data: couldn't find anything

Allergies:

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

Symptoms: Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis; Parazlyzed from the neck down; I had spasticity in my legs; Weird sensations in my body; Pain in my arms; Retention in my bladder/overactive bladder; Lost control over bowels; Hands are weak; Chest pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis), PARALYSIS (Parazlyzed from the neck down), URINARY RETENTION (Retention in my bladder/overactive bladder), ANAL INCONTINENCE (Lost control over bowels), MUSCLE SPASTICITY (I had spasticity in my legs), FEELING ABNORMAL (Weird sensations in my body) and PAIN IN EXTREMITY (Pain in my arms) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to nuts (Tree nuts), Birch pollen allergy and Vegetable allergy. Concomitant products included LORAZEPAM for Anxiety, SERTRALINE for Depression. On 05-Apr-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PARALYSIS (Parazlyzed from the neck down) (seriousness criteria hospitalization and medically significant), MUSCLE SPASTICITY (I had spasticity in my legs) (seriousness criterion hospitalization), FEELING ABNORMAL (Weird sensations in my body) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Pain in my arms) (seriousness criterion hospitalization). In May 2021, the patient experienced URINARY RETENTION (Retention in my bladder/overactive bladder) (seriousness criteria hospitalization and medically significant) and ANAL INCONTINENCE (Lost control over bowels) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYELITIS TRANSVERSE (Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced MUSCULAR WEAKNESS (Hands are weak) and BACK PAIN (Back pain). an unknown date, the patient experienced CHEST PAIN (Chest pain). The patient was hospitalized for 9 days until 04-Jun-2021 due to MYELITIS TRANSVERSE, then for 9 days until 28-Jun-2021 due to ANAL INCONTINENCE, FEELING ABNORMAL, MUSCLE SPASTICITY, PAIN IN EXTREMITY, PARALYSIS and URINARY RETENTION. The patient was treated with BACLOFEN for Muscle relaxant, at a dose of 10 mg once a day; BACLOFEN for Muscle relaxant, at a dose of 10 mg and FLUDROCORTISONE for Blood pressure abnormal, at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Acute Transverse Myelitis/Idiopathic Acute Transverse Myelitis), PARALYSIS (Parazlyzed from the neck down), URINARY RETENTION (Retention in my bladder/overactive bladder), ANAL INCONTINENCE (Lost control over bowels), MUSCLE SPASTICITY (I had spasticity in my legs), FEELING ABNORMAL (Weird sensations in my body), PAIN IN EXTREMITY (Pain in my arms), MUSCULAR WEAKNESS (Hands are weak), CHEST PAIN (Chest pain) and BACK PAIN (Back pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Magnetic resonance imaging: abnormal (abnormal) Abnormal Diagnosed with Acute Transverse Myelitis. Spine was inflamed from C2 - C7. On an unknown date, Blood test: couldn't find anything (normal) couldn't find anything. On an unknown date, Urine analysis: couldn't find anything (normal) couldn't find anything. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that on 21-JUL-2021 neurogenic bladder test was done, results were not reported. Patient was given 5 rounds of steroids and had a lumbar puncture. The steroids were very effective in getting my paralysis down. MRI of her thoracic spine is scheduled on August 27th because of new chest and back pain. Went back to the Urologist to have a neurogenic bladder test. The patient reported that she was prescribed a bladder medication, Gemsa, and she also straight cath herself about 6 times or more a day. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-230242 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LORAZEPAM; SERTRALINE

Current Illness: Allergy to nuts (Tree nuts); Birch pollen allergy; Vegetable allergy

ID: 1644558
Sex: F
Age: 62
State: CO

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/28/2021
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 Date: 20210326; Test Name: Blood Pressure; Result Unstructured Data: Increased Blood Pressure 134/104 mmHg; Test Date: 20210408; Test Name: Blood Pressure; Result Unstructured Data: Blood Pressure increased to 180/112 mmHg; Test Date: 20210329; Test Name: Urine output; Result Unstructured Data: Urine output decreased

Allergies:

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

Symptoms: Fluttering on the heart (worst when bending); May be Myocarditis related; Extreme Diarrhea; Menstrual cramps; Menstrual Bleeding; Pounding on the heart (worst when bending); Can not walk 5 blocks without being out of breath; Swollen Lymph node on the back of neck; Fatigue; Pain in the Right hand/burning pain from wrist to shoulder; Could not touch anything; Lost sense of taste; Lost sense of smell; Vitreous detachment in the right eye; Red rash from nose to chin on the right side of the face; Pain gland in the Right ear (PMJ); Stabbing pain in bladder; Stabbing pain in kidney; Chest Pain; Jaw Pain; Hearing sounds (Banging on metal); Could not lift arm over the head; Pain on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS DETACHMENT (Vitreous detachment in the right eye), CARDIAC FLUTTER (Fluttering on the heart (worst when bending)) and MYOCARDITIS (May be Myocarditis related) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (Hearing sounds (Banging on metal)), MOBILITY DECREASED (Could not lift arm over the head) and VACCINATION SITE PAIN (Pain on the Injection Site). On 26-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) and PAIN IN JAW (Jaw Pain). On 29-Mar-2021, the patient experienced BLADDER PAIN (Stabbing pain in bladder) and RENAL PAIN (Stabbing pain in kidney). On 30-Mar-2021, the patient experienced EAR PAIN (Pain gland in the Right ear (PMJ)). On 31-Mar-2021, the patient experienced VITREOUS DETACHMENT (Vitreous detachment in the right eye) (seriousness criterion medically significant) and RASH ERYTHEMATOUS (Red rash from nose to chin on the right side of the face). On 04-Apr-2021, the patient experienced AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell). On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the Right hand/burning pain from wrist to shoulder) and HYPERAESTHESIA (Could not touch anything). On 09-Apr-2021, the patient experienced CARDIAC FLUTTER (Fluttering on the heart (worst when bending)) (seriousness criterion medically significant), MYOCARDITIS (May be Myocarditis related) (seriousness criterion medically significant), DIARRHOEA (Extreme Diarrhea), DYSMENORRHOEA (Menstrual cramps), MENSTRUAL DISORDER (Menstrual Bleeding), PALPITATIONS (Pounding on the heart (worst when bending)), GAIT DISTURBANCE (Can not walk 5 blocks without being out of breath), LYMPHADENOPATHY (Swollen Lymph node on the back of neck) and FATIGUE (Fatigue). On 18-Mar-2021, TINNITUS (Hearing sounds (Banging on metal)), MOBILITY DECREASED (Could not lift arm over the head) and VACCINATION SITE PAIN (Pain on the Injection Site) outcome was unknown. On 26-Mar-2021, CHEST PAIN (Chest Pain) and PAIN IN JAW (Jaw Pain) outcome was unknown. On 03-Apr-2021, BLADDER PAIN (Stabbing pain in bladder) and RENAL PAIN (Stabbing pain in kidney) outcome was unknown. On 07-Apr-2021, RASH ERYTHEMATOUS (Red rash from nose to chin on the right side of the face) outcome was unknown. On 08-Apr-2021, PAIN IN EXTREMITY (Pain in the Right hand/burning pain from wrist to shoulder) and HYPERAESTHESIA (Could not touch anything) outcome was unknown. On 09-Apr-2021, CARDIAC FLUTTER (Fluttering on the heart (worst when bending)) and PALPITATIONS (Pounding on the heart (worst when bending)) outcome was unknown. On 10-Apr-2021, MENSTRUAL DISORDER (Menstrual Bleeding) outcome was unknown. On 11-Apr-2021, AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell) outcome was unknown. On 12-Apr-2021, DIARRHOEA (Extreme Diarrhea) outcome was unknown. On 14-Apr-2021, DYSMENORRHOEA (Menstrual cramps) and LYMPHADENOPATHY (Swollen Lymph node on the back of neck) outcome was unknown. At the time of the report, VITREOUS DETACHMENT (Vitreous detachment in the right eye), MYOCARDITIS (May be Myocarditis related), EAR PAIN (Pain gland in the Right ear (PMJ)), GAIT DISTURBANCE (Can not walk 5 blocks without being out of breath) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement (117-62): 134/104 (High) Increased Blood Pressure 134/104 mmHg. On 29-Mar-2021, Urine output: decreased (Low) Urine output decreased. On 08-Apr-2021, Blood pressure measurement (117-62): 180/112 (High) Blood Pressure increased to 180/112 mmHg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient Laboratory data was mentioned as PCR test result was negative, Blood and urine test performed result was negative. No concomitant medications were provided by the reporter. Doctor would like to prescribe Steroids but patient was not take it.

Other Meds:

Current Illness:

ID: 1644559
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Vertigo; Dr visit due to an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) 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 VERTIGO (Vertigo) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had to go to the hospital. Treatment medication was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644560
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Side effects after a week of getting vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after a week of getting vaccinated) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after a week of getting vaccinated). At the time of the report, VACCINATION COMPLICATION (Side effects after a week of getting vaccinated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No information on concomitant medications were reported. No information on treatment medications were reported.

Other Meds:

Current Illness:

Date Died:

ID: 1644561
Sex: F
Age: 71
State: AR

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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 ends up bleeding; Swollen face; Sunken eyes; Couldn't speak; legs were cramping; burning legs; Blood clots on brain; Stroke; Blood clots on legs (left and right); stinging in leg; Fever; Diarrhea; Chills; Lower gut pain; Headache; back pain; Fall; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Blood clots on legs (left and right)), HAEMORRHAGE (she ends up bleeding), PYREXIA (Fever), DIARRHEA (Diarrhea), CHILLS (Chills), GASTROINTESTINAL PAIN (Lower gut pain), HEADACHE (Headache), PAIN IN EXTREMITY (stinging in leg), FALL (Fall), SWELLING FACE (Swollen face), LID SULCUS DEEPENED (Sunken eyes), APHASIA (Couldn't speak), BACK PAIN (back pain), MUSCLE SPASMS (legs were cramping), BURNING SENSATION (burning legs) and CEREBRAL THROMBOSIS (Blood clots on brain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Blood pressure high and Hysterectomy in 1981. Concurrent medical conditions included Penicillin allergy (penicillin allergy) and Drug allergy (Codeine allergy). In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), GASTROINTESTINAL PAIN (Lower gut pain) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization) and BACK PAIN (back pain) (seriousness criterion hospitalization). On 11-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Blood clots on legs (left and right)) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (stinging in leg) (seriousness criterion hospitalization), MUSCLE SPASMS (legs were cramping) (seriousness criterion hospitalization), BURNING SENSATION (burning legs) (seriousness criterion hospitalization) and CEREBRAL THROMBOSIS (Blood clots on brain) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced FALL (Fall) (seriousness criterion hospitalization). In July 2021, the patient experienced SWELLING FACE (Swollen face) (seriousness criterion hospitalization), LID SULCUS DEEPENED (Sunken eyes) (seriousness criterion hospitalization) and APHASIA (Couldn't speak) (seriousness criterion hospitalization). On an unknown date, the patient experienced HAEMORRHAGE (she ends up bleeding) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (blood transfusion) for Thrombosis. The patient died on an unknown date. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, THROMBOSIS (Blood clots on legs (left and right)), HAEMORRHAGE (she ends up bleeding), PYREXIA (Fever), DIARRHOEA (Diarrhea), CHILLS (Chills), GASTROINTESTINAL PAIN (Lower gut pain), HEADACHE (Headache), PAIN IN EXTREMITY (stinging in leg), FALL (Fall), SWELLING FACE (Swollen face), LID SULCUS DEEPENED (Sunken eyes), APHASIA (Couldn't speak), BACK PAIN (back pain), MUSCLE SPASMS (legs were cramping), BURNING SENSATION (burning legs) and CEREBRAL THROMBOSIS (Blood clots on brain) outcome was unknown. Patient was sent to the hospital that day and several tests were conducted like urine and Pet scan. No pulse on her legs as per husband and it also revealed that she had blood clots on both her left and right leg. She had 3 surgeries to take out the blood clot, however, she ended up bleeding. It got worse and hit her brain but fortunately, she did some therapy and after about 6 weeks, she was progressing well. Added that she fell three times in 2 days as per husband. Three weeks ago, he could not remember the exact date at around 7:15PM, he found his wife with swollen face, sunken eyes and couldn't speak. That day, he called 911 and was sent at the medical facility and was referred to a neurologist. They found out that she had massive blood clot on her brain that keeps on leaking and major stroke. She laid there for 3 days and the doctor told the husband that brain scan showed worst results and so they decided to remove her breathing tool and or extubated. She lasted for about 12 hours and died. No concomitant drugs were provided. Company comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Stroke

Other Meds:

Current Illness: Drug allergy (Codeine allergy); Penicillin allergy (penicillin allergy).

ID: 1644562
Sex: M
Age:
State: CO

Vax Date: 08/03/2021
Onset Date:
Rec V Date: 08/28/2021
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: Swelling; Redness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644563
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: cystitis; 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 CYSTITIS (cystitis) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CYSTITIS (cystitis). At the time of the report, CYSTITIS (cystitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter.

Other Meds:

Current Illness:

ID: 1644564
Sex: M
Age: 67
State: FL

Vax Date: 02/24/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
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: has been putting up with eye troubles; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (has been putting up with eye troubles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 044A21A) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol, Diabetes and Blood pressure high. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced EYE DISORDER (has been putting up with eye troubles). At the time of the report, EYE DISORDER (has been putting up with eye troubles) outcome was unknown. concomitant medication were reported include High cholesterol-Diabetes-High blood pressure medication. Treatment information not provided.

Other Meds:

Current Illness: Blood pressure high; Diabetes; High cholesterol

ID: 1644565
Sex: M
Age:
State: NY

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: serum creatine; Result Unstructured Data: serum creatine increased from baseline 1.25 to 1.96 mg/dL; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: blood pressure 97/55 mmHg; Test Date: 2021; Test Name: Temperature; Result Unstructured Data: temperature 36.9?C; Test Date: 20210605; Test Name: CD4; Result Unstructured Data: one week after hospitalization showed 66% (normal: 30% - 56%); Test Date: 20210605; Test Name: CD4+ T cell count; Result Unstructured Data: one week after hospitalization, showed absolute CD4+ T cell count of 384/uL (normal: 325 - 1251 u/L); Test Date: 20210605; Test Name: CD4/CD8; Result Unstructured Data: CD4/CD8 ratio of 4.38 (normal: 0.86 - 4.14); Test Date: 20210605; Test Name: CD8 percentage; Result Unstructured Data: one week after hospitalization showed CD8 percentage of 15% (normal: 30% - 56%); Test Date: 20210605; Test Name: CD8+ T cell; Result Unstructured Data: one week after hospitalization showed absolute CD8+ T cell count of 88/uL (normal: 90 - 775 u/L); Test Date: 2021; Test Name: Chest computed tomography; Result Unstructured Data: extensive bilateral patchy interstitial and nodular ground glass opacities, consistent with the findings of COVID-19.; Test Date: 2021; Test Name: hemoglobin A1c level; Result Unstructured Data: insulin-dependent diabetes mellitus with a hemoglobin A1c level of 8.4%; Test Date: 2021; Test Name: Pulse; Result Unstructured Data: 100 beats per minute; Test Date: 20210402; Test Name: absolute lymphocyte count; Result Unstructured Data: two months prior to admission showed an absolute lymphocyte count of 1.01 k/uL (normal: 1 - 3.30 k/uL); Test Date: 2021; Test Name: absolute lymphocyte count; Result Unstructured Data: absolute lymphocyte count 0.11 k/uL on admission noted lymphopenia (normal: 1 - 3.30 k/uL); Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: oxygen saturation 92% while breathing ambient air; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: was started on supplemental oxygen, delivered by nasal cannula at 2 L/minute, which improved his oxygen saturation values to 94 to 99%; Comments: On day 5 of hospitalization, the supplemental oxygen was discontinued while he was able to breathe comfortably on ambient air with oxygen saturation 97 to 99%.; Test Date: 2021; Test Name: respiratory rate; Result Unstructured Data: On examination, the patient appeared to be tachypneic; Test Date: 20210531; Test Name: anti-SARS-CoV-2 S enzyme immunoassay; Test Result: Negative ; Result Unstructured Data: Antibody tests against the SARS-CoV-2 nucleocapsid and receptor-binding domain (RBD) of the spike protein using the anti-SARS-CoV-2 S enzyme immunoassay (Roche Elecsys) were both negative; Comments: Anti-nucleocapsid total antibody cutoff index (COI) in this patient was 0.14 (COI = 0.99 was determined negative by the manufacturer) while the anti-spike RBD total antibody level was 0.40 U/mL (= 0.79 U/mL was determined negative).; Test Date: 20210706; Test Name:

Allergies:

Symptom List: Unevaluable event

Symptoms: tachypneic; Severe COVID-19; Vaccine Breakthrough infection; This literature-study case was reported in a literature article and describes the occurrence of TACHYPNOEA (tachypneic) and COVID-19 (Severe COVID-19) in a 73-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. LITERATURE REFERENCE: A case of severe COVID-19 despite full vaccination with mRNA-1273 SARS-CoV-2 Vaccine (Moderna) in a kidney transplant recipient. Transpl Infect Dis. 2021 The patient's past medical history included Renal transplant on 10-Feb-2020 and Immunosuppressant drug therapy since an unknown date. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Hypertension and Acute kidney injury. Concomitant products included PREDNISONE, MYCOPHENOLATE MOFETIL and TACROLIMUS for Immunosuppressant drug therapy. On 11-Feb-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 TACHYPNOEA (tachypneic) (seriousness criterion hospitalization prolonged), COVID-19 (Severe COVID-19) (seriousness criterion hospitalization prolonged) and VACCINE BREAKTHROUGH INFECTION (Vaccine Breakthrough infection). The patient was hospitalized until 07-Jun-2021 due to COVID-19 and TACHYPNOEA. The patient was treated with DEXAMETHASONE (intravenous) at a dose of 6 milligram and REMDESIVIR (intravenous) at an unspecified dose and frequency. At the time of the report, TACHYPNOEA (tachypneic), COVID-19 (Severe COVID-19) and VACCINE BREAKTHROUGH INFECTION (Vaccine Breakthrough infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Lymphocyte count (1-3.30): 1.01 k/ul (normal) two months prior to admission showed an absolute lymphocyte count of 1.01 k/uL. On 02-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. On 02-Apr-2021, White blood cell count (3.80-10.50): 5.62 k/ul (normal) two months prior to admission showed a white blood cell count of 5.62 k/uL. On 31-May-2021, SARS-CoV-2 antibody test: negative (Negative) Antibody tests against the SARS-CoV-2 nucleocapsid and receptor-binding domain (RBD) of the spike protein using the anti-SARS-CoV-2 S enzyme immunoassay (Roche Elecsys) were both negative. On 31-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-Jun-2021, CD4 lymphocytes (30-56): 66 (High) one week after hospitalization showed 66% and 384/ul (normal) one week after hospitalization, showed absolute CD4+ T cell count of 384/uL. On 05-Jun-2021, CD4/CD8 ratio (0.86-4.14): 4.38 (High) CD4/CD8 ratio of 4.38. On 05-Jun-2021, CD8 lymphocytes (30-56): 15% (Low) one week after hospitalization showed CD8 percentage of 15% and 88/ul (Low) one week after hospitalization showed absolute CD8+ T cell count of 88/uL. In 2021, Blood creatine (1.25-1.96): high (High) serum creatine increased from baseline 1.25 to 1.96 mg/dL. In 2021, Blood pressure measurement: 97/55 mmhg (Low) blood pressure 97/55 mmHg. In 2021, Body temperature: 36.9?c (normal) temperature 36.9?C. In 2021, Computerised tomogram thorax: abnormal (abnormal) extensive bilateral patchy interstitial and nodular ground glass opacities, consistent with the findings of COVID-19.. In 2021, Glycosylated haemoglobin: 8.4% % (abnormal) insulin-dependent diabetes mellitus with a hemoglobin A1c level of 8.4%. In 2021, Heart rate: 100 (abnormal) 100 beats per minute. In 2021, Lymphocyte count (1-3.30): 0.11 k/ul (abnormal) absolute lymphocyte count 0.11 k/uL on admission noted lymphopenia. In 2021, Oxygen saturation: 92% (normal) oxygen saturation 92% while breathing ambient air and 94% to 99% (normal) was started on supplemental oxygen, delivered by nasal cannula at 2 L/minute, which improved his oxygen saturation values to 94 to 99%. In 2021, Respiratory rate: 35 breaths/min (abnormal) On examination, the patient appeared to be tachypneic. In 2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal swab tested positive for SARS-CoV-2 by real-time reverse transcriptase?polymerase-chain-reaction (rRT-PCR) assay. In 2021, White blood cell count (3.80-10.50): 11.74 k/ul (High) white blood cell count 11.74 k/uL on admission noted leukocytosis. On 06-Jul-2021, SARS-CoV-2 antibody test: negative (Negative) A month after discharge the SARS-CoV-2 nucleocapsid antibody remained negative (COI=0.18, reference range = 0.99) and the anti-spike RBD protein antibody turned positive with a low titer of 2.31 U/mL (reference range = 0.79 U/mL).. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TACHYPNOEA (tachypneic), COVID-19 (Severe COVID-19) and VACCINE BREAKTHROUGH INFECTION (Vaccine Breakthrough infection) to be possibly related. Race of the patient reported. The patient presented to our emergency department (ED) on 29-May-2021, with decreased oral intake, nausea, lethargy, and progressive shortness of breath and cough for two weeks. On examination, the patient appeared to be tachypneic. In patient daily tacrolimus levels ranged between 3.8 to 6.0 ng/mL. Patient received intravenous (IV) remdesivir for 4 days but it was discontinued one day early due to acute kidney injury (serum creatine increased from baseline 1.25 to 1.96 mg/dL). After completing 10 days of IV dexamethasone 6 mg/day, patient was discharged home 07-Jun-2021. Patient's serum creatine had normalized to his baseline at the time of discharge and two weeks post-discharge his tacrolimus level had fallen to 2.2 ng/mL "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"; Sender's Comments: "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"

Other Meds: PREDNISONE; MYCOPHENOLATE MOFETIL; TACROLIMUS

Current Illness: Acute kidney injury; Diabetes mellitus insulin-dependent; Hypertension; Immunosuppressant drug therapy

ID: 1644566
Sex: M
Age:
State: NV

Vax Date: 04/01/2021
Onset Date: 05/20/2021
Rec V Date: 08/28/2021
Hospital: Y

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: afib; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criteria hospitalization and medically significant). On 22-Jul-2021, the patient experienced CHEST PAIN (Chest pain). The patient was hospitalized from 20-May-2021 to 20-May-2021 due to ATRIAL FIBRILLATION. On 20-May-2021, ATRIAL FIBRILLATION (afib) had resolved. On 22-Jul-2021, CHEST PAIN (Chest pain) had resolved. Patient Never had any heart issues until after vaccine,Now on prescribed meds and awaiting treatment and testing by cardiologist. he is not claiming his heart issue was caused by vaccine, but thought it should be reported for records. Company Comment Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-259218 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: MULTIPLE VITAMIN

Current Illness:

ID: 1644567
Sex: M
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Blood pressure was 97/57 mm Hg; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Patient was afebrile with a temperature of 98.6? Fahrenheit (38.6? Celsius); Test Date: 2021; Test Name: B-type natriuretic peptide; Result Unstructured Data: B-type natriuretic peptide level was 48.0 pg/mL; Test Date: 2021; Test Name: Left heart catheterization; Result Unstructured Data: Left heart catheterization revealed angiographically normal coronary arteries. Left ventricular end-diastolic pressure was 18 mmHg.; Test Date: 2021; Test Name: Chest radiograph; Result Unstructured Data: Chest radiograph was unremarkable with no signs of focal consolidation, pneumothorax, or pleural effusion; Test Date: 2021; Test Name: Urine drug screen; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: echocardiogram revealed low-normal left ventricular ejection fraction (LVEF) of 50?55% with mid to apical anterior and anterolateral segments appearing hypokinetic; Test Date: 2021; Test Name: ECG; Result Unstructured Data: ECG revealed normal sinus rhythm with diffuse ST elevation; Comments: Initial ECG on admission showing diffuse ST elevations seen in leads V3?V6, I, II, and aVF. PR segment depression is noted in leads V3?V6; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: heart rate 100 beats/min; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: heart rate improved to a range of 70?80 beats per minute; Test Date: 2021; Test Name: HIV screen; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: CMR/Cardiac MRI; Result Unstructured Data: showed a normal LVEF (58 %) with findings of dyssnchrony of the septal wall. Also showed subepicardial late gadolinium enhancement (LGE) involving the lateral wall and inferior segments at the midventricular and apical LV. Mild adjacent pericardial LGE was also noted. These findings were consistent with perimyocarditis.; Comments: multiple imaging modalities during patient's hospitalization found evidence of wall motion abnormalities consistent with a diagnosis of perimyocarditis; Test Date: 2021; Test Name: CMR/Cardiac MRI; Result Unstructured Data: one month following discharge, a repeat cardiac MRI was performed which showed improved subepicardial and adjacent pericardial delayed enhancement in the mid and distal left ventricle. Also showed resolution of the previously noted dyssnchrony suggestive of improving perimyocarditis.; Test Date: 2021; Test Name: complete metabolic panel; Result Unstructured Data: complete metabolic panel was unremarkable; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: oxygen saturation was 99 % on room air; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: respiratory rate 16 breaths/min; Test Date: 2021; Test Name: viral respiratory panel; Test Result: Negative ; Result Unstructured Data: Ne

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Perimyocarditis; body aches; fever; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Perimyocarditis) in a 22-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. LITERATURE REFERENCE: Perimyocarditis following frst dose of the mRNA-1273 SARS-CoV-2 (Moderna) vaccine in a healthy young male. BMC Cardiovasc Disord. 2021;21(1):375 The patient's past medical history included COVID-19 (Six months prior patient had a mild case of COVID-19). 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 MYOCARDITIS (Perimyocarditis) (seriousness criteria hospitalization prolonged and medically significant), MYALGIA (body aches) and PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Chest pain and Pericardial effusion, at a dose of 650 milligram three times a day; COLCHICINE for Chest pain and Pericardial effusion, at a dose of .6 milligram twice a day and METOPROLOL for Myocardial infarction, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Perimyocarditis) was resolving and MYALGIA (body aches) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 97/57 mm hg (abnormal) Blood pressure was 97/57 mm Hg. In 2021, Body temperature: 98.6? fahrenheit (normal) Patient was afebrile with a temperature of 98.6? Fahrenheit (38.6? Celsius). In 2021, Brain natriuretic peptide (Unknown-< 100): 48.0 pg/ml (normal) B-type natriuretic peptide level was 48.0 pg/mL. In 2021, Catheterisation cardiac: normal (normal) Left heart catheterization revealed angiographically normal coronary arteries. Left ventricular end-diastolic pressure was 18 mmHg.. In 2021, Chest X-ray: unremarkable (normal) Chest radiograph was unremarkable with no signs of focal consolidation, pneumothorax, or pleural effusion. In 2021, Drug screen: negative (Negative) Negative. In 2021, Echocardiogram: low-normal (abnormal) echocardiogram revealed low-normal left ventricular ejection fraction (LVEF) of 50?55% with mid to apical anterior and anterolateral segments appearing hypokinetic. In 2021, Electrocardiogram: abnormal (abnormal) ECG revealed normal sinus rhythm with diffuse ST elevation. In 2021, HIV test: negative (Negative) Negative. In 2021, Heart rate: 100 beats/min (normal) heart rate 100 beats/min and 70?80 beats per minute (normal) heart rate improved to a range of 70?80 beats per minute. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) showed a normal LVEF (58 %) with findings of dyssnchrony of the septal wall. Also showed subepicardial late gadolinium enhancement (LGE) involving the lateral wall and inferior segments at the midventricular and apical LV. Mild adjacent pericardial LGE was also noted. These findings were consistent with perimyocarditis. and improved (normal) one month following discharge, a repeat cardiac MRI was performed which showed improved subepicardial and adjacent pericardial delayed enhancement in the mid and distal left ventricle. Also showed resolution of the previously noted dyssnchrony suggestive of improving perimyocarditis.. In 2021, Metabolic function test: unremarkable (normal) complete metabolic panel was unremarkable. In 2021, Oxygen saturation: 99% (normal) oxygen saturation was 99 % on room air. In 2021, Respiratory rate: 16 breaths/min (normal) respiratory rate 16 breaths/min. In 2021, Respiratory viral panel: negative (Negative) Negative. In 2021, SARS-CoV-2 test: negative (Negative) Negative. In 2021, Troponin (3-20): 13,702 ng/l (High) High sensitivity troponin was 13,702 ng/L, normal (normal) troponin downtrended and elevated (High) markedly elevated troponin. In 2021, White blood cell count: 8700/cm3 (normal) white blood cell count was 8700/cm3 with a neutrophilic predominance of 83%. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Perimyocarditis), MYALGIA (body aches) and PYREXIA (fever) to be possibly related. Patient took no medications or over the-counter supplements and denied any significant family history of chronic conditions including cardiovascular disease. Patient also denied any tobacco, alcohol, or recreational drug use. On physical examination, patient was tachycardic with a regular rhythm. No murmurs, rubs, or gallops were appreciated on auscultation. No jugular venous distension, tenderness to palpation of the chest wall, or lower extremity edema were noted. Because of patient's pleuritic chest pain shortly after vaccination, author's leading diagnosis was acute pericarditis. However, they also kept life-threatening causes such as acute coronary syndrome in their differential diagnosis. Patient was discharged with plans to complete a two week course of aspirin, three months of colchicine, and metoprolol. Patient did not require endomyocardial biopsy during his hospitalization since he remained clinically stable. Was also not started on guideline-directed medical therapy for heart failure since his imaging showed no signs of ventricular dysfunction. Metoprolol was started to help prevent heart failure, life-threatening arrythmias, and also limit ?mechanical inflammation'. Patient was recommended abstinence from strenuous activity to decrease risk of remodeling and sudden death as well. Given the hypersensitivity myocarditis that the patient suffered following the first dose of the Moderna vaccine and lack of information available at the time, after a patient-centered discussion, he elected to forego the second dose of the vaccine. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644568
Sex: M
Age:
State: PA

Vax Date: 08/05/2021
Onset Date: 08/07/2021
Rec V Date: 08/28/2021
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: Echocardiogram; Result Unstructured Data: normal echocardiogram. Diagnosis: Myocarditis; Test Date: 20210807; Test Name: Heart rate; Result Unstructured Data: high rate beat; Test Date: 20210807; Test Name: Troponine level; Result Unstructured Data: Elevated troponin level

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Myocarditis; chest pain; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Aug-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 07-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and CHEST PAIN (chest pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Heart rate: high (High) high rate beat. On 07-Aug-2021, Troponin: eelvated (High) Elevated troponin level. On an unknown date, Echocardiogram: normal (normal) normal echocardiogram. Diagnosis: Myocarditis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Company comment: Based on the current available information and temporal association between the use of second dose of the product mRNA-1273 and the start date of the serious expected event of Myocarditis, a causal relationship cannot be excluded. Non-serious event of Chest pain was more consistent with the manifestation of Myocarditis.; Sender's Comments: Based on the current available information and temporal association between the use of second dose of the product mRNA-1273 and the start date of the serious expected event of Myocarditis, a causal relationship cannot be excluded. Non-serious event of Chest pain was more consistent with the manifestation of Myocarditis.

Other Meds:

Current Illness:

ID: 1644569
Sex: M
Age:
State:

Vax Date: 04/16/2021
Onset Date:
Rec V Date: 08/28/2021
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: Dizziness, Can't stop falling; sleepiness; Weakness; Migraines; Insomnia; Shaking and tremors; Itching, I have dug holes in skin, feels like similarly experienced allergic reaction; Backache; Crappy like if you were sick like the flu; total fatigue; Muscle and body aches:; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lyme disease, Fibromyalgia and Normal pressure hydrocephalus. On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), TREMOR (Shaking and tremors), PRURITUS (Itching, I have dug holes in skin, feels like similarly experienced allergic reaction), BACK PAIN (Backache), INFLUENZA (Crappy like if you were sick like the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:). At the time of the report, DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), TREMOR (Shaking and tremors), PRURITUS (Itching, I have dug holes in skin, feels like similarly experienced allergic reaction) and BACK PAIN (Backache) had not resolved and ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), INFLUENZA (Crappy like if you were sick like the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:) outcome was unknown. No information concomitant medications were reported. No information on treatment medications were reported. Patient felt like a bomb went off in my body as one of the event.

Other Meds:

Current Illness: Fibromyalgia; Lyme disease; Normal pressure hydrocephalus.

ID: 1644570
Sex: F
Age:
State: FL

Vax Date: 08/07/2021
Onset Date: 08/08/2021
Rec V Date: 08/28/2021
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: arm itchy; arm hot; redness has spread to her entire upper area and is red, it hurts and is hot/arm red; it hurts; fever; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy), FEELING HOT (arm hot), SOMNOLENCE (slept all day), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts and is hot/arm red) and MYALGIA (it hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart block second degree and Pacemaker insertion (cardiac). Concurrent medical conditions included Congestive heart failure and Allergy multiple. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and LOSARTAN for an unknown indication. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced SOMNOLENCE (slept all day) and PYREXIA (fever). On an unknown date, the patient experienced PRURITUS (arm itchy), FEELING HOT (arm hot), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts and is hot/arm red) and MYALGIA (it hurts). On 09-Aug-2021, SOMNOLENCE (slept all day) and PYREXIA (fever) had resolved. At the time of the report, PRURITUS (arm itchy), FEELING HOT (arm hot), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts and is hot/arm red) and MYALGIA (it hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Concomitant product included for patient Multiple Vitamin as needed for an unknown indication. Patient second vaccine due date on 04-SEP-2021.

Other Meds: PLAVIX; LOSARTAN

Current Illness: Allergy multiple; Congestive heart failure

ID: 1644571
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: tongue feels as if it is swollen; tongue feels as if it is sprained; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained) 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 SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained). At the time of the report, SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644572
Sex: F
Age: 53
State: FL

Vax Date: 03/22/2021
Onset Date: 04/25/2021
Rec V Date: 08/28/2021
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: Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Confirmed with Rapid test on 11-Dec-2020) in December 2020. Concurrent medical conditions included Sulfonamide allergy (Reaction to sulfa). Concomitant products included CHLORTHALIDONE for Kidney stone, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet) (seriousness criterion medically significant). The patient was treated with GABAPENTIN ongoing since an unknown date for Peripheral neuropathy, at a dose of 300 mg twice a day and CANNABIDIOL (CBD OIL) ongoing since an unknown date for Peripheral neuropathy, at a dose of UNK, prn. At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet) had not resolved. Additional concomitant medications included Khor-Con (15 mg) by oral route of administration started in 2007 for low potassium. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. FU1 received does not change company causality assessment. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Reporter's information updated. Dose 2 batch number added. Medical history notes updated; treatment and concomitant medications were added or updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. FU1 received does not change company causality assessment.

Other Meds: CHLORTHALIDONE; MULTIVITAMIN [VITAMINS NOS]; VITAMIN D NOS

Current Illness: Sulfonamide allergy (Reaction to sulfa)

ID: 1644573
Sex: U
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 PRODUCT DOSE OMISSION ISSUE (only received one dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment medication were reported. Patient received his first dose of the Moderna vaccine back in late Apr 2021 or early May2021.

Other Meds:

Current Illness:

ID: 1644574
Sex: F
Age: 64
State: TX

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
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: She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away; Covid-19 after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19 after the 1st dose) and INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (Covid-19 after the 1st dose). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away). The patient was treated with Manual therapy (monoclonal antibodies on 29-Mar-2021) for COVID-19. At the time of the report, COVID-19 (Covid-19 after the 1st dose) and INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1644575
Sex: F
Age: 52
State: NY

Vax Date: 05/10/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: antibody test; Result Unstructured Data: 20; Test Name: blood pressure; Result Unstructured Data: 120/60 mmHg; Test Date: 20200308; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: patient has not received the second dose of the vaccine; was very sick with all the symptoms; chills; high fever; nauseous; dizzy; ringing in the ears; They noticed an Inflammation in left side of her brain; They noticed an Inflammation in left side of her brain that was causing weakness in left side; This spontaneous case was reported by a consumer and describes the occurrence of NONINFECTIVE ENCEPHALITIS (They noticed an Inflammation in left side of her brain) and HEMIPARESIS (They noticed an Inflammation in left side of her brain that was causing weakness in left side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (having covid tested positive 8-MAR-2020) on 08-Mar-2020. Concurrent medical conditions included Drug allergy (allergy to a lot of medications.) and General physical condition normal (She states she is a healthy person with no secondary conditions). On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced DIZZINESS (dizzy), TINNITUS (ringing in the ears) and NAUSEA (nauseous). On 11-May-2021, the patient experienced ILLNESS (was very sick with all the symptoms), CHILLS (chills) and PYREXIA (high fever). In May 2021, the patient experienced NONINFECTIVE ENCEPHALITIS (They noticed an Inflammation in left side of her brain) (seriousness criterion medically significant) and HEMIPARESIS (They noticed an Inflammation in left side of her brain that was causing weakness in left side) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine). On 12-May-2021, DIZZINESS (dizzy), TINNITUS (ringing in the ears), ILLNESS (was very sick with all the symptoms) and NAUSEA (nauseous) had resolved. On 13-May-2021, CHILLS (chills) and PYREXIA (high fever) had resolved. At the time of the report, NONINFECTIVE ENCEPHALITIS (They noticed an Inflammation in left side of her brain) was resolving, HEMIPARESIS (They noticed an Inflammation in left side of her brain that was causing weakness in left side) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Antibody test: 20 (High) 20. On an unknown date, Blood pressure measurement: 120/60 (normal) 120/60 mmHg. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient had an MRI of her brain, neck, and back. Patient was stated that no secondary conditions Concomitant products were not provided. Treatment medication were not reported. Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness: Drug allergy (allergy to a lot of medications.); General physical condition normal (She states she is a healthy person with no secondary conditions)

ID: 1644576
Sex: F
Age: 63
State: FL

Vax Date: 04/05/2021
Onset Date: 04/11/2021
Rec V Date: 08/28/2021
Hospital: Y

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: At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid; feel extremely sick / started getting very sick had Covid; Patient never got the second dose/nevrer got the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid) and MALAISE (feel extremely sick / started getting very sick had Covid) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus and Autoimmune disorder NOS. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced MALAISE (feel extremely sick / started getting very sick had Covid) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced COVID-19 (At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient never got the second dose/nevrer got the 2nd shot). The patient was hospitalized on 23-Apr-2021 due to COVID-19 and MALAISE. The patient was treated with REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid) and MALAISE (feel extremely sick / started getting very sick had Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient never got the second dose/nevrer got the 2nd shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use information was not provided. On 11Apr2021 the patient started to feel extremely sick for about 2 weeks. At first they thought they had the flu and took over the counter medication for that, then went to the hospital were they were diagnosed with covid-19 on the 23Apr2021 and was admitted for 7 days. Patient never got the second dose so they are inquiring whether they should get it now or start over the series. This case concerns a 63-year-old female hospitalized with serious unexpected events of COVID-19 and malaise, and non-serious product dose omission issue. Event latency 7 days after first dose mRNA-1273. Treated with remdesivir. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Non-Significant follow up; Sender's Comments: This case concerns a 63-year-old female hospitalized with serious unexpected events of COVID-19 and malaise, and non-serious product dose omission issue. Event latency 7 days after first dose mRNA-1273. Treated with remdesivir. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Autoimmune disorder NOS; Diabetes mellitus

ID: 1644577
Sex: M
Age:
State: MD

Vax Date: 05/18/2021
Onset Date:
Rec V Date: 08/28/2021
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: Patient hasn't received 2nd dose past 36 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose past 36 days) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-May-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 (Patient hasn't received 2nd dose past 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose past 36 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644578
Sex: F
Age: 73
State: CA

Vax Date: 07/10/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210809; Test Name: Body temperature; Result Unstructured Data: At 10 pm-101.5 Degree Celsius; Test Date: 20210810; Test Name: Body temperature; Result Unstructured Data: 101.1 Degree Celsius

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Face is really flushed; Started running a fever; she's totally spent; She feels very weak, her whole body feels weak,; Is in extreme pain all through her stomach area; Face is really hot; Getting chills real bad; Lot of pain in the injection site, all the time since yesterday, severe pain; This spontaneous case was reported by a non-health professional and describes the occurrence of FLUSHING (Face is really flushed), ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot) and CHILLS (Getting chills real bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack (2 heart attacks) and Stent placement. Concurrent medical conditions included Blood pressure high. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot), CHILLS (Getting chills real bad), VACCINATION SITE PAIN (Lot of pain in the injection site, all the time since yesterday, severe pain) and FATIGUE (she's totally spent). On 09-Aug-2021 at 10:00 PM, the patient experienced PYREXIA (Started running a fever). On 10-Aug-2021, the patient experienced FLUSHING (Face is really flushed). The patient was treated with Manual therapy (Cold compresses in face, neck and arm to try to bring the fever down) for Pyrexia. At the time of the report, FLUSHING (Face is really flushed), ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot), VACCINATION SITE PAIN (Lot of pain in the injection site, all the time since yesterday, severe pain), PYREXIA (Started running a fever) and FATIGUE (she's totally spent) had not resolved and CHILLS (Getting chills real bad) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, Body temperature: 101.5 (High) At 10 pm-101.5 Degree Celsius. On 10-Aug-2021, Body temperature: 101.1 (High) 101.1 Degree Celsius. Concomitant medication includes high blood pressure medication. The patient had no adverse events after first dose of vaccine. No treatment medications were reported

Other Meds:

Current Illness: Blood pressure high

ID: 1644579
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 08/07/2021
Rec V Date: 08/28/2021
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: Test Date: 20210807; Test Name: Body temperature; Result Unstructured Data: with a 1degree elevation in temperature

Allergies:

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

Symptoms: Developed a sore throat; Runny nosr three days ago; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Developed a sore throat) and RHINORRHOEA (Runny nosr three days ago) 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. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Developed a sore throat) and RHINORRHOEA (Runny nosr three days ago). At the time of the report, OROPHARYNGEAL PAIN (Developed a sore throat) and RHINORRHOEA (Runny nosr three days ago) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Body temperature: high (High) with a 1degree elevation in temperature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644580
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick) 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 ILLNESS (got very sick). At the time of the report, ILLNESS (got very sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter This case was linked to MOD-2021-282508 (Patient Link).

Other Meds:

Current Illness:

ID: 1644581
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: alanine aminotransferase; Result Unstructured Data: 707 U/L on HD 1; Test Name: alanine aminotransferase; Result Unstructured Data: 1257 U/L on HD 3, increased to greater than one thousand, 2 weeks later of vaccine; Test Name: Aspartate aminotransferase; Result Unstructured Data: 284 U/L on HD 1; Test Name: Aspartate aminotransferase; Result Unstructured Data: 446 U/L on HD 3, increased to greater than one thousand, 2 weeks later of vaccine; Test Name: liver biopsy; Result Unstructured Data: no granulomas, steatosis or evidence of necroinflammatory injury, on HD 4; Test Name: Alkaline phosphatase; Result Unstructured Data: 82 U/L on HD 1; Test Name: total bilirubin; Result Unstructured Data: 1.0 mg/dl, on HD 1; Test Name: IgG subsets; Result Unstructured Data: specifically IgG4 measuring 100 mg/dL; Test Name: IgM antibody; Test Result: Negative ; Result Unstructured Data: negative, on HD 3; Test Name: peripheral blood smear; Result Unstructured Data: rare schistocytes, giant platelets, no platelet clumping, toxic neutrophils and atypical lymphocytes without immature WBCs or blasts; Test Name: body temperature; Result Unstructured Data: normal; Test Name: haemoglobin; Result Unstructured Data: normal; Test Name: hepatitis B virus; Test Result: Positive ; Result Unstructured Data: positive; Test Name: platelet count; Result Unstructured Data: 91 10^9/L, abnormal; Test Name: platelet count; Result Unstructured Data: 28 10^9/L, On hospital day (HD) 1; Test Name: platelet count; Result Unstructured Data: 213 10^9/L On hospital day (HD) 5; Test Name: serum pregnancy test; Test Result: Negative ; Result Unstructured Data: negative; Test Name: SARS- CoV-2 PCR; Test Result: Negative ; Result Unstructured Data: negative; Test Name: serology test; Test Result: Negative ; Result Unstructured Data: including microsomal antibody, antismooth muscle antibody, antimitochondrial antibody, ANA were negative; Test Name: abdominal ultrasound; Result Unstructured Data: with Doppler showed normal liver and spleen morphology with no identifiable thrombus; Test Name: white blood cell count; Result Unstructured Data: normal

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Immune thrombocytopenic purpura (ITP); Acute liver injury; Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities; Arm soreness at the injection site; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)) and LIVER INJURY (Acute liver injury) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Immune thrombocytopenic purpura and acute liver injury after COVID-19 vaccine. Previously administered products included for Menstrual cramps: Acetaminophen (lastly took a week prior to hospitalization). Concurrent medical conditions included Menses irregular (on oral contraceptives). 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 IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)) (seriousness criteria hospitalization and medically significant), LIVER INJURY (Acute liver injury) (seriousness criterion medically significant), PETECHIAE (Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities) and VACCINATION SITE PAIN (Arm soreness at the injection site). The patient was hospitalized for 5 days due to IMMUNE THROMBOCYTOPENIA. The patient was treated with DEXAMETHASONE (intravenous) for Immune thrombocytopenic purpura, at a dose of 40 milligram once a day and N-ACETYLCYSTEINE for Adverse event, at an unspecified dose and frequency. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)), LIVER INJURY (Acute liver injury), PETECHIAE (Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities) and VACCINATION SITE PAIN (Arm soreness at the injection site) outcome was unknown. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (10-45): 707 u/l (High) 707 U/L on HD 1 and 1257 u/l (High) 1257 U/L on HD 3, increased to greater than one thousand, 2 weeks later of vaccine. On an unknown date, Aspartate aminotransferase (10-40): 284 u/l (High) 284 U/L on HD 1 and 446 u/l (High) 446 U/L on HD 3, increased to greater than one thousand, 2 weeks later of vaccine. On an unknown date, Biopsy liver: normal (normal) no granulomas, steatosis or evidence of necroinflammatory injury, on HD 4. On an unknown date, Blood alkaline phosphatase: 82 u/l (normal) 82 U/L on HD 1. On an unknown date, Blood bilirubin: 1.0 mg/dl (normal) 1.0 mg/dl, on HD 1. On an unknown date, Blood immunoglobulin G (2-96): 100 mg/dl (High) specifically IgG4 measuring 100 mg/dL. On an unknown date, Blood immunoglobulin M: negative (Negative) negative, on HD 3. On an unknown date, Blood smear test: rare schistocytes, giant platelets, no platelet (abnormal) rare schistocytes, giant platelets, no platelet clumping, toxic neutrophils and atypical lymphocytes without immature WBCs or blasts. On an unknown date, Body temperature: normal (normal) normal. On an unknown date, Haemoglobin: normal (normal) normal. On an unknown date, Hepatitis B virus test: positive (Positive) positive. On an unknown date, Platelet count (150-400): 91 (Low) 91 10^9/L, abnormal, 28 (Low) 28 10^9/L, On hospital day (HD) 1 and 213 (normal) 213 10^9/L On hospital day (HD) 5. On an unknown date, Pregnancy test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Serology test: negative (Negative) including microsomal antibody, antismooth muscle antibody, antimitochondrial antibody, ANA were negative. On an unknown date, Ultrasound abdomen: normal (normal) with Doppler showed normal liver and spleen morphology with no identifiable thrombus. On an unknown date, White blood cell count: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)), LIVER INJURY (Acute liver injury), PETECHIAE (Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities) and VACCINATION SITE PAIN (Arm soreness at the injection site) to be possibly related. It was reported that the patient only had initial side effect after vaccination was arm soreness at the injection site. Approximately 1 week later, developed a petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities. The treatment for Immune thrombocytopenic purpura (ITP) included two doses of intravenous immunoglobulin (IVIg) 1 g/kg/day. Treatment was not reported for other events. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness: Menses irregular (on oral contraceptives)

ID: 1644582
Sex: M
Age: 39
State: IN

Vax Date: 07/27/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20220729; Test Name: heartbeat; Result Unstructured Data: High

Allergies:

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

Symptoms: Had heart pain; Chest was hurting; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Had heart pain) in a 39-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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced ANGINA PECTORIS (Had heart pain) (seriousness criterion medically significant) and CHEST PAIN (Chest was hurting). At the time of the report, ANGINA PECTORIS (Had heart pain) and CHEST PAIN (Chest was hurting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2022, Heart rate: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Patient felt as if he was going to have a heart attack and it happened while lying down at bedtime. The symptoms would disappear whenever he got up & walked around. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644583
Sex: M
Age:
State: GA

Vax Date: 07/16/2021
Onset Date:
Rec V Date: 08/28/2021
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: coma for a day / doesn't remember getting out of bed; not feeling well; sick; lethargic; Sleep excessive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed) in a male patient of an unknown age 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 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed) (seriousness criterion medically significant), MALAISE (not feeling well), ILLNESS (sick), LETHARGY (lethargic) and HYPERSOMNIA (Sleep excessive). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed), MALAISE (not feeling well), ILLNESS (sick) and LETHARGY (lethargic) was resolving and HYPERSOMNIA (Sleep excessive) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Lab data was not provided. Treatment product was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and therefore, causality for the events is assessed as possibly related. No further information will be requested. Patient niece was a doctor, and told him that the batch may have been exposed to high humidity.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and therefore, causality for the events is assessed as possibly related. No further information will be requested.

Other Meds:

Current Illness:

ID: 1644584
Sex: U
Age:
State:

Vax Date: 08/01/2020
Onset Date: 08/01/2020
Rec V Date: 08/28/2021
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: 2021; Test Name: Antibody test; Result Unstructured Data: have no antibodies

Allergies:

Symptom List: Pain in extremity

Symptoms: In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic) 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. In August 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2020, the patient experienced ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: abnormal (abnormal) have no antibodies. No concomitant medications were reported. No reactions to shot. In January the study was unblinded and She was given the second shot. She got tested two times in 2021 and have no antibodies Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644585
Sex: M
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
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: a hot cold for 4/5 hours; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (a hot cold for 4/5 hours) and CHILLS (Chills) 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. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (a hot cold for 4/5 hours) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (a hot cold for 4/5 hours) and CHILLS (Chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. This case was linked to MOD-2021-279823 (Patient Link).

Other Meds:

Current Illness:

ID: 1644586
Sex: M
Age:
State: GA

Vax Date: 08/04/2021
Onset Date: 08/04/2021
Rec V Date: 08/28/2021
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: Moderna covid vaccine found to be out of date after administration on 8/4/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment and concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1644587
Sex: F
Age: 61
State: NJ

Vax Date: 07/28/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: high; Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time)

Allergies:

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

Symptoms: felt a little weird after the shot and felt like she had covid all over again; could not lift her arm for about 7 days / could not stand on feet for 2-3 days; sore arm / had extreme body aches / still had extreme body aches; high fever of 103 degrees F while she was on Tylenol / still experiencing low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time); extreme tiredness / very tired at times and have to lay down; started feeling very sick and lasted for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling very sick and lasted for 3 days), FEELING ABNORMAL (felt a little weird after the shot and felt like she had covid all over again), MOBILITY DECREASED (could not lift her arm for about 7 days / could not stand on feet for 2-3 days), PAIN (sore arm / had extreme body aches / still had extreme body aches) and PYREXIA (high fever of 103 degrees F while she was on Tylenol / still experiencing low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient was hospitalized but completely recovered.) in March 2021. Concomitant products included AMLODIPINE, ATORVASTATIN, CITALOPRAM HYDROBROMIDE (CITALOPRAM HBR), CIMETIDINE, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ), LEVOTHYROXINE and PARACETAMOL (TYLENOL) for an unknown indication. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced MALAISE (started feeling very sick and lasted for 3 days). On an unknown date, the patient experienced FEELING ABNORMAL (felt a little weird after the shot and felt like she had covid all over again), MOBILITY DECREASED (could not lift her arm for about 7 days / could not stand on feet for 2-3 days), PAIN (sore arm / had extreme body aches / still had extreme body aches), PYREXIA (high fever of 103 degrees F while she was on Tylenol / still experiencing low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time)) and FATIGUE (extreme tiredness / very tired at times and have to lay down). At the time of the report, MALAISE (started feeling very sick and lasted for 3 days) and MOBILITY DECREASED (could not lift her arm for about 7 days / could not stand on feet for 2-3 days) had resolved, FEELING ABNORMAL (felt a little weird after the shot and felt like she had covid all over again) and FATIGUE (extreme tiredness / very tired at times and have to lay down) outcome was unknown and PAIN (sore arm / had extreme body aches / still had extreme body aches) and PYREXIA (high fever of 103 degrees F while she was on Tylenol / still experiencing low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time)) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 (High) high. On 10-Aug-2021, Body temperature: 99-100 (Low) low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She had high fever of 103 degrees Fahrenheit (F) while she was on Tylenol. 13 days later she is still experiencing low grade fever from 99 to 100 degrees F (higher temperature close to 100 towards night time), still has extreme body aches, very tired at times and have to lay down. No treatment information was provided.

Other Meds: AMLODIPINE; ATORVASTATIN; CITALOPRAM HBR; CIMETIDINE; VALSARTAN HCTZ; LEVOTHYROXINE; TYLENOL

Current Illness:

ID: 1644588
Sex: F
Age:
State: CA

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Ageusia; Brain operation; Diplopia; Headache; Malaise; Sensory loss; Vision blurred; This case was received via FDA VAERS (Reference number: 1505378) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of AGEUSIA (Ageusia), BRAIN OPERATION (Brain operation), DIPLOPIA (Diplopia), HEADACHE (Headache), MALAISE (Malaise), SENSORY LOSS (Sensory loss) and VISION BLURRED (Vision blurred) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Operation NOS on 16-Jul-2021. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced AGEUSIA (Ageusia) (seriousness criteria hospitalization and disability), DIPLOPIA (Diplopia) (seriousness criteria hospitalization and disability), HEADACHE (Headache) (seriousness criteria hospitalization and disability), MALAISE (Malaise) (seriousness criteria hospitalization and disability), SENSORY LOSS (Sensory loss) (seriousness criteria hospitalization and disability) and VISION BLURRED (Vision blurred) (seriousness criteria hospitalization and disability). 27-Jul-2021, the patient experienced BRAIN OPERATION (Brain operation) (seriousness criteria hospitalization and disability). At the time of the report, AGEUSIA (Ageusia), BRAIN OPERATION (Brain operation), DIPLOPIA (Diplopia), HEADACHE (Headache), MALAISE (Malaise), SENSORY LOSS (Sensory loss) and VISION BLURRED (Vision blurred) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient received 1st Moderna Vaccine shot and was very sick first two weeks, on 3rd week she started getting headaches, blurry vision that was little to double vision and lost all taste and feeling in hand. They could only do a brain surgery to relieve pressure. It was reported that the original problem was in too dangerous of a spot to remove. Patient was sent back home a week ago. Treatment medication was not provided by the reporter. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644589
Sex: F
Age: 60
State: IN

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
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: makes my head feel really high; shaking; kinda feel weak; makes my stomach nauseous; shot site was itchy and a little painful; shot site is itchy, was a little painful; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and NAUSEA (makes my stomach nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Halidol.). Concomitant products included AMITRIPTYLINE, CITALOPRAM, FOLIC ACID, ADALIMUMAB (HUMIRA), HYDROXYCHLOROQUINE, CALCIUM FOLINATE (LEUCOVORINE), LEVOTHYROXINE, LOSARTAN and METHOTREXATE for an unknown indication. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and VACCINATION SITE PAIN (shot site was itchy and a little painful). On 09-Aug-2021, the patient experienced HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak) and NAUSEA (makes my stomach nauseous). At the time of the report, HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful), NAUSEA (makes my stomach nauseous) and VACCINATION SITE PAIN (shot site was itchy and a little painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reported that the patient was having the same as the effects when she took Erythromycin. No treatment information was provided.

Other Meds: AMITRIPTYLINE; CITALOPRAM; FOLIC ACID; HUMIRA; HYDROXYCHLOROQUINE; LEUCOVORINE; LEVOTHYROXINE; LOSARTAN; METHOTREXATE

Current Illness: Allergy to antibiotic (Erythromycin); Drug allergy (Halidol.)

ID: 1644590
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Idiopathic pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details were not provided.

Other Meds: ESBRIET

Current Illness: Idiopathic pulmonary fibrosis

ID: 1644591
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: Hospitalization; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalization) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) had resolved. Not Provided Concomitant products were not provided. Treatment medication were not reported. Patient was hospitalized for 2 to 3 days. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644592
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got very sick). At the time of the report, ILLNESS (Got very sick) outcome was unknown. No concomitant medication reported . No treatment medication reported . This case was linked to MOD-2021-281964 (Patient Link).

Other Meds:

Current Illness:

ID: 1644593
Sex: F
Age: 53
State: TX

Vax Date: 07/06/2021
Onset Date: 08/07/2021
Rec V Date: 08/28/2021
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: 2 little balls or nodules very close together on her left clavicle that were painful to touch; Left arm pit was swollen; Next to her chest beside her breast was painful; Under her arm was painful; Left Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch), PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful), INJECTION SITE PAIN (Left Arm hurt) and AXILLARY PAIN (Under her arm was painful) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 045C21A) for COVID-19 vaccination. Concurrent medical conditions included Menopause. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced INJECTION SITE PAIN (Left Arm hurt). On 09-Aug-2021 at 6:00 PM, the patient experienced NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch), PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful) and AXILLARY PAIN (Under her arm was painful). At the time of the report, NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch) was resolving and PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful), INJECTION SITE PAIN (Left Arm hurt) and AXILLARY PAIN (Under her arm was painful) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness: Menopause

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am