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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1644894
Sex: F
Age: 47
State:

Vax Date: 07/12/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Chest heaviness; Prolonged vertigo; Head was heavy; It hit her; Fatigue and good fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest heaviness), VERTIGO (Prolonged vertigo), HEAD DISCOMFORT (Head was heavy), VACCINATION COMPLICATION (It hit her) and FATIGUE (Fatigue and good fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04D21A) for COVID-19 vaccination. Concurrent medical conditions included Hyperacusis (Susceptible to hearing distortion), Vertigo, Hypersensitivity (Hypersensitive to certain sounds) and Hearing disability (Hearing distortion.). Concomitant products included SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and VITAMINS NOS for an unknown indication. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), VERTIGO (Prolonged vertigo), HEAD DISCOMFORT (Head was heavy), VACCINATION COMPLICATION (It hit her) and FATIGUE (Fatigue and good fatigue). In July 2021, VERTIGO (Prolonged vertigo) had resolved. At the time of the report, CHEST DISCOMFORT (Chest heaviness), HEAD DISCOMFORT (Head was heavy), VACCINATION COMPLICATION (It hit her) and FATIGUE (Fatigue and good fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were provided by reporter. This case was linked to MOD-2021-285106 (Patient Link).

Other Meds: ALDACTONE [SPIRONOLACTONE]; VITAMINS NOS

Current Illness: Hearing disability (Hearing distortion.); Hyperacusis (Susceptible to hearing distortion); Hypersensitivity (Hypersensitive to certain sounds); Vertigo

ID: 1644895
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Health compromised with COPD; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Health compromised with COPD) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD (Severe COPD). 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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Health compromised with COPD). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Health compromised with COPD) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown Concomitant medications were not provided. Treatment information was not provided. No lab data provided by reporter.

Other Meds:

Current Illness: COPD (Severe COPD)

ID: 1644896
Sex: F
Age: 47
State:

Vax Date: 07/12/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she is unhappy being at home; From last night through today, she has cold, sweats, fever, chills; She is a bit wobbly.; From last night through today, she has cold, sweats, fever, chills; migraines/she is unhappy being at home and having migraines.; chills/had a lot of chills; fever; knocked out with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (From last night through today, she has cold, sweats, fever, chills), MIGRAINE (migraines/she is unhappy being at home and having migraines.), FEELING ABNORMAL (she is unhappy being at home), HYPERHIDROSIS (From last night through today, she has cold, sweats, fever, chills) and GAIT DISTURBANCE (She is a bit wobbly.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 093D21A and 04D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hearing impaired (vestibular acusis), Hyperacusis (Susceptible to hearing distortion and hypersensitive to certain sounds. She had been experiencing it more on a daily level in the last couple of years.) and Vertigo. Concomitant products included SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and VITAMINS NOS for an unknown indication. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced CHILLS (chills/had a lot of chills). On 11-Aug-2021, the patient experienced NASOPHARYNGITIS (From last night through today, she has cold, sweats, fever, chills), MIGRAINE (migraines/she is unhappy being at home and having migraines.), HYPERHIDROSIS (From last night through today, she has cold, sweats, fever, chills) and GAIT DISTURBANCE (She is a bit wobbly.). On an unknown date, the patient experienced FEELING ABNORMAL (she is unhappy being at home). The patient was treated with NAPROXEN for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (From last night through today, she has cold, sweats, fever, chills), MIGRAINE (migraines/she is unhappy being at home and having migraines.), FEELING ABNORMAL (she is unhappy being at home), HYPERHIDROSIS (From last night through today, she has cold, sweats, fever, chills), GAIT DISTURBANCE (She is a bit wobbly.) and CHILLS (chills/had a lot of chills) had not resolved. The patient received the second dose and was knocked out with fatigue, chills, fever for 2 days. She attempted to run a quick errand and had a lot of chills, fever, migraines. From the previous night through, she had cold, sweats, fever and chills. She was unhappy being at home and had migraines. The migraine, cold, sweats, fever, chills was nonstop. She knew Tylenol was the recommended pain medication with the vaccine, but she did not had Tylenol but naproxen and wanted to know if she can take it as at that stage there was no sign of migraine ongoing. This case was linked to MOD-2021-285078 (Patient Link). Reporter did not allow further contact

Other Meds: ALDACTONE [SPIRONOLACTONE]; VITAMINS NOS

Current Illness: Hearing impaired (vestibular acusis); Hyperacusis (Susceptible to hearing distortion and hypersensitive to certain sounds. She had been experiencing it more on a daily level in the last couple of years.); Vertigo

ID: 1644897
Sex: M
Age: 49
State: CO

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: More than 35 days between Moderna Covid-19 vaccines; sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and PRODUCT DOSE OMISSION IN ERROR (More than 35 days between Moderna Covid-19 vaccines) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (More than 35 days between Moderna Covid-19 vaccines). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown and PRODUCT DOSE OMISSION IN ERROR (More than 35 days between Moderna Covid-19 vaccines) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644898
Sex: F
Age: 61
State: CT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 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: Over 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over 35 days since first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Over 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 35 days since first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants and treatment were reported.

Other Meds:

Current Illness:

ID: 1644899
Sex: M
Age: 58
State: TX

Vax Date: 03/21/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
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: cold/flue-like symptoms; fever; the lymph nodes of the same arm of the injection are swollen/problems with his lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (cold/flue-like symptoms), VACCINATION SITE LYMPHADENOPATHY (the lymph nodes of the same arm of the injection are swollen/problems with his lymph nodes) and PYREXIA (fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (the lymph nodes of the same arm of the injection are swollen/problems with his lymph nodes). On 22-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (cold/flue-like symptoms) and PYREXIA (fever). On 23-Apr-2021, INFLUENZA LIKE ILLNESS (cold/flue-like symptoms) and PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (the lymph nodes of the same arm of the injection are swollen/problems with his lymph nodes) outcome was unknown. No treatment medications are provided No concomitant medications are provided. Caller stated that he has wasted a lot of money on this and that it's consistently bothering him.

Other Meds:

Current Illness:

ID: 1644900
Sex: F
Age:
State: FL

Vax Date: 02/09/2021
Onset Date: 03/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Elevated heart rate; Brain fog; Dehydrated; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DEHYDRATION (Dehydrated), FEELING ABNORMAL (Brain fog) and HEART RATE INCREASED (Elevated heart rate) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The patient's past medical history included Hashimoto's thyroiditis in September 2000, Upset stomach, Insomnia and Rash. Concurrent medical conditions included Drug allergy (Sensation to all medicine). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for Hashimoto's thyroiditis. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021 at 7:30 AM, the patient experienced VERTIGO (Vertigo). On 17-Mar-2021 at 3:00 AM, the patient experienced DEHYDRATION (Dehydrated). On 22-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog). On 28-Mar-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate). At the time of the report, VERTIGO (Vertigo), DEHYDRATION (Dehydrated), FEELING ABNORMAL (Brain fog) and HEART RATE INCREASED (Elevated heart rate) had not resolved. Not Provided No treatment was provided.

Other Meds: TIROSINT

Current Illness: Drug allergy (Sensation to all medicine)

ID: 1644901
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Patient received an expired vaccine; temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. 4 Moderna vials affected by temperature excursion (Lot 038C21A). Of those 4 vials, 3 of the vials were used to administer vaccinations to 9 patients over 3 days between 09-Aug-2021 to 11-Aug-2021. Patient received an expired vaccine past 30 days in the fridge. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1644902
Sex: F
Age: 45
State: MO

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Product storage error; Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) 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 information was provided. No treatment medication were provided. This case was linked to MOD-2021-285598 (Patient Link).

Other Meds:

Current Illness:

ID: 1644903
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid). At the time of the report, COVID-19 (got Covid) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs were provided No treatment drugs were provided

Other Meds:

Current Illness:

ID: 1644904
Sex: M
Age: 27
State: TX

Vax Date: 07/27/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feeling that he worked out hard and that his left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feeling that he worked out hard and that his left arm was sore) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (feeling that he worked out hard and that his left arm was sore). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency and BACLOFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (feeling that he worked out hard and that his left arm was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided.

Other Meds:

Current Illness:

ID: 1644905
Sex: F
Age: 69
State: VT

Vax Date: 03/13/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Mostly 102F to 103.6 F; Test Name: COVID-19 PCR Test; Test Result: Negative; Result Unstructured Data: Negative.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Delirium; Diarrhea; Dizziness; Dehydration; Sweating when fever broke; Loss of Appetite; Panic/Same panic and anxiety; Anxiety/Same panic and anxiety; Even worse swelling; More pain; More redness; Hardness at injection site; Fever (mostly 102F to 103.6F)/High fever; Fatigue to the degree of immobile/Much worse fatigue; Nausea; Vomiting; Muscle pain throughout body; Joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection; Fatigue; Panic; Anxiety; Experience was terrifying/3 days of the same general body symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Passed out, Feeling sick and Infusion (Infusion for osteoporosis). Concurrent medical conditions included Contrast media allergy, Lactose intolerant, Osteoporosis and Thyroid disorder. Concomitant products included VITAMINS NOS for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DEHYDRATION (Dehydration), HYPERHIDROSIS (Sweating when fever broke), DECREASED APPETITE (Loss of Appetite), PANIC ATTACK (Panic/Same panic and anxiety), ANXIETY (Anxiety/Same panic and anxiety), SWELLING (Even worse swelling), PAIN (More pain), ERYTHEMA (More redness), VACCINATION SITE INDURATION (Hardness at injection site), PYREXIA (Fever (mostly 102F to 103.6F)/High fever), FATIGUE (Fatigue to the degree of immobile/Much worse fatigue), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Muscle pain throughout body) and ARTHRALGIA (Joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection). In April 2021, the patient experienced PANIC REACTION (Panic ), ANXIETY (Anxiety), FEELING ABNORMAL (Experience was terrifying/3 days of the same general body symptoms) and FATIGUE (Fatigue). On 14-Apr-2021, DELIRIUM (Delirium), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DEHYDRATION (Dehydration), DECREASED APPETITE (Loss of Appetite), PANIC ATTACK (Panic/Same panic and anxiety), ANXIETY (Anxiety/Same panic and anxiety), SWELLING (Even worse swelling), PAIN (More pain), ERYTHEMA (More redness), VACCINATION SITE INDURATION (Hardness at injection site), FATIGUE (Fatigue to the degree of immobile/Much worse fatigue), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Muscle pain throughout body) and ARTHRALGIA (Joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection) had resolved. In April 2021, HYPERHIDROSIS (Sweating when fever broke), PANIC REACTION (Panic ), ANXIETY (Anxiety), FEELING ABNORMAL (Experience was terrifying/3 days of the same general body symptoms), PYREXIA (Fever (mostly 102F to 103.6F)/High fever) and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 to 103.6 (High) Mostly 102F to 103.6F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On 10-Apr-2021, the patient received second dose of Moderna vaccine and has side effects as: even worse swelling, more pain, more redness, more hardness at injection site. Fever for 54 hours, mostly 102F to 103.6F, fatigue to the degree of immobile, nausea, diarrhea, vomiting, delirium, dizziness, dehydration, muscle pain throughout body, joint pain in entire arm, hand, elbow, shoulder, ribs, hip and neck on side of injection, severe sweating when fever broke for 8 hours, loss of appetite, severe panic, and severe anxiety. Duration 4 days. Two weeks later: the patient had 3 days of the same general body symptoms, including the high fever, much worse fatigue, plus the same panic and anxiety and state that all of this experience was absolutely terrifying. Patient had all COVID-19 PCR tests before, during, and after these weeks: all negative. Patient experienced severe reactions to other vaccines in past: flu vaccine, yellow fever etc. Patient did not go anaphylactic, but does experience severe swelling. On one opportunity, as a child, received a vaccine and had swelling being so strong, that patient passed out. Patient was concerned to have a third dose in the future in part because local clinical does not have so much information on what to do. Concomitant medication included Tyrod medication and a couple of Vitamins. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-284720 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMINS NOS

Current Illness: Contrast media allergy; Lactose intolerant; Osteoporosis; Thyroid disorder.

ID: 1644906
Sex: F
Age: 84
State: SC

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Abnormal.

Allergies:

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

Symptoms: Her joints started swelling & now she's in a wheelchair; Incontinence; Drainage; Left knee is hurting pretty bad right now; Didn't take the 2nd dose on time due to her running a temperature; Sore, tight, swollen glands in her neck; Running a temperature; Chest congestion; Flu-like symptoms; Sores in her mouth; Strep throat; she couldn't turn over in the bed because her left arm hurt for 4 or 5 days; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Her joints started swelling & now she's in a wheelchair) in an 84-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. The patient's past medical history included Heart valve disorders. Concurrent medical conditions included Vision abnormal (Losing eyesight in her left eye) and Swelling of legs (Legs swelling when she sits down). On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CHEST DISCOMFORT (Chest congestion), INFLUENZA LIKE ILLNESS (Flu-like symptoms), STOMATITIS (Sores in her mouth), PHARYNGITIS STREPTOCOCCAL (Strep throat), PAIN IN EXTREMITY (she couldn't turn over in the bed because her left arm hurt for 4 or 5 days), LYMPHADENOPATHY (Sore, tight, swollen glands in her neck) and PYREXIA (Running a temperature). On an unknown date, the patient experienced JOINT SWELLING (Her joints started swelling & now she's in a wheelchair) (seriousness criterion disability), INCONTINENCE (Incontinence), (Drainage), ARTHRALGIA (Left knee is hurting pretty bad right now) and INTENTIONAL DOSE OMISSION (Didn't take the 2nd dose on time due to her running a temperature). At the time of the report, JOINT SWELLING (Her joints started swelling & now she's in a wheelchair), CHEST DISCOMFORT (Chest congestion), INFLUENZA LIKE ILLNESS (Flu-like symptoms), STOMATITIS (Sores in her mouth), PHARYNGITIS STREPTOCOCCAL (Strep throat), INCONTINENCE (Incontinence), (Drainage), LYMPHADENOPATHY (Sore, tight, swollen glands in her neck), PYREXIA (Running a temperature) and ARTHRALGIA (Left knee is hurting pretty bad right now) outcome was unknown and PAIN IN EXTREMITY (she couldn't turn over in the bed because her left arm hurt for 4 or 5 days) and INTENTIONAL DOSE OMISSION (Didn't take the 2nd dose on time due to her running a temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) Abnormal. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date. Concomitant product use was not provided by the reporter. Treatment for the event included drainage. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-285289 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Swelling of legs (Legs swelling when she sits down); Vision abnormal (Losing eyesight in her left eye).

ID: 1644907
Sex: F
Age:
State: WA

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
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: Patient has not received her 2nd shot; Redness around the injection site; Pain soreness around the injection site; Dizzy; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd shot), DIZZINESS (Dizzy), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain soreness around the injection site) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd shot), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain soreness around the injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd shot) had resolved and DIZZINESS (Dizzy), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain soreness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications details were provided. No Treatment Medications details were provided.

Other Meds:

Current Illness:

ID: 1644908
Sex: M
Age: 27
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: Right after the first dose, he felt it was hard to breathe but went away after 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Right after the first dose, he felt it was hard to breathe but went away after 15 minutes) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 638C21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy (Codeine), Drug allergy (Tramadol), Drug allergy (Toradol), Drug allergy (Gabapentin) and Fruit allergy (mangoes). On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced DYSPNOEA (Right after the first dose, he felt it was hard to breathe but went away after 15 minutes). On 09-Jul-2021, DYSPNOEA (Right after the first dose, he felt it was hard to breathe but went away after 15 minutes) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. It was reported that patient did not take any medication with the symptoms, just increased his water intake and also confirms that patient was not taking any regular prescribed medications or any supplements. This case was linked to MOD-2021-284335 (Patient Link).

Other Meds:

Current Illness: Drug allergy (Tramadol); Drug allergy (Toradol); Drug allergy (Gabapentin); Drug allergy (Codeine); Fruit allergy (mangoes); Penicillin allergy

ID: 1644909
Sex: F
Age: 64
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: still gets a little queasy; site of injection got really red; body aches/muscle aches; feels fatigued; saw soreness under her armpit; couldn't barely get out of bed; arm was really bothering; lump under her armpit; (lump) red; (lump) hot; location of vaccination is hot to the touch,site of injection got really hot; Diarrhea; dizziness; felt really bad; restlessness; location of vaccination is very itchy,(lump) itchy; Vomit; had a splitting headache/terrible headaches/Still has a headache but it is not lingering; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't barely get out of bed), LIMB DISCOMFORT (arm was really bothering), AXILLARY MASS (lump under her armpit), ERYTHEMA ((lump) red) and FEELING HOT ((lump) hot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in February 2021. Family history included Allergy to vaccine since an unknown date. Concomitant products included GABAPENTIN, LEVOTHYROXINE and METHOCARBAMOL for an unknown indication. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced HEADACHE (had a splitting headache/terrible headaches/Still has a headache but it is not lingering). On 09-Aug-2021, the patient experienced MOBILITY DECREASED (couldn't barely get out of bed), LIMB DISCOMFORT (arm was really bothering), AXILLARY MASS (lump under her armpit), ERYTHEMA ((lump) red), FEELING HOT ((lump) hot), VACCINATION SITE WARMTH (location of vaccination is hot to the touch,site of injection got really hot), DIARRHOEA (Diarrhea), DIZZINESS (dizziness), FEELING ABNORMAL (felt really bad), RESTLESSNESS (restlessness), VACCINATION SITE PRURITUS (location of vaccination is very itchy,(lump) itchy), VOMITING (Vomit), VACCINATION SITE ERYTHEMA (site of injection got really red), MYALGIA (body aches/muscle aches), FATIGUE (feels fatigued) and AXILLARY PAIN (saw soreness under her armpit). On an unknown date, the patient experienced NAUSEA (still gets a little queasy). At the time of the report, MOBILITY DECREASED (couldn't barely get out of bed), LIMB DISCOMFORT (arm was really bothering), AXILLARY MASS (lump under her armpit), ERYTHEMA ((lump) red), FEELING HOT ((lump) hot), VACCINATION SITE WARMTH (location of vaccination is hot to the touch,site of injection got really hot), DIARRHOEA (Diarrhea), DIZZINESS (dizziness), FEELING ABNORMAL (felt really bad), RESTLESSNESS (restlessness), VACCINATION SITE PRURITUS (location of vaccination is very itchy,(lump) itchy), VOMITING (Vomit), NAUSEA (still gets a little queasy), VACCINATION SITE ERYTHEMA (site of injection got really red), MYALGIA (body aches/muscle aches), FATIGUE (feels fatigued), AXILLARY PAIN (saw soreness under her armpit) and HEADACHE (had a splitting headache/terrible headaches/Still has a headache but it is not lingering) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. It was reported that the patient had COVID in February and was very sick but ended up recovering from it. She received supplements. She received the vaccine in her upper arm muscle. She stated that today is the first day she was able to sit up and stay out of bed. She wanted to know if her symptoms were normal if she had to wait it out or not if she could put ice in her arm. She also stated that her son had an allergy to MMR vaccine when he was 18 months old and was wondering if he can receive the Moderna COVID19 Vaccine.

Other Meds: GABAPENTIN; LEVOTHYROXINE; METHOCARBAMOL

Current Illness: Allergy to vaccine

ID: 1644910
Sex: F
Age: 30
State: MO

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) 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. ARNP reported that 6 patients received the first dose of expired Moderna COVID-19 vaccine on 12AUG2021. It was reported that the vial did not undergo any previous temperature excursions. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD21-129698, MOD21-129760, MOD21-129763, MOD21-129764, MOD21-129765 (E2B Linked Report). This case was linked to MOD-2021-285598 (Patient Link).; Sender's Comments: MOD21-129698: MOD21-129760: MOD21-129763: MOD21-129764: MOD21-129765:

Other Meds:

Current Illness:

ID: 1644911
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Enlarged heart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Enlarged heart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (Enlarged heart). At the time of the report, CARDIOMEGALY (Enlarged heart) had not resolved. No concomitant medications were provided by reporter. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1644912
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Patient received an expired vaccine; received an expired vaccine past 30 days in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED DEVICE USED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge) 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 EXPIRED DEVICE USED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge). At the time of the report, EXPIRED DEVICE USED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1644913
Sex: F
Age: 58
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Raised, hot, and painful on the right calf; Varicose Veins bulging out; Pain in the right side of body; Bulge on the injection site; Pain in the left knee; Has No Energy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Has No Energy), FEELING HOT (Raised, hot, and painful on the right calf), VARICOSE VEIN (Varicose Veins bulging out), PAIN (Pain in the right side of body) and VACCINATION SITE SWELLING (Bulge on the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939982) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced ASTHENIA (Has No Energy), PAIN (Pain in the right side of body), VACCINATION SITE SWELLING (Bulge on the injection site) and ARTHRALGIA (Pain in the left knee). On 03-Aug-2021, the patient experienced FEELING HOT (Raised, hot, and painful on the right calf) and VARICOSE VEIN (Varicose Veins bulging out). On 06-Aug-2021, FEELING HOT (Raised, hot, and painful on the right calf) and VARICOSE VEIN (Varicose Veins bulging out) had resolved. At the time of the report, ASTHENIA (Has No Energy), PAIN (Pain in the right side of body), VACCINATION SITE SWELLING (Bulge on the injection site) and ARTHRALGIA (Pain in the left knee) 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: 1644914
Sex: F
Age: 65
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: all of the sudden her ankles are swollen which is not normal; Medicine taste in her mouth; Arm hurts; Having hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Medicine taste in her mouth), PAIN IN EXTREMITY (Arm hurts), HOT FLUSH (Having hot flashes) and JOINT SWELLING (all of the sudden her ankles are swollen which is not normal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy. Concomitant products included LORATADINE for an unknown indication. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced TASTE DISORDER (Medicine taste in her mouth), PAIN IN EXTREMITY (Arm hurts) and HOT FLUSH (Having hot flashes). On 12-Aug-2021, the patient experienced JOINT SWELLING (all of the sudden her ankles are swollen which is not normal). At the time of the report, TASTE DISORDER (Medicine taste in her mouth), PAIN IN EXTREMITY (Arm hurts), HOT FLUSH (Having hot flashes) and JOINT SWELLING (all of the sudden her ankles are swollen which is not normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was also not reported.

Other Meds: LORATADINE

Current Illness: Allergy

ID: 1644915
Sex: M
Age: 14
State: NE

Vax Date: 07/21/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Patient is14 years old and he presented at the clinic and got a vaccine; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is14 years old and he presented at the clinic and got a vaccine) and VACCINATION SITE PAIN (Sore arm) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 14 years old and he presented at the clinic and got a vaccine) and VACCINATION SITE PAIN (Sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 14 years old and he presented at the clinic and got a vaccine) had resolved and VACCINATION SITE PAIN (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1644916
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

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

Symptoms: Patient received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The nurse reported that the shipment of vaccines were received on 08-Jul-2021 to a different team and was placed in the refrigerator. The vaccines were received to her on 30-Jul-2021 The number of Moderna vials affected were 4 vials of those 3 of the vials were used to administer vaccinations to 9 patients over 3 days from 09-Aug-2021 to 11-Aug-2021. No Concomitant medications was provided by reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1644917
Sex: U
Age:
State:

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

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

Lab Data: Test Name: COVID 19; Test Result: Positive ; Result Unstructured Data: Rapid test

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: 2-3 teachers who tested positive for COVID (via rapid test)after the vaccination went to the doctor they were negative; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST FALSE POSITIVE (2-3 teachers who tested positive for COVID (via rapid test)after the vaccination went to the doctor they were negative) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST FALSE POSITIVE (2-3 teachers who tested positive for COVID (via rapid test)after the vaccination went to the doctor they were negative). At the time of the report, SARS-COV-2 TEST FALSE POSITIVE (2-3 teachers who tested positive for COVID (via rapid test)after the vaccination went to the doctor they were negative) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Rapid test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1644918
Sex: F
Age:
State: SC

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: tingling in leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in leg) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (tingling in leg). At the time of the report, PARAESTHESIA (tingling in leg) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644919
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: injection site where it's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site where it's sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site where it's sore). At the time of the report, VACCINATION SITE PAIN (injection site where it's sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644920
Sex: F
Age: 41
State: CT

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Cloggeal ear; flu like symptoms; Skin hot touch; feeling really hot,then really cold; Sweating; Eustachian nose inflammation; Exhausted; Pain all over body; Systemic Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Systemic Inflammation), EAR DISCOMFORT (Cloggeal ear), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (Skin hot touch) and FEELING OF BODY TEMPERATURE CHANGE (feeling really hot,then really cold) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting hypersensitivity, Drug allergy, Drug allergy, Drug allergy, Fibromyalgia, Complex regional pain syndrome and Pituitary tumor NOS. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for Gastroesophageal reflux disease, HYDROCODONE for Pain. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INFLAMMATION (Systemic Inflammation). On an unknown date, the patient experienced EAR DISCOMFORT (Cloggeal ear), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (Skin hot touch), FEELING OF BODY TEMPERATURE CHANGE (feeling really hot,then really cold), HYPERHIDROSIS (Sweating), NASAL INFLAMMATION (Eustachian nose inflammation), FATIGUE (Exhausted) and MYALGIA (Pain all over body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Systemic Inflammation) had resolved with sequelae and EAR DISCOMFORT (Cloggeal ear), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (Skin hot touch), FEELING OF BODY TEMPERATURE CHANGE (feeling really hot,then really cold), HYPERHIDROSIS (Sweating), NASAL INFLAMMATION (Eustachian nose inflammation), FATIGUE (Exhausted) and MYALGIA (Pain all over body) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Had done lots of blood work done. Blood work all normal This case was linked to MOD-2021-031548 (Patient Link).

Other Meds: HYDROCODONE; PANTOPRAZOLE 40

Current Illness: Bee sting hypersensitivity; Complex regional pain syndrome; Drug allergy; Fibromyalgia; Pituitary tumor NOS

ID: 1644921
Sex: F
Age: 63
State: MA

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

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

Lab Data: Test Name: antibody test; Test Result: Positive ; Result Unstructured Data: antibody test that shows positive and says 60

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: very sick; diarrhea; She was having bile coming out of her and her body kept pushing out; couldn't eat; lost 13 lbs; didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DIARRHOEA (diarrhea), BILE ACID MALABSORPTION (She was having bile coming out of her and her body kept pushing out), FEEDING DISORDER (couldn't eat) and WEIGHT DECREASED (lost 13 lbs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anal cancer. In March 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 (very sick), DIARRHOEA (diarrhea), BILE ACID MALABSORPTION (She was having bile coming out of her and her body kept pushing out), FEEDING DISORDER (couldn't eat), WEIGHT DECREASED (lost 13 lbs) and PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, ILLNESS (very sick), DIARRHOEA (diarrhea), BILE ACID MALABSORPTION (She was having bile coming out of her and her body kept pushing out) and WEIGHT DECREASED (lost 13 lbs) outcome was unknown, FEEDING DISORDER (couldn't eat) was resolving and PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) antibody test that shows positive and says 60. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medication was not provided.

Other Meds:

Current Illness: Anal cancer

ID: 1644922
Sex: F
Age: 84
State: SC

Vax Date: 02/08/2021
Onset Date: 03/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Her joints started swelling and now she's in a wheelchair; Her left knee is hurting pretty bad right now; Had incontinence right after that shot; She didn't take the 2nd dose on time due to her running a temperature; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Her joints started swelling and now she's in a wheelchair) and ARTHRALGIA (Her left knee is hurting pretty bad right now) in an 85-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. The patient's past medical history included Swelling of legs (Legs swelling when she sits down). Concurrent medical conditions included Heart valve disorders (Heart valve problem) and Low vision, one eye (Losing eyesight in her left eye). On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INCONTINENCE (Had incontinence right after that shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She didn't take the 2nd dose on time due to her running a temperature). On an unknown date, the patient experienced JOINT SWELLING (Her joints started swelling and now she's in a wheelchair) (seriousness criterion disability) and ARTHRALGIA (Her left knee is hurting pretty bad right now) (seriousness criterion disability). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She didn't take the 2nd dose on time due to her running a temperature) had resolved. At the time of the report, JOINT SWELLING (Her joints started swelling and now she's in a wheelchair), ARTHRALGIA (Her left knee is hurting pretty bad right now) and INCONTINENCE (Had incontinence right after that shot) outcome was unknown. No relevant concomitant medications were reported. No treatment information was 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 serious unexpected events of Joint swelling and Arthralgia and non-serious event of Incontinence, a causal relationship cannot be excluded. The causality for Inappropriate schedule of product administration assessed as not applicable. Patient received 2nd dose and incontinence right after that shot while still at vaccine facility. She had a problem with incontinence but not that bad. Four to 5 weeks ago her joints started swelling and then she was in a wheelchair. Her left knee was hurting pretty bad. This case was linked to MOD-2021-285156 (Patient Link).; 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 serious unexpected events of Joint swelling and Arthralgia and non-serious event of Incontinence, a causal relationship cannot be excluded. The causality for Inappropriate schedule of product administration assessed as not applicable.

Other Meds:

Current Illness: Heart valve disorders (Heart valve problem); Low vision, one eye (Losing eyesight in her left eye)

ID: 1644923
Sex: F
Age: 35
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: hot flashes; spots on hand and feet; feels like cant process thoughts; Shortness of breath; dizziness; swelling in feet jaw and left hand; swelling in feet jaw and left hand; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), PIGMENTATION DISORDER (spots on hand and feet), THOUGHT BLOCKING (feels like cant process thoughts), DYSPNOEA (Shortness of breath) and DIZZINESS (dizziness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003E21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HOT FLUSH (hot flashes), PIGMENTATION DISORDER (spots on hand and feet), THOUGHT BLOCKING (feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (dizziness), SWELLING FACE (swelling in feet jaw and left hand) and PERIPHERAL SWELLING (swelling in feet jaw and left hand). The patient was treated with ALBUTEROL [SALBUTAMOL] for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Swelling, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (hot flashes), PIGMENTATION DISORDER (spots on hand and feet), THOUGHT BLOCKING (feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (dizziness), SWELLING FACE (swelling in feet jaw and left hand) and PERIPHERAL SWELLING (swelling in feet jaw and left hand) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No Medical History information was reported. This case was linked to MOD-2021-285527 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644924
Sex: F
Age: 67
State: WI

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Extreme Fatigue; Pain moved from one shoulder to the other, down her spine and tail bone; Red Flushing of the Face; Red Flushing of the Face; Severe Headache; Severe body ache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Red Flushing of the Face), ERYTHEMA (Red Flushing of the Face), HEADACHE (Severe Headache), MYALGIA (Severe body ache) and ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (never did a PCR test to confirm that in fact she had COVID-19 in 2020.) in 2020. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced FLUSHING (Red Flushing of the Face), ERYTHEMA (Red Flushing of the Face), HEADACHE (Severe Headache) and MYALGIA (Severe body ache). On 22-Jul-2021, the patient experienced ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone). On 24-Jul-2021, the patient experienced FATIGUE (Extreme Fatigue). The patient was treated with TYLENOL for Pain, at an unspecified dose and frequency. On 21-Jul-2021, FLUSHING (Red Flushing of the Face) and ERYTHEMA (Red Flushing of the Face) had resolved. At the time of the report, HEADACHE (Severe Headache), MYALGIA (Severe body ache), ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone) and FATIGUE (Extreme Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. Two weeks after vaccination, the patient visited her doctor's office. The ARNP told her that some spike protein may have deposited into her joints, that is why she is having so much pain. Also the ARNP told her that because she had COVID-19 Disease early on, she had this reaction to the vaccine and experienced severe side effects. ARNP prescribed Anti-Inflammatory medication which helped with the pain. But the patient states that she is still aware the problem is there, even after taking the anti-inflammatory medication. Patient stated that she was very unhappy.

Other Meds:

Current Illness:

ID: 1644925
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: some right arm and leg twitching; a small red patch by the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache). At the time of the report, MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1644926
Sex: M
Age:
State: FL

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 105.2F

Allergies:

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

Symptoms: Two days after the shot, he was diagnosed as having TIA; it set immediately into his lungs and almost shut down his respiratory system; fever that spiked at 105.2F; became deathly ill after his 1st shot; felt as bad as when he had Covid the 2nd time but didn't last as long; lost sense of smell; lost sense of taste; deep, dry, unproductive cough; felt as bad; extreme shortness of breath; pounding headache and he has never had a headache; nausea; muscle aches; joint aches; This spontaneous case was reported by a physician and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Two days after the shot, he was diagnosed as having TIA), RESPIRATORY FAILURE (it set immediately into his lungs and almost shut down his respiratory system) and HYPERPYREXIA (fever that spiked at 105.2F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Two days after the shot, he was diagnosed as having TIA) (seriousness criterion medically significant), RESPIRATORY FAILURE (it set immediately into his lungs and almost shut down his respiratory system) (seriousness criterion medically significant), HYPERPYREXIA (fever that spiked at 105.2F) (seriousness criterion medically significant), ILLNESS (became deathly ill after his 1st shot), COVID-19 (felt as bad as when he had Covid the 2nd time but didn't last as long), ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), COUGH (deep, dry, unproductive cough), FEELING ABNORMAL (felt as bad), DYSPNOEA (extreme shortness of breath), HEADACHE (pounding headache and he has never had a headache), NAUSEA (nausea), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Two days after the shot, he was diagnosed as having TIA), RESPIRATORY FAILURE (it set immediately into his lungs and almost shut down his respiratory system), HYPERPYREXIA (fever that spiked at 105.2F), ILLNESS (became deathly ill after his 1st shot), COVID-19 (felt as bad as when he had Covid the 2nd time but didn't last as long), ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), COUGH (deep, dry, unproductive cough), FEELING ABNORMAL (felt as bad), DYSPNOEA (extreme shortness of breath), HEADACHE (pounding headache and he has never had a headache), NAUSEA (nausea), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105.2 (High) 105.2F. 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 are reported. No treatment medications are reported. The patient wanted to query as he was working with anti vacers and anti maskers every day he wants to know if he can get a second dose after 42 days or can he get a different vaccine for his 2nd dose. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644928
Sex: F
Age: 70
State: OH

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210306; Test Name: Blood pressure; Result Unstructured Data: High

Allergies:

Symptom List: Tremor

Symptoms: Tongue had a tingling sensation; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue had a tingling sensation) and LIP SWELLING (lips started to swell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included Itching. Concurrent medical conditions included Pollen allergy, Dust allergy, Mite allergy and Allergy to plants (Allergic to trees). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tongue had a tingling sensation) and LIP SWELLING (lips started to swell). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Mar-2021, PARAESTHESIA ORAL (Tongue had a tingling sensation) had resolved. At the time of the report, LIP SWELLING (lips started to swell) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: unknown (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported.. Patient was recommended to take second dose of vaccine by the allergist in facility with emergency room was reported.

Other Meds:

Current Illness: Allergy to plants (Allergic to trees); Dust allergy; Mite allergy; Pollen allergy

ID: 1644929
Sex: M
Age:
State: GA

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

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: is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) 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 ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient received the Moderna vaccine earlier this year, and was now experiencing an adverse reaction which he does not know if it was related to the vaccine but he says it might help a lot of people, he was currently in the hospital. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644930
Sex: F
Age: 67
State: GA

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) had resolved. No Treatment medications were reported.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; FLEXERIL [CEFIXIME]

Current Illness:

ID: 1644931
Sex: M
Age: 46
State: CO

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: More than 36 days have passed and patient did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025H21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose) had resolved. No concomitant medication reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644932
Sex: F
Age: 59
State: CA

Vax Date: 08/05/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Gave patient her second dose early; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave patient her second dose early) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001C21A) for COVID-19 vaccination. No medical history was provided by reporter. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave patient her second dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave patient her second dose early) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave patient her second dose early) to be not applicable. No Concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1644933
Sex: F
Age: 58
State: CA

Vax Date: 06/21/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: blood pressure was out range; Test Date: 2021; Test Name: Troponin; Result Unstructured Data: troponin was not zero

Allergies:

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

Symptoms: Really tired; I was sweating; Troponin was not zero as it should be, and that this was an indicator of heart attack; My blood pressure was out rages; Shortness of breath; I felt like I was going to pass out; It made me scare to get the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Troponin was not zero as it should be, and that this was an indicator of heart attack), PRESYNCOPE (I felt like I was going to pass out), BLOOD PRESSURE ABNORMAL (My blood pressure was out rages), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (I was sweating) and FATIGUE (Really tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 501C21A) 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 LISINOPRIL for an unknown indication. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRESYNCOPE (I felt like I was going to pass out) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and FATIGUE (Really tired) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Troponin was not zero as it should be, and that this was an indicator of heart attack) (seriousness criteria hospitalization and medically significant), BLOOD PRESSURE ABNORMAL (My blood pressure was out rages) (seriousness criterion hospitalization), HYPERHIDROSIS (I was sweating) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (It made me scare to get the second shot.). The patient was hospitalized for 5 days due to BLOOD PRESSURE ABNORMAL, DYSPNOEA, HYPERHIDROSIS, MYOCARDIAL INFARCTION and PRESYNCOPE. At the time of the report, MYOCARDIAL INFARCTION (Troponin was not zero as it should be, and that this was an indicator of heart attack), PRESYNCOPE (I felt like I was going to pass out), BLOOD PRESSURE ABNORMAL (My blood pressure was out rages), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (I was sweating) and FATIGUE (Really tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It made me scare to get the second shot.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (abnormal) blood pressure was out range. In 2021, Troponin: abnormal (abnormal) troponin was not zero. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant product use included unspecified beta-blockers. Patient was admitted to the hospital for 5 days. All the rest of the tests were normal. No treatment information was reported. 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: LISINOPRIL

Current Illness:

ID: 1644934
Sex: U
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Off label Dosing; Off label Dosing to 16 year-old patient; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient). At the time of the report, OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1644935
Sex: F
Age: 35
State: IL

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Hurt to move the arm; Horrible aches in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm). On 16-Jun-2021, PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided. Treatment information was not provided. This case was linked to MOD-2021-259182 (Patient Link).

Other Meds:

Current Illness:

ID: 1644936
Sex: M
Age: 51
State: TX

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

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

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

Allergies:

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

Symptoms: Throat felt like burning; Body temperature raised; Dizzy; Loss of taste; Loss of smell; Chills are so strong felt they're killing patient; Body aches; Tired of speaking; Headache; Arm swelled a little; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled a little), THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy) and AGEUSIA (Loss of taste) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled a little). On 07-Aug-2021, the patient experienced THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache). On 30-Jul-2021, PERIPHERAL SWELLING (Arm swelled a little) had resolved. At the time of the report, THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter No treatment medication were provided by the reporter

Other Meds:

Current Illness:

ID: 1644937
Sex: F
Age: 31
State: MA

Vax Date: 04/13/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Trouble sleeping; Felt it going through the left side of her body like a warm flow; Pain in her left hip; Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg; Pain under her arm, into her armpit; Pain spread in the left side of her back, described as nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) in a 31-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 reported. On 13-Apr-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-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 NEURALGIA (Pain spread in the left side of her back, described as nerve pain). On 17-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip), MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) and AXILLARY PAIN (Pain under her arm, into her armpit). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was treated with Physical therapy (Massage unit) for Neuralgia and Physical therapy (Massage unit) for Myalgia. On 17-May-2021, FEELING HOT (Felt it going through the left side of her body like a warm flow) had resolved. On 31-May-2021, AXILLARY PAIN (Pain under her arm, into her armpit) had resolved. At the time of the report, NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) had not resolved. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1644938
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Breathing problems that got progressively worse; Emphysema; diagnosed as having emphysema/ It was as bad; Like having elephants sitting on your chest or needing a ventolator to help breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems that got progressively worse), EMPHYSEMA (Emphysema), FEELING ABNORMAL (diagnosed as having emphysema/ It was as bad) and CHEST DISCOMFORT (Like having elephants sitting on your chest or needing a ventolator to help breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 DYSPNOEA (Breathing problems that got progressively worse), EMPHYSEMA (Emphysema), FEELING ABNORMAL (diagnosed as having emphysema/ It was as bad) and CHEST DISCOMFORT (Like having elephants sitting on your chest or needing a ventolator to help breath). At the time of the report, DYSPNOEA (Breathing problems that got progressively worse), EMPHYSEMA (Emphysema), FEELING ABNORMAL (diagnosed as having emphysema/ It was as bad) and CHEST DISCOMFORT (Like having elephants sitting on your chest or needing a ventolator to help breath) outcome was unknown. Concomitant product information was not provided. Treatment information was provided but not specified.

Other Meds:

Current Illness:

ID: 1644939
Sex: F
Age: 35
State: NC

Vax Date: 07/08/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Swelling in feet jaw and left hand; Hot flashes; spots on hands and feet; Feels like cant process thoughts; Shortness of breath; Dizziness; Could not lift head or move; fever temperature 103; shaking like tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking like tremors), PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet) and THOUGHT BLOCKING (Feels like cant process thoughts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003E21A and 003E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced TREMOR (shaking like tremors) and PYREXIA (fever temperature 103). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet), THOUGHT BLOCKING (Feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness) and MOBILITY DECREASED (Could not lift head or move). The patient was treated with ALBUTEROL [SALBUTAMOL] for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking like tremors), PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet), THOUGHT BLOCKING (Feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), MOBILITY DECREASED (Could not lift head or move) and PYREXIA (fever temperature 103) outcome was unknown. No concomitant medication were provided by the reporter This case was linked to MOD-2021-285303 (Patient Link).

Other Meds:

Current Illness:

ID: 1644940
Sex: F
Age: 33
State: AR

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: felt bad; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and FATIGUE (fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (felt bad) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products information was not provided. Treatment information was provided. This case was linked to MOD-2021-285588 (Patient Link).

Other Meds:

Current Illness:

ID: 1644941
Sex: M
Age: 72
State: CA

Vax Date: 04/13/2021
Onset Date: 05/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Given vaccine after sitting out punctured for a day.; Given another dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644942
Sex: F
Age:
State: IL

Vax Date: 07/21/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
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: a patient who received the 1st dose on 21Jul21, she came today with the shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Significant Follow up: Patient race and ethnicity are updated, Route of administration, lot no, anatomical location were updated.

Other Meds:

Current Illness:

ID: 1644943
Sex: F
Age: 72
State:

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

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

Lab Data:

Allergies:

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

Symptoms: she received one dose of the Moderna Covid-19 vaccine in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine; metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in her mouth) and PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DYSGEUSIA (metallic taste in her mouth). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine). At the time of the report, DYSGEUSIA (metallic taste in her mouth) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1644944
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: started experiencing the same pain after being under the sun on the same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (started experiencing the same pain after being under the sun on the same day) in a 68-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (started experiencing the same pain after being under the sun on the same day). At the time of the report, PAIN (started experiencing the same pain after being under the sun on the same day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am