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: 1706650
Sex: U
Age:
State:

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 09/17/2021
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: slight numbness in my left cheek-same side as injection; 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 HYPOAESTHESIA (slight numbness in my left cheek-same side as injection) 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 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced HYPOAESTHESIA (slight numbness in my left cheek-same side as injection). At the time of the report, HYPOAESTHESIA (slight numbness in my left cheek-same side as injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1706651
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) in an elderly 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 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding) had resolved. No Concomitant medications were reported No treatment medications were reported

Other Meds:

Current Illness:

ID: 1706652
Sex: U
Age:
State:

Vax Date: 05/22/2021
Onset Date:
Rec V Date: 09/17/2021
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: Arm is very swollen; 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 PERIPHERAL SWELLING (Arm is very 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 22-May-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 PERIPHERAL SWELLING (Arm is very swollen). At the time of the report, PERIPHERAL SWELLING (Arm is very swollen) outcome was unknown. No concomitant medication was reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1706653
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Hair loss; 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 ALOPECIA (Hair loss) 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 ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706654
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Having fever after moderna 2nd dose and not reducing; 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 PYREXIA (Having fever after moderna 2nd dose and not reducing) 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, the patient experienced PYREXIA (Having fever after moderna 2nd dose and not reducing). At the time of the report, PYREXIA (Having fever after moderna 2nd dose and not reducing) outcome was unknown. No Concomitant medications were reported. No Treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1706655
Sex: F
Age:
State:

Vax Date: 04/27/2020
Onset Date:
Rec V Date: 09/17/2021
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: Coughing up mucus; This is not a good feeling; Coughing all through the night; Been sick with headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-May-2021 and was forwarded to Moderna on 24-May-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 SECRETION DISCHARGE (Coughing up mucus), MALAISE (This is not a good feeling), COUGH (Coughing all through the night) and HEADACHE (Been sick with headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-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 SECRETION DISCHARGE (Coughing up mucus), MALAISE (This is not a good feeling), COUGH (Coughing all through the night) and HEADACHE (Been sick with headache). At the time of the report, SECRETION DISCHARGE (Coughing up mucus), MALAISE (This is not a good feeling), COUGH (Coughing all through the night) and HEADACHE (Been sick with headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. No concomitant medication was provided. No treatment medication information was provided.

Other Meds:

Current Illness:

ID: 1706656
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Tachycardia; Fever; 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 TACHYCARDIA (Tachycardia) and 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 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 TACHYCARDIA (Tachycardia) and PYREXIA (Fever). At the time of the report, TACHYCARDIA (Tachycardia) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received and contains no new information

Other Meds:

Current Illness:

ID: 1706657
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Arm hurts moderate bad; 'm having bad body aches; Feel nauseated; Chills; 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 LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) 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 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 LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills). At the time of the report, LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1706658
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) 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 HYPOAESTHESIA (numbness). At the time of the report, HYPOAESTHESIA (numbness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment drugs were reported

Other Meds:

Current Illness:

ID: 1706659
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: high blood pressure; lightheadedness; 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 HYPERTENSION (high blood pressure) and DIZZINESS (lightheadedness) 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, the patient experienced HYPERTENSION (high blood pressure) and DIZZINESS (lightheadedness). At the time of the report, HYPERTENSION (high blood pressure) and DIZZINESS (lightheadedness) outcome was unknown. No Concomitant medications were reported. No Treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1706660
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Chest pain; 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 CHEST PAIN (Chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1706661
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: my head feels like it will explode; 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 HEAD DISCOMFORT (my head feels like it will explode) 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, the patient experienced HEAD DISCOMFORT (my head feels like it will explode). At the time of the report, HEAD DISCOMFORT (my head feels like it will explode) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706662
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: arm patient got the shot feel hot; 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 FEELING HOT (arm patient got the shot feel hot) 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 FEELING HOT (arm patient got the shot feel hot). At the time of the report, FEELING HOT (arm patient got the shot feel hot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment information was provided. No Concomitant medication was provided

Other Meds:

Current Illness:

ID: 1706663
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 09/17/2021
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: Having headaches for the past couple days; 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 HEADACHE (Having headaches for the past couple days) 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. In May 2021, the patient experienced HEADACHE (Having headaches for the past couple days). At the time of the report, HEADACHE (Having headaches for the past couple days) outcome was unknown. No concomitant products were reported. No treatment information was reported by the reporter.

Other Meds:

Current Illness:

ID: 1706664
Sex: F
Age: 18
State: MD

Vax Date: 01/04/2021
Onset Date: 02/02/2021
Rec V Date: 09/17/2021
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: fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Anemia since 10-Oct-2020. Concomitant products included IRON from 01-Jan-2021 to an unknown date for Anemia. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021 at 12:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).). At the time of the report, PYREXIA (fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).) had resolved. No Treatment information was provided

Other Meds: IRON

Current Illness: Anemia

ID: 1706665
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: fast heartbeat after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat after vaccination) 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 HEART RATE INCREASED (fast heartbeat after vaccination). At the time of the report, HEART RATE INCREASED (fast heartbeat after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants , treatments are provided

Other Meds:

Current Illness:

ID: 1706666
Sex: M
Age: 61
State: NJ

Vax Date: 05/04/2021
Onset Date: 06/04/2021
Rec V Date: 09/17/2021
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: Night sweats; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue). On 05-Jun-2021, NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant product details was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-245689 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information received on 12-JUL-2021 included no new information. On 07-Sep-2021: Follow-up Information received contains No New Information

Other Meds:

Current Illness:

ID: 1706667
Sex: F
Age: 72
State: FL

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: Nerve conduction studies; Result Unstructured Data: unknown

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pain in arm for days; Left arm swelled; The vaccination site is swollen, red, and heat; Vaccination site is swollen; Redness of left arm vaccination site; Carrying a low grade fever had 100.7 at ear, 99 is a fever for me"; Patient advised by her doctor to not get the second vaccine as my allergic reaction would be worse; Feeling hot; The patient noticed her face, lips, eyes and tongue were selling up fast; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021. The most recent information was received on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm for days), PERIPHERAL SWELLING (Left arm swelled), VACCINATION SITE WARMTH (The vaccination site is swollen, red, and heat), FEELING HOT (Feeling hot) and SWELLING (The patient noticed her face, lips, eyes and tongue were selling up fast) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (sulfa allergy.), Drug allergy (Levaquin allergy.), Allergy to antibiotic (antibiotics allergy.), Allergy to antibiotic (tetracycline allergy.), Drug allergy (codeine allergy.), Chiari malformation, Mast cell activation syndrome, Dysautonomia since 12-Oct-2018, Syncope vasovagal since 12-Oct-2018, Mast cell activation syndrome (On 6-30-2021 the mast cell activation syndrome got worsen with vaccine.) since October 2018, Hypertension (Improved with meds.), Hypotension (Improved with meds), High cholesterol (Improved with treatment.), Mitral valve prolapse, Drug allergy, Allergy to antibiotic, Allergy to antibiotic, Drug allergy, Drug allergy, Allergy to chemicals and Allergy to vaccine. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol increased, ROSUVASTATIN CALCIUM (ROSUVASTATIN +PHARMA) for Cholesterol, LISINOPRIL for Hypertension, FISH OIL (FISH OIL OMEGA 3) for Triglycerides, VITAMIN B12 NOS and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced FEELING HOT (Feeling hot) and SWELLING (The patient noticed her face, lips, eyes and tongue were selling up fast). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm for days), PERIPHERAL SWELLING (Left arm swelled), VACCINATION SITE WARMTH (The vaccination site is swollen, red, and heat), VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Redness of left arm vaccination site), PYREXIA (Carrying a low grade fever had 100.7 at ear, 99 is a fever for me") and PRODUCT DOSE OMISSION ISSUE (Patient advised by her doctor to not get the second vaccine as my allergic reaction would be worse). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Swelling, at a dose of 50 mg and PREDNISONE for Fever, at an unspecified dose and frequency. On 15-Jul-2021, FEELING HOT (Feeling hot) and SWELLING (The patient noticed her face, lips, eyes and tongue were selling up fast) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm for days), PERIPHERAL SWELLING (Left arm swelled), VACCINATION SITE WARMTH (The vaccination site is swollen, red, and heat), VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Redness of left arm vaccination site) and PYREXIA (Carrying a low grade fever had 100.7 at ear, 99 is a fever for me") outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient advised by her doctor to not get the second vaccine as my allergic reaction would be worse) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Nerve conduction studies: abnormal (abnormal) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications include ice. The concomitant medication included omega 3 ethyl esters. The patient stayed well hydrated for a few days with no improvement. Patient was treated with prednisone for 6 days for fever which helped. Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant follow up : included patient details and medical history. New events and concomitant medications were added.

Other Meds: LISINOPRIL; CRESTOR; VITAMIN B12 NOS; VITAMIN D3; FISH OIL OMEGA 3; ROSUVASTATIN +PHARMA

Current Illness: Allergy to antibiotic (tetracycline allergy.); Allergy to antibiotic (antibiotics allergy.); Allergy to antibiotic; Allergy to chemicals; Allergy to vaccine; Chiari malformation; Drug allergy (sulfa allergy.); Drug allergy (Levaquin allergy.); Drug allergy (codeine allergy.); Drug allergy; Dysautonomia; High cholesterol (Improved with treatment.); Hypertension (Improved with meds.); Hypotension (Improved with meds); Mast cell activation syndrome (On 6-30-2021 the mast cell activation syndrome got worsen with vaccine.); Mast cell activation syndrome; Mitral valve prolapse; Syncope vasovagal

ID: 1706668
Sex: F
Age: 74
State: MD

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 09/17/2021
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: jaw, lips and tongue were at the verge of going numb; chest felt very tight; stomach became upset, didn't feel nausea, just felt off/stomach becoming queezy; Heart palpitations,Rapid heart beat; blood pressure went up; Felt very lightheaded; felt awful; Sensation to lips and tongue; painful muscles in chest; major headache on the back and front of her head that went down to her neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (jaw, lips and tongue were at the verge of going numb), CHEST DISCOMFORT (chest felt very tight), ABDOMINAL DISCOMFORT (stomach became upset, didn't feel nausea, just felt off/stomach becoming queezy), PALPITATIONS (Heart palpitations,Rapid heart beat) and BLOOD PRESSURE INCREASED (blood pressure went up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Headache (stopped in 2011. Returned almost daily since vaccine) in 1970. Concurrent medical conditions included Blood pressure high since 1995, Gastroesophageal reflux disease since 2008, Irritable bowel syndrome since 2005, Costochondritis (reoccurring low/moderate level of chest mussel pain), Drug allergy (ight headed, strong pressure headache extending down back of neck, pressure in chest, tingling and pressure sensation in jaw, lips and tongue, heart palpitations, elevated blood pressure, queezy stomach) on 08-Oct-2014, Drug allergy (experiencing Costochondritis, given heart burn med (contained Lidocaine) same symptoms as above only very mild) on 16-Feb-2017 and Drug allergy (Dermatologist testing for Lidocaine reaction, no response to under-skin testing, intermuscular injection of small amount caused mild symptoms, which lead to not allergic but sensitive to lidocaine) on 27-Aug-2019. Concomitant products included CANDESARTAN and HYDROCHLOROTHIAZIDE for Blood pressure management, ATORVASTATIN for Cholesterol, ESOMEPRAZOLE MAGNESIUM for Gastroesophageal reflux disease, UBIDECARENONE (CO Q-10) for Muscle ache. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (jaw, lips and tongue were at the verge of going numb), CHEST DISCOMFORT (chest felt very tight), ABDOMINAL DISCOMFORT (stomach became upset, didn't feel nausea, just felt off/stomach becoming queezy), PALPITATIONS (Heart palpitations,Rapid heart beat), BLOOD PRESSURE INCREASED (blood pressure went up), DIZZINESS (Felt very lightheaded), FEELING ABNORMAL (felt awful), SENSORY LOSS (Sensation to lips and tongue), MYALGIA (painful muscles in chest) and HEADACHE (major headache on the back and front of her head that went down to her neck). The patient was treated with PREDNISONE at a dose of 10 milligram and IBUPROFEN ongoing since an unknown date at a dose of 1200 milligram every twelve hours. At the time of the report, HYPOAESTHESIA (jaw, lips and tongue were at the verge of going numb), CHEST DISCOMFORT (chest felt very tight), ABDOMINAL DISCOMFORT (stomach became upset, didn't feel nausea, just felt off/stomach becoming queezy), PALPITATIONS (Heart palpitations,Rapid heart beat), BLOOD PRESSURE INCREASED (blood pressure went up), DIZZINESS (Felt very lightheaded), FEELING ABNORMAL (felt awful), SENSORY LOSS (Sensation to lips and tongue), MYALGIA (painful muscles in chest) and HEADACHE (major headache on the back and front of her head that went down to her neck) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-252887 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Significant follow up received. Patient demographics, medical history ,concomitant treatment medicine, outcome of the events had been updated.

Other Meds: CANDESARTAN; HYDROCHLOROTHIAZIDE; ESOMEPRAZOLE MAGNESIUM; ATORVASTATIN; CO Q-10

Current Illness: Blood pressure high; Costochondritis (reoccurring low/moderate level of chest mussel pain); Gastroesophageal reflux disease; Irritable bowel syndrome

ID: 1706669
Sex: F
Age: 46
State: CA

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 09/17/2021
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: covid arm; Left arm which was hard in between elbow and shoulder; Amr was pink; Sore left armpit; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink), AXILLARY PAIN (Sore left armpit) and PRURITUS (itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and DASATINIB MONOHYDRATE (SPRYCEL) for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink), AXILLARY PAIN (Sore left armpit) and PRURITUS (itchy). The patient was treated with IBUPROFEN (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink) and AXILLARY PAIN (Sore left armpit) outcome was unknown and PRURITUS (itchy) 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. This case was linked to MOD-2021-253150 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: contact details of reporter, treatment medication, new events were added

Other Meds: VITAMIN C ACID; SPRYCEL

Current Illness: Chronic myeloid leukemia

ID: 1706670
Sex: F
Age: 77
State: FL

Vax Date: 03/29/2021
Onset Date: 04/26/2021
Rec V Date: 09/17/2021
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: rare yeast infection/yeast infection and also looked like shingles; lethargic; red/black color at injections site/arm turned blackish and purple; Sore arm/sore for 1 week 10 days; itching sporadically at injection site; fever; chills; Headache; Hypersensitivity reaction; erythema/redness; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (rare yeast infection/yeast infection and also looked like shingles), LETHARGY (lethargic), ERYTHEMA (erythema/redness), VACCINATION SITE DISCOLOURATION (red/black color at injections site/arm turned blackish and purple) and VACCINATION SITE PAIN (Sore arm/sore for 1 week 10 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046b21A and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: tubersole in 2010. Past adverse reactions to the above products included Rash with tubersole. Concurrent medical conditions included Egg allergy (skin test), Sulfonamide allergy (Reaction occurred: rash), Penicillin allergy (Reaction occurred: itch) and Latex allergy. Concomitant products included LISINOPRIL from 2014 to an unknown date for Blood pressure high, HYDROCHLOROTHIAZIDE for Blood pressure increased, DIAZEPAM (VALIUM) from 1988 to an unknown date for Vestibular migraine, PROBIOTICS NOS and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 29-Mar-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021 at 12:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced ERYTHEMA (erythema/redness) and HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced HERPES ZOSTER (rare yeast infection/yeast infection and also looked like shingles), LETHARGY (lethargic), VACCINATION SITE DISCOLOURATION (red/black color at injections site/arm turned blackish and purple), VACCINATION SITE PAIN (Sore arm/sore for 1 week 10 days), VACCINATION SITE PRURITUS (itching sporadically at injection site), PYREXIA (fever), CHILLS (chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form and FLUCONAZOLE for Yeast infection, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (rare yeast infection/yeast infection and also looked like shingles), VACCINATION SITE DISCOLOURATION (red/black color at injections site/arm turned blackish and purple), VACCINATION SITE PAIN (Sore arm/sore for 1 week 10 days) and HEADACHE (Headache) had not resolved and LETHARGY (lethargic), ERYTHEMA (erythema/redness), HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE PRURITUS (itching sporadically at injection site), PYREXIA (fever) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (rare yeast infection/yeast infection and also looked like shingles), VACCINATION SITE DISCOLOURATION (red/black color at injections site/arm turned blackish and purple), VACCINATION SITE PAIN (Sore arm/sore for 1 week 10 days), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (Headache) to be possibly related. No further causality assessments were provided for LETHARGY (lethargic), ERYTHEMA (erythema/redness), VACCINATION SITE PRURITUS (itching sporadically at injection site), PYREXIA (fever) and CHILLS (chills). Patient experienced sore arm in the past with TB- testing. Treatment include anti-histamine cream. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received and added past allergy due to vaccine and concomitant medication and treatment medication.

Other Meds: LISINOPRIL; VALIUM; PROBIOTICS NOS; PREMARIN; HYDROCHLOROTHIAZIDE

Current Illness: Egg allergy (skin test); Latex allergy; Penicillin allergy (Reaction occurred: itch); Sulfonamide allergy (Reaction occurred: rash)

ID: 1706671
Sex: M
Age: 71
State: PA

Vax Date: 01/19/2021
Onset Date: 04/01/2021
Rec V Date: 09/17/2021
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: Shingles; blister on thigh and groin area; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and BLISTER (blister on thigh and groin area) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. no medical information reported. The patient's past medical history included Shingles (20 years ago and was supposed to receive the vaccine but was never vaccinated). Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), ATORVASTATIN, ALLOPURINOL, DILTIAZEM and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021 at 9:00 AM, the patient experienced HERPES ZOSTER (Shingles). In April 2021, the patient experienced BLISTER (blister on thigh and groin area). At the time of the report, HERPES ZOSTER (Shingles) had resolved and BLISTER (blister on thigh and groin area) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided. It was reported that patient Developed SHINGLES ( second time , had 25 years ago) typical symptoms , small blisters on and across upper thigh and goin area, MOST PAINFULL no none treatment , had to take It course, lasted 3 months and finally healed and pain went away, the blisters did leave a scared area. I have since had the SHINGLES shot ( one of two) . Patient is not looking to go through that again Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: significant follow up received on 01-sep-2021,including concomitant medication and patient height and weight, race and ethnic information and batch/lot no.of both doses

Other Meds: EDARBYCLOR; ATORVASTATIN; ALLOPURINOL; DILTIAZEM; PSYLLIUM HUSKS

Current Illness:

ID: 1706672
Sex: F
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: she didn't get her second dose one month after her 1st dose because her husband; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband) 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 Treatment information were not provided. No Concomitant drugs were not provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: The Followup received in which dosage information is mentioned.(The patient chose to receive her second vaccine even though it was past the recommended time frame).Changed the patient gender male to female as per follow up document.

Other Meds:

Current Illness:

ID: 1706673
Sex: M
Age: 43
State: DE

Vax Date: 03/18/2021
Onset Date: 04/14/2021
Rec V Date: 09/17/2021
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 Date: 20210606; Test Name: Chest abdomen CT scan; Result Unstructured Data: Normal; Test Date: 20210606; Test Name: EEG; Result Unstructured Data: Normal; Test Date: 20210606; Test Name: Brain MRI; Result Unstructured Data: Normal

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: he was no longer behaving in the same fashion; would giggle inappropriately when asked questions; needed to be reminded to chew and swallow food, could no longer feed and dress himself, no longer recognized people in his life; no longer had an interest in the many things he previously was interested in; become incontinent; became confused easil, was confused by simple directions; speech loss, He had stopped talking; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEHAVIOUR DISORDER (he was no longer behaving in the same fashion), APHASIA (speech loss, He had stopped talking), CONFUSIONAL STATE (became confused easil, was confused by simple directions), MEMORY IMPAIRMENT (needed to be reminded to chew and swallow food, could no longer feed and dress himself, no longer recognized people in his life) and DECREASED INTEREST (no longer had an interest in the many things he previously was interested in) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neurological impairment (Reaction--loss of speech, cognitive and physical impairment) since 1980, Seizures since 2019, Drug allergy (Haldol), Drug allergy (Accutane), Drug allergy (Inderol) and Drug allergy (Depakote). Concomitant products included CLONAZEPAM and ZIPRASIDONE for Myocardial infarction, LEVETIRACETAM (KEPRA) for Seizure. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced APHASIA (speech loss, He had stopped talking). On 01-Jun-2021, the patient experienced CONFUSIONAL STATE (became confused easil, was confused by simple directions), DECREASED INTEREST (no longer had an interest in the many things he previously was interested in) and INCONTINENCE (become incontinent). On 23-Jun-2021, the patient experienced MEMORY IMPAIRMENT (needed to be reminded to chew and swallow food, could no longer feed and dress himself, no longer recognized people in his life). On an unknown date, the patient experienced BEHAVIOUR DISORDER (he was no longer behaving in the same fashion) and INAPPROPRIATE AFFECT (would giggle inappropriately when asked questions). At the time of the report, BEHAVIOUR DISORDER (he was no longer behaving in the same fashion) and INAPPROPRIATE AFFECT (would giggle inappropriately when asked questions) outcome was unknown and APHASIA (speech loss, He had stopped talking), CONFUSIONAL STATE (became confused easil, was confused by simple directions), MEMORY IMPAIRMENT (needed to be reminded to chew and swallow food, could no longer feed and dress himself, no longer recognized people in his life), DECREASED INTEREST (no longer had an interest in the many things he previously was interested in) and INCONTINENCE (become incontinent) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Computerised tomogram: normal (normal) Normal. On 06-Jun-2021, Electroencephalogram: normal (normal) Normal. On 06-Jun-2021, Magnetic resonance imaging: normal (normal) Normal. Treatment information in response to events was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Significant followup received contains event outcome and date, concomitant product and dosage details was updated.

Other Meds: CLONAZEPAM; ZIPRASIDONE; KEPRA

Current Illness: Drug allergy (Inderol); Drug allergy (Haldol); Drug allergy (Depakote); Drug allergy (Accutane); Neurological impairment (Reaction--loss of speech, cognitive and physical impairment); Seizures

ID: 1706674
Sex: M
Age: 38
State: FL

Vax Date: 04/26/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210429; Test Name: COVID-19 TEST; Test Result: Positive ; Result Unstructured Data: Positive for covid after the 1st dose

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Has not received the 2nd dose yet passed 40 day period; Positive for covid after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, SARS-CoV-2 test: (Positive) Positive for covid after the 1st dose. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: TCR attached- outcome and Second dose information added.

Other Meds:

Current Illness:

ID: 1706675
Sex: F
Age: 61
State: CA

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 09/17/2021
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: Medicine taste in her throat; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Medicine taste in her throat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced TASTE DISORDER (Medicine taste in her throat). At the time of the report, TASTE DISORDER (Medicine taste in her throat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had reported that his adverse event is currently fine and got resolved by itself. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added event outcome and narrative was updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1706676
Sex: F
Age: 56
State: MI

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 09/17/2021
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: numb; tingling; hasn't slept; feeling light headed; whole body feeling cold; being sore; nausea; headache; feel like she has to vomit; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed) and FEELING COLD (whole body feeling cold) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PEPPERMINT [MENTHA X PIPERITA] at an unspecified dose and frequency. On 15-Jul-2021, PARAESTHESIA (tingling) had resolved. At the time of the report, HYPOAESTHESIA (numb) had not resolved and INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient also experienced being sore. No concomitant medication was provided by reporter. Patient also had water to stay hydrated and advised to take rest at home after vaccination. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up received and does not contain any new information.

Other Meds:

Current Illness:

ID: 1706677
Sex: F
Age: 67
State: CA

Vax Date: 06/06/2021
Onset Date:
Rec V Date: 09/17/2021
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: Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On 06-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 VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm) outcome was unknown. Concomitant product use was not provided. Treatment information was unknown. This case was linked to MOD-2021-262572 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: TCR received on 10 Sep 2021,contains Non Significant Information.

Other Meds:

Current Illness:

ID: 1706678
Sex: F
Age: 65
State: OH

Vax Date: 07/09/2021
Onset Date: 07/20/2021
Rec V Date: 09/17/2021
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: severe pain in the feet/"aching"/ "pain is crazy"; cramping; "bone hurts"; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-122190) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. Concurrent medical conditions included Neuropathy. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts"). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts") 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. Concomitant medication included cholesterol medication. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-significant follow-up: Follow up document contain no new information

Other Meds:

Current Illness: Neuropathy

ID: 1706679
Sex: F
Age:
State: IL

Vax Date: 05/10/2021
Onset Date:
Rec V Date: 09/17/2021
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: Greater than 35 days between doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine) 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 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine) had resolved. Concomitant medication list was not provided. Treatment information was not provided. Patient received her second dose of Moderna Covid-19 Vaccine sometime during the week of 13 July 2021. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received and contains no new information.

Other Meds:

Current Illness:

ID: 1706680
Sex: F
Age: 51
State: MS

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 09/17/2021
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: Injection site was Itchy after 1st dose; Injection site was red after 1st dose; Injection site was painful after 1st dose; Arm was swollen at injection site after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose). At the time of the report, VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 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 information was provided. No treatment medication information was provided. This case was linked to MOD-2021-262880 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Form attached included no new information.

Other Meds:

Current Illness:

ID: 1706681
Sex: M
Age: 24
State: WI

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 09/17/2021
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: received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet) 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 product reported by reporter. No treatment medication reported by reporter. Patient want their second dose now but HCP wanted to know what the recommendation is since its been 84 days since the first dose. Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up received, contain no new information.

Other Meds:

Current Illness:

ID: 1706682
Sex: F
Age: 59
State: CA

Vax Date: 07/26/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data: Test Name: blood test; Result Unstructured Data: Normal; Test Name: chest x-ray; Result Unstructured Data: Normal; Test Name: EKG; Result Unstructured Data: Normal

Allergies:

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

Symptoms: chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack; little red trail in her vision right after she looks outside; were in pain or anxiety; headache is very severe; numbness; tingling around the rightankle", " needles and pins; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00183340 and 058A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), TEMAZEPAM and SUMATRIPTAN for an unknown indication. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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 CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) (seriousness criterion hospitalization), ERYTHROPSIA (little red trail in her vision right after she looks outside), ANXIETY (were in pain or anxiety) and HEADACHE (headache is very severe). At the time of the report, CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack), ERYTHROPSIA (little red trail in her vision right after she looks outside) and ANXIETY (were in pain or anxiety) outcome was unknown and HEADACHE (headache is very severe) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Took migraine medicine for headache (medicine name is unknown) This case was linked to MOD-2021-308647 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received included concomitant medication, second dose details, laboratory data and new events was added and action taken was updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.

Other Meds: TEMAZEPAM; PANTOPRAZOLE; SUMATRIPTAN

Current Illness: Migraine

ID: 1706683
Sex: F
Age: 60
State: PA

Vax Date: 02/07/2021
Onset Date: 07/16/2021
Rec V Date: 09/17/2021
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: Antibody test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210307; Test Name: Antibody test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210307; Test Name: Antibody test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Tremor

Symptoms: Got her 3 rd dose of the Moderna COVID-19 Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL OVERDOSE (Got her 3 rd dose of the Moderna COVID-19 Vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 048A21A and 011D21A) for COVID-19 vaccination. The patient's past medical history included Lung transplant. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced INTENTIONAL OVERDOSE (Got her 3 rd dose of the Moderna COVID-19 Vaccine). At the time of the report, INTENTIONAL OVERDOSE (Got her 3 rd dose of the Moderna COVID-19 Vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Antibody test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Antibody test: negative (Negative) Negative. Concomitant product included several unspecified medications. Treatment information was unknown. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: regulatory authority FU- No new information

Other Meds:

Current Illness:

ID: 1706684
Sex: F
Age: 42
State: CA

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: became anemic and lost a lot of blood during these months; I'm concerned because it's a lot/it'll leak like a water faucet/also had a lot of clots / it lasted for 22 days; chest problems; Then 3-5 days later, her cycle came back / It'll stop for 3-5 days, but it'll come around longer; Activities of daily living impaired; itchy; swelling in my arm where I got the shot; red and really swollen; received the first dose of Moderna COVID19 Vaccine on 24Apr2021, did not receive the second dose yet; menstrual cycle wasn't due yet / since 24Apr2021, I've been on my cycle on and off; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD LOSS ANAEMIA (became anemic and lost a lot of blood during these months), HEAVY MENSTRUAL BLEEDING (I'm concerned because it's a lot/it'll leak like a water faucet/also had a lot of clots / it lasted for 22 days) and CHEST DISCOMFORT (chest problems) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual cycle wasn't due yet / since 24Apr2021, I've been on my cycle on and off) and PRODUCT DOSE OMISSION ISSUE (received the first dose of Moderna COVID19 Vaccine on 24Apr2021, did not receive the second dose yet). On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling in my arm where I got the shot) and VACCINATION SITE ERYTHEMA (red and really swollen). On an unknown date, the patient experienced BLOOD LOSS ANAEMIA (became anemic and lost a lot of blood during these months) (seriousness criteria hospitalization and medically significant), HEAVY MENSTRUAL BLEEDING (I'm concerned because it's a lot/it'll leak like a water faucet/also had a lot of clots / it lasted for 22 days) (seriousness criteria hospitalization and medically significant), CHEST DISCOMFORT (chest problems) (seriousness criterion hospitalization), POLYMENORRHOEA (Then 3-5 days later, her cycle came back / It'll stop for 3-5 days, but it'll come around longer) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired). The patient was hospitalized on 19-Aug-2021 due to BLOOD LOSS ANAEMIA, CHEST DISCOMFORT and HEAVY MENSTRUAL BLEEDING. On 24-Apr-2021, PRODUCT DOSE OMISSION ISSUE (received the first dose of Moderna COVID19 Vaccine on 24Apr2021, did not receive the second dose yet) had resolved. On 02-Aug-2021, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling in my arm where I got the shot) and VACCINATION SITE ERYTHEMA (red and really swollen) had resolved. At the time of the report, BLOOD LOSS ANAEMIA (became anemic and lost a lot of blood during these months), HEAVY MENSTRUAL BLEEDING (I'm concerned because it's a lot/it'll leak like a water faucet/also had a lot of clots / it lasted for 22 days) and CHEST DISCOMFORT (chest problems) had not resolved and MENSTRUATION IRREGULAR (menstrual cycle wasn't due yet / since 24Apr2021, I've been on my cycle on and off), POLYMENORRHOEA (Then 3-5 days later, her cycle came back / It'll stop for 3-5 days, but it'll come around longer) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications are provided. The patient reports that she put Vaseline on her arm and covered her arm, so that she wouldn't scratch it..Patient was admitted to hospital after chest discomfort on 19 -Aug-2021 and received blood transfusion for the next 2 days. Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information is requested. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-Sep-2021: Patient demographic updated. Events Blood loss anemia, Heavy menstrual bleeding and Chest discomfort added with seriousness hospitalization. On 09-Sep-2021: Followup received, contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information is requested.

Other Meds:

Current Illness:

ID: 1706685
Sex: F
Age: 73
State: VA

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 09/17/2021
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: Arm was really sore; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really sore) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia (For a long time but had not been bothered by it in several years). Concomitant products included METFORMIN for Diabetes, ATENOLOL, LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR), ALPRAZOLAM (XANAX), ACETYLSALICYLIC ACID (BABY ASPIRIN), DULOXETINE and VITAMIN D NOS for an unknown indication. On 25-Jan-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 PAIN IN EXTREMITY (Arm was really sore) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm was really sore) and HEADACHE (Headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment medications were provided. The patient received both doses of the Moderna COVID-19 Vaccine on it's right arm (it's not entirely sure), patient takes Blood pressure pill (on nap time), Baton for the hair and nails and Acidol for the stomach to put good bacteria in your system as concomitant. This case was linked to MOD-2021-276528 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received: Added medical history (fibromyalgia) On 08-Sep-2021: Follow up received and contains concomitant details

Other Meds: ATENOLOL; LISINOPRIL; METFORMIN; SINGULAIR; XANAX; BABY ASPIRIN; DULOXETINE; VITAMIN D NOS

Current Illness: Fibromyalgia (For a long time but had not been bothered by it in several years)

ID: 1706686
Sex: F
Age: 38
State: NC

Vax Date: 03/20/2021
Onset Date: 04/17/2021
Rec V Date: 09/17/2021
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: mild soreness in the arm; Fatigue after the second; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination. No medical history was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID (VIT C), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PROBIOTICS NOS for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-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 in November 2020 and the estimated date of delivery was 10-Aug-2021. On 17-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 17-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) to be possibly related. No further causality assessments were provided for PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second). No treatment medications were reported. Last menstrual period was reported as beginning of November This is a case of vaccine exposure during pregnancy with associated AEs for PT fatigue and pain in extremity for this female. This case was linked to MOD-2021-278047 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received and updated contact information. Changes from the initial document included addition of event and change in PT term for another event; Sender's Comments: This is a case of vaccine exposure during pregnancy with associated AEs for PT fatigue and pain in extremity for this female.

Other Meds: SYNTHROID; VIT C; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; PROBIOTICS NOS

Current Illness:

ID: 1706687
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: platelet count; Result Unstructured Data: gone up to more than 1 million

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: issue with her platelet/platelet count had gone up to more than 1 million; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (issue with her platelet/platelet count had gone up to more than 1 million) 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 PLATELET COUNT INCREASED (issue with her platelet/platelet count had gone up to more than 1 million). At the time of the report, PLATELET COUNT INCREASED (issue with her platelet/platelet count had gone up to more than 1 million) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 1 million (High) gone up to more than 1 million. No concomitant medications reported. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow-up information received contain significant information- event outcome updated to not recovered/ not resolved.

Other Meds:

Current Illness:

ID: 1706688
Sex: F
Age: 66
State: MI

Vax Date: 03/11/2021
Onset Date: 08/10/2021
Rec V Date: 09/17/2021
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: Poison ivy; Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Poison ivy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart). On an unknown date, the patient experienced DERMATITIS CONTACT (Poison ivy). On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart) had resolved. At the time of the report, DERMATITIS CONTACT (Poison ivy) outcome was unknown. Treatment information was not provided by the reporter. Patient did not experienced any event after second dose administered. Patient did not take any oral medication to combat the itching. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up receive on 9-AUG-2021 Event poison ivy updated On 08-Sep-2021: Follow up received. Second dose added, event inappropriate schedule of drug administered added and action taken changed to not applicable

Other Meds: VITAMINS NOS

Current Illness:

ID: 1706689
Sex: F
Age: 29
State: MI

Vax Date: 08/04/2021
Onset Date: 08/05/2021
Rec V Date: 09/17/2021
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: dizziness; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088B21A) for COVID-19 vaccination. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and NORETHISTERONE (NORLYDA) for an unknown indication. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LEXAPRO; NORLYDA

Current Illness:

ID: 1706690
Sex: F
Age: 54
State: SC

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210806; Test Name: Heart pumping fast; Result Unstructured Data: Heart pumping fast

Allergies:

Symptom List: Pain in extremity

Symptoms: Anxiety prior to scheduled appointment for 2nd shot; Dizziness; vision seems off; tightness in throat; head feels tingly; Heart pumping fast; Anxiety after first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly) and PALPITATIONS (Heart pumping fast) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and VACCINATION COMPLICATION (Anxiety after first shot). On 03-Sep-2021, the patient experienced ANXIETY (Anxiety prior to scheduled appointment for 2nd shot). On 07-Aug-2021, VACCINATION COMPLICATION (Anxiety after first shot) had resolved. At the time of the report, DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and ANXIETY (Anxiety prior to scheduled appointment for 2nd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Heart rate: high (High) Heart pumping fast. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were reported. No Treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant Follow-up include event of Anxiety .

Other Meds:

Current Illness:

ID: 1706691
Sex: M
Age:
State: NY

Vax Date: 04/15/2021
Onset Date: 08/05/2021
Rec V Date: 09/17/2021
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: 2nd dose received 2.5 months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 2.5 months after the first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 2.5 months after the first dose). On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 2.5 months after the first dose) had resolved. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The patient denied of experiencing any adverse reactions after 1st or 2nd dose of the vaccine and had already spoken to the physician regarding the effectiveness of the dose. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contains updated phone number of reporter and updated narrative

Other Meds:

Current Illness:

ID: 1706692
Sex: F
Age: 38
State: ME

Vax Date: 04/22/2021
Onset Date: 05/20/2021
Rec V Date: 09/17/2021
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: Felt like the flu; Shooting pain in the left arm /achy; Malaise; Nausea; Little headache; Possible mild fever; Tiny chill; Intense chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), CHEST PAIN (Intense chest pain), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy) and PYREXIA (Possible mild fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced CHEST PAIN (Intense chest pain). On 21-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Possible mild fever) and CHILLS (Tiny chill). On an unknown date, the patient experienced MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy), NAUSEA (Nausea) and HEADACHE (Little headache). At the time of the report, MALAISE (Malaise), CHEST PAIN (Intense chest pain), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy), PYREXIA (Possible mild fever), CHILLS (Tiny chill), NAUSEA (Nausea) and HEADACHE (Little headache) outcome was unknown. No concomitant medications details were provided. No treatment medications details were provided. This case was linked to MOD-2021-280640 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Non-Significant Follow up- Reporter email address and contact details updated.

Other Meds:

Current Illness:

ID: 1706693
Sex: F
Age:
State: MN

Vax Date: 03/29/2021
Onset Date: 04/26/2021
Rec V Date: 09/17/2021
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: Lips started to peel/peeling; "My whole life is miserable for it", "I don't want to live because of this" and "I'm getting desperate".; "so sore" that if you press kind of hard, it hurts; It feels raw/dry; It's "sticky" when she puts her fingers on it/After a while, her bottom lip got the same/ got so bad; The more she put on, the worse it got/She eventually got new skin coming through, but then the whole process started again. They got dry again and peeled.; Bad reaction to Nystatin oral; Lips are swollen and puffy underneath; Thinks her teeth might have a problem that it's affecting the lips; Can't have a healthy diet/ grabbing food with a spoon/drinking through a straw to avoid her lips and must eat softer foods; Fever; Hurt a little bit in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIP EXFOLIATION (Lips started to peel/peeling), FEELING ABNORMAL ("My whole life is miserable for it", "I don't want to live because of this" and "I'm getting desperate".), LIP PAIN ("so sore" that if you press kind of hard, it hurts), CHAPPED LIPS (It feels raw/dry) and ORAL DISCOMFORT (It's "sticky" when she puts her fingers on it/After a while, her bottom lip got the same/ got so bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCODONE, LORAZEPAM, VITAMINS NOS, MAGNESIUM and PROBIOTICS NOS for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (Hurt a little bit in the injection site). On 29-Apr-2021, the patient experienced LIP EXFOLIATION (Lips started to peel/peeling), FEELING ABNORMAL ("My whole life is miserable for it", "I don't want to live because of this" and "I'm getting desperate".), LIP PAIN ("so sore" that if you press kind of hard, it hurts), CHAPPED LIPS (It feels raw/dry), ORAL DISCOMFORT (It's "sticky" when she puts her fingers on it/After a while, her bottom lip got the same/ got so bad), CONDITION AGGRAVATED (The more she put on, the worse it got/She eventually got new skin coming through, but then the whole process started again. They got dry again and peeled.), HYPERSENSITIVITY (Bad reaction to Nystatin oral), LIP SWELLING (Lips are swollen and puffy underneath), DENTAL DISCOMFORT (Thinks her teeth might have a problem that it's affecting the lips), DIET FAILURE (Can't have a healthy diet/ grabbing food with a spoon/drinking through a straw to avoid her lips and must eat softer foods) and PYREXIA (Fever). At the time of the report, LIP EXFOLIATION (Lips started to peel/peeling), FEELING ABNORMAL ("My whole life is miserable for it", "I don't want to live because of this" and "I'm getting desperate".), LIP PAIN ("so sore" that if you press kind of hard, it hurts), CHAPPED LIPS (It feels raw/dry), ORAL DISCOMFORT (It's "sticky" when she puts her fingers on it/After a while, her bottom lip got the same/ got so bad), CONDITION AGGRAVATED (The more she put on, the worse it got/She eventually got new skin coming through, but then the whole process started again. They got dry again and peeled.), HYPERSENSITIVITY (Bad reaction to Nystatin oral), LIP SWELLING (Lips are swollen and puffy underneath), DENTAL DISCOMFORT (Thinks her teeth might have a problem that it's affecting the lips), DIET FAILURE (Can't have a healthy diet/ grabbing food with a spoon/drinking through a straw to avoid her lips and must eat softer foods), VACCINATION SITE PAIN (Hurt a little bit in the injection site) and PYREXIA (Fever) outcome was unknown. This case was linked to MOD-2021-280787.

Other Meds: HYDROCODONE; LORAZEPAM; VITAMINS NOS; MAGNESIUM; PROBIOTICS NOS

Current Illness:

ID: 1706694
Sex: F
Age:
State: FL

Vax Date: 02/01/2021
Onset Date: 05/05/2021
Rec V Date: 09/17/2021
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: Cannot sleep; Sudden pain in either forearm or hand Pain; Pinched nerve; Numbness in rt arm from shoulder to finger tiips; wake up not feeling right; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips), INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain), FEELING ABNORMAL (wake up not feeling right) and NERVE COMPRESSION (Pinched nerve) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Dilaudid), Allergy to antibiotic (Doxicycline), Age-related macular degeneration, Hyperlipidemia since 21-Dec-2015, Hypertension since 21-Dec-2015, Impaired fasting glucose since 15-Jun-2017 and Sleep apnea since 06-Jun-2016. Concomitant products included ATORVASTATIN from 21-Dec-2015 to an unknown date for Cholesterol, DILTIAZEM HYDROCHLORIDE (DILTIAZEM AN) from 21-Dec-2015 to an unknown date for Hypertension, HYDROCHLOROTHIAZIDE from 21-Dec-2015 to an unknown date, SPIRULINA [SPIRULINA SPP.] from 17-Oct-2019 to an unknown date and CALCIUM CARBONATE from 09-Jul-2019 to an unknown date for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FEELING ABNORMAL (wake up not feeling right). On 15-May-2021, the patient experienced HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips). On an unknown date, the patient experienced INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain) and NERVE COMPRESSION (Pinched nerve). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips) had not resolved, INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain) and FEELING ABNORMAL (wake up not feeling right) outcome was unknown and NERVE COMPRESSION (Pinched nerve) was resolving. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up 2 information included no new information. On 06-Sep-2021: Follow-up information included patient demographics, medical history, concomitant and treatment information, dose 1 outcome, dose 2 info, and new events.

Other Meds: DILTIAZEM AN; ATORVASTATIN; HYDROCHLOROTHIAZIDE; SPIRULINA [SPIRULINA SPP.]; CALCIUM CARBONATE

Current Illness: Age-related macular degeneration; Allergy to antibiotic (Doxicycline); Drug allergy (Dilaudid); Drug allergy (Codeine); Hyperlipidemia; Hypertension; Impaired fasting glucose; Sleep apnea

ID: 1706695
Sex: M
Age: 22
State: CO

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 09/17/2021
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: first Moderna injection in May/2021 and did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose) had resolved. No concomitant medication details was reported. No treatment medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 08-Sep-2021 contains significant information, added dose two details.

Other Meds:

Current Illness:

ID: 1706696
Sex: F
Age: 62
State: SD

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 09/17/2021
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: her arm hurt for a long long time; Rash; a raised red dot at the injection site; tired; chills; fever; health care provider removed the needle during administration so she had some of the vaccine on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mastectomy. Concurrent medical conditions included Migraine. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and UNDERDOSE (health care provider removed the needle during administration so she had some of the vaccine on her arm). At the time of the report, PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired), CHILLS (chills) and PYREXIA (fever) outcome was unknown and UNDERDOSE (health care provider removed the needle during administration so she had some of the vaccine on her arm) had resolved. Treatment information was not provided. No lab data provided by reporter. Other concomitant Excedrin that patient had taken for migraines . This case was linked to MOD-2021-285640 (Patient Link).

Other Meds:

Current Illness: Migraine

ID: 1706697
Sex: M
Age: 58
State: OR

Vax Date: 01/01/2021
Onset Date: 08/09/2021
Rec V Date: 09/17/2021
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: Caller got Pfizer vaccine and Moderna vaccine; kind like the flu; uncomfortable; felt nauseous; Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug; arm is sore/sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug), INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine), INFLUENZA LIKE ILLNESS (kind like the flu), DISCOMFORT (uncomfortable) and MYALGIA (arm is sore/sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. The patient's past medical history included Pneumonia (had pneumonia four times and was hospitalized once), Staphylococcal infection (Staph in the left knee) and Surgery. Concurrent medical conditions included COPD, Asthma and Overweight. Concomitant products included NAPROXEN, GABAPENTIN, CARISOPRODOL (SOMA [CARISOPRODOL]), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), SALBUTAMOL (ALBUTEROL HFA) and SUMATRIPTAN for an unknown indication. In January 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug), MYALGIA (arm is sore/sore) and HEADACHE (headache). On 10-Aug-2021, the patient experienced NAUSEA (felt nauseous). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine), INFLUENZA LIKE ILLNESS (kind like the flu) and DISCOMFORT (uncomfortable). On 09-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug) and HEADACHE (headache) had resolved. On 13-Aug-2021, NAUSEA (felt nauseous) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine) had resolved, INFLUENZA LIKE ILLNESS (kind like the flu) and DISCOMFORT (uncomfortable) outcome was unknown and MYALGIA (arm is sore/sore) had not resolved. Concomitant medication includes paxil. No treatment drugs were reported. He took a nausea pill. Yesterday was still a little nauseous.

Other Meds: NAPROXEN; GABAPENTIN; SOMA [CARISOPRODOL]; STATIN [ATORVASTATIN CALCIUM]; ALBUTEROL HFA; SUMATRIPTAN

Current Illness: Asthma; COPD; Overweight

ID: 1706698
Sex: U
Age: 66
State: MI

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 09/17/2021
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: updated patient information; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (updated patient information) in a 67-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 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (updated patient information). At the time of the report, EXPIRED PRODUCT ADMINISTERED (updated patient information) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1706699
Sex: F
Age: 41
State:

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/17/2021
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: pain on the upper part of her right ear which extended to her right eye; dizziness; heart palpitations; bad bruise on her left arm where the vaccine was administered; pain on the right side of her head and the upper part of her right ear which extended to her right eye; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054(?)C21A) for COVID-19 vaccination. No medical history is provided by reporter. On 06-Aug-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 EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant drugs were not provided

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am