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: 1681615
Sex: F
Age: 63
State: TN

Vax Date: 12/30/2020
Onset Date: 08/20/2020
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: I feel general body aches all over; I was having a very high fever/I have a fever every night that keeps me awake. I have a fever in the morning when I wake up; I was extremely hot, my blood was boiling. I was so hot; I was afraid I was going to faint/I was afraid I was going to faint. I was afraid I was going to have a stroke/At first I thought I was going to die. I seriously wonder if I got brain damage; Heart was beating so fast; I was drinking a lot to flush everything up; Second shot on 27Jan2021 and Third shot on 20Aug2021; I have a fever every night that keeps me awake/Last night, I didn't go to bed until 4 o'clock because of my fever; Headaches are persistent; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (I was extremely hot, my blood was boiling. I was so hot), INSOMNIA (I have a fever every night that keeps me awake/Last night, I didn't go to bed until 4 o'clock because of my fever), POLYDIPSIA (I was drinking a lot to flush everything up), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot on 27Jan2021 and Third shot on 20Aug2021) and FEELING ABNORMAL (I was afraid I was going to faint/I was afraid I was going to faint. I was afraid I was going to have a stroke/At first I thought I was going to die. I seriously wonder if I got brain damage) 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 information was given by reporter. Concomitant products included FAMOTIDINE for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headaches are persistent). In August 2021, the patient experienced INSOMNIA (I have a fever every night that keeps me awake/Last night, I didn't go to bed until 4 o'clock because of my fever). On 20-Aug-2021, the patient experienced FEELING HOT (I was extremely hot, my blood was boiling. I was so hot), POLYDIPSIA (I was drinking a lot to flush everything up), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot on 27Jan2021 and Third shot on 20Aug2021), FEELING ABNORMAL (I was afraid I was going to faint/I was afraid I was going to faint. I was afraid I was going to have a stroke/At first I thought I was going to die. I seriously wonder if I got brain damage), TACHYCARDIA (Heart was beating so fast), MYALGIA (I feel general body aches all over) and PYREXIA (I was having a very high fever/I have a fever every night that keeps me awake. I have a fever in the morning when I wake up). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot on 27Jan2021 and Third shot on 20Aug2021) had resolved. At the time of the report, FEELING HOT (I was extremely hot, my blood was boiling. I was so hot), INSOMNIA (I have a fever every night that keeps me awake/Last night, I didn't go to bed until 4 o'clock because of my fever), POLYDIPSIA (I was drinking a lot to flush everything up), FEELING ABNORMAL (I was afraid I was going to faint/I was afraid I was going to faint. I was afraid I was going to have a stroke/At first I thought I was going to die. I seriously wonder if I got brain damage), TACHYCARDIA (Heart was beating so fast) and HEADACHE (Headaches are persistent) outcome was unknown, MYALGIA (I feel general body aches all over) was resolving and PYREXIA (I was having a very high fever/I have a fever every night that keeps me awake. I have a fever in the morning when I wake up) had not resolved. It was stated regarding treatment the patient put cold compresses on her everywhere, and drank iced water also. she kept doing that through out the night. Now, she do that in the head and neck area.

Other Meds: Famotidine

Current Illness:

ID: 1681616
Sex: M
Age: 57
State: CT

Vax Date: 08/24/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
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 Date: 20210825; Test Name: Heart beat; Result Unstructured Data: Fast

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Dizziness; Weakness; Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and DYSPNOEA (Trouble breathing) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and DYSPNOEA (Trouble breathing). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and DYSPNOEA (Trouble breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Heart rate: fast (High) Fast. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient takes psychiatric medication. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1681617
Sex: U
Age:
State: CO

Vax Date: 02/10/2021
Onset Date: 05/01/2021
Rec V Date: 09/08/2021
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: Lost almost 50 lbs in 6 weeks; Have had hair loss; Breathing problems; Severe pain in lower legs, ankles and feet; Numbness in lower legs, ankles and feet; Swelling in lower legs, ankles and feet; Swelling in lower legs, ankles and feet; Crazy stuff going on with white blood cells; Some days i was barely able to get out of bed; Severe pain in lower legs, ankles and feet; Immune system is compramised; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost almost 50 lbs in 6 weeks), ALOPECIA (Have had hair loss), DYSPNOEA (Breathing problems), PAIN IN EXTREMITY (Severe pain in lower legs, ankles and feet) and HYPOAESTHESIA (Numbness in lower legs, ankles and feet) in a patient of an unknown age and gender 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 Vasculitis. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced WEIGHT DECREASED (Lost almost 50 lbs in 6 weeks), ALOPECIA (Have had hair loss), DYSPNOEA (Breathing problems), PAIN IN EXTREMITY (Severe pain in lower legs, ankles and feet), HYPOAESTHESIA (Numbness in lower legs, ankles and feet), PERIPHERAL SWELLING (Swelling in lower legs, ankles and feet), JOINT SWELLING (Swelling in lower legs, ankles and feet), WHITE BLOOD CELL DISORDER (Crazy stuff going on with white blood cells), MOBILITY DECREASED (Some days i was barely able to get out of bed) and ARTHRALGIA (Severe pain in lower legs, ankles and feet). In 2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system is compramised). At the time of the report, WEIGHT DECREASED (Lost almost 50 lbs in 6 weeks), ALOPECIA (Have had hair loss), DYSPNOEA (Breathing problems), PAIN IN EXTREMITY (Severe pain in lower legs, ankles and feet), HYPOAESTHESIA (Numbness in lower legs, ankles and feet), PERIPHERAL SWELLING (Swelling in lower legs, ankles and feet), JOINT SWELLING (Swelling in lower legs, ankles and feet), WHITE BLOOD CELL DISORDER (Crazy stuff going on with white blood cells), MOBILITY DECREASED (Some days i was barely able to get out of bed), IMMUNE SYSTEM DISORDER (Immune system is compramised) and ARTHRALGIA (Severe pain in lower legs, ankles and feet) outcome was unknown. No concomitant medication was reported. Patient is taking steroids as a treatment medication. It was reported that the patient had diminished oxygen capacity in lab investigation.

Other Meds:

Current Illness: Vasculitis

ID: 1681618
Sex: M
Age: 65
State: MD

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
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: patient received a dose of the vaccine from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681619
Sex: M
Age:
State: TN

Vax Date: 08/25/2021
Onset Date:
Rec V Date: 09/08/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) outcome was unknown.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided by the reporter. It was reported that Pharmacist called 25Aug2021 and stated that a vial at room temperature yesterday 25Aug2021 at 10:30AM was not salvaged correctly and was administered to 2 patients today around 12:45pm Pharmacist asking if doses needs to be repeated. Agent spoke from SRL information which pharmacist also requested in email. 2 doses given from 1 vial. Total amount of time vial exposed to room temperature range (8-25 C or 46-77 F): Room temperature for greater then 24 hours. Approximately 24Aug2021 10:30AM to 25Aug2021 12:45pm date and time of dose administration.No treatment medication provided by the reporter.

Other Meds:

Current Illness:

ID: 1681620
Sex: F
Age:
State: MA

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Warm to the touch on injection site / warmer than touching other parts of body; Itching like a mosquito bite; Swelling on injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066DLA) for COVID-19 vaccination. The patient's past medical history included Anxiety and Depression. Concomitant products included OMEPRAZOLE for Product used for unknown indication. On 13-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 VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: Omeprazole

Current Illness:

ID: 1681621
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1681622
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 09/08/2021
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: Brain fog; Nausea for weeks; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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. In April 2021, the patient experienced FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm). At the time of the report, FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was mentioned. No treatment medication was mentioned. This case was linked to MOD-2021-296133 (Patient Link).

Other Meds:

Current Illness:

ID: 1681623
Sex: U
Age:
State: NV

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/08/2021
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: lipid panel test; Result Unstructured Data: High; Test Name: lipid panel test; Result Unstructured Data: cholesterol levels were significantly lower than before; Test Name: Triglyceride; Result Unstructured Data: low; Test Name: HDL; Result Unstructured Data: High

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219; HDL increase; lower triglyceride levels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels). At the time of the report, BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: 237 (High) High and 219 (Low) cholesterol levels were significantly lower than before. On an unknown date, Blood triglycerides: down (Low) low. On an unknown date, High density lipoprotein: increased (High) High. No concomitant medications were provided. No Treatment medications were reported. Patient also went through Lipid Panel Test which resulted into lower cholesterol levels than before. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1681624
Sex: M
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) 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.

Other Meds:

Current Illness:

ID: 1681625
Sex: F
Age: 50
State: NJ

Vax Date: 01/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
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: uncomfortable; Arthritic pains/pain moved up to left ankle; burning sensation in right foot; swelling in both feet; left foot pain/side of foot is painful to touch; crook in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet) and DISCOMFORT (uncomfortable) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MULTIVITAMINS [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and ANGELICA SINENSIS ROOT, CIMICIFUGA RACEMOSA ROOT, DIOSCOREA SPP., GLYCINE MAX (PHYTOESTROGEN) for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch ) and FOOT DEFORMITY (crook in her foot). On 29-Jul-2021, the patient experienced BURNING SENSATION (burning sensation in right foot) and PERIPHERAL SWELLING (swelling in both feet). On an unknown date, the patient experienced DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle). At the time of the report, PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet), DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle) outcome was unknown. Patient reported that a week and a half after the second dose she experienced left foot pain and a crook in her foot which she went to her podiatrist and was given an ace band for her foot. Patient reported after she has been experiencing a burning sensation in her right foot, swelling in both feet on 29 July 2021, uncomfortable, arthritic pain , pain in left foot moved up to left ankle, discomfort, side of foot was painful to touch. No treatment information was provided.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; SYNTHROID; PHYTOESTROGEN

Current Illness:

ID: 1681626
Sex: M
Age:
State: NY

Vax Date: 03/24/2021
Onset Date: 04/01/2021
Rec V Date: 09/08/2021
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: Wakes up in the middle of the night; Flu like symptoms; Pain in right hip and knee; Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second), SLEEP DISORDER (Wakes up in the middle of the night), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (Pain in right hip and knee) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019B21A) for COVID-19 vaccination. Concurrent medical conditions included Iodine allergy, Blood pressure abnormal since May 2013 and Heartburn since May 2013. Concomitant products included LISINOPRIL for Blood pressure abnormal, OMEPRAZOLE for Heartburn. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second). In May 2021, the patient experienced ARTHRALGIA (Pain in right hip and knee). On an unknown date, the patient experienced SLEEP DISORDER (Wakes up in the middle of the night) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second) and ARTHRALGIA (Pain in right hip and knee) had not resolved and SLEEP DISORDER (Wakes up in the middle of the night) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Patient had got X-Rays done for Hip and Knee, results were not provided and was getting physical Therapy done for the same. Patient received both shots on the left arm and ever since had been having trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second. It being bothering 2-3 times per day and even wakes up in the middle of the night. The family doctor wasn't sure if was related to the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional event, event outcome, patient demographics, medical history, concomitant medications, reporter contact details updated

Other Meds: OMEPRAZOLE; LISINOPRIL

Current Illness: Blood pressure abnormal; Heartburn; Iodine allergy

ID: 1681627
Sex: F
Age: 0
State: CO

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 09/08/2021
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: Left side of her face was red and swollen.; She woke up in the morning and found little swelling on left side of body.; Left side of her face was red and swollen.; About 2 minutes later, her lips got tingling; her lips got tingling and they were swollen for about an hour.; 10 hours later, she had 2 big sneezes; She couldn't breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and SWELLING FACE (Left side of her face was red and swollen.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and ERYTHEMA (Left side of her face was red and swollen.). On an unknown date, the patient experienced SWELLING FACE (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of body.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose), SWELLING FACE (Left side of her face was red and swollen.), ERYTHEMA (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of body.) 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.

Other Meds: SYNTHROID; ADVAIR

Current Illness:

ID: 1681628
Sex: M
Age: 60
State: TX

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm), PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift), CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm) and MYALGIA (After 2nd dose, he had more soreness.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy.On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced MYALGIA (After 2nd dose, he had more soreness.). On 03-Aug-2021, the patient experienced PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift). On an unknown date, the patient experienced LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm) and CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm). At the time of the report, LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm), PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift), CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm) and MYALGIA (After 2nd dose, he had more soreness.) had not resolved. The patient stated that he had worsened pain in arm and could feel the soreness on a daily bases. Patient race information contain Black. The patient stated that some time in late July early August, his pain in my arm became unbearable, while he was helping unload a container. He stated that it has gotten to the point where he can't lift anything weighting around ten pounds above his waist without experiencing severe pain. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-295912 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant Followup. Vaccine information updated. Patient's race information and relevant history updated. New event-condition aggravated included.

Other Meds:

Current Illness: Seasonal allergy

ID: 1681629
Sex: M
Age: 38
State: CO

Vax Date: 04/12/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: He was sick; he was super sore; He did not receive the second one because he didn't want to have further reactions; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He was sick), MYALGIA (he was super sore) and PRODUCT DOSE OMISSION ISSUE (He did not receive the second one because he didn't want to have further reactions) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (He was sick), MYALGIA (he was super sore) and PRODUCT DOSE OMISSION ISSUE (He did not receive the second one because he didn't want to have further reactions). At the time of the report, ILLNESS (He was sick) and MYALGIA (he was super sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He did not receive the second one because he didn't want to have further reactions) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were provided. No treatments were provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Reporter details, Patient details, Product Start date, Batch no. were added and new events Myalgia and Illness were added.

Other Meds:

Current Illness:

ID: 1681630
Sex: M
Age:
State: AL

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
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: second dose they administered a 1mL dose and not the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose). At the time of the report, OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681631
Sex: F
Age: 22
State:

Vax Date: 08/04/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: sore right injection site arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications was provided. No Treatment medications was provided.

Other Meds:

Current Illness:

ID: 1681632
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Reaction at the injection site Big, red lump or mark; Reaction at the injection site Big, red lump or mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Reaction at the injection site Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site Big, red lump or mark) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Reaction at the injection site Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site Big, red lump or mark). At the time of the report, VACCINATION SITE MASS (Reaction at the injection site Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site Big, red lump or mark) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. The patient had big red lump measuring 5 inches vertically 3 or 4 inches horizontally at the injection site after one week of COVID-19 vaccination.

Other Meds:

Current Illness:

ID: 1681633
Sex: F
Age: 38
State: FL

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: platelet count; Result Unstructured Data: normal; Test Date: 20210514; Test Name: platelet count drop; Result Unstructured Data: Low

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: small bruising in her legs; anxiety; only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (small bruising in her legs), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (only received one dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (small bruising in her legs), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (only received one dose). At the time of the report, CONTUSION (small bruising in her legs), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (only received one dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Platelet count: low (Low) Low. In June 2021, Platelet count: 190 (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient experienced platelet count drop so severe that doctors recommended not getting the second dose. A month ago she did her bloodwork and her platelets were at 190 which is good & would like to get it. Concomitant medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1681634
Sex: F
Age: 61
State: IN

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210326; Test Name: Body Temperature; Result Unstructured Data: 100.6 degrees fahrenheit; Test Date: 20210327; Test Name: Body Temperature; Result Unstructured Data: 100.4 degrees fahrenheit; Test Date: 20210328; Test Name: Body Temperature; Result Unstructured Data: 99 degrees fahrenheit

Allergies:

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

Symptoms: Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M2DA and 028A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypersensitivity, Gluten intolerance, Shellfish allergy and Allergic contact dermatitis (contact allergy). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 ABDOMINAL PAIN UPPER (Stomach pain). The patient was treated with PARACETAMOL (TYLENOL) from 26-Mar-2021 to 28-Mar-2021 at a dose of 1 dosage form twice a day. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.6 (High) 100.6 degrees fahrenheit. On 27-Mar-2021, Body temperature: 100.4 (High) 100.4 degrees fahrenheit. On 28-Mar-2021, Body temperature: 99 (normal) 99 degrees fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. This case was linked to MOD-2021-059765 (Patient Link).

Other Meds:

Current Illness: Allergic contact dermatitis (contact allergy); Gluten intolerance; Hypersensitivity; Shellfish allergy

ID: 1681635
Sex: F
Age:
State: MA

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 09/08/2021
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: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: The patient's BP was 132, right before the shot.; Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: The patient's BP was dropped to 120 after 30 minutes.; Test Date: 20210804; Test Name: Body temperature; Result Unstructured Data: The patient's body temperature was 96.9 Fahrenheit.

Allergies:

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

Symptoms: Her breathing was a little bit labored to the point where she had to tell herself to breath in & out; At 3 am she felt very out of breath just walking to the bathroom; Horrible major leg cramps in both legs from her feet to her thighs; Had foggy thinking; Felt spacy; Her throat was tight again but at the back of the mouth / her throat felt tight again but at back of her mouth; Felt a burning up left her arm / felt a burning on the back part of her neck / felt burning in the middle of her back below the shoulder blades; Exhausted/Tired; Chills; Mild allergic reaction; Lightheaded; Weak; Sleepy; Thirsty; A finger in left hand went numb for a few minutes (that happens with that finger every few months even before the shot); Had a weird taste in her mouth; Her chest felt tight in the middle; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Mild allergic reaction), DIZZINESS (Lightheaded), ASTHENIA (Weak), SOMNOLENCE (Sleepy) and THIRST (Thirsty) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anesthesia (An allergic reaction to anesthesia) and Injection (With MRI dye Patient had a swollen tongue, face turned red, and throat constriction was at the top of the throat at the back of the mouth.). Concurrent medical conditions included Allergy NOS (mild allergic reaction, an allergic reaction to anesthesia.). On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPERSENSITIVITY (Mild allergic reaction), DIZZINESS (Lightheaded), ASTHENIA (Weak), SOMNOLENCE (Sleepy), THIRST (Thirsty), HYPOAESTHESIA (A finger in left hand went numb for a few minutes (that happens with that finger every few months even before the shot)), TASTE DISORDER (Had a weird taste in her mouth), CHEST DISCOMFORT (Her chest felt tight in the middle), FEELING ABNORMAL (Felt spacy), THROAT TIGHTNESS (Her throat was tight again but at the back of the mouth / her throat felt tight again but at back of her mouth), BURNING SENSATION (Felt a burning up left her arm / felt a burning on the back part of her neck / felt burning in the middle of her back below the shoulder blades), FATIGUE (Exhausted/Tired) and CHILLS (Chills). On 04-Aug-2021, the patient experienced MUSCLE SPASMS (Horrible major leg cramps in both legs from her feet to her thighs), FEELING ABNORMAL (Had foggy thinking) and DYSPNOEA (At 3 am she felt very out of breath just walking to the bathroom). On an unknown date, the patient experienced DYSPNOEA (Her breathing was a little bit labored to the point where she had to tell herself to breath in & out). On 03-Aug-2021, BURNING SENSATION (Felt a burning up left her arm / felt a burning on the back part of her neck / felt burning in the middle of her back below the shoulder blades) had resolved. At the time of the report, HYPERSENSITIVITY (Mild allergic reaction), DIZZINESS (Lightheaded), ASTHENIA (Weak), SOMNOLENCE (Sleepy), THIRST (Thirsty), HYPOAESTHESIA (A finger in left hand went numb for a few minutes (that happens with that finger every few months even before the shot)), TASTE DISORDER (Had a weird taste in her mouth), CHEST DISCOMFORT (Her chest felt tight in the middle), MUSCLE SPASMS (Horrible major leg cramps in both legs from her feet to her thighs), FEELING ABNORMAL (Had foggy thinking), DYSPNOEA (Her breathing was a little bit labored to the point where she had to tell herself to breath in & out), DYSPNOEA (At 3 am she felt very out of breath just walking to the bathroom), FEELING ABNORMAL (Felt spacy), FATIGUE (Exhausted/Tired) and CHILLS (Chills) outcome was unknown and THROAT TIGHTNESS (Her throat was tight again but at the back of the mouth / her throat felt tight again but at back of her mouth) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Blood pressure measurement: 132 (High) The patient's BP was 132, right before the shot. and 120 (normal) The patient's BP was dropped to 120 after 30 minutes.. On 04-Aug-2021, Body temperature: 96.9 (Low) The patient's body temperature was 96.9 Fahrenheit.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The consumer stated that a couple minutes after the shot patient throat felt constricted near larynx lower than the back of the mouth with the MRI dye. It gradually subsided after about 30 minutes. It was still there but wasn't as bad. She felt lightheaded, weak, tired, sleepy, and thirsty. The consumer stated that previously, with MRI dye patient had a swollen tongue, face turned red, and throat constriction was at the top of the throat at the back of the mouth.

Other Meds:

Current Illness: Allergy NOS (mild allergic reaction, an allergic reaction to anesthesia.)

ID: 1681636
Sex: F
Age: 83
State: CA

Vax Date: 08/16/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy; arm got a big thing on it; Arm got a big thing on it, on hands. It hurt a little bit and it itched; Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched), VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) and VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched) and VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy). On 24-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy). On 20-Aug-2021, VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched) and VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported

Other Meds:

Current Illness:

ID: 1681637
Sex: F
Age: 49
State: TN

Vax Date: 08/21/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: There is a knot/nodule between the armpits and arm; Armpits on the left side are swollen; The injection site is red and swollen; The injection site is red and swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of NODULE (There is a knot/nodule between the armpits and arm), SWELLING (Armpits on the left side are swollen), VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 and Sickness. Concurrent medical conditions included Rheumatoid arthritis. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SWELLING (Armpits on the left side are swollen), VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen). On an unknown date, the patient experienced NODULE (There is a knot/nodule between the armpits and arm). The patient was treated with PARACETAMOL (TYLENOL) for Nodule, Swelling, Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, NODULE (There is a knot/nodule between the armpits and arm) and SWELLING (Armpits on the left side are swollen) had not resolved and VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.She stated that she takes several medications but does not provide additional details

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1681638
Sex: M
Age: 87
State: TX

Vax Date: 01/19/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Droopy; Feeling minimal pain now; Drugged; Nausea; Possible Fever; Real bad chills; Pain in left Shoulder and Neck; Couldn't stop Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Droopy), TREMOR (Couldn't stop Shaking), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged) and ARTHRALGIA (Pain in left Shoulder and Neck) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A, 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Couldn't stop Shaking), ARTHRALGIA (Pain in left Shoulder and Neck) and CHILLS (Real bad chills). On an unknown date, the patient experienced ASTHENIA (Droopy), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged), NAUSEA (Nausea) and PYREXIA (Possible Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Droopy), TREMOR (Couldn't stop Shaking), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged), ARTHRALGIA (Pain in left Shoulder and Neck), NAUSEA (Nausea), CHILLS (Real bad chills) and PYREXIA (Possible Fever) outcome was unknown. Concomitant medication included Thyroid medication. This case was linked to MOD-2021-298768, MOD-2021-298769 (Patient Link).

Other Meds:

Current Illness:

ID: 1681639
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: can't walk; hurts to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk). At the time of the report, GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported. This case was linked to MOD-2021-218564, MOD-2021-218567, MOD-2021-293322 (Patient Link).

Other Meds:

Current Illness:

ID: 1681640
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Mild rash 6in long injection site 3rd day after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot) 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. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot). At the time of the report, VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment medications was provided.

Other Meds:

Current Illness:

ID: 1681641
Sex: M
Age: 43
State: MA

Vax Date: 02/26/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
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: 3rd dose subcutaneous; Inappropriate scheduled of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 001A21A and 201B21A) for COVID-19 vaccination. Concurrent medical conditions included Immunodeficiency. Concomitant products included LAMOTRIGINE (LAMICTAL), OXCARBAZEPINE, GABAPENTIN, QUETIAPINE, HYDROCHLOROTHIAZIDE, OMEPRAZOLE, NALTREXONE HYDROCHLORIDE (NALTREXONE [NALTREXONE HYDROCHLORIDE]), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), LYSINE, COLECALCIFEROL (D3), MELATONIN, NATTOKINASE, RESVERATROL, GLYCERINE MONOLAURATE, INOSINE (MONOLAURIN [GLYCERINE MONOLAURATE;INOSINE]), FISH OIL, ASCORBIC ACID (VIT C), LEVETIRACETAM (LEVRA) and IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous). 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered). On 25-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) had resolved. Caller states that Patient is immunodeficient. She also stated that she got a sore arm with the1st dose and with the 2nd she got fever. Concomitant medications also included Sertiamen along with above mentioned medications. No treatment details were reported. This case was linked to MOD-2021-296521, MOD-2021-296516 (Patient Link).

Other Meds: LAMICTAL; OXCARBAZEPINE; GABAPENTIN; QUETIAPINE; HYDROCHLOROTHIAZIDE; OMEPRAZOLE; NALTREXONE [NALTREXONE HYDROCHLORIDE]; PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; LYSINE; D3; MELATONIN; NATTOKINA

Current Illness: Immunodeficiency

ID: 1681642
Sex: F
Age: 32
State: CA

Vax Date: 01/06/2021
Onset Date: 02/12/2021
Rec V Date: 09/08/2021
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: 20 weeks pregnant after 2nd dose; Hives all over her body after 2nd dose; Red rash all over her body after 2nd dose / Quit antihistamine rash comes back; Itchy all over her body after 2nd dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back), PRURITUS (Itchy all over her body after 2nd dose) and MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011J209) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Dec-2021. On 12-Feb-2021, the patient experienced URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back) and PRURITUS (Itchy all over her body after 2nd dose). On 25-Aug-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, Hives and Pruritus, at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form. On 25-Aug-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose) had resolved. At the time of the report, URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back) and PRURITUS (Itchy all over her body after 2nd dose) outcome was unknown. Concomitant medication details were not reported by the reporter. Patient stated that as long as she took Zyrtec the rash goes away, but when she stops taking Zyrtec the rash came back. The doctor also prescribed one week Steroid Medrol dose pack which she finished taking. Patient was thinking about getting a booster shot. The LMP of the patient was reported as 08-MAR-2021.; 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. This is a case of maternal exposure before pregnancy.

Other Meds:

Current Illness:

ID: 1681643
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Spinal stenosis. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Spinal stenosis. 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 VACCINATION SITE PAIN (Arm hurt). At the time of the report, VACCINATION SITE PAIN (Arm hurt) had resolved. Treatment information was not provided. This case was linked to MOD-2021-296540, MOD-2021-022507 (Patient Link).

Other Meds: TYLENOL; IBUPROFEN

Current Illness: Spinal stenosis

ID: 1681644
Sex: F
Age: 60
State: TX

Vax Date: 01/02/2021
Onset Date: 02/02/2021
Rec V Date: 09/08/2021
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: left injection site arm sore; left injection site arm red; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included MECLOZINE HYDROCHLORIDE (BONINE) for an unknown indication. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever) outcome was unknown. No treatment details were reported. This case was linked to MOD-2021-296560 (Patient Link).

Other Meds: BONINE

Current Illness:

ID: 1681645
Sex: M
Age:
State: NJ

Vax Date: 07/28/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Sore arm; 1st dose Pfizer- 2nd dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination. Concurrent medical conditions included Autism. On 28-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna). On 26-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 25-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer- 2nd dose Moderna) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness: Autism

ID: 1681646
Sex: F
Age: 33
State: MS

Vax Date: 08/15/2021
Onset Date: 08/26/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fatigue; Sore arm; knot at the injection site.; red knot at the injection site.; swollen at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (knot at the injection site.), VACCINATION SITE ERYTHEMA (red knot at the injection site.), VACCINATION SITE SWELLING (swollen at the injection site.), FATIGUE (Fatigue) and MYALGIA (Sore arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History was provided. Concomitant products included ETONOGESTREL (NEXPLANON) for an unknown indication. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE NODULE (knot at the injection site.), VACCINATION SITE ERYTHEMA (red knot at the injection site.) and VACCINATION SITE SWELLING (swollen at the injection site.). On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (Sore arm). At the time of the report, VACCINATION SITE NODULE (knot at the injection site.), VACCINATION SITE ERYTHEMA (red knot at the injection site.), VACCINATION SITE SWELLING (swollen at the injection site.), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Birth control orally and now injectable (Nexplanon) No Treatment Medications were provided.

Other Meds: NEXPLANON

Current Illness:

ID: 1681647
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: upper arm has a large red rash about 3"; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (upper arm has a large red rash about 3") 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (upper arm has a large red rash about 3"). At the time of the report, RASH ERYTHEMATOUS (upper arm has a large red rash about 3") outcome was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681648
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Got covid-19, not as severe; Was a little sick; Stomach problems; Whoopping headache/massive headache/constant headache/headache all day for days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid-19, not as severe), ILLNESS (Was a little sick), ABDOMINAL DISCOMFORT (Stomach problems) and HEADACHE (Whoopping headache/massive headache/constant headache/headache all day for days) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Had covid-19 two and a half weeks ago). 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 COVID-19 (Got covid-19, not as severe), ILLNESS (Was a little sick), ABDOMINAL DISCOMFORT (Stomach problems) and HEADACHE (Whoopping headache/massive headache/constant headache/headache all day for days). At the time of the report, COVID-19 (Got covid-19, not as severe), ILLNESS (Was a little sick), ABDOMINAL DISCOMFORT (Stomach problems) and HEADACHE (Whoopping headache/massive headache/constant headache/headache all day for days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment information was not reported This case was linked to MOD-2021-297301 (Patient Link).

Other Meds:

Current Illness:

ID: 1681649
Sex: F
Age: 29
State: MO

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face), HYPOAESTHESIA ORAL (Numbness on lips) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 14-Dec-2020.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face) and HYPOAESTHESIA ORAL (Numbness on lips). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 06-Jan-2021, FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face) and HYPOAESTHESIA ORAL (Numbness on lips) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered) had resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. The symptoms went away in 1-2 hours post their onset.

Other Meds:

Current Illness:

ID: 1681650
Sex: F
Age: 51
State: NJ

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: back pain; a bad thing; not being able to work; cold sweats; pressure on his chest and back; feeling like she couldn't breath; numbness in her hands; pain in feet; headaches; severe body aches; arm pain; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats) and CHEST DISCOMFORT (pressure on his chest and back) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet), HEADACHE (headaches), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee). At the time of the report, BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee) outcome was unknown and HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet) and HEADACHE (headaches) had not resolved. Concomitant medications were not provided. Treatment information was not reported. The patient reported that her HCP (Healthcare Provider) thought she had symptoms of COVID-19, but her tests came back negative with no reported date. The patient's bloodwork was normal as well. 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: 1681651
Sex: F
Age:
State: FL

Vax Date: 07/30/2021
Onset Date:
Rec V Date: 09/08/2021
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: Ever since have the shot I'm feeling worse/Each day seems to be getting worse; Burning feeling on the bottom of the right foot/ and burning in my muscle; Something is happening to the muscle that never happened before; Muscle pain/Aching in my muscle; Shooting pain into my brain; Rash on my bottom; Burning feeling on the bottom of the right foot/ and burning in my muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle) and HEADACHE (Shooting pain into my brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to vaccine. On 30-Jul-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 VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle). At the time of the report, VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle) 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. The patient stated that she is scare to death and high risk patient.

Other Meds:

Current Illness: Allergy to vaccine

ID: 1681652
Sex: M
Age: 55
State: TX

Vax Date: 07/23/2021
Onset Date: 07/31/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: hundreds of dots on the legs, they are bleeding; blood all over his mucous, with a mix of yellow, grey and red mucous; rash/red little dots all over the body; blood all over his mucous, with a mix of yellow, grey and red mucous; sleeping like crazy, sleeping 80 percent of the time; can not move; lack of energy; can not taste anything; feels like "crap"; Fever; Headache; Rash both legs; Rash all over; This spontaneous case was reported by a consumer and describes the occurrence of PURPURA (hundreds of dots on the legs, they are bleeding), MUCOSAL DISORDER (blood all over his mucous, with a mix of yellow, grey and red mucous), RASH ERYTHEMATOUS (rash/red little dots all over the body), SECRETION DISCHARGE (blood all over his mucous, with a mix of yellow, grey and red mucous) and SOMNOLENCE (sleeping like crazy, sleeping 80 percent of the time) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 066021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced PURPURA (hundreds of dots on the legs, they are bleeding), MUCOSAL DISORDER (blood all over his mucous, with a mix of yellow, grey and red mucous), RASH ERYTHEMATOUS (rash/red little dots all over the body), SECRETION DISCHARGE (blood all over his mucous, with a mix of yellow, grey and red mucous), SOMNOLENCE (sleeping like crazy, sleeping 80 percent of the time), HYPOKINESIA (can not move), ASTHENIA (lack of energy), AGEUSIA (can not taste anything), FEELING ABNORMAL (feels like "crap"), PYREXIA (Fever), HEADACHE (Headache), RASH (Rash both legs) and RASH (Rash all over). At the time of the report, PURPURA (hundreds of dots on the legs, they are bleeding), MUCOSAL DISORDER (blood all over his mucous, with a mix of yellow, grey and red mucous), RASH ERYTHEMATOUS (rash/red little dots all over the body), SECRETION DISCHARGE (blood all over his mucous, with a mix of yellow, grey and red mucous), SOMNOLENCE (sleeping like crazy, sleeping 80 percent of the time), HYPOKINESIA (can not move), ASTHENIA (lack of energy), AGEUSIA (can not taste anything), FEELING ABNORMAL (feels like "crap"), PYREXIA (Fever), HEADACHE (Headache), RASH (Rash both legs) and RASH (Rash all over) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Relevant concomitant medications included, Immune Vitamins were reported. Treatment information was not provided. Patient said that all the symptoms started 8 days after the first dose and he is still experiencing these symptoms. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information included updated reporter address and contact details.; 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: 1681653
Sex: F
Age: 38
State: FL

Vax Date: 08/22/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: 202108; Test Name: Heart rate; Result Unstructured Data: Faster heart rate that came and went periodically

Allergies:

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

Symptoms: Sore arm; Faster heart rate that came and went periodically; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The medical history information was not provided by the reporter. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Heart rate: irregular (abnormal) Faster heart rate that came and went periodically. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. Patient reported experiencing the symptoms beginning a day and a half ago after the first dose. Patient did not take any medication for symptoms. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received on 27-Aug-2021, Updated patient's date of birth, age, vaccine start date and vaccine facility information.

Other Meds: NP THYROID

Current Illness:

ID: 1681654
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Side effect after he got the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect after he got the dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect after he got the dose). At the time of the report, VACCINATION COMPLICATION (Side effect after he got the dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681655
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) 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 August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Contracted COVID). At the time of the report, COVID-19 (Contracted COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681656
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: increased

Allergies:

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

Symptoms: Temperature 101 degrees Farenheight/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature). At the time of the report, BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (abnormal) increased. 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.

Other Meds:

Current Illness:

ID: 1681657
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a 20-year-old female patient 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 FATIGUE (Chronic fatigue). At the time of the report, FATIGUE (Chronic fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided by the reporter. Treatment medication include muscle relaxant prescribed by a HCP.

Other Meds:

Current Illness:

ID: 1681658
Sex: M
Age: 68
State: NY

Vax Date: 01/23/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
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: 20210818; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: coughing; congestion; , sneezing; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HEADACHE (headache) and COUGH (coughing). 18-Aug-2021, the patient experienced NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever). On 26-Aug-2021, HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test positive: Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD-2021-296717 (Patient Link).

Other Meds:

Current Illness:

ID: 1681659
Sex: F
Age: 65
State: CT

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 09/08/2021
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: brain bleeds; did not each much because did not feel hungry; She couldn't move; was throwing up all bile; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain bleeds), DECREASED APPETITE (did not each much because did not feel hungry), MOVEMENT DISORDER (She couldn't move) and VOMITING (was throwing up all bile) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain bleeds) (seriousness criteria hospitalization, disability, medically significant and life threatening), DECREASED APPETITE (did not each much because did not feel hungry) (seriousness criteria hospitalization, disability and life threatening), MOVEMENT DISORDER (She couldn't move) (seriousness criteria hospitalization, disability and life threatening) and VOMITING (was throwing up all bile) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, CEREBRAL HAEMORRHAGE (brain bleeds), DECREASED APPETITE (did not each much because did not feel hungry), MOVEMENT DISORDER (She couldn't move) and VOMITING (was throwing up all bile) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported. Company comment: Based on the current available information and temporal association between the use of the product mRNA-1273 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 mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1681660
Sex: F
Age: 55
State: TX

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 09/08/2021
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: myalgia; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (myalgia) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Concomitant products included VITAMINS NOS and GABAPENTIN for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NAUSEA (nausea). On 09-Feb-2021, the patient experienced MYALGIA (myalgia). On 09-Jan-2021, NAUSEA (nausea) outcome was unknown. On 10-Feb-2021, MYALGIA (myalgia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment was not specified. This case was linked to MOD-2021-297337 (Patient Link).

Other Meds: VITAMINS NOS; GABAPENTIN

Current Illness:

ID: 1681661
Sex: M
Age: 28
State: TX

Vax Date: 07/28/2021
Onset Date:
Rec V Date: 09/08/2021
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: Sleep Paralysis with Lucid dreaming; when he sleeps he has difficulty breathing; fatigue; mild fever; Horrible but bearable sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 and Sleep paralysis. On 28-Jul-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 SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm). At the time of the report, SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient says he has similar symptoms when he had Covid, its like he is having Covid again. Concomitant medication were not provided Treatment information was not provided This case was linked to MOD-2021-297642 (Patient Link).

Other Meds:

Current Illness:

ID: 1681662
Sex: F
Age: 54
State: OK

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: got sick after both shots; explosive diarrhea after the first shot for about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after both shots) and DIARRHOEA (explosive diarrhea after the first shot for about 5 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick after both shots) and DIARRHOEA (explosive diarrhea after the first shot for about 5 days). At the time of the report, ILLNESS (got sick after both shots) outcome was unknown and DIARRHOEA (explosive diarrhea after the first shot for about 5 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medication was not reported. The treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1681663
Sex: F
Age:
State: WA

Vax Date: 01/02/2021
Onset Date: 04/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: pulmonay angiogram; Test Result: Negative ; Result Unstructured Data: PE, COVID and perocardiis ruled out by pulmonay angiogram; Test Name: blood pressure measurement; Result Unstructured Data: Blood pressure was high; Test Name: pulmonary function test; Result Unstructured Data: PFTs showed reduced FEV and FEV1, to about 70% normal, with a 25% response to bronchodilator.; Test Name: Respiration; Result Unstructured Data: More than 20

Allergies:

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

Symptoms: This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Difficulty breathing/I also felt somewhat breathless o the stairs), RESPIRATORY RATE INCREASED (Respirations >20 per min), GAIT INABILITY (I could hardly walk upstairs) and COUGH (Dry cough that dissipated over several weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Clotting disorder (prothrombin abnormality, clotting disorder) since 1999, Hernia (Small hiatal hernia) since 2018 and Hypertension (BP was increasing for a few months before, in 2020) since 2000. Concomitant products included OMEPRAZOLE for Heartburn, HYDROCHLOROTHIAZIDE and AMLODIPINE for Hypertension. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing/I also felt somewhat breathless o the stairs) and RESPIRATORY RATE INCREASED (Respirations >20 per min). On an unknown date, the patient experienced GAIT INABILITY (I could hardly walk upstairs) and COUGH (Dry cough that dissipated over several weeks). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing/I also felt somewhat breathless o the stairs) and RESPIRATORY RATE INCREASED (Respirations >20 per min) had resolved with sequelae, GAIT INABILITY (I could hardly walk upstairs) outcome was unknown and COUGH (Dry cough that dissipated over several weeks) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Angiogram pulmonary: negative (Negative) PE, COVID and perocardiis ruled out by pulmonay angiogram. On an unknown date, Blood pressure measurement: high (High) Blood pressure was high. On an unknown date, Pulmonary function test: normal percent (normal) PFTs showed reduced FEV and FEV1, to about 70% normal, with a 25% response to bronchodilator.. On an unknown date, Respiratory rate: more than 20 (High) More than 20. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient did ECG and Blood troponins test.and studies included stress echo. Albuterol inhaler was used for treatment. Patient was sent to a cardiologist for increased BP management and had full workup to exclude infarct, studies included stress echo. Meds increased and BP was lowered, over a few weeks, but the dyspnoea did not improve. Following the second vaccine, also at about 48 hours, began coughing a lot, dry cough. It decreased over several weeks, now some days worse than others, but it is not bad at all now. Patient was referred to pulmonology and PFTs showed reduced FEV and FEV1, to about 70% normal, with a 25% response to bronchodilator. Since then used an albuterol inhaler before exercise and that helped walking a lot. Recently, past 3 weeks felt much better and stopped the inhaler. Was breathless on 1 flight of stairs, but can walk normally on flat ground now. The only other possibility was related to small hiatal hernia and felt that taking Omeprazole was possibly helping the coughing. So I am undergoing evaluation with a thoracic surgeon to determine whether there is reflux causing the coughing and a reactive bronchospasm. This case was linked to MOD-2021-297768 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: n 30-Aug-2021: follow up received on 30 -aug-2021 contains Patient demographics, race and ethnicity were updated. Relevant history, lab data was added. concomitant and treatment medication were added. New adverse event and events outcome was updated.

Other Meds: HYDROCHLOROTHIAZIDE; AMLODIPINE; OMEPRAZOLE

Current Illness: Clotting disorder (prothrombin abnormality, clotting disorder); Hernia (Small hiatal hernia); Hypertension (BP was increasing for a few months before, in 2020)

ID: 1681664
Sex: F
Age: 52
State: FL

Vax Date: 08/03/2021
Onset Date: 08/04/2021
Rec V Date: 09/08/2021
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: Heart flutters; Heart palpitations; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart flutters) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced CARDIAC FLUTTER (Heart flutters) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations). At the time of the report, CARDIAC FLUTTER (Heart flutters), PAIN IN EXTREMITY (Sore arm) and PALPITATIONS (Heart palpitations) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient was asking if she should get her 2nd shot on Aug 31st. Patient has an appointment with a new primary care physician on 4Sep2021 and wants to know if she can extend the shot after that. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 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 mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Anxiety

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am