VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1707056
Sex: F
Age: 43
State: KY

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Tingling in all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in all over the body) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06EZ1A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Depression, Diabetes and Skin disorder. Concomitant products included TRAZODONE for Depression, METFORMIN and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for Diabetes, TERAZOSIN HYDROCHLORIDE (VICARD [TERAZOSIN HYDROCHLORIDE]) for Hypertension, HYDROCORTISONE and BETAMETHASONE for Skin disorder. On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced PARAESTHESIA (Tingling in all over the body). At the time of the report, PARAESTHESIA (Tingling in all over the body) outcome was unknown. No treatment information was reported.

Other Meds: VICARD [TERAZOSIN HYDROCHLORIDE]; TRAZODONE; METFORMIN; INVOKANA [CANAGLIFLOZIN]; HYDROCORTISONE; BETAMETHASONE

Current Illness: Depression; Diabetes; Hypertension; Skin disorder

ID: 1707057
Sex: M
Age: 63
State: OK

Vax Date: 08/06/2021
Onset Date: 09/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Received dose from Vial punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from Vial punctured more than 12 hours before) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021 at 8:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021 at 8:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from Vial punctured more than 12 hours before). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from Vial punctured more than 12 hours before) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 07-SEP-2021 contains Non-Significant information-Reporter information added, vaccine route of administration, specific anatomical site updated.

Other Meds:

Current Illness:

ID: 1707058
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: pain in the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1707059
Sex: F
Age: 54
State: CA

Vax Date: 08/05/2021
Onset Date: 08/30/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: pharmacist would not give her the second dose; left hip joint pain (last 4 to 5 days); left hip joint pain is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose), ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing). On 02-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose), ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing) 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 medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1707060
Sex: F
Age: 54
State: MS

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A little sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after first dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 038A21A and 002F21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (A little sore arm after first dose). On 08-Mar-2021, MYALGIA (A little sore arm after first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Skyrizi injection took by patient in Feb2021 600mg, and in May 2021 300mg and it is scheduled in SEP 2021. No treatment information was reported by reporter. This case was linked to MOD-2021-307235, MOD-2021-307237 (Patient Link).

Other Meds: SKYRIZI [RISANKIZUMAB]

Current Illness: Autoimmune disorder; Psoriasis

ID: 1707061
Sex: F
Age:
State: CA

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication is provided No treatment medication is provided Reporter stated the vial was received on 19-Jan-2021 and on 10-Mar-2021 it was moved from freezer to refrigerator. This case was linked to MOD-2021-314646 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Updated reporter details, Patient information added, dose number added On 09-Sep-2021: Follow-up appended. Patient initials were updated..

Other Meds:

Current Illness:

ID: 1707062
Sex: M
Age: 38
State: KS

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Bloodshot eye; Pain in arm; Pain localised; Shoulder pain; Muscle tension; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension). At the time of the report, OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1707063
Sex: F
Age: 80
State: FL

Vax Date: 01/27/2021
Onset Date: 08/24/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: 100.5; Test Date: 2021; Test Name: COVID-19 Virus test; Test Result: Negative; Result Unstructured Data: Negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe aching), FEELING ABNORMAL (felt generally awful), MOBILITY DECREASED (strictly in bed all day), DIARRHEA (diarrea) and DECREASED APPETITE (no appetite) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PAIN (severe aching), FEELING ABNORMAL (felt generally awful), CHILLS (chills) and PYREXIA (woke up with a temperature of 100.5). On 25-Aug-2021, the patient experienced MOBILITY DECREASED (strictly in bed all day). 25-Aug-2021, the patient experienced DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), FATIGUE (huge fatigue), HEADACHE (headache) and NAUSEA (nausea). On 31-Aug-2021, the patient experienced ASTHENIA (15 to 20 minutes of energy). On an unknown date, the patient experienced PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy) and DIZZINESS POSTURAL (worse with standing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, MOBILITY DECREASED (strictly in bed all day) had resolved. On 26-Aug-2021, PYREXIA (woke up with a temperature of 100.5) had resolved. On 29-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN (severe aching), FEELING ABNORMAL (felt generally awful), DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy), DIZZINESS POSTURAL (worse with standing), ASTHENIA (15 to 20 minutes of energy), FATIGUE (huge fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Aug-2021, Body temperature: 100.5 (High) 100.5. No relevant concomitant product were reported

Other Meds:

Current Illness:

ID: 1707064
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Having a really bad headache last night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Having a really bad headache last night) 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. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (Having a really bad headache last night). The patient was treated with IBUPROFEN on 02-Sep-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Having a really bad headache last night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter.

Other Meds:

Current Illness:

ID: 1707065
Sex: F
Age: 44
State: CO

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: weird symptoms; right ear started hurting bad/pain has been coming and going; swooshing sound; ended up being my heart rate which I could hear in my head; ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), TINNITUS (swooshing sound), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), TINNITUS (swooshing sound), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection). At the time of the report, FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection) outcome was unknown and TINNITUS (swooshing sound) had not 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. The patient experienced some weird symptoms since receiving the vaccine. A couple of days after the first dose her right ear started hurting bad. This was accompanied by a swooshing sound, which ended up being her heart rate which she could hear in her head, tinnitus and was worse with lying down, sitting or stress. The patient was treated for an ear infection with sulfatide or cephalosporin. The patient had vexing and weeing kind of pain. She also has had headaches which have been continuous since then feeling like pressure in her head. She has seen an ENT specialist and neurologist who did MRIs showing no brain tumor or blood flow issues. She saw neuro yesterday who concluded that her symptoms were due to intercranial hypertension. She is now scheduled to get a spinal tap on 14SEP2021. This case was linked to MOD-2021-307252 (Patient Link).

Other Meds:

Current Illness:

ID: 1707066
Sex: F
Age:
State: CA

Vax Date: 08/29/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The rash is itchy; Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D22A) for COVID-19 vaccination. No Medical History information was reported. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy). At the time of the report, RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was given. No treatment medication was given. It was reported that, patient was scared about getting the Moderna second vaccine. She did state that her vaccine paperwork from where she went for her vaccine, was documented as the left arm, but said it was given in the right arm.

Other Meds:

Current Illness:

ID: 1707067
Sex: F
Age: 77
State: DE

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: All day in bed; All night long throwing up and it was coming from the other end too; All night long throwing up and it was coming from the other end too/ Threw up 25 times; Hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), BEDRIDDEN (All day in bed), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026P21A) for COVID-19 vaccination. No medical history was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times). On 04-Aug-2021, the patient experienced BEDRIDDEN (All day in bed). On 05-Aug-2021, BEDRIDDEN (All day in bed) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included cancer, heart medicine and 13 medicines every morning. No treatment drug was reported. The patient went home after vaccination and felt hot and cold. After supper time, went to bed but that night was all night long throwing up and it was coming from the other end too. On Thursday patient was also in bed. On 03-Sep-2021, Friday, the patient was feeling a little bit better.

Other Meds:

Current Illness:

ID: 1707068
Sex: F
Age:
State: NJ

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; itching, swollen and hot to the touch at the injection site; itching, swollen and hot to the touch at the injection site; hot to the touch at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (itching, swollen and hot to the touch at the injection site), VACCINATION SITE SWELLING (itching, swollen and hot to the touch at the injection site) and VACCINATION SITE WARMTH (hot to the touch at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 49E21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (itching, swollen and hot to the touch at the injection site), VACCINATION SITE SWELLING (itching, swollen and hot to the touch at the injection site) and VACCINATION SITE WARMTH (hot to the touch at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (itching, swollen and hot to the touch at the injection site), VACCINATION SITE SWELLING (itching, swollen and hot to the touch at the injection site) and VACCINATION SITE WARMTH (hot to the touch at the injection site) outcome was unknown. no concomitant medications are provided. patient used icepack for hot spot. She stated both shots and only had sore arm with the 2nd shot. This case was linked to MOD-2021-307222 (Patient Link).

Other Meds:

Current Illness:

ID: 1707069
Sex: U
Age:
State:

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: First dose on 10-JUN-2021 and it's now 2-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 10-JUN-2021 and it's now 2-SEP-2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 10-JUN-2021 and it's now 2-SEP-2021). On 10-Jun-2021, PRODUCT DOSE OMISSION ISSUE (First dose on 10-JUN-2021 and it's now 2-SEP-2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. The treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707070
Sex: F
Age: 61
State: NJ

Vax Date: 08/22/2021
Onset Date: 09/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No patient treatment and concomitant medication were provided. Patient past medication history was not given. On 03-Sep-2021 she found out by rapid test she was COVID-19 positive. She was due for her second shot on 21-Sept-2021.

Other Meds:

Current Illness:

ID: 1707071
Sex: F
Age: 34
State: NC

Vax Date: 08/02/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Bleeding/bled for almost a month straight/after that it was off and on; It almost ruined her marriage and broke a lot of her friendships; Turned her into the beast; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) and FEELING ABNORMAL (Turned her into the beast) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FA7484) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on) (seriousness criterion hospitalization), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) (seriousness criterion hospitalization) and FEELING ABNORMAL (Turned her into the beast) (seriousness criterion hospitalization). At the time of the report, HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) and FEELING ABNORMAL (Turned her into the beast) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The concomitant medications were not reported. The treatment information was not provided. The patient reported that after the vaccine and the social circumstances she had been through she was admitted in the psychiatric hospital . She was drugged and was raped at the hospital . The patient also reported that she will not get second dose of moderna vaccine. Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1707072
Sex: M
Age: 69
State: NY

Vax Date: 06/07/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache comes instant of cough; feels in back of neck; not getting good blood flow to capillaries; feels in back of neck; constipated; pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it; COVID-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck) and CONSTIPATION (constipated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD and Venous stasis (in Leg). Concomitant products included AMLODIPINE, BENAZEPRIL and HYDROCHLOROTHIAZIDE for Blood pressure, PRAVASTATIN for Cholesterol. On 07-Jun-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 COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment medication was mentioned

Other Meds: AMLODIPINE; BENAZEPRIL; HYDROCHLOROTHIAZIDE; PRAVASTATIN

Current Illness: COPD; Venous stasis (in Leg)

ID: 1707073
Sex: F
Age:
State: TX

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: strong reaction to the first shot/pretty rough night; very intense body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Fibromyalgia, Arthritis, Hives (breaks in hives in response to foods.) and Food allergy. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination adverse reaction, Myalgia, Pyrexia and Chills, at an unspecified dose and frequency. In 2021, VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication inhaler was provided. This case was linked to MOD-2021-307238, MOD-2021-307256 (Patient Link).

Other Meds:

Current Illness: Arthritis; Asthma; Fibromyalgia; Food allergy; Hives (breaks in hives in response to foods.)

ID: 1707074
Sex: F
Age: 43
State: CA

Vax Date: 07/14/2021
Onset Date: 08/12/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: Blood work; Result Unstructured Data: normal; Test Date: 20210830; Test Name: Blood work; Result Unstructured Data: normal; Test Date: 20210814; Test Name: Chest X-ray; Result Unstructured Data: normal; Test Date: 20210830; Test Name: Chest X-ray; Result Unstructured Data: normal; Test Date: 20210814; Test Name: EKG; Result Unstructured Data: normal; Test Date: 20210830; Test Name: EKG; Result Unstructured Data: normal; Test Date: 20210814; Test Name: Heart rate; Result Unstructured Data: 100 to 78

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: My heart was heavy; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (My heart was heavy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC DISCOMFORT (My heart was heavy). At the time of the report, CARDIAC DISCOMFORT (My heart was heavy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood test: normal (normal) normal. On 14-Aug-2021, Chest X-ray: normal (normal) normal. On 14-Aug-2021, Electrocardiogram: normal (normal) normal. On 14-Aug-2021, Heart rate: 100 to 78 (abnormal) 100 to 78. On 30-Aug-2021, Blood test: normal (normal) normal. On 30-Aug-2021, Chest X-ray: normal (normal) normal. On 30-Aug-2021, Electrocardiogram: normal (normal) normal. Concomitant medications were not provided. Treatment medications were not provided. Patient states that on 12-AUG-2021 she started feeling like her heart was heavy. Her watch read her heart rate and the heart rate increased. Even after getting results as normal for labs, these symptoms continue and she has made an appointment with a cardiologist whom she has not yet seen.

Other Meds:

Current Illness:

ID: 1707075
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. This case was linked to MOD-2021-307201 (Patient Link).

Other Meds:

Current Illness:

ID: 1707076
Sex: F
Age: 62
State: CA

Vax Date: 04/12/2021
Onset Date: 04/26/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Second dose schedule more than 36 days from first dose; Allergy flare up; Eyes swelling; Rash on face; Rash on neck; Rash on arm and waistline; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swelling), ALLERGY TO VACCINE (Allergy flare up), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedule more than 36 days from first dose), RASH (Rash on arm and waistline) and RASH (Rash on face) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergic reaction to drug excipient, Latex allergy and Allergy to synthetic fabric. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced RASH (Rash on arm and waistline). On 03-May-2021, the patient experienced EYE SWELLING (Eyes swelling), RASH (Rash on face) and RASH (Rash on neck). On 10-May-2021, the patient experienced ALLERGY TO VACCINE (Allergy flare up). On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedule more than 36 days from first dose). The patient was treated with PREDNISONE (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eyes swelling), ALLERGY TO VACCINE (Allergy flare up), RASH (Rash on arm and waistline), RASH (Rash on face) and RASH (Rash on neck) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedule more than 36 days from first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Two weeks after vaccination, the patient got a big rash on her arm and waistline. It got worse so she went to an urgent care and was given with corticosteroids and a cream. The symptoms went away but then after a week, it got more severe. The rashes went up to her face and neck and her eyes were swollen and she was then given again with higher dose of steroids. But few days after, for the third time, patient had flare up. She was prescribed with oral prednisone, a different cream and EpiPen incase of possible anaphylactic reaction. The patient was fine afterwards and consulted an allergologist. It was found out that she was allergic to polysorbent 80, latex and fabric polyester.

Other Meds: SYNTHROID; LIPITOR

Current Illness: Allergic reaction to drug excipient; Allergy to synthetic fabric; Latex allergy

ID: 1707077
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: 102 temp day after the booster shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 temp day after the booster shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 temp day after the booster shot). At the time of the report, PYREXIA (102 temp day after the booster shot) outcome was unknown. No concomitant medication provided. No treatment medication provided.

Other Meds:

Current Illness:

ID: 1707078
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches). At the time of the report, FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1707079
Sex: M
Age: 67
State: FL

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: little more soreness than the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little more soreness than the 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (little more soreness than the 1st dose). At the time of the report, MYALGIA (little more soreness than the 1st dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication include A-fib medication and Cholesterol medication. Treatment information was not provided. This case was linked to MOD-2021-308606, MOD-2021-308612 (Patient Link).

Other Meds:

Current Illness: Cholesterol.

ID: 1707080
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: itching was gone again after Moderna booster shot; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Itching (all over my body that I had for years). On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot) had resolved. No concomitant medications were provided by the reporter. Treatment information was not provided. My itching all over my body that I had for years disappeared after my first Moderna shot February 1, 2021 the next day. About two weeks ago some of the itching recurred, so I got a Moderna booster shot and my itching was gone again. This case was linked to MOD-2021-278963 (Patient Link).

Other Meds:

Current Illness:

ID: 1707081
Sex: F
Age: 55
State: MS

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A little sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication. On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (A little sore arm after second dose). On 09-Apr-2021, MYALGIA (A little sore arm after second dose) had resolved. Patient took Skyrizi injection in Feb 2021 (600mg) and May 2021 (300mg) and she was scheduled to have another Skyrizi injection in Sep 2021. Treatment Information was not provided. The patient had a little sore arm which lasted for 2 days. This case was linked to MOD-2021-307186, MOD-2021-307237 (Patient Link).

Other Meds: SKYRIZI [RISANKIZUMAB RZAA]

Current Illness: Autoimmune disorder; Psoriasis

ID: 1707082
Sex: F
Age: 55
State: MS

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: A little sore arm after third dose; Second dose on 07-APR-2021 and the third dose on 19-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis and Autoimmune disorder. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication. On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (A little sore arm after third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021). On 19-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021) had resolved. On 21-Aug-2021, MYALGIA (A little sore arm after third dose) had resolved. Patient took Skyrizi injection in Feb 2021 (600mg) and May 2021 (300mg) and she was scheduled to have another Skyrizi injection in Sep 2021. Treatment Information was not provided. This case was linked to MOD-2021-307186, MOD-2021-307235 (Patient Link).

Other Meds: SKYRIZI

Current Illness: Autoimmune disorder; Psoriasis

ID: 1707083
Sex: F
Age:
State: TX

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: felt a little punky; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt a little punky), FATIGUE (fatigue) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Fibromyalgia, Arthritis and Food allergy (breaks in hives in response to foods). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 VACCINATION COMPLICATION (felt a little punky), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, VACCINATION COMPLICATION (felt a little punky), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included inhaler. No treatment medications were reported for second dose. This case was linked to MOD-2021-307220, MOD-2021-307256 (Patient Link).

Other Meds:

Current Illness: Arthritis; Asthma; Fibromyalgia; Food allergy (breaks in hives in response to foods)

ID: 1707084
Sex: M
Age: 41
State: FL

Vax Date: 08/15/2021
Onset Date: 09/04/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: temperature is about 100F; Test Date: 20210904; Test Name: Heart beat; Result Unstructured Data: Patient feels like his heart is beating a little bit too fast with 97 beats per minute

Allergies:

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

Symptoms: Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021); achy; feels like heart is beating too fast; slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)), MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 014F21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN for Diabetes, APIXABAN (ELIQUIS) for an unknown indication. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)) had resolved and MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Body temperature: 100f (High) temperature is about 100F. On 04-Sep-2021, Heart rate: 97 beats per minute (High) Patient feels like his heart is beating a little bit too fast with 97 beats per minute. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient taken concomitant drug Blood pressure pill Treatment information was not provided

Other Meds: ELIQUIS; METFORMIN

Current Illness:

ID: 1707085
Sex: F
Age:
State: KS

Vax Date: 08/02/2021
Onset Date: 08/31/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: Body temperature; Result Unstructured Data: Patient reported that the next day after vaccination she had a fever about 101?F

Allergies:

Symptom List: Nausea

Symptoms: arm was very very hot/ it was very hot; wasn't functioning; itchy on the arm; it was not hives, hives looked different; patient reported lots of body aches/ very sore; the next day had a fever about 101?F; felt really awful; saw a bunch of spots on the ceiling, no matter where it looked/ splattering spot that could see/ saw spots on the ceiling/ something happened to my vision; the patient reported to be tired the day of the vaccine; tingling in a finger of that arm/ index finger and the middle finger next to the index/tingling that persisted/felt like a nerve or something/weird tingling; reported redness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in a finger of that arm/ index finger and the middle finger next to the index/tingling that persisted/felt like a nerve or something/weird tingling), ERYTHEMA (reported redness on the arm), FEELING HOT (arm was very very hot/ it was very hot), IMPAIRED WORK ABILITY (wasn't functioning) and PRURITUS (itchy on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PARAESTHESIA (tingling in a finger of that arm/ index finger and the middle finger next to the index/tingling that persisted/felt like a nerve or something/weird tingling). 31-Aug-2021, the patient experienced VISUAL IMPAIRMENT (saw a bunch of spots on the ceiling, no matter where it looked/ splattering spot that could see/ saw spots on the ceiling/ something happened to my vision) and FATIGUE (the patient reported to be tired the day of the vaccine). On 01-Sep-2021, the patient experienced VACCINATION COMPLICATION (felt really awful) and PYREXIA (the next day had a fever about 101?F). On an unknown date, the patient experienced ERYTHEMA (reported redness on the arm), FEELING HOT (arm was very very hot/ it was very hot), IMPAIRED WORK ABILITY (wasn't functioning), PRURITUS (itchy on the arm), URTICARIA (it was not hives, hives looked different) and MYALGIA (patient reported lots of body aches/ very sore). At the time of the report, PARAESTHESIA (tingling in a finger of that arm/ index finger and the middle finger next to the index/tingling that persisted/felt like a nerve or something/weird tingling) had not resolved and ERYTHEMA (reported redness on the arm), FEELING HOT (arm was very very hot/ it was very hot), IMPAIRED WORK ABILITY (wasn't functioning), PRURITUS (itchy on the arm), URTICARIA (it was not hives, hives looked different), VACCINATION COMPLICATION (felt really awful), VISUAL IMPAIRMENT (saw a bunch of spots on the ceiling, no matter where it looked/ splattering spot that could see/ saw spots on the ceiling/ something happened to my vision), FATIGUE (the patient reported to be tired the day of the vaccine), MYALGIA (patient reported lots of body aches/ very sore) and PYREXIA (the next day had a fever about 101?F) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 101?f (High) Patient reported that the next day after vaccination she had a fever about 101?F. Patient reported that she just needed to stay in bed. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-307313 (Patient Link).

Other Meds:

Current Illness:

ID: 1707086
Sex: M
Age: 88
State: NE

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: first two shots were Pfizer and third dose as Moderna; first two shots were Pfizer and third dose as Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) had resolved and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took his first dose of Pfizer COVID-19 Vaccine on 07-JAN-2021 and second dose on 06-FEB-2021. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1707087
Sex: F
Age: 66
State: WA

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna; Rash on arm (injection site); Difficulty breathing; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)), DIZZINESS (Light headedness) and PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Tylenol) and Drug allergy (Codeine). Concomitant products included VITAMINS NOS, APPLE CIDER VINEGAR and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)) and DIZZINESS (Light headedness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna). The patient was treated with EPINEPHRINE (intravenous) on 28-Feb-2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)) and DIZZINESS (Light headedness) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient confirmed that she felt fine after taking treatment drugs. As per her doctor, she's not allergic to anything.

Other Meds: VITAMINS NOS; APPLE CIDER VINEGAR; PRILOSEC [OMEPRAZOLE]

Current Illness: Drug allergy (Tylenol); Drug allergy (Codeine)

ID: 1707088
Sex: F
Age: 74
State: KY

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06EZ1A) for COVID-19 vaccination. No medical history was reported by patient. Concurrent medical conditions included COPD, Constipation, Heart disorder, Anxiety, GERD and Spasticity. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for COPD, ISOSORBIDE for Cardiac disorder, LUBIPROSTONE (AMITIZA) for Constipation, PANTOPRAZOL [PANTOPRAZOLE] for GERD, ACETYLSALICYLIC ACID (ASPIRINE) for Heart disorder, BACLOFEN for Spasticity, PARACETAMOL (TYLENOL) for an unknown indication. On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Patient took diazepine as a concomitant medication for anxiety No treatment medication was reported by patient.

Other Meds: TYLENOL; SPIRIVA; AMITIZA; ASPIRINE; PANTOPRAZOL [PANTOPRAZOLE]; ISOSORBIDE; BACLOFEN

Current Illness: Anxiety; Constipation; COPD; GERD; Heart disorder; Spasticity

ID: 1707089
Sex: M
Age: 64
State: FL

Vax Date: 08/01/2021
Onset Date: 09/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: coughing; swelling under his left arm; kept him up; yelling at my wife is a side effect too; eight hours later patient had fever; chills; lymph nodes are swelled up; Frequent pain in knee; still has a fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too) and PYREXIA (still has a fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in February 2021. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PYREXIA (still has a fever). On an unknown date, the patient experienced COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee). The patient was treated with PARACETAMOL (TYLENOL) on 02-Sep-2021 for Adverse event, at a dose of 1 dosage form and IVERMECTIN for Adverse event, at a dose of 1 dosage form. At the time of the report, COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee) outcome was unknown and PYREXIA (still has a fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other treatment medicine: Patient took advil on 03-sep-2021 for fever No concomitant medicine were reported by the reporter

Other Meds:

Current Illness:

ID: 1707090
Sex: M
Age: 57
State: PR

Vax Date: 08/24/2021
Onset Date: 09/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210903; Test Name: Blood pressure; Result Unstructured Data: 128/75

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: very sleepy; I feel nervous; I feel like something is not ok; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), ANXIETY (I feel nervous), MALAISE (I feel like something is not ok) and TACHYCARDIA (tachycardia) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced SOMNOLENCE (very sleepy), ANXIETY (I feel nervous), MALAISE (I feel like something is not ok) and TACHYCARDIA (tachycardia). At the time of the report, SOMNOLENCE (very sleepy), ANXIETY (I feel nervous) and MALAISE (I feel like something is not ok) outcome was unknown and TACHYCARDIA (tachycardia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Blood pressure measurement: 128/75 (High) 128/75. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Patient did not have history of myocarditis/pericarditis. However, patient mentioned that his heart was big. Patient's blood pressure was also high 128/75 (Patient usually had it around 65/70).

Other Meds:

Current Illness:

ID: 1707091
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Anaphylatic shock; Got Covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylatic shock) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Animal protein allergy. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (Anaphylatic shock) (seriousness criterion medically significant) and COVID-19 (Got Covid-19). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylatic shock) and COVID-19 (Got Covid-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. A few people who had anaphylatic shock after getting the Covid-19 Vaccine got Covid. Company Comment : Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Regarding the event anaphylactic shock very limited information provided, however a causal relationship can not be excluded.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Regarding the event anaphylactic shock very limited information provided, however a causal relationship can not be excluded.

Other Meds:

Current Illness: Animal protein allergy

ID: 1707092
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I have a large red area that is hard and its also hot, kinda itchy; I have a large red area that is hard and its also hot, kinda itchy; I have a large red area that is hard and its also hot, kinda itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy). At the time of the report, ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant and Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1707093
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: A friend of mine got her first dose today and seems to have an allergic reaction; rash; swelling; tingling in her neck and face; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (A friend of mine got her first dose today and seems to have an allergic reaction), RASH (rash), SWELLING (swelling) and PARAESTHESIA (tingling in her neck and face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (A friend of mine got her first dose today and seems to have an allergic reaction), RASH (rash), SWELLING (swelling) and PARAESTHESIA (tingling in her neck and face). At the time of the report, ALLERGY TO VACCINE (A friend of mine got her first dose today and seems to have an allergic reaction), RASH (rash), SWELLING (swelling) and PARAESTHESIA (tingling in her neck and face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1707094
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 1707095
Sex: F
Age: 97
State: NE

Vax Date: 09/03/2021
Onset Date: 01/07/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: first two shots were Pfizer/third dose as Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 07-Jan-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna). On 06-Feb-2021, INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1707096
Sex: F
Age:
State: KS

Vax Date: 08/02/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: The arm felt a little bit warm; Had some redness on the arm; Some itching; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches). At the time of the report, FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient reported that the AE maybe lasted for 2-3 days No Concomitant medication was reported. No Treatment information was reported. This case was linked to MOD-2021-307243 (Patient Link).

Other Meds:

Current Illness:

ID: 1707097
Sex: F
Age:
State: SC

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received dose from vial punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-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 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1707098
Sex: M
Age: 54
State: CA

Vax Date: 08/10/2021
Onset Date: 08/17/2021
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Left arm went limp/ walks with a limp; Has a hard time putting words together; Left leg was heavy; Mind was foggy; Suffered a stroke on his left side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side), GAIT DISTURBANCE (Left arm went limp/ walks with a limp), APHASIA (Has a hard time putting words together), LIMB DISCOMFORT (Left leg was heavy) and FEELING ABNORMAL (Mind was foggy) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced GAIT DISTURBANCE (Left arm went limp/ walks with a limp) (seriousness criterion hospitalization), APHASIA (Has a hard time putting words together) (seriousness criterion hospitalization), LIMB DISCOMFORT (Left leg was heavy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Mind was foggy) (seriousness criterion hospitalization). The patient was hospitalized from 17-Aug-2021 to 20-Aug-2021 due to APHASIA, CEREBROVASCULAR ACCIDENT, FEELING ABNORMAL, GAIT DISTURBANCE and LIMB DISCOMFORT. The patient was treated with TPA for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side), GAIT DISTURBANCE (Left arm went limp/ walks with a limp), APHASIA (Has a hard time putting words together), LIMB DISCOMFORT (Left leg was heavy) and FEELING ABNORMAL (Mind was foggy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. On 17-Aug-2021, the patient went to emergency room, was transported to the hospital and was admitted through 20-Aug-2021. The received TPA treatment immediately. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1707099
Sex: U
Age:
State: AR

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bad reaction that went over their shoulder; developed a bad reaction in their arm on the site if the injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction that went over their shoulder) and VACCINATION SITE REACTION (developed a bad reaction in their arm on the site if the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Bad reaction that went over their shoulder) and VACCINATION SITE REACTION (developed a bad reaction in their arm on the site if the injection). At the time of the report, VACCINATION COMPLICATION (Bad reaction that went over their shoulder) and VACCINATION SITE REACTION (developed a bad reaction in their arm on the site if the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment was not specified.

Other Meds:

Current Illness:

ID: 1707100
Sex: M
Age: 19
State: MA

Vax Date: 07/08/2021
Onset Date: 07/29/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.). On 29-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1707101
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: havent gotten 2nd jab. Its been over a month.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (havent gotten 2nd jab. Its been over a month.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (havent gotten 2nd jab. Its been over a month.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (havent gotten 2nd jab. Its been over a month.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient have concerned that can he suffer from blood clots that form after 2nd shot No concomitant medications were reported No treatment information was provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707102
Sex: M
Age:
State: OK

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm was hard like a charley horse; he felt run down and tired; Arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore) 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. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore). At the time of the report, INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore) outcome was unknown. Concomitant product use was not provided. Treatment product information was not provided. This case was linked to MOD-2021-269938, MOD-2021-270022 (Patient Link).

Other Meds:

Current Illness:

ID: 1707103
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 1/3 of the dose of the normal Moderna COVID-19 Vaccine; Received third dose because of low levels of B12; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12). At the time of the report, ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) had resolved and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12) outcome was unknown. Concomitant medication was not provided Treatment information was not reported Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Followup document added Lot no and event

Other Meds:

Current Illness:

ID: 1707104
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: nauseous; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 04-Sep-2021 and was forwarded to Moderna on 04-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, patient chest feels right after 5 hours of vaccine administration. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1707105
Sex: F
Age:
State: SC

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-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 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was stated that the o~Number of doses/vials: "2 doses/ 1 vial" o~Date the vial was initially stored in the refrigerator: "He thinks on 31AUG2021 but not 100% sure." o~"The vial was first punctured and left at room temperature on 01SEP2021 o~"Date(s) of administration of vaccine when applicable: "02SEP2021" o~Did the vial undergo any previous temperature excursions? "NO" o~Total amount of time the vial was exposed to room temperature range (46? to 77? F): "A little over 24 hours" Concomitant medications were not reported. Treatment medications were not reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am