VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1559421
Sex: F
Age: 71
State: MO

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
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: CONCERNED; RED BLOTCHES DONT SEEM TO BE GOING AWAY; REDNESS ON HER LEFT ARM; TWO BIG RED BLOTCHES; SORENESS IN LEFT ARM; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORENESS IN LEFT ARM), ERYTHEMA (REDNESS ON HER LEFT ARM), RASH MACULAR (TWO BIG RED BLOTCHES), ANXIETY (CONCERNED) and RASH MACULAR (RED BLOTCHES DONT SEEM TO BE GOING AWAY) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included Thyroidectomy, Corneal biopsy (on 2011 and 2013) and Osteopenia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (SORENESS IN LEFT ARM). On 07-Feb-2021, the patient experienced ERYTHEMA (REDNESS ON HER LEFT ARM) and RASH MACULAR (TWO BIG RED BLOTCHES). On 17-Feb-2021, the patient experienced ANXIETY (CONCERNED) and RASH MACULAR (RED BLOTCHES DONT SEEM TO BE GOING AWAY). On 07-Feb-2021, PAIN IN EXTREMITY (SORENESS IN LEFT ARM) had resolved. At the time of the report, ERYTHEMA (REDNESS ON HER LEFT ARM), RASH MACULAR (TWO BIG RED BLOTCHES), ANXIETY (CONCERNED) and RASH MACULAR (RED BLOTCHES DONT SEEM TO BE GOING AWAY) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant drug includes prolia june 2020 was last injection, Citracal with iron, prednisolone eye drops. No treatment was reported. This case was linked to MOD-2021-090016 (Patient Link).

Other Meds: SYNTHROID; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1559422
Sex: F
Age: 69
State:

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/15/2021
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: reaction on their arm; arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen; arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen; arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen; arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen; arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen; This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (reaction on their arm), VACCINATION SITE BRUISING (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), VACCINATION SITE WARMTH (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), INJECTION SITE PRURITUS (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen) and VACCINATION SITE SWELLING (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 17-Feb-2021 to an unknown date for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SKIN REACTION (reaction on their arm), VACCINATION SITE BRUISING (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), VACCINATION SITE WARMTH (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), INJECTION SITE PRURITUS (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), VACCINATION SITE SWELLING (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen) and INJECTION SITE ERYTHEMA (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SKIN REACTION (reaction on their arm), VACCINATION SITE BRUISING (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), VACCINATION SITE WARMTH (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), INJECTION SITE PRURITUS (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen), VACCINATION SITE SWELLING (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen) and INJECTION SITE ERYTHEMA (arm was very red, now it comes and go, but it is larger, the center looks bruised, it is warm to the touch, itchy and swollen) 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. The patient took cortisone cream, ice, for treatment. Concomitant product includes airborne gummies 3 per day indication for use multi vitamin+ c ongoing. Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Patient details was reported. Concomitant drug was reported. Event outcome was reported.

Other Meds: LIPITOR

Current Illness:

ID: 1559423
Sex: F
Age: 78
State: WI

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/15/2021
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 pain in injection site since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm pain in injection site since vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm pain in injection site since vaccination). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Arm pain in injection site since vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant medication included unspecified high blood pressure medications.

Other Meds: METFORMIN; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1559424
Sex: F
Age: 80
State: SC

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/15/2021
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: Clumps; ILLNESS; Could not get up from bed; Very dizzy; Cycles of feeling chilly and feeling very hot; Smoke vision; chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Clumps), ILLNESS (ILLNESS), MOBILITY DECREASED (Could not get up from bed), DIZZINESS (Very dizzy) and FEELING OF BODY TEMPERATURE CHANGE (Cycles of feeling chilly and feeling very hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20 Not clear the last letter) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus. Concomitant products included LISINOPRIL and METFORMIN. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Clumps), ILLNESS (ILLNESS), MOBILITY DECREASED (Could not get up from bed), DIZZINESS (Very dizzy), FEELING OF BODY TEMPERATURE CHANGE (Cycles of feeling chilly and feeling very hot), VISUAL IMPAIRMENT (Smoke vision) and CHILLS (chills). At the time of the report, ADVERSE REACTION (Clumps), ILLNESS (ILLNESS), MOBILITY DECREASED (Could not get up from bed), DIZZINESS (Very dizzy), FEELING OF BODY TEMPERATURE CHANGE (Cycles of feeling chilly and feeling very hot), VISUAL IMPAIRMENT (Smoke vision) and CHILLS (chills) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication included paracetamol. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LISINOPRIL; METFORMIN

Current Illness: Hypertension; Type 2 diabetes mellitus

ID: 1559425
Sex: F
Age: 22
State: MI

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
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: full body rash; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (full body rash) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (Penicillin). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (full body rash). At the time of the report, RASH (full body rash) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness: Penicillin allergy (Penicillin)

ID: 1559426
Sex: M
Age: 62
State: NY

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
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: Test Name: ultrasound; Test Result: Negative ; Test Name: X-rays; Test Result: Negative

Allergies:

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

Symptoms: swelling from his elbow to wrist; now his right hand is swollen as well; hot to the touch; Can't use his hand; He has pain in every joint of his hand and fingers.; sore arm; felt like he had flu like symptoms; He was tired and had chills; He was tired and had chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like he had flu like symptoms), JOINT SWELLING (swelling from his elbow to wrist), PERIPHERAL SWELLING (now his right hand is swollen as well) and VACCINATION SITE WARMTH (hot to the touch) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Obesity and Atrial fibrillation. Concurrent medical conditions included Hypertension and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTAN "AGP") and SPIRONOLACTONE for an unknown indication. On 03-Feb-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 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like he had flu like symptoms), CHILLS (He was tired and had chills) and FATIGUE (He was tired and had chills). On 07-Feb-2021, the patient experienced JOINT SWELLING (swelling from his elbow to wrist), PERIPHERAL SWELLING (now his right hand is swollen as well), VACCINATION SITE WARMTH (hot to the touch), FEELING ABNORMAL (Can't use his hand) and ARTHRALGIA (He has pain in every joint of his hand and fingers.). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like he had flu like symptoms), JOINT SWELLING (swelling from his elbow to wrist), PERIPHERAL SWELLING (now his right hand is swollen as well), VACCINATION SITE WARMTH (hot to the touch), FEELING ABNORMAL (Can't use his hand), CHILLS (He was tired and had chills), FATIGUE (He was tired and had chills) and ARTHRALGIA (He has pain in every joint of his hand and fingers.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: negative Negative. On an unknown date, X-ray: negative Negative. No treatment was reported. Action taken in response to mRNA-1273 was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: TCR

Other Meds: LOSARTAN "AGP"; SPIRONOLACTONE

Current Illness: Hypertension; Penicillin allergy

ID: 1559427
Sex: F
Age: 80
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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: every time i take something to drink i have to use the bathroom immediately; feels sick as a dog; barely can walk; body aches; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (every time i take something to drink i have to use the bathroom immediately), VACCINATION COMPLICATION (feels sick as a dog), GAIT DISTURBANCE (barely can walk) and MYALGIA (body aches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Medical History Information not Reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (every time i take something to drink i have to use the bathroom immediately), VACCINATION COMPLICATION (feels sick as a dog), GAIT DISTURBANCE (barely can walk) and MYALGIA (body aches). At the time of the report, BOWEL MOVEMENT IRREGULARITY (every time i take something to drink i have to use the bathroom immediately), VACCINATION COMPLICATION (feels sick as a dog), GAIT DISTURBANCE (barely can walk) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication and treatment information were not reported.

Other Meds:

Current Illness:

ID: 1559428
Sex: F
Age: 73
State: FL

Vax Date: 02/05/2021
Onset Date: 02/07/2021
Rec V Date: 08/15/2021
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: Swelling around injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling around injection site). At the time of the report, VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling around injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. Treatment information included ice for swelling.

Other Meds:

Current Illness:

ID: 1559429
Sex: F
Age: 55
State: AL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/15/2021
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: redspot; pain and soreness; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MACULAR (redspot) and PAIN (pain and soreness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 016M20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Vitamin D low (She does have low Vitamin D as of 09-2020) in September 2020. Concomitant products included LISINOPRIL for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D low. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced RASH MACULAR (redspot) and PAIN (pain and soreness). On 13-Jan-2021, RASH MACULAR (redspot) and PAIN (pain and soreness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: LISINOPRIL; VITAMIN D 2000

Current Illness: Hypertension

ID: 1559430
Sex: F
Age: 81
State: CA

Vax Date: 01/29/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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: rash/itchiness at the injection site.; rash/itchiness at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash/itchiness at the injection site.) and VACCINATION SITE RASH (rash/itchiness at the injection site.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042130A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (rash/itchiness at the injection site.) and VACCINATION SITE RASH (rash/itchiness at the injection site.). At the time of the report, VACCINATION SITE PRURITUS (rash/itchiness at the injection site.) and VACCINATION SITE RASH (rash/itchiness at the injection site.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1559431
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/15/2021
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: body soreness and aching; not feeling well; hurting on the joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body soreness and aching), MALAISE (not feeling well) and ARTHRALGIA (hurting on the joints) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body soreness and aching), MALAISE (not feeling well) and ARTHRALGIA (hurting on the joints). At the time of the report, PAIN (body soreness and aching), MALAISE (not feeling well) and ARTHRALGIA (hurting on the joints) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1559432
Sex: F
Age: 65
State: SC

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/15/2021
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: redness got bigger; itching at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness got bigger), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history was not reported. Concurrent medical conditions included Osteoarthritis (new diagnosis of possibly rheumatoid or osteoarthritis). Concomitant products included MELOXICAM and CIPROFLOXACIN for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 10-Feb-2021, the patient experienced ERYTHEMA (redness got bigger). The patient was treated with DIPHENHYDRAMINE for Itching, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness got bigger), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: MELOXICAM; CIPROFLOXACIN

Current Illness: Osteoarthritis (new diagnosis of possibly rheumatoid or osteoarthritis)

ID: 1559433
Sex: F
Age: 28
State: MA

Vax Date: 02/08/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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: hot to the touch; extremely sore; red; rash getting bigger/ spreading; A spontaneous report was received from a healthcare professional concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash getting bigger spreading/vaccination site rash, extremely sore/vaccination site pain, hot to the touch/vaccination site warmth, red/vaccination site erythema. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the event(s) rash getting bigger spreading. On an unknown date, the patient experienced events, extremely sore, hot to the touch, red and has spreading on her left arm No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), rash getting bigger spreading, extremely sore, hot to the touch, red was unknown.

Other Meds:

Current Illness:

ID: 1559434
Sex: F
Age: 53
State: TX

Vax Date: 01/14/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
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: Body Aches; Headache; Fatigue; A spontaneous report was received from a nurse, concerning herself, a female patient of 53-years-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, headache, body aches and fatigue. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 14 Jan 2021, intramuscularly, in the right upper arm. On 09 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly, in the right upper arm for prophylaxis of COVID-19 infection. On 09- Feb-2021, after the second dose of vaccine, the patient experienced, headache, body aches and fatigue. Treatment of the event included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, headache, body aches and fatigue, was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1559435
Sex: F
Age: 64
State: TX

Vax Date: 01/12/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
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: A bit sore; I have Pleurisy, pain in my right lung when I move.; A spontaneous report was received from a healthcare professional concerning a 64-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events i have pleurisy, pain in my right lung when i move, a bit sore. The patient's medical history was not provided. Concomitant medications reported were Medication for asthma, Medication for high blood pressure for drug use for unknown indication. On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 8 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 132L2OA) via unknown route for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the event(s) i have pleurisy, pain in my right lung when i move. On an unknown date, the patient experienced the event(s) A bit sore. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), i have pleurisy, pain in my right lung when i move, , a bit sore was unknown.

Other Meds:

Current Illness:

ID: 1559436
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: weak; sensation of throat closing; mild tachycardia; shaky; nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea) in a 21-year-old female patient who received mRNA-1273 (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included Obesity and Anxiety. Concurrent medical conditions included Penicillin allergy (Allergies to Penicillin and Sulfa). On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea). The patient was treated with EPINEPHRINE (intramuscular) at a dose of 0.03 mg; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and FAMOTIDINE at an unspecified dose and frequency. At the time of the report, ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter considered ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea) to be possibly related. This case was linked to MOD-2021-055838, MOD-2021-029012, MOD-2021-032365, MOD-2021-055838 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No new information was received.

Other Meds:

Current Illness: Penicillin allergy (Allergies to Penicillin and Sulfa)

ID: 1559437
Sex: F
Age: 77
State:

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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: Did not has enough strength to pull herself up; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Did not has enough strength to pull herself up) and INJECTION SITE PAIN (Pain at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (Did not has enough strength to pull herself up) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, ASTHENIA (Did not has enough strength to pull herself up) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559438
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: headache off and on mostly on; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache off and on mostly on) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 HEADACHE (headache off and on mostly on). At the time of the report, HEADACHE (headache off and on mostly on) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1559439
Sex: M
Age:
State: FL

Vax Date: 01/28/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
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: little bit of a sore arm; redness on the site of the injection; arm was itchy; became more swollen; hardness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), INJECTION SITE ERYTHEMA (redness on the site of the injection), INJECTION SITE PRURITUS (arm was itchy), INJECTION SITE SWELLING (became more swollen) and INJECTION SITE INDURATION (hardness) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE PRURITUS (arm was itchy), INJECTION SITE SWELLING (became more swollen) and INJECTION SITE INDURATION (hardness). On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm) and INJECTION SITE ERYTHEMA (redness on the site of the injection). At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm) and INJECTION SITE ERYTHEMA (redness on the site of the injection) outcome was unknown and INJECTION SITE PRURITUS (arm was itchy), INJECTION SITE SWELLING (became more swollen) and INJECTION SITE INDURATION (hardness) had resolved. Not Provided 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 relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559440
Sex: F
Age: 45
State: NY

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/15/2021
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: fever; muscle pain; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), MYALGIA (muscle pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cancer (Breast cancer and on chemotherapy treatment). On 04-Feb-2021, 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 (fever), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, PYREXIA (fever), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were not reported. No treatment information was provided.

Other Meds:

Current Illness: Cancer (Breast cancer and on chemotherapy treatment)

ID: 1559441
Sex: M
Age: 85
State: FL

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
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: Wrist stiffness; Swollen wrist; Hand stiffness; Finger stiffness; Swollen fingers; Finger pain; Finger pain; Swollen fingers; Swollen hand; Hand pain; Wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Wrist stiffness), JOINT SWELLING (Swollen wrist), MUSCULOSKELETAL STIFFNESS (Hand stiffness), MUSCULOSKELETAL STIFFNESS (Finger stiffness) and the first episode of PERIPHERAL SWELLING (Swollen fingers) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism. Concomitant products included ATORVASTATIN and THYROID (ARMOUR THYROID) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced JOINT STIFFNESS (Wrist stiffness), JOINT SWELLING (Swollen wrist), MUSCULOSKELETAL STIFFNESS (Hand stiffness), MUSCULOSKELETAL STIFFNESS (Finger stiffness), the first episode of PERIPHERAL SWELLING (Swollen fingers), the first episode of PAIN IN EXTREMITY (Finger pain), the second episode of PAIN IN EXTREMITY (Finger pain), the second episode of PERIPHERAL SWELLING (Swollen fingers), PERIPHERAL SWELLING (Swollen hand), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Wrist pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (Wrist stiffness), JOINT SWELLING (Swollen wrist), MUSCULOSKELETAL STIFFNESS (Hand stiffness), MUSCULOSKELETAL STIFFNESS (Finger stiffness), the last episode of PAIN IN EXTREMITY (Finger pain), the last episode of PERIPHERAL SWELLING (Swollen fingers), PERIPHERAL SWELLING (Swollen hand), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Wrist pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ATORVASTATIN; ARMOUR THYROID

Current Illness: Hypothyroidism

ID: 1559442
Sex: F
Age:
State: NC

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/15/2021
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: bones hurt; takes all of my energy to get up; had a rough night.; fatigued; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt), ASTHENIA (takes all of my energy to get up), SLEEP DISORDER (had a rough night.), FATIGUE (fatigued) and HEADACHE (severe headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bones hurt), ASTHENIA (takes all of my energy to get up), SLEEP DISORDER (had a rough night.), FATIGUE (fatigued) and HEADACHE (severe headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BONE PAIN (bones hurt), ASTHENIA (takes all of my energy to get up), SLEEP DISORDER (had a rough night.), FATIGUE (fatigued) and HEADACHE (severe headache) outcome was unknown. No concomitant product was reported by the reporter Treatment medication included Aspirin Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: TCR / NNI

Other Meds:

Current Illness:

ID: 1559443
Sex: M
Age: 74
State: MI

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
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: Rash behind left ear; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash behind left ear) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (Rash behind left ear). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash behind left ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included hydrocortisone. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: NNI

Other Meds:

Current Illness:

ID: 1559444
Sex: F
Age: 76
State: FL

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). On 14-Feb-2021 at 2:00 AM, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 14-Feb-2021 at 4:00 AM, CHILLS (chills) had resolved. On 15-Feb-2021 at 11:00 AM, PYREXIA (fever) and HEADACHE (headache) had resolved. No Concomitant medications was reported . Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-Jul-2021, contains Non-Significant Information.

Other Meds:

Current Illness:

ID: 1559445
Sex: F
Age:
State: NC

Vax Date: 01/20/2021
Onset Date: 01/30/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559446
Sex: F
Age: 59
State: NC

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: injection spot is red; injection spot is itching; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), INJECTION SITE ERYTHEMA (injection spot is red) and INJECTION SITE PRURITUS (injection spot is itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 10-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection spot is red) and INJECTION SITE PRURITUS (injection spot is itching). On 03-Feb-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (injection spot is red) and INJECTION SITE PRURITUS (injection spot is itching) outcome was unknown. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559447
Sex: F
Age: 71
State: NC

Vax Date: 01/20/2021
Onset Date: 02/17/2021
Rec V Date: 08/15/2021
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: Sore Throat; Earache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Earache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Earache). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Earache) 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. Concomitant medication were not reported Treatment medication information were not reported Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow Up received on 26-Apr-2021 contains non significant information

Other Meds:

Current Illness:

ID: 1559448
Sex: M
Age: 36
State: AZ

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/15/2021
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: coughing up green mucus; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (coughing up green mucus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up green mucus). At the time of the report, PRODUCTIVE COUGH (coughing up green mucus) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559449
Sex: F
Age: 90
State: CA

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 08/15/2021
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: swelling and rash on her arm (opposite to injection); swelling and rash on her arm (opposite to injection); Headache; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NASAL CONGESTION (stuffy nose), PERIPHERAL SWELLING (swelling and rash on her arm (opposite to injection)) and RASH (swelling and rash on her arm (opposite to injection)) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Headache) and NASAL CONGESTION (stuffy nose). On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling and rash on her arm (opposite to injection)) and RASH (swelling and rash on her arm (opposite to injection)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Rash, at an unspecified dose and frequency. On 25-Jan-2021, HEADACHE (Headache) and NASAL CONGESTION (stuffy nose) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling and rash on her arm (opposite to injection)) and RASH (swelling and rash on her arm (opposite to injection)) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559450
Sex: F
Age: 58
State: NJ

Vax Date: 01/20/2021
Onset Date: 02/15/2021
Rec V Date: 08/15/2021
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: UTI/ bladder infection; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI/ bladder infection) and CYSTITIS (Bladder infection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included UTI since an unknown date. Concomitant products included NITROFURANTOIN for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI/ bladder infection) and CYSTITIS (Bladder infection). At the time of the report, URINARY TRACT INFECTION (UTI/ bladder infection) and CYSTITIS (Bladder infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: NITROFURANTOIN

Current Illness: UTI

ID: 1559451
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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: feel sick; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel sick), NAUSEA (nausea) and VOMITING (vomiting) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ILLNESS (feel sick), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ILLNESS (feel sick), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Upon internal review on 04-Aug-2021, the age was corrected to 37 years.

Other Meds:

Current Illness:

ID: 1559452
Sex: F
Age: 59
State: NJ

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
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: She has soreness in arm; Stomach ache; Pain in shoulder near collar bone; Pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She has soreness in arm), ABDOMINAL PAIN UPPER (Stomach ache), ARTHRALGIA (Pain in shoulder near collar bone) and VACCINATION SITE PAIN (Pain in arm of injection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm of injection). On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (She has soreness in arm), ABDOMINAL PAIN UPPER (Stomach ache) and ARTHRALGIA (Pain in shoulder near collar bone). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 11-Feb-2021, VACCINATION SITE PAIN (Pain in arm of injection) had resolved. At the time of the report, PAIN IN EXTREMITY (She has soreness in arm), ABDOMINAL PAIN UPPER (Stomach ache) and ARTHRALGIA (Pain in shoulder near collar bone) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medication not reported. This case was linked to MOD-2021-175651 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: updated outcome of the events to recovered.

Other Meds:

Current Illness:

ID: 1559453
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). 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 PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details included Calazime cream. 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. Reporter did not allow further contact; 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: 1559454
Sex: F
Age: 81
State:

Vax Date: 01/20/2021
Onset Date: 01/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: itching at injection site after a week of first vaccine; rash at the injection site after a week of first vaccine; Skin rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching at injection site after a week of first vaccine), INJECTION SITE RASH (rash at the injection site after a week of first vaccine) and RASH (Skin rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (itching at injection site after a week of first vaccine), INJECTION SITE RASH (rash at the injection site after a week of first vaccine) and RASH (Skin rash). At the time of the report, PRURITUS (itching at injection site after a week of first vaccine), INJECTION SITE RASH (rash at the injection site after a week of first vaccine) and RASH (Skin rash) 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. concomitant medication information is not provided.

Other Meds:

Current Illness:

ID: 1559455
Sex: F
Age:
State: NJ

Vax Date: 02/11/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: stool turned black; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (stool turned black) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The patient's past medical history included Migraine and Depression. Concomitant products included VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced FAECES DISCOLOURED (stool turned black). At the time of the report, FAECES DISCOLOURED (stool turned black) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included HRD medicine, depression medicine, migraine medicine and hemapoex vitamin. No treatment information was reported.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1559456
Sex: F
Age: 78
State: NC

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/15/2021
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: extreme heat; anxious; Covid arm; allergic reaction/bumpiness; warmth; itching; swelling; some pain in my injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (extreme heat), ANXIETY (anxious), HYPERSENSITIVITY (Covid arm), ALLERGY TO VACCINE (allergic reaction/bumpiness) and FEELING HOT (warmth) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (fatigue). On 04-Feb-2021, the patient experienced TEMPERATURE INTOLERANCE (extreme heat), ANXIETY (anxious), HYPERSENSITIVITY (Covid arm), ALLERGY TO VACCINE (allergic reaction/bumpiness), FEELING HOT (warmth), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (some pain in my injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 27-Jan-2021, FATIGUE (fatigue) had resolved. On 08-Feb-2021, ANXIETY (anxious), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (some pain in my injection site) had resolved. At the time of the report, TEMPERATURE INTOLERANCE (extreme heat), ALLERGY TO VACCINE (allergic reaction/bumpiness), FEELING HOT (warmth) and VACCINATION SITE SWELLING (swelling) was resolving and HYPERSENSITIVITY (Covid arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to the company on 17-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (extreme heat), ANXIETY (anxious), HYPERSENSITIVITY (Covid arm), ALLERGY TO VACCINE (allergic reaction/bumpiness) and FEELING HOT (warmth) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (fatigue). On 04-Feb-2021, the patient experienced TEMPERATURE INTOLERANCE (extreme heat), ANXIETY (anxious), HYPERSENSITIVITY (Covid arm), ALLERGY TO VACCINE (allergic reaction/bumpiness), FEELING HOT (warmth), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (some pain in my injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 27-Jan-2021, FATIGUE (fatigue) had resolved. On 08-Feb-2021, ANXIETY (anxious), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (some pain in my injection site) had resolved. At the time of the report, TEMPERATURE INTOLERANCE (extreme heat), ALLERGY TO VACCINE (allergic reaction/bumpiness), FEELING HOT (warmth) and VACCINATION SITE SWELLING (swelling) was resolving and HYPERSENSITIVITY (Covid arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by reporter.

Other Meds:

Current Illness:

ID: 1559457
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: worse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (worse reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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 ADVERSE REACTION (worse reactions). At the time of the report, ADVERSE REACTION (worse reactions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-029147 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-029147:

Other Meds:

Current Illness:

ID: 1559458
Sex: F
Age: 53
State:

Vax Date: 01/08/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: covid-19 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 202102; Test Name: covid-19 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 202102; Test Name: covid-19 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Exposed to Covid-19; Diarrhea; Chested cough; Vomits; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to Covid-19), DIARRHOEA (Diarrhea), COUGH (Chested cough) and VOMITING (Vomits) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy, Celiac disease and Asthma. Concomitant products included VITAMINS NOS for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Diarrhea), COUGH (Chested cough) and VOMITING (Vomits). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to Covid-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to Covid-19), DIARRHOEA (Diarrhea), COUGH (Chested cough) and VOMITING (Vomits) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative. 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 details were not reported by the reporter.

Other Meds: VITAMINS NOS

Current Illness: Asthma; Celiac disease; Drug allergy; Penicillin allergy

ID: 1559459
Sex: F
Age: 66
State: IL

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 08/15/2021
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: Weakness; Dehydration; Fatigue; Rigors; Nausea; Vomiting; Cramping; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DEHYDRATION (Dehydration), MUSCLE SPASMS (Cramping), FATIGUE (Fatigue) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping), VOMITING (Vomiting) and NAUSEA (Nausea). On 13-Jan-2021, the patient experienced ASTHENIA (Weakness), DEHYDRATION (Dehydration), FATIGUE (Fatigue) and CHILLS (Rigors). At the time of the report, ASTHENIA (Weakness), DEHYDRATION (Dehydration), MUSCLE SPASMS (Cramping), FATIGUE (Fatigue), VOMITING (Vomiting), CHILLS (Rigors) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was on anti-diarrhea and anti-emetic medications. Concomitant product use was not provided by the reporter

Other Meds:

Current Illness:

ID: 1559460
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Disgusted with the salty metallic taste in her mouth; Lost some weight; Feels depressed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Disgusted with the salty metallic taste in her mouth), WEIGHT DECREASED (Lose some weight) and DEPRESSION (Feels depressed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Chronic lymphocytic leukaemia. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Disgusted with the salty metallic taste in her mouth), WEIGHT DECREASED (Lose some weight) and DEPRESSION (Feels depressed). At the time of the report, DYSGEUSIA (Disgusted with the salty metallic taste in her mouth), WEIGHT DECREASED (Lose some weight) and DEPRESSION (Feels depressed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. The patient went to her dentist and doctor in regards to her reaction, but they are unsure of what caused it. Her sense of smell is fine and she had some blood work done (results are pending).

Other Meds:

Current Illness: Chronic lymphocytic leukaemia

ID: 1559461
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: real strong reaction to first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (real strong reaction to first dose) 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 ADVERSE REACTION (real strong reaction to first dose). At the time of the report, ADVERSE REACTION (real strong reaction to first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Treatment was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1559462
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: mild throat swelling; worsening symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of PHARYNGEAL SWELLING (mild throat swelling) and CONDITION AGGRAVATED (worsening symptoms) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Penicillin allergy and Allergy (Sulfa allergy.). 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 PHARYNGEAL SWELLING (mild throat swelling) and CONDITION AGGRAVATED (worsening symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; EPINEPHRINE (intramuscular) ongoing since an unknown date at a dose of 0.3 mg and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (mild throat swelling) and CONDITION AGGRAVATED (worsening symptoms) had resolved. Not Provided 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 details were not reported by the reporter. This case was linked to MOD-2021-028961, MOD-2021-055838, MOD-2021-032365 (Patient Link).

Other Meds:

Current Illness: Allergy (Sulfa allergy.); Hypertension; Penicillin allergy

ID: 1559463
Sex: F
Age: 67
State: OK

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 08/15/2021
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: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 156/128; Test Name: Blood pressure; Result Unstructured Data: 196/148; Test Name: Pulse; Test Result: Inconclusive ; Result Unstructured Data: pulse 126; Test Name: Oxygen saturation; Result Unstructured Data: 70's; Test Name: Oxygen saturation; Result Unstructured Data: 80's

Allergies:

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

Symptoms: Insomnia; High blood pressure; Headache; a very very bad reaction; a violent debilitating migraine for 13 days; she can barely move her body; couldn't move her arm for 3 days; she was very very ill; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (a very very bad reaction), MIGRAINE (a violent debilitating migraine for 13 days), MALAISE (she was very very ill), DISCOMFORT (she can barely move her body) and LIMB DISCOMFORT (couldn't move her arm for 3 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine, Rheumatoid arthritis, Fibromyalgia, Parkinson's disease and Osteoarthritis. Concomitant products included GABAPENTIN (NEUROTIN [GABAPENTIN]), FLUOXETINE HYDROCHLORIDE (PROZAC), TOPIRAMATE, ZOLPIDEM TARTRATE (AMBIEN), CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), TRAMADOL HYDROCHLORIDE (ULTRAM ER) and FENTANYL (FENTANYL ABZ) for an unknown indication. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (she was very very ill). On 05-Feb-2021, the patient experienced ADVERSE REACTION (a very very bad reaction), MIGRAINE (a violent debilitating migraine for 13 days), DISCOMFORT (she can barely move her body) and LIMB DISCOMFORT (couldn't move her arm for 3 days). On an unknown date, the patient experienced INSOMNIA (Insomnia), HYPERTENSION (High blood pressure) and HEADACHE (Headache). The patient was treated with SUMATRIPTAN at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Migraine, at an unspecified dose and frequency and PROPRANOLOL HYDROCHLORIDE (INDERAL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (a very very bad reaction), MIGRAINE (a violent debilitating migraine for 13 days), MALAISE (she was very very ill), DISCOMFORT (she can barely move her body), LIMB DISCOMFORT (couldn't move her arm for 3 days), INSOMNIA (Insomnia), HYPERTENSION (High blood pressure) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 156/128 (Inconclusive) 156/128 and 196/148 (High) 196/148. On an unknown date, Heart rate: 126 (Inconclusive) pulse 126. On an unknown date, Oxygen saturation: 70 (High) 70's and 80 (Low) 80's. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Lab tests, Toradol and Inderal treatment medication, Insomnia, Hypertension and Headache events added.

Other Meds: NEUROTIN [GABAPENTIN]; PROZAC; TOPIRAMATE; AMBIEN; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; ULTRAM ER; FENTANYL ABZ

Current Illness: Fibromyalgia; Migraine; Osteoarthritis; Parkinson's disease; Rheumatoid arthritis

ID: 1559464
Sex: F
Age: 71
State: NC

Vax Date: 01/31/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
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: Oval warm and raised red patch of two inches wide and one and half inches long on the arm; Oval warm and raised red patch of two inches wide and one and half inches long on the arm; Oval warm and raised red patch of two inches wide and one and half inches long on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Oval warm and raised red patch of two inches wide and one and half inches long on the arm), VACCINATION SITE ERYTHEMA (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) and VACCINATION SITE SWELLING (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Oval warm and raised red patch of two inches wide and one and half inches long on the arm), VACCINATION SITE ERYTHEMA (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) and VACCINATION SITE SWELLING (Oval warm and raised red patch of two inches wide and one and half inches long on the arm). At the time of the report, VACCINATION SITE WARMTH (Oval warm and raised red patch of two inches wide and one and half inches long on the arm), VACCINATION SITE ERYTHEMA (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) and VACCINATION SITE SWELLING (Oval warm and raised red patch of two inches wide and one and half inches long on the arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1559465
Sex: F
Age: 64
State: PA

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Date: 20210214; Test Name: body temperature; Result Unstructured Data: 100F

Allergies:

Symptom List: Vomiting

Symptoms: blurry vision it's like looking through a straw hole; it's like looking through a straw hole; hoarseness in voice; high fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision it's like looking through a straw hole), VISUAL IMPAIRMENT (it's like looking through a straw hole), DYSPHONIA (hoarseness in voice) and PYREXIA (high fever of 100F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concurrent medical conditions included Clot blood and Fatigue. Concomitant products included APIXABAN (ELIQUIS), FLUOXETINE HYDROCHLORIDE (PROZAC), FLUOXETINE, PIROXICAM (MAXIDENE), FAMOTIDINE (PEPCID AC), LEVOTHYROXINE and CLONIDINE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VISION BLURRED (blurry vision it's like looking through a straw hole), VISUAL IMPAIRMENT (it's like looking through a straw hole), DYSPHONIA (hoarseness in voice) and PYREXIA (high fever of 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (blurry vision it's like looking through a straw hole), VISUAL IMPAIRMENT (it's like looking through a straw hole), DYSPHONIA (hoarseness in voice) and PYREXIA (high fever of 100F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100 (High) 100F. 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. The patient had a total of 31 symptoms from it at that time. treatment information was not provided

Other Meds: ELIQUIS; PROZAC; FLUOXETINE; MAXIDENE; PEPCID AC; LEVOTHYROXINE; CLONIDINE

Current Illness: Clot blood; Fatigue

ID: 1559466
Sex: F
Age: 87
State: FL

Vax Date: 01/11/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Date: 20210218; Test Name: Body temperature; Result Unstructured Data: 98.3

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: fatigue; headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (low grade fever) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 15-Feb-2021, HEADACHE (headache) had resolved. On 17-Feb-2021, PYREXIA (low grade fever) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 98.3 (normal) 98.3. No concomitant products were provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI-No new information

Other Meds:

Current Illness:

ID: 1559467
Sex: M
Age: 86
State: NC

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/15/2021
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: Red rash, not at the injection site, but down below; Arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash, not at the injection site, but down below) and PERIPHERAL SWELLING (Arm is swollen) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30L20A and 30L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash, not at the injection site, but down below) and PERIPHERAL SWELLING (Arm is swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash, not at the injection site, but down below) and PERIPHERAL SWELLING (Arm is swollen) outcome was unknown. No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1559468
Sex: F
Age: 78
State: FL

Vax Date: 01/02/2021
Onset Date: 01/01/2021
Rec V Date: 08/15/2021
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: 90 days since her first dose; COVID-19/got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/got COVID) and PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. No Medical History information was reported. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced COVID-19 (COVID-19/got COVID). In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (90 days since her first dose). The patient was treated with BAMLANIVIMAB at a dose of 1 dosage form. In 2021, COVID-19 (COVID-19/got COVID) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product details was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Added Treatment information and batch number for suspect drug On 26-Jun-2021: Follow up information received on 26-JUN-2021 contains No New Information On 07-Jul-2021: Follow up document received on 07-JUL-2021 contains No New Information On 26-Jul-2021: NNI; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This report refers to a case of Product Dose Omission for mRNA-1273, with no associated AEs.

Other Meds:

Current Illness:

ID: 1559469
Sex: F
Age: 42
State: MD

Vax Date: 02/07/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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: Upper shoulder soreness; chills; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Upper shoulder soreness), CHILLS (chills) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Feb-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 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Upper shoulder soreness), CHILLS (chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Upper shoulder soreness), CHILLS (chills) and HEADACHE (Headache) 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 details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1559470
Sex: F
Age:
State: TX

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
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: severe migraine; felt fatigued like having the flu; felt dizzy; redness; bruise on the injection site; rash in face; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull headache), MIGRAINE (severe migraine), INFLUENZA LIKE ILLNESS (felt fatigued like having the flu), DIZZINESS (felt dizzy) and ERYTHEMA (redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (dull headache), MIGRAINE (severe migraine), INFLUENZA LIKE ILLNESS (felt fatigued like having the flu), DIZZINESS (felt dizzy), ERYTHEMA (redness), RASH (rash in face) and CONTUSION (bruise on the injection site). On 17-Feb-2021, ERYTHEMA (redness) had resolved. At the time of the report, HEADACHE (dull headache), MIGRAINE (severe migraine), INFLUENZA LIKE ILLNESS (felt fatigued like having the flu), DIZZINESS (felt dizzy), RASH (rash in face) and CONTUSION (bruise on the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am