VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1644794
Sex: F
Age:
State: CA

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: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown. No concomitant medications was provided. No treatment medications was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644795
Sex: F
Age: 36
State: MO

Vax Date: 08/02/2021
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: "Big red welts"; Were itchy "as crap.",Itchiness; Worried; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. 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 an unknown date, the patient experienced URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness). At the time of the report, URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1644796
Sex: F
Age: 76
State: SC

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: it's hard to even turn over in bed; it hurts; her arm is still hurting in the muscle, very much/it never really subsided; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (it's hard to even turn over in bed), PAIN (it hurts) and MYALGIA (her arm is still hurting in the muscle, very much/it never really subsided) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (it's hard to even turn over in bed), PAIN (it hurts) and MYALGIA (her arm is still hurting in the muscle, very much/it never really subsided). At the time of the report, HYPOKINESIA (it's hard to even turn over in bed), PAIN (it hurts) and MYALGIA (her arm is still hurting in the muscle, very much/it never really subsided) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was provided No concomitant medication was provided

Other Meds:

Current Illness:

ID: 1644797
Sex: F
Age:
State:

Vax Date: 07/06/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Freezing cold; Arm hurt; Covid arm/covid arm all the way down her hand; Couldn't eat; Couldn't sleep; Left side of her neck was extremely sweaty; Eyes hurt; Can't breathe well; Throat hurt; Nose hurt; Felt like she was going to die; Chills; Fatigued; Massive headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat) and INSOMNIA (Couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache). At the time of the report, FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache) outcome was unknown. No concomitant or treatment drug reported by reporter. This case was linked to MOD-2021-283872 (Patient Link).

Other Meds:

Current Illness:

ID: 1644798
Sex: U
Age:
State:

Vax Date: 01/06/2021
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: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: I got my first shot on 1-6-21 and did not get my 2nd one; over 6 Months since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my first shot on 1-6-21 and did not get my 2nd one) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 Months since first dose) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my first shot on 1-6-21 and did not get my 2nd one) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 Months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my first shot on 1-6-21 and did not get my 2nd one) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 Months since first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were mentioned by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: non-significant follow up received on 11-AUG-2021 and contains No new information was updated.

Other Meds:

Current Illness:

ID: 1644799
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
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: blood clots; heart attack; migraine, a definite link between the protein spike from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) and MYOCARDIAL INFARCTION (heart attack) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 THROMBOSIS (blood clots) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant) and MIGRAINE (migraine, a definite link between the protein spike from the vaccine). At the time of the report, THROMBOSIS (blood clots), MYOCARDIAL INFARCTION (heart attack) and MIGRAINE (migraine, a definite link between the protein spike from the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided by the reporter. Company comment: Very limited information regarding this events has been provided at this time. However, 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: Very limited information regarding this events has been provided at this time. However, 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: 1644800
Sex: F
Age:
State:

Vax Date: 08/06/2021
Onset Date: 08/08/2021
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: Throat is bothering me; low grade fever; warmness at the right arm injection site; redness at the right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness at the right arm injection site), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), VACCINATION SITE ERYTHEMA (redness at the right arm injection site) and PYREXIA (low grade fever) 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 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the right arm injection site) and VACCINATION SITE ERYTHEMA (redness at the right arm injection site). On 11-Aug-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat is bothering me) and PYREXIA (low grade fever). At the time of the report, VACCINATION SITE WARMTH (warmness at the right arm injection site), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), VACCINATION SITE ERYTHEMA (redness at the right arm injection site) and PYREXIA (low grade fever) outcome was unknown. No concomitant medication use was reported. No treatment information was reported. Action taken with the drug in response to events was not applicable.

Other Meds:

Current Illness:

ID: 1644801
Sex: F
Age: 24
State: PA

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: arms broke out in hives initially on the right where the injection was done then spread to the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. On 31-Jul-2021, VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were given by the reporter.

Other Meds:

Current Illness:

ID: 1644802
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 16 year-old patient received Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No medication history was reported. HCP reported patients did not experience any adverse reaction. Reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1644803
Sex: F
Age: 65
State: PA

Vax Date: 07/16/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Confusion; Nausea; Nervous attacks; Shortness of breath; Couldn't sleep at night; Tremors; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors) and CONFUSIONAL STATE (Confusion) in a 65-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 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors) and NAUSEA (Nausea). On 11-Aug-2021, the patient experienced CONFUSIONAL STATE (Confusion). At the time of the report, NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors), CONFUSIONAL STATE (Confusion) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. The patient was told to take Benadryl by the pharmacist.

Other Meds:

Current Illness:

ID: 1644804
Sex: M
Age: 69
State: NV

Vax Date: 08/09/2021
Onset Date: 08/09/2021
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: Screaming; He was so scared of when he would go to doctor for the second shot, it would going to finish him off/kill him off; Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse; swollen arm; red arm; arm really painful; weakness; lymph nodes in arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), FEAR OF DEATH (He was so scared of when he would go to doctor for the second shot, it would going to finish him off/kill him off) and PAIN IN EXTREMITY (arm really painful) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cervical spinal stenosis (He routinely takes narcotics for cervical stenosis). Concomitant products included MORPHINE SULFATE (MORPHINE SULPHATE) and OXYCODONE for Spinal stenosis cervical, Symbitotic colostrom powder (COLOSTRUM) from 11-Aug-2021 to an unknown date for an unknown indication. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (arm really painful), ASTHENIA (weakness) and LYMPHADENOPATHY (lymph nodes in arm swollen). On 10-Aug-2021, the patient experienced PAIN (Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse). On 11-Aug-2021, the patient experienced FEAR OF DEATH (He was so scared of when he would go to doctor for the second shot, it would going to finish him off/kill him off). On an unknown date, the patient experienced SCREAMING (Screaming). At the time of the report, PAIN (Really painful all the way down to the wrist. It radiates to the entire left arm. He routinely takes narcotics for cervical stenosis and he states they are not helping at all for his pain. It is been getting worse and worse and worse and worse) had not resolved and PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), FEAR OF DEATH (He was so scared of when he would go to doctor for the second shot, it would going to finish him off/kill him off), PAIN IN EXTREMITY (arm really painful), ASTHENIA (weakness), SCREAMING (Screaming) and LYMPHADENOPATHY (lymph nodes in arm swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: MORPHINE SULPHATE; OXYCODONE; COLOSTRUM

Current Illness: Cervical spinal stenosis (He routinely takes narcotics for cervical stenosis)

ID: 1644805
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: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Itchy skin below the injection site closer to bicep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep) 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 VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep). At the time of the report, VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644806
Sex: F
Age: 42
State: FL

Vax Date: 08/06/2021
Onset Date: 08/08/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. Medical history was not provided. On 06-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 AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. List of concomitant medication were not given.

Other Meds:

Current Illness:

ID: 1644807
Sex: F
Age: 93
State: NJ

Vax Date: 07/29/2021
Onset Date: 08/06/2021
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: It was very itchy; It was bright red; Swollen right arm at injection site/size of palm of the hand around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and TRICLOSAN (CETAPHIL ANTIBACTERIAL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. List of concomitant medication were not given. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644808
Sex: M
Age: 76
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
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: He had fever for 2 days and it went away; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had fever for 2 days and it went away) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391C20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in March 2020. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (He had fever for 2 days and it went away). On 11-Feb-2021, PYREXIA (He had fever for 2 days and it went away) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported by the reporter. This case was linked to MOD-2021-283961 (Patient Link).

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]; JARDIANCE

Current Illness:

ID: 1644809
Sex: M
Age:
State: CA

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

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

Lab Data: Test Date: 202102; Test Name: Blood pressure; Result Unstructured Data: High

Allergies:

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

Symptoms: Lingering fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lingering fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical information history was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FATIGUE (Lingering fatigue). At the time of the report, FATIGUE (Lingering fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: high (High) High. No concomitant medications were reported. No treatment medications were mentioned Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644810
Sex: M
Age: 79
State: IL

Vax Date: 04/12/2021
Onset Date: 04/12/2021
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: Doesn't see well anymore; Doesn't hear well anymore; Decided not to get the second dose in the series; "Didn't feel good"; Left arm hurt; Some dizziness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and DIZZINESS (Some dizziness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), DIZZINESS (Some dizziness) and PYREXIA (Slight fever). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series). At the time of the report, FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore), DIZZINESS (Some dizziness) and PYREXIA (Slight fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient had no known drug or food allergies. No treatment medications were reported.

Other Meds: LISINOPRIL; ATORVASTATIN

Current Illness:

ID: 1644811
Sex: M
Age: 76
State: NY

Vax Date: 02/09/2021
Onset Date: 04/01/2021
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: Light headedness; Leg weakness / he even feels it on his legs; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Leg weakness / he even feels it on his legs) and HEADACHE (Headaches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 0391C20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in March 2020. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In April 2021, the patient experienced DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Leg weakness / he even feels it on his legs) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Leg weakness / he even feels it on his legs) and HEADACHE (Headaches) had not resolved. Treatment information was not provided. It was reported that the patient went to the emergency room and brain MRI, EEG, PET scan, heart PET scan and stress test was done but results were not known. The patient reported that the symptoms started lasting 1 second, progressively they got worse and now they last for 1 minute which the patient can have up to 10 times a day.

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]; JARDIANCE

Current Illness:

ID: 1644812
Sex: M
Age: 57
State: FL

Vax Date: 12/28/2020
Onset Date: 08/10/2021
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: Test Date: 20210811; Test Name: COVID19 virus test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: arm pain; low grade fever; Chest congestion; nasal congestion/sinus shot up; a lost sense of taste and smell; Breakthrough Infection; loss of taste; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY CONGESTION (Chest congestion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication. On 28-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), NASAL CONGESTION (nasal congestion/sinus shot up), ANOSMIA (a lost sense of taste and smell), INFECTION (Breakthrough Infection), AGEUSIA (loss of taste) and PYREXIA (low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PULMONARY CONGESTION (Chest congestion), NASAL CONGESTION (nasal congestion/sinus shot up), ANOSMIA (a lost sense of taste and smell), INFECTION (Breakthrough Infection), AGEUSIA (loss of taste), PAIN IN EXTREMITY (arm pain) and PYREXIA (low grade fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The primary reporter summarized the events he experienced as a breakthrough-infection with SARS-CoV 2 (confirmed by a positive covid test). The last vaccination dose was administered more than 6 months before the onset of the events. It is currently unknown for how long the vaccination by mRNA-1273 protects against SARS-CoV 2 infection. Therefore, a lack of protection due to time elapsed is a possibility. The patient?s medical condition of hypertension may be a confounding factor (established risk factor). The events experienced by the patient are rather caused by the documented Covid-19 disease than by mRNA-1273.; Sender's Comments: The primary reporter summarized the events he experienced as a breakthrough-infection with SARS-CoV 2 (confirmed by a positive covid test). The last vaccination dose was administered more than 6 months before the onset of the events. It is currently unknown for how long the vaccination by mRNA-1273 protects against SARS-CoV 2 infection. Therefore, a lack of protection due to time elapsed is a possibility.The patient?s medical condition of hypertension may be a confounding factor (established risk factor). The events experienced by the patient are rather caused by the documented Covid-19 disease than by mRNA-1273.

Other Meds: AMLODIPINE; SIMVASTATIN

Current Illness: Cholesterol; Hypertension

ID: 1644813
Sex: F
Age: 22
State: ID

Vax Date: 03/01/2021
Onset Date: 08/10/2021
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: Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221; 1st dose in March 2021/received 2nd dose 10Aug20221; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in March 2021/received 2nd dose 10Aug20221) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by reporter. No concomitant medication reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Feb-2021 and the estimated date of delivery was 16-Nov-2021. On 10-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in March 2021/received 2nd dose 10Aug20221). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the second week of the pregnancy. On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in March 2021/received 2nd dose 10Aug20221) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment medication reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644814
Sex: F
Age: 17
State: OK

Vax Date: 08/11/2021
Onset Date: 08/11/2021
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: 17 year old pregnant patient that was given her first dose; 17 year old pregnant patient that was given her first dose; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose). At the time of the report, EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details was reported. Company Comment: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender's Comments: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1644815
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Side effects with addison disease; This spontaneous case was reported by a consumer and describes the occurrence of ADDISON'S DISEASE (Side effects with Addison disease) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADDISON'S DISEASE (Side effects with Addison disease) (seriousness criterion medically significant). At the time of the report, ADDISON'S DISEASE (Side effects with Addison disease) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication and treatment medication were not reported. Company comment: This is a spontaneous report. Hence, the causality is implied. Very limited information regarding this event has been provided at this time. Further information cannot be obtained. Reporter did not allow further contact; Sender's Comments: This is a spontaneous report. Hence, the causality is implied. Very limited information regarding this event has been provided at this time. Further information cannot be obtained.

Other Meds:

Current Illness:

ID: 1644816
Sex: U
Age:
State: PA

Vax Date: 05/20/2021
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: Patients who stated they received the first dose 6 weeks ago or longer; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer) 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 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644817
Sex: F
Age: 62
State: TN

Vax Date: 03/10/2021
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: Titer Test; Test Result: Negative ; Result Unstructured Data: Patient says she had no B cells and no T cells.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: didn't feel good at all; showed some type of reaction; more like the flu; vomited; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Neuromyelitis optica. Concurrent medical conditions included Autoimmune disorder. Concomitant products included RITUXIMAB (RITUXAN), LEVOTHYROXINE, PANTOPRAZOLE SODIUM, CURCUMA LONGA ROOT (TURMERIC CURCUMIN [CURCUMA LONGA ROOT]), METOPROLOL, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE), MONTELUKAST SODIUM, FLUCONAZOLE, LORATADINE, LUBIPROSTONE, GABAPENTIN, OXCARBAZEPINE, BACLOFEN, FLUTICASONE PROPIONATE, MUPIROCIN, TRIAMCINOLONE ACETONIDE, DENOSUMAB (PROLIA), VACCINIUM MACROCARPON FRUIT (THERACRAN ONE), MAGNESIUM CITRATE, FOLIC ACID, VITAMIN B COMPLEX, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), ZINC, BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS GASSERI (PHILLIPS COLON HEALTH) and VITAMIN B12 NOS for an unknown indication. On 10-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 FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever). At the time of the report, FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral titre: negative (Negative) Patient says she had no B cells and no T cells.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant included 500mg of steroid at that time of Rituxan,mybetriq,Vitamin D 4000 mg were added. Patient has a history of neuromyelitis optica as a primary diagnosis which she states can effect the brain/has effected her brain stem. Patient provided prescription medications and reports that vitamins are recommended by physician. Second dose done on 07April2021 was noted.

Other Meds: RITUXAN; LEVOTHYROXINE; PANTOPRAZOLE SODIUM; TURMERIC CURCUMIN [CURCUMA LONGA ROOT]; METOPROLOL; TELMISARTAN/HYDROCHLOROTHIAZIDE; MONTELUKAST SODIUM; FLUCONAZOLE; LORATADINE; LUBIPROSTONE; GABAPENTIN; OXCARBAZEPINE; BACLOFEN; FLUTICASONE PR

Current Illness:

ID: 1644818
Sex: M
Age: 26
State: LA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
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: Worried because he was exposed to COVID-19; Redness; Sore arm; Light headache; Little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19), ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19). On 11-Aug-2021, ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued) had resolved. At the time of the report, EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant treatment was provided. No treatment medication was provided. The patient was exposed to COVID-19 since the patient works in close quarters with the people and the patient's boss was tested positive for COVID-19. The patient did not had any COVID-19 symptoms but was worried about being asymptomatic and if that might affect the efficacy of the vaccine.

Other Meds:

Current Illness:

ID: 1644819
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: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Neck is breaking out; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Neck is breaking out) 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 RASH (Neck is breaking out). At the time of the report, RASH (Neck is breaking out) outcome was unknown. 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: 1644820
Sex: M
Age: 66
State: TX

Vax Date: 01/29/2021
Onset Date: 03/04/2021
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: Limited range for motion in left shoulder; Left shoulder weakness; Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle; Left shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Limited range for motion in left shoulder), MUSCULAR WEAKNESS (Left shoulder weakness), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle) and ARTHRALGIA (Left shoulder pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MOBILITY DECREASED (Limited range for motion in left shoulder), MUSCULAR WEAKNESS (Left shoulder weakness), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle) and ARTHRALGIA (Left shoulder pain). At the time of the report, MOBILITY DECREASED (Limited range for motion in left shoulder), MUSCULAR WEAKNESS (Left shoulder weakness) and ARTHRALGIA (Left shoulder pain) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle) had resolved. No concomitant medications were provided by the reporter No treatment information was provided by the reporter Patient reported that he might have shoulder injury related to vaccine administration SIRVA It was reported that the patient experienced problems with his left shoulder at the time of report and scheduled for appointment with his doctor next week

Other Meds:

Current Illness:

ID: 1644821
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Out of system, It's a vastly shot that I got; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Out of system, It's a vastly shot that I got) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Out of system, It's a vastly shot that I got). At the time of the report, FEELING ABNORMAL (Out of system, It's a vastly shot that I got) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644822
Sex: F
Age: 17
State: CA

Vax Date: 06/30/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient was 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 30-Jun-2021, the patient received 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 was 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported. Pharmacist realized that she vaccinated a patient that was 17, but turning 18 before the patients second dose. This case was linked to MOD-2021-283794 (Patient Link).

Other Meds:

Current Illness:

ID: 1644823
Sex: F
Age:
State:

Vax Date: 03/31/2021
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: Patient received both doses about 5 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart) had resolved. No Concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644824
Sex: F
Age: 23
State:

Vax Date: 08/10/2021
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: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: rash is itching; rash is burning; rash on her chest/rash on her belly; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly). At the time of the report, RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1644825
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: i have them too, i got them after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (i have them too, i got them after my vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. 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 VITREOUS FLOATERS (i have them too, i got them after my vaccine). At the time of the report, VITREOUS FLOATERS (i have them too, i got them after my vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up received contains no new information.

Other Meds:

Current Illness:

ID: 1644826
Sex: F
Age: 80
State: FL

Vax Date: 08/10/2021
Onset Date: 08/11/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: her arm felt hot; arm swollen; red; very sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (red) and MYALGIA (very sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (red) and MYALGIA (very sore). At the time of the report, FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen) and MYALGIA (very sore) outcome was unknown and ERYTHEMA (red) had resolved. No concomitant medication was provided No treatment received by the patient

Other Meds:

Current Illness:

ID: 1644827
Sex: F
Age: 40
State: TX

Vax Date: 04/30/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-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 (difficulty breathing). At the time of the report, DYSPNOEA (difficulty breathing) outcome was unknown. No concomitant medication and treatment information provided.

Other Meds:

Current Illness:

ID: 1644828
Sex: F
Age: 74
State: AL

Vax Date: 02/26/2021
Onset Date: 03/15/2021
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: Erythema, Pruritus

Symptoms: Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size; Consumer was given 2nd dose too early; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early) and LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early). On 26-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size). On 15-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size) outcome was unknown. Concomitant medications were provided for Cholesterol (low dose 5 mg) and Blood pressure. No treatment information was provided. The patient visited the local ED and did tests. Radiologist looked at the tests and notified consumer the swelling and size of the lymph node was size of golf ball. Patient has got 4 ultrasounds since swelling. Consumer got a ultrasound on 11-Aug-2021 and awaiting results.

Other Meds:

Current Illness:

ID: 1644829
Sex: F
Age: 45
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: continues to have a rash on their abdomen; sensitivity to everything, "my senses are in overdrive."; sensitive to heat; sensitive to light; swollen tongue; headache; dizziness; insomnia; daily swelling in hands and feet; a feeling of continuous shaking on the inside of the body; ringing in the ears that come and go; leg pain; leg tiredness; nerve pain started in the patients' feet and moved up their legs; mouth is sore; very painful to brush their teeth; feels like their gums are bleeding, but they are not; started having menstrual periods every 2 weeks; patient not receive the second dose; by the end of the day they cannot urinate; entire body was covered in hives and rash; entire body was covered in redness; entire body was itchy; entire body was swollen; sudden swollen face and tongue; inability to breath; entire body felt tingling; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (by the end of the day they cannot urinate), SWELLING FACE (sudden swollen face and tongue), DYSPNOEA (inability to breath), PARAESTHESIA (entire body felt tingling) and URTICARIA (entire body was covered in hives and rash) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included GABAPENTIN for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced SWELLING FACE (sudden swollen face and tongue), DYSPNOEA (inability to breath) and PARAESTHESIA (entire body felt tingling). On 09-Mar-2021, the patient experienced URTICARIA (entire body was covered in hives and rash), ERYTHEMA (entire body was covered in redness), PRURITUS (entire body was itchy) and SWELLING (entire body was swollen). In June 2021, the patient experienced DYSURIA (by the end of the day they cannot urinate). On an unknown date, the patient experienced RASH (continues to have a rash on their abdomen), SENSITIVE SKIN (sensitivity to everything, "my senses are in overdrive."), TEMPERATURE INTOLERANCE (sensitive to heat), PHOTOPHOBIA (sensitive to light), SWOLLEN TONGUE (swollen tongue), HEADACHE (headache), DIZZINESS (dizziness), INSOMNIA (insomnia), PERIPHERAL SWELLING (daily swelling in hands and feet), TREMOR (a feeling of continuous shaking on the inside of the body), TINNITUS (ringing in the ears that come and go), PAIN IN EXTREMITY (leg pain), FATIGUE (leg tiredness), NEURALGIA (nerve pain started in the patients' feet and moved up their legs), ORAL PAIN (mouth is sore), PAIN (very painful to brush their teeth), GINGIVAL BLEEDING (feels like their gums are bleeding, but they are not), MENSTRUATION IRREGULAR (started having menstrual periods every 2 weeks) and PRODUCT DOSE OMISSION ISSUE (patient not receive the second dose). At the time of the report, DYSURIA (by the end of the day they cannot urinate), SWELLING FACE (sudden swollen face and tongue), DYSPNOEA (inability to breath), PARAESTHESIA (entire body felt tingling), URTICARIA (entire body was covered in hives and rash), ERYTHEMA (entire body was covered in redness), PRURITUS (entire body was itchy), SWELLING (entire body was swollen), RASH (continues to have a rash on their abdomen), SENSITIVE SKIN (sensitivity to everything, "my senses are in overdrive."), TEMPERATURE INTOLERANCE (sensitive to heat), PHOTOPHOBIA (sensitive to light), SWOLLEN TONGUE (swollen tongue), HEADACHE (headache), DIZZINESS (dizziness), INSOMNIA (insomnia), PERIPHERAL SWELLING (daily swelling in hands and feet), TREMOR (a feeling of continuous shaking on the inside of the body), TINNITUS (ringing in the ears that come and go), PAIN IN EXTREMITY (leg pain), FATIGUE (leg tiredness), NEURALGIA (nerve pain started in the patients' feet and moved up their legs), ORAL PAIN (mouth is sore), PAIN (very painful to brush their teeth), GINGIVAL BLEEDING (feels like their gums are bleeding, but they are not), MENSTRUATION IRREGULAR (started having menstrual periods every 2 weeks) and PRODUCT DOSE OMISSION ISSUE (patient not receive the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was treated with antihistamines.

Other Meds: GABAPENTIN

Current Illness:

ID: 1644830
Sex: M
Age: 16
State: SC

Vax Date: 06/24/2021
Onset Date: 06/24/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: He was too young; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment information provided. The pharmacist recommended getting the Pfizer vaccine as the second dose.

Other Meds:

Current Illness:

Date Died:

ID: 1644831
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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) 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 CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This is a fatal case of cardiac arrest in a female, age unknown, who received mRNA-1273 on an unknown date. Cause of death was cardiac arrest. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This is a fatal case of cardiac arrest in a female, age unknown, who received mRNA-1273 on an unknown date. Cause of death was cardiac arrest. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac arrest

Other Meds:

Current Illness:

ID: 1644832
Sex: M
Age: 58
State:

Vax Date: 02/10/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: sore right shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right shoulder deltoid muscle) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Nervous system disorder NOS (Patient has a long history of nerve problems prior to vaccination). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore right shoulder deltoid muscle) outcome was unknown. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness: Nervous system disorder NOS (Patient has a long history of nerve problems prior to vaccination)

ID: 1644833
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: had my second shot and am very ill; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had my second shot and am very ill) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had my second shot and am very ill). At the time of the report, VACCINATION COMPLICATION (had my second shot and am very ill) outcome was unknown. NO Concomitant drug reported. NO Treatment drug reported.

Other Meds:

Current Illness:

ID: 1644834
Sex: F
Age: 37
State: ND

Vax Date: 08/10/2021
Onset Date: 08/10/2021
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: Dose administered to patient from a vial punctured more than 24 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and CITALOPRAM 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 EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: WELLBUTRIN; CITALOPRAM

Current Illness:

ID: 1644835
Sex: M
Age:
State: AL

Vax Date: 02/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe Pruritus/ local itching or pruritus; Red rash/ local redness and rash; Hives; Raised area develops; Has severely impacted my quality of life especially loss of quality sleep; Allergic reaction; Unavoidably scratching; Felt like poisen ivey but without raised expanding blisters; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Severe Pruritus/ local itching or pruritus), RASH ERYTHEMATOUS (Red rash/ local redness and rash), URTICARIA (Hives), SWELLING (Raised area develops) and INSOMNIA (Has severely impacted my quality of life especially loss of quality sleep) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 2 diabetes mellitus since 1999, Asthma, Hay fever and Drug allergy (Anectine allergy- Stopped breathing during surgery) since 1985. On 12-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021 at 8:00 AM, the patient experienced PRURITUS (Severe Pruritus/ local itching or pruritus), RASH ERYTHEMATOUS (Red rash/ local redness and rash), SWELLING (Raised area develops) and INSOMNIA (Has severely impacted my quality of life especially loss of quality sleep). 13-Mar-2021 at 8:00 AM, the patient experienced URTICARIA (Hives), ALLERGIC REACTION TO EXCIPIENT (Allergic reaction), SCRATCH (Unavoidably scratching) and VACCINATION COMPLICATION (Felt like poisen ivey but without raised expanding blisters). The patient was treated with PREDNISONE for Allergic reaction, at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe Pruritus/ local itching or pruritus), RASH ERYTHEMATOUS (Red rash/ local redness and rash), URTICARIA (Hives), SWELLING (Raised area develops), INSOMNIA (Has severely impacted my quality of life especially loss of quality sleep), ALLERGIC REACTION TO EXCIPIENT (Allergic reaction), SCRATCH (Unavoidably scratching) and VACCINATION COMPLICATION (Felt like poisen ivey but without raised expanding blisters) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (Severe Pruritus/ local itching or pruritus), RASH ERYTHEMATOUS (Red rash/ local redness and rash) and URTICARIA (Hives) to be possibly related. No further causality assessments were provided for SWELLING (Raised area develops), INSOMNIA (Has severely impacted my quality of life especially loss of quality sleep), ALLERGIC REACTION TO EXCIPIENT (Allergic reaction), SCRATCH (Unavoidably scratching) and VACCINATION COMPLICATION (Felt like poisen ivey but without raised expanding blisters). No concomitant medication provided by the reporter. Treatment medications included antihistamines and steroids. Dermatologist prescribed steroid injections that worked temporarily. Itchy on the forearms then progressed to the neck and shoulders. The patient stated that the steroids prescribed were raising blood glucose. The itchy rash continued for five months with no end in sight. The patient never experienced the more common redness or pain at injection site. No fever or other symptoms commonly reported. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Reporters contact details, patients demographics, medical history, treatment medication added and event verbatim updated to include hives, local pruritus, local erythema and local rash.

Other Meds:

Current Illness: Asthma; Drug allergy (Anectine allergy- Stopped breathing during surgery); Hay fever; Type 2 diabetes mellitus

ID: 1644836
Sex: U
Age:
State:

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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: the 1st shot in march should i just start over; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over) 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 March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1644837
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: shoulder pain with numbness down into my fingers; shoulder pain with numbness down into my fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers). At the time of the report, HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644838
Sex: F
Age:
State: NC

Vax Date: 08/09/2021
Onset Date:
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: injection site soreness; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No medical history and laboratory data was provided by the reporter. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion). At the time of the report, INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion) 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. Patient stated to contact only through phone only.

Other Meds:

Current Illness:

ID: 1644839
Sex: F
Age:
State: WV

Vax Date: 01/20/2021
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: Left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm pain) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20a and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Left arm pain). At the time of the report, LIMB DISCOMFORT (Left arm pain) outcome was unknown. No concomitant medications were reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1644840
Sex: F
Age: 71
State: LA

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

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

Lab Data:

Allergies:

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

Symptoms: Felt like a bus hit; Couldn't move; Extreme high blood pressure; Blur vision; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like a bus hit), MOBILITY DECREASED (Couldn't move), HYPERTENSION (Extreme high blood pressure), VISION BLURRED (Blur vision) and DEHYDRATION (Dehydrated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included PANTOPRAZOLE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 FEELING ABNORMAL (Felt like a bus hit), MOBILITY DECREASED (Couldn't move), HYPERTENSION (Extreme high blood pressure), VISION BLURRED (Blur vision) and DEHYDRATION (Dehydrated). At the time of the report, FEELING ABNORMAL (Felt like a bus hit), MOBILITY DECREASED (Couldn't move), HYPERTENSION (Extreme high blood pressure), VISION BLURRED (Blur vision) and DEHYDRATION (Dehydrated) outcome was unknown. Treatment included IV Saline drip for dehydration

Other Meds: PANTOPRAZOLE; LIPITOR

Current Illness:

ID: 1644841
Sex: M
Age: 42
State: AZ

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210731; Test Name: Heart rate; Result Unstructured Data: Increased.

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Allergic reaction; Increased Heart Rate; Fever; Shortness of Breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Increased Heart Rate), PYREXIA (Fever), DYSPNOEA (Shortness of Breath) and HYPERSENSITIVITY (Allergic reaction) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced HEART RATE INCREASED (Increased Heart Rate) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and DYSPNOEA (Shortness of Breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. On 31-Jul-2021, HEART RATE INCREASED (Increased Heart Rate) and DYSPNOEA (Shortness of Breath) had resolved. On 01-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Heart rate: increased (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1644842
Sex: M
Age:
State: TX

Vax Date: 06/26/2021
Onset Date: 07/06/2021
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: Cough; Pain in ears; Pain in throat; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), EAR PAIN (Pain in ears), OROPHARYNGEAL PAIN (Pain in throat) and EAR INFECTION (ear infection) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced COUGH (Cough), EAR PAIN (Pain in ears), OROPHARYNGEAL PAIN (Pain in throat) and EAR INFECTION (ear infection). At the time of the report, COUGH (Cough), EAR PAIN (Pain in ears), OROPHARYNGEAL PAIN (Pain in throat) and EAR INFECTION (ear infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient was given antibiotic. This case was linked to MOD-2021-284101 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1644843
Sex: F
Age: 70
State: LA

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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Red ring in her arm was like poison ivy; It would itch so bad it would wake her up in the middles of the night; A devil itch; Itching very badly; Had a red ring in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091621A) for COVID-19 vaccination. The patient's past medical history included Surgery (vein surgery) on 10-Aug-2021. Concurrent medical conditions included Diabetes, Hypertension and Infarction (Multiple infarct). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), CARVEDILOL (COREG), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), GLIMEPIRIDE and APIXABAN (ELIQUIS) for an unknown indication. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: BENICAR; COREG; METFORMIN; CRESTOR; GLIMEPIRIDE; ELIQUIS

Current Illness: Diabetes; Hypertension; Infarction (Multiple infarct)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am