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: 1627538
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: my vaccination site is warm; vaccination site is red; vaccination site is kind of swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen). At the time of the report, VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Relevant concomitant medications was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627539
Sex: F
Age: 48
State: MD

Vax Date: 04/17/2021
Onset Date: 05/16/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: "blisters on lips"; arm pain; joint pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER ("blisters on lips"), PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills). On 19-May-2021, the patient experienced LIP BLISTER ("blisters on lips"). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Lip blister, at an unspecified dose and frequency. On 17-May-2021, PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, LIP BLISTER ("blisters on lips") outcome was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1627540
Sex: U
Age:
State:

Vax Date: 06/13/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Concomitant product use was not reported. Treatment Information was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627541
Sex: F
Age:
State: SC

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Patient was 16 yo at first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at 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. Concomitant product use was not reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received and contains non-significant information

Other Meds:

Current Illness:

ID: 1627542
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: can't sleep; 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 INSOMNIA (can't sleep) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (can't sleep). At the time of the report, INSOMNIA (can't sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not reported. Treatment information was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627543
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: morning urine is dark like blood/ morning urine is being dark red/peeing out blood; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood). At the time of the report, CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient reported having no fever or pain. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1627544
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: very sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (very sick). At the time of the report, VACCINATION COMPLICATION (very sick) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1627545
Sex: U
Age:
State:

Vax Date: 06/13/2021
Onset Date: 06/13/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: developed a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (developed a cough) 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 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced COUGH (developed a cough). At the time of the report, COUGH (developed a cough) outcome was unknown. Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.

Other Meds:

Current Illness:

ID: 1627546
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced RENAL PAIN (got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot). At the time of the report, RENAL PAIN (got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627547
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: severe lip swelling; breakout; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (severe lip swelling) and VACCINATION COMPLICATION (breakout) 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 LIP SWELLING (severe lip swelling) and VACCINATION COMPLICATION (breakout). At the time of the report, LIP SWELLING (severe lip swelling) and VACCINATION COMPLICATION (breakout) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1627548
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Received the Moderna COVID-19 Vaccine and have experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Received the Moderna COVID-19 Vaccine and have experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Received the Moderna COVID-19 Vaccine and have experienced a side effect). At the time of the report, VACCINATION COMPLICATION (Received the Moderna COVID-19 Vaccine and have experienced a side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1627549
Sex: F
Age:
State: CA

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

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

Lab Data: Test Name: CBC; Result Unstructured Data: The test was done twice, in Dec 2020 and also in Mar/Apr 2021 and was normal.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: mild anemia or blood disorder; mild anemia or blood disorder; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder). At the time of the report, ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) The test was done twice, in Dec 2020 and also in Mar/Apr 2021 and was normal.. The patients cardiologist ordered a complete blood test in Dec-2021 and it was found to be normal. The test was repeated in Mar-2021/Apr-2021 and another one was done last week. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627550
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: veins n skin are turning purple; veins n skin are turning purple; having a reaction; I'm dying/you just killed me; 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 VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me) 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 VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me). At the time of the report, VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627551
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: elevated temperature at injection site; swelling; muscle pain; red area around the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (elevated temperature at injection site), SWELLING (swelling), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (red area around the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (elevated temperature at injection site), SWELLING (swelling), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (red area around the injection site). At the time of the report, INJECTION SITE WARMTH (elevated temperature at injection site) and VACCINATION SITE ERYTHEMA (red area around the injection site) outcome was unknown and SWELLING (swelling) and MYALGIA (muscle pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627552
Sex: M
Age: 16
State: TX

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Did not get the second dose of Moderna; 16 year old received the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine) and INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No treatment medication were given. No relevant concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated reporter information, patient information, suspect product details and event start date.

Other Meds:

Current Illness:

ID: 1627553
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: 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 AGEUSIA (can't taste anything after covid shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (can't taste anything after covid shot). At the time of the report, AGEUSIA (can't taste anything after covid shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627554
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: swelling, 11cm; redness; warmth; delayed skin reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (swelling, 11cm), ERYTHEMA (redness), FEELING HOT (warmth) and SKIN REACTION (delayed skin reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling, 11cm), ERYTHEMA (redness), FEELING HOT (warmth) and SKIN REACTION (delayed skin reaction). The patient was treated with Manual therapy (ice) for Swelling; Manual therapy (ice) for Erythema; Manual therapy (ice) for Feeling hot and Manual therapy (ice) for Skin reaction. At the time of the report, SWELLING (swelling, 11cm), ERYTHEMA (redness), FEELING HOT (warmth) and SKIN REACTION (delayed skin reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. It was reported that the patient was okay and the patient's physician told that it was delayed skin reaction. The patient had no systemic symptoms. Treatment medication was not provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627555
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: my sde affect is very sore/is very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (my sde affect is very sore/is very painful) 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 PAIN (my sde affect is very sore/is very painful). At the time of the report, PAIN (my sde affect is very sore/is very painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627556
Sex: M
Age:
State: KY

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Soreness stopped after a day or 2 at the arm but it went to chest; Soreness stopped after a day or 2 at the arm; Patient's left shoulder was sore next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest), PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose). On an unknown date, the patient experienced CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose) outcome was unknown and PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the concomitant medicines for the patient included unspecified diabetes medications and unspecified blood pressure medications. This case was linked to MOD-2021-220610 (Patient Link).

Other Meds:

Current Illness:

ID: 1627557
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. Treatment medication was not provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627558
Sex: M
Age: 45
State: MI

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: little achy; little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little achy) and HEADACHE (little headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (little achy) and HEADACHE (little headache). At the time of the report, MYALGIA (little achy) and HEADACHE (little headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications reported. Treatment information not reported. This case was linked to MOD-2021-220441 (Patient Link).

Other Meds:

Current Illness:

ID: 1627559
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: my arm itches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my arm itches) 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 PRURITUS (my arm itches). At the time of the report, PRURITUS (my arm itches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment details were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627560
Sex: F
Age:
State: VA

Vax Date: 05/15/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sharp pains in the upper chest; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Sharp pains in the upper chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Food allergy. Concomitant products included BUPROPION, ROSUVASTATIN CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN 81), CETIRIZINE and SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) for an unknown indication. On 15-May-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Sharp pains in the upper chest). At the time of the report, CHEST PAIN (Sharp pains in the upper chest) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Allergies to medications and other products was reported Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up and received concomitants; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: BUPROPION; ROSUVASTATIN CALCIUM; ASPIRIN 81; CETIRIZINE; ELDERBERRY [SAMBUCUS NIGRA FRUIT]

Current Illness: Food allergy

ID: 1627561
Sex: M
Age: 64
State: FL

Vax Date: 04/14/2021
Onset Date: 05/14/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Sciatic nerve pain that starts from the right buttocks to right foot; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031b21A and 036B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Peanut allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Sciatica, at a dose of 220 mg about 12 tablets today, and it did not do anything. 4 tablets; CELECOXIB (CELEBREX) for Back pain, at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot) had not resolved. Treatment medication included two different chiropractors. Patient went to his orthopedic surgeon, he ordered an MRI. date was July 7, 2021 and he was in agony every day. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow-up relevant history allergy to peanuts and Treatment medication changed to Celebrex and tramadol.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1627562
Sex: M
Age: 55
State: SC

Vax Date: 06/04/2021
Onset Date: 06/07/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Rash is itching; Right arm swollen with rash; Right arm rash is red; Right arm rash under the wrist has like a mass; Abrasions on left wrist/Abrasions on right wrist; Sore arm after the vaccination; Rash on both arms/Rash on right forearm/Rash on right hand biceps; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass) and SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps). On an unknown date, the patient experienced RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) and MYALGIA (Sore arm after the vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist), MYALGIA (Sore arm after the vaccination) and RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient was prescribed steroid cream to put twice a day, not specified.

Other Meds:

Current Illness:

ID: 1627563
Sex: M
Age: 74
State: IL

Vax Date: 02/08/2021
Onset Date: 03/10/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blood pressure and heart rate go up sometimes; problems with his heart and chest; having a cardio infections because of the funny things going on in my body; heart rate is low/Heart rate is goes down to about 50; having a cardio infections because of the funny things going on in my body; i watch my blood pressure change; chills; soreness of both of my arms; Lower blood pressure/blood pressure and heart rate go up sometimes; decreased oxygen levels; difficulty breathing; higher heart rate compared to my average/blood pressure and heart rate go up sometimes; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (difficulty breathing), TACHYCARDIA (higher heart rate compared to my average/blood pressure and heart rate go up sometimes), HYPERTENSION (blood pressure and heart rate go up sometimes), HYPOTENSION (Lower blood pressure/blood pressure and heart rate go up sometimes) and OXYGEN SATURATION DECREASED (decreased oxygen levels) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Aortic aneurysm. Concomitant products included LISINOPRIL, FUROSEMIDE (LASIX [FUROSEMIDE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and DILTIAZEM for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), TACHYCARDIA (higher heart rate compared to my average/blood pressure and heart rate go up sometimes), HYPOTENSION (Lower blood pressure/blood pressure and heart rate go up sometimes), OXYGEN SATURATION DECREASED (decreased oxygen levels), PAIN IN EXTREMITY (soreness of both of my arms) and CHILLS (chills). On an unknown date, the patient experienced HYPERTENSION (blood pressure and heart rate go up sometimes), CARDIAC DISORDER (problems with his heart and chest), CARDIAC INFECTION (having a cardio infections because of the funny things going on in my body), BRADYCARDIA (heart rate is low/Heart rate is goes down to about 50), FEELING ABNORMAL (having a cardio infections because of the funny things going on in my body) and BLOOD PRESSURE FLUCTUATION (i watch my blood pressure change). At the time of the report, DYSPNOEA (difficulty breathing), TACHYCARDIA (higher heart rate compared to my average/blood pressure and heart rate go up sometimes), HYPERTENSION (blood pressure and heart rate go up sometimes), HYPOTENSION (Lower blood pressure/blood pressure and heart rate go up sometimes), OXYGEN SATURATION DECREASED (decreased oxygen levels), CARDIAC DISORDER (problems with his heart and chest), CARDIAC INFECTION (having a cardio infections because of the funny things going on in my body), BRADYCARDIA (heart rate is low/Heart rate is goes down to about 50), FEELING ABNORMAL (having a cardio infections because of the funny things going on in my body), PAIN IN EXTREMITY (soreness of both of my arms), BLOOD PRESSURE FLUCTUATION (i watch my blood pressure change) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not reported. Patient reported that he had echo-cardiogram done on 22-JUN-2021 and states that he maybe having possible cardio infection. Patient provided information from cardiac report, which includes atherosclerosis plaque seen in the aortic arch and in the descending thoracic aorta. Patient reports oxygen level was 92. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional events and lab data were added to the case. On 06-Jul-2021: Follow-up information received included: Added medical history, added lab data and added new events. On 04-Aug-2021: NNI Follow-up SD added.

Other Meds: LISINOPRIL; LASIX [FUROSEMIDE]; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; DILTIAZEM

Current Illness:

ID: 1627564
Sex: F
Age: 46
State: IN

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Patient did not receive 2nd dose between day 25-35 of the 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st 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 were reported. No treatment information was reported

Other Meds:

Current Illness:

ID: 1627565
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: experienced a side effect; headache; ran fever for 10 days; lost of taste; lost sense of smell; severe body aches; dirreah for days and for no reason; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste) and ANOSMIA (lost sense of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. 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 VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ). At the time of the report, VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1627566
Sex: U
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sick on stomach; Threw up 9 times; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick on stomach) and VOMITING (Threw up 9 times) 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 June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced ABDOMINAL DISCOMFORT (Sick on stomach) and VOMITING (Threw up 9 times). At the time of the report, ABDOMINAL DISCOMFORT (Sick on stomach) and VOMITING (Threw up 9 times) outcome was unknown. No concomitant medications were mentioned. No treatment details were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627567
Sex: U
Age:
State:

Vax Date: 06/12/2021
Onset Date: 06/12/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: very sick; vomiting; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). At the time of the report, ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1627568
Sex: F
Age: 86
State: ND

Vax Date: 01/28/2021
Onset Date: 03/07/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included SIMVASTATIN for Blood cholesterol abnormal, BENAZEPRIL for Blood pressure abnormal, TRIAMTERENE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheadedness). The patient was treated with PARACETAMOL (TYLENOL) for Lightheadedness, at a dose of 2 dosage form every six hours and IBUPROFEN for Lightheadedness, at a dose of 2 dosage form every six hours. At the time of the report, DIZZINESS (Lightheadedness) had not resolved. Action taken with mRNA-1273 in response to the events were not Applicable Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-Jul-2021 contains Non significant information

Other Meds: BENAZEPRIL; TRIAMTERENE; SIMVASTATIN

Current Illness: Blood cholesterol abnormal; Blood pressure abnormal

ID: 1627569
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 1627570
Sex: F
Age:
State:

Vax Date: 06/13/2021
Onset Date: 06/14/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a patient family member or friend, describes the occurrence of chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 14, 2021, patient experienced chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache. At the time of the report, chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not provided. Reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1627571
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Teeth sensitivity on the side of vaccine injection area; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area) 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 HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area). At the time of the report, HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1627572
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: sick; first vaccine in February and did not get the second; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second). At the time of the report, ILLNESS (sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant information provided. Patient received the first vaccine in February of 2021 but did not get the second because the first made patient sick. The patient wished to receive the second vaccine. No treatment information provided.

Other Meds:

Current Illness:

ID: 1627573
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) 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 CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1627574
Sex: M
Age: 59
State: CA

Vax Date: 05/14/2021
Onset Date: 06/12/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Back Pain; did not have the mental capacity to get water; Excessive sweating; Severe fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gout. Concurrent medical conditions included Hyperlipidemia. Concomitant products included ATENOLOL for Hypertension. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) for Fever, at an unspecified dose and frequency. On 14-Jun-2021, BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved. The patient has used hydration and blankets to try and counteract the symptoms. He stopped taking cholesterol injection but will resume taking on 16-JUL-2021 Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: FU received, updated patient medical history

Other Meds: ATENOLOL

Current Illness: Hyperlipidemia

ID: 1627575
Sex: M
Age: 60
State: MO

Vax Date: 03/21/2021
Onset Date: 04/18/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Date: 20210618; Test Name: Chest X-ray; Result Unstructured Data: normal; Test Date: 20210611; Test Name: ct scan; Result Unstructured Data: normal

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: recovering kidneys; Sore arm for two days; I had sparkles in my eyes; Burning Left Foot; ringing in both ears, started soft and grew louder, loud buzzing in my head; I developed a persistant dry cough; Dry cough turned into shortness of breath; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I developed a persistant dry cough), DYSPNOEA (Dry cough turned into shortness of breath), BURNING SENSATION (Burning Left Foot) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Kidney disorder. Concomitant products included OMEGA-3 FATTY ACIDS from 07-Jan-2019 to an unknown date for Fatty acid supplementation, MAGNESIUM from 02-Jan-2021 to an unknown date for Magnesium supplementation, CYANOCOBALAMIN (B-12) from 07-Jan-2019 to an unknown date for Vitamin B12 supplementation. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 03-May-2021, the patient experienced COUGH (I developed a persistant dry cough) (seriousness criterion hospitalization prolonged). 03-May-2021, the patient experienced DYSPNOEA (Dry cough turned into shortness of breath) (seriousness criterion hospitalization prolonged). On 11-May-2021, the patient experienced BURNING SENSATION (Burning Left Foot) (seriousness criterion hospitalization prolonged) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) (seriousness criterion hospitalization prolonged). On 11-Jun-2021, the patient experienced VISUAL IMPAIRMENT (I had sparkles in my eyes). On an unknown date, the patient experienced RENAL DISORDER (recovering kidneys) and MYALGIA (Sore arm for two days). The patient was hospitalized from 11-Jun-2021 to 28-Jul-2021 due to BURNING SENSATION, COUGH, DYSPNOEA and TINNITUS. At the time of the report, COUGH (I developed a persistant dry cough), DYSPNOEA (Dry cough turned into shortness of breath), BURNING SENSATION (Burning Left Foot) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) had not resolved, VISUAL IMPAIRMENT (I had sparkles in my eyes) outcome was unknown, RENAL DISORDER (recovering kidneys) was resolving and VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Sore arm for two days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jun-2021, Computerised tomogram: normal (normal) normal. On 18-Jun-2021, Chest X-ray: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COUGH (I developed a persistant dry cough), DYSPNOEA (Dry cough turned into shortness of breath), BURNING SENSATION (Burning Left Foot) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) to be possibly related. No further causality assessments were provided for VISUAL IMPAIRMENT (I had sparkles in my eyes), RENAL DISORDER (recovering kidneys), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Sore arm for two days). Treatment information was not provided by the reporter. Upon follow up information received on 13 Aug 2021, event myalgia was added. Other relevant history added. Company comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-259201 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received on 30-JUL-2021. Contains No New Information. On 13-Aug-2021: Follow-up received on 13-AUG-2021 and included New event , Relevant history and reporters were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.

Other Meds: B-12; OMEGA-3 FATTY ACIDS; MAGNESIUM

Current Illness: Kidney disorder

ID: 1627576
Sex: M
Age:
State: IN

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 103.7

Allergies:

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

Symptoms: Developed a huge rash at injection site; Itchy rash; swollen glands; 103.7 fever; nauseous; pain in head; Delirium; confusion; couldn't get out of bed i had no known coverage; Ear hurt; Throat hurt; weak; Migraine; sweating; Vein burst in left wrist and stomach; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken bones and Surgery. Concurrent medical conditions included Neck pain. Concomitant products included OXYCODONE from 05-Jan-2021 to an unknown date for Neck pain. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), MOBILITY DECREASED (couldn't get out of bed i had no known coverage), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head). On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash) and INJECTION SITE RASH (Developed a huge rash at injection site). On 05-Feb-2021, MOBILITY DECREASED (couldn't get out of bed i had no known coverage) had resolved with sequelae, INJECTION SITE RASH (Developed a huge rash at injection site) had resolved. At the time of the report, DELIRIUM (Delirium), CONFUSIONAL STATE (confusion), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head) was resolving and RASH PRURITIC (Itchy rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment information was not provided. This case was linked to MOD-2021-280549 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon follow-up receipt: New events were added. Product second dose added, Concomitant medication information added. Patient demographics added.

Other Meds: OXYCODONE

Current Illness:

ID: 1627577
Sex: M
Age: 71
State: MT

Vax Date: 04/30/2021
Onset Date: 05/20/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received the 2nd dose 20 days after their first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 030B21A) 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) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose). On 20-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627578
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: sore jaw; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (sore jaw) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (sore jaw). At the time of the report, PAIN IN JAW (sore jaw) 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: 1627579
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: rash side effect; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash side effect) 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 RASH (rash side effect). At the time of the report, RASH (rash side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. Treatment medication was not provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627580
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/14/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Name: Prostatic specific antigen; Result Unstructured Data: High

Allergies:

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

Symptoms: I had my PSA jump from O.01 to 1.8 after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8 after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Prostatectomy (Patient got prostate removed 6 years ago and followed up immediately with radiation). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8 after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8 after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: 1.8 (High) High. No concomitant drugs were reported. No treatment medications were reported. Patient reported that the Prostate specific antigen reading was less than 0.01 for 6 years. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up document received. Added information about the start date of the event (prostate specific antigen increased).

Other Meds:

Current Illness:

ID: 1627581
Sex: F
Age:
State: MD

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1627582
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: sores in mouth; chapped lips; fever; chills; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627583
Sex: F
Age: 76
State: FL

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Date: 20210311; Test Name: Magnetic resonance imaging; Result Unstructured Data: Seems to be an abscess

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Right arm has a lump on it; The right arm got sore; Right arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen). At the time of the report, VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) Seems to be an abscess. Patient was on concomitant medications blood pressure medications and diabetes medications. Treatment medication was not provided

Other Meds:

Current Illness:

ID: 1627584
Sex: M
Age:
State: NY

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced MYALGIA (a sore arm). At the time of the report, MYALGIA (a sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment medication provided.

Other Meds:

Current Illness:

ID: 1627585
Sex: M
Age:
State: KY

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: soreness still flares up at the chest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (soreness still flares up at the chest) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (soreness still flares up at the chest). The patient was treated with PARACETAMOL (TYLENOL) for Chest pain, at a dose of UNK dosage form. At the time of the report, CHEST PAIN (soreness still flares up at the chest) outcome was unknown. It was reported that the patient's concomitant medications included unspecified diabetes medications and unspecified blood pressure medications. This case was linked to MOD-2021-220389 (Dose 1) (Patient Link).

Other Meds:

Current Illness:

ID: 1627586
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: covid positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (covid positive). At the time of the report, SARS-COV-2 TEST POSITIVE (covid positive) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1627587
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: missed the window for dose 2 of the vaccine/one week past the 42 day; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am