VAERS 2021 Database www.vaers.hhs.gov

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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: 1790206
Sex: U
Age:
State: TX

Vax Date: 09/02/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
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: first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose). On 27-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1790207
Sex: F
Age:
State: IN

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/16/2021
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: didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved. The patient stated that she received 1st dose of the Moderna COVID19 vaccine on April 2021 and didn't receive the 2nd dose as she "had to had surgery" that was due to a private cause unrelated to the vaccine. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790208
Sex: M
Age: 32
State: OK

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 10/16/2021
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: Itchy injection site; Swollen Injection site; Inject site hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE PAIN (Inject site hurts) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE PAIN (Inject site hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen Injection site) had not resolved and VACCINATION SITE PAIN (Inject site hurts) outcome was unknown. No concomitant product use was provided by the reporter.

Other Meds:

Current Illness:

ID: 1790209
Sex: F
Age: 46
State: NY

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20211001; Test Name: Body temperature; Result Unstructured Data: her body temperature was 99 almost 100; Test Date: 20211003; Test Name: stroke test; Test Result: Negative; Result Unstructured Data: Negative.

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Numbness on the side of her face; Menstruation came early; Body Is under stress; Dizziness; Tongue has changed; Can't taste; Totally weak/Could not change her linen; Swollen lips; Swollen tongue; Weakness in her right side; needles and pin feeling on the right side of her face/paresthesia right side of face; fever, her body temperature was 99, almost 100; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (Weakness in her right side) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PYREXIA (fever, her body temperature was 99, almost 100). On 02-Oct-2021, the patient experienced HEMIPARESIS (Weakness in her right side) (seriousness criterion medically significant), PARAESTHESIA (needles and pin feeling on the right side of her face/paresthesia right side of face), ASTHENIA (Totally weak/Could not change her linen), LIP SWELLING (Swollen lips) and SWOLLEN TONGUE (Swollen tongue). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on the side of her face), MENSTRUATION IRREGULAR (Menstruation came early), STRESS (Body Is under stress), DIZZINESS (Dizziness), TONGUE DISCOMFORT (Tongue has changed) and AGEUSIA (Can't taste). At the time of the report, HEMIPARESIS (Weakness in her right side), PARAESTHESIA (needles and pin feeling on the right side of her face/paresthesia right side of face), HYPOAESTHESIA (Numbness on the side of her face), ASTHENIA (Totally weak/Could not change her linen), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), MENSTRUATION IRREGULAR (Menstruation came early), STRESS (Body Is under stress), DIZZINESS (Dizziness), TONGUE DISCOMFORT (Tongue has changed), AGEUSIA (Can't taste) and PYREXIA (fever, her body temperature was 99, almost 100) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 99 (High) her body temperature was 99 almost 100. On 03-Oct-2021, Computerised tomogram: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Company Comment: This case concerns a 38-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hemiparesis. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 38-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hemiparesis. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1790210
Sex: F
Age: 29
State: PA

Vax Date: 06/10/2021
Onset Date: 05/05/2021
Rec V Date: 10/16/2021
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: gave birth; 2nd dose was administered more than 35 days after 1st dose; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of DELIVERY (gave birth), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose). On 30-Sep-2021, the patient experienced DELIVERY (gave birth). The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, DELIVERY (gave birth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. No concomitant medications were reported. This case concerns a 30 year old pregnant female with no relevant history who experienced the non-serious, unlisted events of Maternal exposure during pregnancy and Inappropriate schedule of vaccine administration of the second dose 37 days after the first dose of mRNA-1273. Re-challenge is not applicable as this was the second dose. Benefit -risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-110128 (Patient Link).; Sender's Comments: This case concerns a 30 year old pregnant female with no relevant history who experienced the non-serious, unlisted events of Maternal exposure during pregnancy and Inappropriate schedule of vaccine administration of the second dose 37 days after the first dose of mRNA-1273. Re-challenge is not applicable as this was the second dose. Benefit -risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1790211
Sex: F
Age: 76
State: FL

Vax Date: 01/21/2021
Onset Date: 02/15/2021
Rec V Date: 10/16/2021
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: Mild allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Mild allergic reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ALLERGY TO VACCINE (Mild allergic reaction). On 18-Feb-2021, ALLERGY TO VACCINE (Mild allergic reaction) had resolved. Concomitant medications was not provided by the reporter Treatment information was not provided This case was linked to MOD-2021-025287 (Patient Link).

Other Meds:

Current Illness:

ID: 1790212
Sex: F
Age: 38
State: CA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 10/16/2021
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: she experienced soreness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (she experienced soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis and Psoriatic arthritis. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (she experienced soreness). At the time of the report, PAIN (she experienced soreness) 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. On 18-MAR-2021 patient took DOSE-2 Moderna vaccine having batch number 001B21A. No treatment information were reported. This case was linked to MOD-2021-339523 (Patient Link).

Other Meds: OTEZLA

Current Illness: Psoriasis; Psoriatic arthritis

ID: 1790213
Sex: F
Age: 74
State: NE

Vax Date: 08/23/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: wasn't feeling good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (wasn't feeling good) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The patient's past medical history included Clostridium difficile infection in 2019. On 23-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 ABNORMAL (wasn't feeling good). At the time of the report, FEELING ABNORMAL (wasn't feeling good) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was mentioned. No treatment medication was mentioned. She wasn't feeling good when her 2nd dose was scheduled, so she didn't go back to get it. She was now ready to get it but doesn't have the phone for the vaccination facility. She states that her daughter in law scheduled the 1st dose for her and will help her reschedule her 2nd dose.

Other Meds:

Current Illness:

ID: 1790214
Sex: F
Age: 56
State: SD

Vax Date: 05/21/2021
Onset Date: 05/28/2021
Rec V Date: 10/16/2021
Hospital: Y

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: Bronchitis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Smoker in May 2021 and Mitral valve disease. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced BRONCHITIS (Bronchitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was hospitalized from 25-Jul-2021 to 27-Jul-2021 due to BRONCHITIS. The patient was treated with PREDNISONE for Bronchitis, at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] for Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Patient took steroid, Prednisone, & a rescue inhaler, albuterol as a treatment Drug. Company comment: This case concerns a 56 year-old, female subject with a history of smoking and mitral valve disease, who experienced unexpected event of bronchitis. The event occurred approximately 1 week after the first dose of Moderna Covid-19 vaccine. The rechallenge is positive since the event reportedly happened after each dose was given as per source document. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 56 year-old, female subject with a history of smoking and mitral valve disease, who experienced unexpected event of bronchitis. The event occurred approximately 1 week after the first dose of Moderna Covid-19 vaccine. The rechallenge is positive since the event reportedly happened after each dose was given as per source document. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790215
Sex: F
Age: 33
State: VA

Vax Date: 01/25/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: lump under the armpit near the breast is size of golf ball,it feels like size of softball; tenderness; is swelling underneath the left armpit, near left breast; is hard around injection site; left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm; swelling is sore,swelling is hurting,hurts when brushing off against anything,painful, causes pain; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under the armpit near the breast is size of golf ball,it feels like size of softball), TENDERNESS (tenderness), SWELLING (is swelling underneath the left armpit, near left breast), VACCINATION SITE INDURATION (is hard around injection site) and VACCINATION SITE SWELLING (left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 024M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergic to ibuprofen), Drug allergy (Allergic to meloxicam), Psoriasis and Autoimmune disorder. Concomitant products included METHOTREXATE for Psoriasis. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced SWELLING (is swelling underneath the left armpit, near left breast), VACCINATION SITE INDURATION (is hard around injection site), VACCINATION SITE SWELLING (left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm) and AXILLARY PAIN (swelling is sore,swelling is hurting,hurts when brushing off against anything,painful, causes pain). On an unknown date, the patient experienced AXILLARY MASS (lump under the armpit near the breast is size of golf ball,it feels like size of softball) and TENDERNESS (tenderness). The patient was treated with PARACETAMOL (TYLENOL) on 03-Oct-2021 for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, AXILLARY MASS (lump under the armpit near the breast is size of golf ball,it feels like size of softball), TENDERNESS (tenderness), SWELLING (is swelling underneath the left armpit, near left breast), VACCINATION SITE INDURATION (is hard around injection site), VACCINATION SITE SWELLING (left arm, around the injection site to across arm it is swollen,swelling- size of softball under the skin across the left arm) and AXILLARY PAIN (swelling is sore,swelling is hurting,hurts when brushing off against anything,painful, causes pain) outcome was unknown. Patient stated that she had not taken methotrexate all this year because she is Changing PCPs.

Other Meds: METHOTREXATE

Current Illness: Autoimmune disorder; Drug allergy (Allergic to meloxicam); Drug allergy (Allergic to ibuprofen); Psoriasis

ID: 1790216
Sex: F
Age: 66
State: NJ

Vax Date: 03/08/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received 3rd dose today despite not being immunocompromised; Got third dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose). On 04-Oct-2021, OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose) had resolved. No concomitant medications were not reported. No treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1790217
Sex: M
Age: 16
State: NY

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: first dose at 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old) 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: 1790218
Sex: M
Age:
State: AL

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: Vaccine administered 12 hours post punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up added patient demographics, vaccine information start date, dose number, route of administration and anatomical location was added.

Other Meds:

Current Illness:

ID: 1790219
Sex: M
Age: 84
State: FL

Vax Date: 12/30/2020
Onset Date: 08/23/2020
Rec V Date: 10/16/2021
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: Test Name: EKG; Result Unstructured Data: An EKG was done after the cardioversion and it was fine.

Allergies:

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

Symptoms: Stomach problems; Pain or irritation on the inner part of his esophagus; Hot flashes; Felt like his heart was beathing very fast; Shortness of breath; Pain or irritation on the inner part of his esophagus; Atrial flutter; Headaches; Flu like symptoms; Feeling druggy; Hurt and soreness on the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (Atrial flutter) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a, 029k20a and 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ulcer. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling druggy) and VACCINATION SITE PAIN (Hurt and soreness on the shoulder). On an unknown date, the patient experienced ATRIAL FLUTTER (Atrial flutter) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Stomach problems), OESOPHAGEAL PAIN (Pain or irritation on the inner part of his esophagus), HOT FLUSH (Hot flashes), HEART RATE INCREASED (Felt like his heart was beating very fast), DYSPNOEA (Shortness of breath), OESOPHAGEAL IRRITATION (Pain or irritation on the inner part of his esophagus) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) at an unspecified dose and frequency. At the time of the report, ATRIAL FLUTTER (Atrial flutter) was resolving, INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling druggy), ABDOMINAL DISCOMFORT (Stomach problems), OESOPHAGEAL PAIN (Pain or irritation on the inner part of his esophagus), HOT FLUSH (Hot flashes), HEART RATE INCREASED (Felt like his heart was beathing very fast), DYSPNOEA (Shortness of breath), OESOPHAGEAL IRRITATION (Pain or irritation on the inner part of his esophagus) and VACCINATION SITE PAIN (Hurt and soreness on the shoulder) outcome was unknown and HEADACHE (Headaches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) An EKG was done after the cardioversion and it was fine. Concomitant medications included blood thinners, blood pressure medication, thyroid medication and cholesterol medication. On 23 Sep 2021, cardioversion was done in an outpatient clinic. ECG, cardiac test and cardiac enzymes laboratory test was performed with unknown result. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received included new events was added.; Sender's Comments: This case concerns a 85 year old male with relevant medical history of Ulcer, who experienced unexpected events of Influenza like illness, feeling abnormal and expected event of vaccination site pain which occurred on the same day after vaccination with the 3rd dose of mRNA (Moderna) , On unknown date after vaccination with the 3rd dose , he experienced unexpected events of atrial flutter , adominal discomfort, esophageal pain , hot flush , heart rate increased , dyspnea , esophageal irritation and expected event of headache. The rechallenge for this case is not applicable . The age and history of ulcer are considered confounders for this case ( Aging can cause abnormalities in the heart and may affect the conduction system that may lead to arrhythmias while the history of ulcer may also explain the possible event of abdmominal pain , possible recurrence? ) . The benefit-risk relationship of mRNA-1273 ( Moderna )is not affected by this report.

Other Meds:

Current Illness:

ID: 1790220
Sex: F
Age: 36
State: NY

Vax Date: 04/08/2021
Onset Date: 05/13/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210622; Test Name: Antibody test; Test Result: Positive; Result Unstructured Data: Sjogren's antibody was positive; Test Date: 20210622; Test Name: C-reactive protein; Result Unstructured Data: High; Test Date: 20210622; Test Name: Platelet count; Result Unstructured Data: High; Test Date: 20210622; Test Name: Westergen count; Result Unstructured Data: High; Test Date: 20210622; Test Name: Rheumatoid factor; Result Unstructured Data: Rheumatoid arthritis numbers were very high.

Allergies:

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

Symptoms: Diagnosed with shingles; Rheumatoid arthritis numbers were high; Left arm injection site was sore; Very tired for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis numbers were high) and HERPES ZOSTER (Diagnosed with shingles) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SPIRONOLACTONE and VITAMINS NOS for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Left arm injection site was sore) and FATIGUE (Very tired for 2 days). On 23-Jun-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis numbers were high) (seriousness criterion medically significant). On 04-Oct-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis numbers were high), HERPES ZOSTER (Diagnosed with shingles) and VACCINATION SITE PAIN (Left arm injection site was sore) outcome was unknown and FATIGUE (Very tired for 2 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Antibody test: positive (Positive) Sjogrens antibody was positive. On 22-Jun-2021, C-reactive protein: high (High) High. On 22-Jun-2021, Platelet count: high (High) High. On 22-Jun-2021, Red blood cell sedimentation rate: high (High) High. On 22-Jun-2021, Rheumatoid factor: high (High) Rheumatoid arthritis numbers were very high.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was diagnosed with shingles on 04-Oct-2021 by my dermatologist. No treatment information was provided. Company comment: This case concerns a 36-year-old female patient with relevant medical history of Rheumatoid arthritis., who experienced the unexpected serious events of Rheumatoid arthritis and Herpes zoster .The event of Rheumatoid arthritis aggravated occurred approximately 1 month 10 days after the second dose of Spikevax. The event of Herpes zoster occurred approximately 4 months 20 days after the second dose of Spikevax. The rechallenge is not applicable since the events occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-340947 (Patient Link).; Sender's Comments: This case concerns a 36-year-old female patient with relevant medical history of Rheumatoid arthritis., who experienced the unexpected serious events of Rheumatoid arthritis and Herpes zoster .The event of Rheumatoid arthritis aggravated occurred approximately 1 month 10 days after the second dose of Spikevax. The event of Herpes zoster occurred approximately 4 months 20 days after the second dose of Spikevax. The rechallenge is not applicable since the events occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: Spironolactone; Vitamins NOS

Current Illness: Rheumatoid arthritis

ID: 1790221
Sex: F
Age: 42
State: OR

Vax Date: 07/23/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: receiving 3rd dose of Moderna instead of flu shot; Sore Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A., 049E21A and 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot). At the time of the report, PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot) had resolved and PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-340958 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: follow-up received: Added event.

Other Meds:

Current Illness:

ID: 1790222
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: her husband had fever and chills; her husband had fever and chills; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome and Immunocompromised. 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 (her husband had fever and chills) and CHILLS (her husband had fever and chills). At the time of the report, PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness: Immunocompromised; Lupus syndrome

ID: 1790223
Sex: M
Age:
State: CA

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: Laboratory test; Result Unstructured Data: Spike in my levels

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Treatment failure of prescribed medication possibly related to Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of TREATMENT FAILURE (Treatment failure of prescribed medication possibly related to Moderna vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylaxis. Co-suspect product included non-company product COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for an unknown indication. 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 and COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) (unknown route) at an unspecified dose. In June 2021, the patient experienced TREATMENT FAILURE (Treatment failure of prescribed medication possibly related to Moderna vaccine) (seriousness criterion medically significant). At the time of the report, TREATMENT FAILURE (Treatment failure of prescribed medication possibly related to Moderna vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Laboratory test: abnormal (abnormal) Spike in my levels. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was reported. No treatment medications were provided. It was reported that the patient's physician switched his medication because it was failing (Genvoya) This case concerns 61-year-old, female patient with no relevant medical. The patient experienced serious events of Treatment failure unspecified days after the third dose of spikevax. The reporter didn't provide the causality of events. Rechallenge is not applicable as the event reported to have occurred after the 3rd dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns 61-year-old, female patient with no relevant medical. The patient experienced serious events of Treatment failure unspecified days after the third dose of spikevax. The reporter didn't provide the causality of events. Rechallenge is not applicable as the event reported to have occurred after the 3rd dose. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: GENVOYA

Current Illness:

ID: 1790224
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Neuropathy after vaccine; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Autoimmune disorder. 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 NEUROPATHY PERIPHERAL (seriousness criteria disability and medically significant). At the time of the report, NEUROPATHY PERIPHERAL outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Company comment: This case concerns a female patient, age unknown, with relevant medical history of Autoimmune disorder, who experienced the serious unexpected event of Neuropathy peripheral. The event occurred after the dose of mRNA-1273 (COVID-19 Vaccine Moderna) (event onset date unknown). The rechallenge was not applicable since only information about one dose was disclosed. The medical history of Autoimmune disorder remains a confounder. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report. Event seriousness assessed as per Health Care (Spontaneous) reporting, however there was no information in the source document supporting that the events resulted in a Disability, persistent or permanent incapacity.

Other Meds:

Current Illness:

ID: 1790225
Sex: F
Age:
State: OK

Vax Date: 02/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/16/2021
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: Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to metals. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot). At the time of the report, PERIPHERAL SWELLING (Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Patient visited several doctors. one told to see a psychiatrist and the other 2 told her to put cream on it. Patient has an appointment with her regular clinic where the first 2 doses were received.

Other Meds:

Current Illness: Allergy to metals

ID: 1790226
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: developed herpes zoster in his T4 area; experienced pain in the chest wall; local pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (developed herpes zoster in his T4 area), MUSCULOSKELETAL CHEST PAIN (experienced pain in the chest wall) and VACCINATION SITE PAIN (local pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 HERPES ZOSTER (developed herpes zoster in his T4 area), MUSCULOSKELETAL CHEST PAIN (experienced pain in the chest wall) and VACCINATION SITE PAIN (local pain). At the time of the report, HERPES ZOSTER (developed herpes zoster in his T4 area) outcome was unknown, MUSCULOSKELETAL CHEST PAIN (experienced pain in the chest wall) had resolved and VACCINATION SITE PAIN (local pain) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported a week after flu shot he experienced chest wall pain and herpes zoster. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received on 07-OCT-2021 has no new information

Other Meds: FLU

Current Illness:

ID: 1790227
Sex: M
Age: 76
State: VA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 10/16/2021
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: Felt a little bit funny; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a little bit funny) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), AMIODARONE, CLOPIDOGREL and QUETIAPINE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt a little bit funny). At the time of the report, FEELING ABNORMAL (Felt a little bit funny) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. This case was linked to MOD-2021-341095 (Patient Link).

Other Meds: PRADAXA; AMIODARONE; CLOPIDOGREL; QUETIAPINE

Current Illness:

ID: 1790228
Sex: F
Age: 56
State: SD

Vax Date: 05/21/2021
Onset Date: 07/25/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210725; Test Name: CAT scan; Result Unstructured Data: Emphysema flair-up; Test Date: 20210812; Test Name: Heart rate; Result Unstructured Data: 155 beats/min; Test Date: 20210725; Test Name: Oxygen saturation; Result Unstructured Data: 84% Low; Test Date: 20210812; Test Name: Oxygen saturation; Result Unstructured Data: Low 84%.

Allergies:

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

Symptoms: Emphysema flair-up; I was short of breath/was short of breath , I just couldn't catch my breath; heart isn't functioning right; my lips were purple; I pushed the 2nd dose out a little, because I was still recovering from bronchitis.; This spontaneous case was reported by a consumer and describes the occurrence of EMPHYSEMA and EMPHYSEMA in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mitral regurgitation. Concurrent medical conditions included Mitral valve prolapse and Ex-tobacco user (quit in May 2021). On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 25-Jul-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization). On 12-Aug-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization) and LIP DISCOLOURATION. On an unknown date, the patient experienced CARDIAC DISORDER. The patient was hospitalized from 25-Jul-2021 to 27-Jul-2021 due to EMPHYSEMA. The patient was treated with PREDNISONE at an unspecified dose and frequency and ALBUTEROL at an unspecified dose and frequency. At the time of the report, EMPHYSEMA, EMPHYSEMA, LIP DISCOLOURATION, CARDIAC DISORDER, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 25-Jul-2021, Computerised tomogram (abnormal) Emphysema flair-up. On 25-Jul-2021, Oxygen saturation 84% Low. On 12-Aug-2021, Heart rate 155 beats/min (High). On 12-Aug-2021, Oxygen saturation (Low) 84%. On 12-AUG-2021 patient went to Emergency room due to Emphysema flair-up. No relevant concomitant medications were reported This case concerns inappropriate schedule of vaccine administration in a 56 year-old female patient with no relevant medical history reported, who experienced the unexpected serious event s of Emphysema flair-up x2. The events occurred approximately 3 weeks and 5 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Although history of emphysema not reported, the source document indicates hospitalization for 2 events of emphysema flair-up.

Other Meds:

Current Illness: Mitral valve prolapse

ID: 1790229
Sex: F
Age: 63
State: NC

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: 3-4 times per week as the disease progresses; Test Name: COVID-19 Test; Test Result: Negative; Result Unstructured Data: Negative.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: my veins broke/broken veins; bruises on my forehead on the tip of my eyebrows/got one two weeks ago and it has not faded/bruises inside of my arms and legs/bruises on the ankle part of my legs look like bands/bruised so bad my veins broke/broken veins and bruises is what bothere; heaviness on the left side of my chest/like someone is pushing on it/; Weird stuff/Bad; Chest pain in the middle of my chest; when she takes big steps she feels it still; Sick; Cant get words out; She stood up and went down on the floor; Throwing up sick; Chilly; Nauseated; like vertigo where I felt nauseated/felt wobbly/vertigo; Flu symptoms; Passed right out; Immediately after I stood up I passed right out/when I would go to take a step I get a little dizzy/put my foot down and nothing is there making me feel wobbly/dizzy spells/stood up and went down on the floor/cant get my words out; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Passed right out) and VEIN RUPTURE (my veins broke/broken veins) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu vaccination (she threw up for a week after taking it). Past adverse reactions to the above products included Vomiting with Flu vaccination. Concurrent medical conditions included Lupus syndrome, Drug allergy, Lupus pneumonitis (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs), Pneumonia, COPD and Nonsmoker. Concomitant products included AMLODIPINE for Blood pressure, BIOTIN for Dry skin, HYDROXYCHLOROQUINE for Lupus syndrome, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach ache, COLECALCIFEROL (VITAMIN D3), METOPROLOL, ESTRADIOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST SODIUM (SINGULAIR) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced SYNCOPE (Passed right out) (seriousness criterion medically significant) and DIZZINESS (Immediately after I stood up I passed right out/when I would go to take a step I get a little dizzy/put my foot down and nothing is there making me feel wobbly/dizzy spells/stood up and went down on the floor/cant get my words out). On 16-Apr-2021, the patient experienced INFLUENZA (Flu symptoms), VERTIGO (like vertigo where I felt nauseated/felt wobbly/vertigo), CHILLS (Chilly) and NAUSEA (Nauseated). On an unknown date, the patient experienced VEIN RUPTURE (my veins broke/broken veins) (seriousness criterion medically significant), CONTUSION (bruises on my forehead on the tip of my eyebrows/got one two weeks ago and it has not faded/bruises inside of my arms and legs/bruises on the ankle part of my legs look like bands/bruised so bad my veins broke/broken veins and bruises is what bothere), CHEST DISCOMFORT (heaviness on the left side of my chest/like someone is pushing on it/), FEELING ABNORMAL (Weird stuff/Bad), CHEST PAIN (Chest pain in the middle of my chest), GAIT DISTURBANCE (when she takes big steps she feels it still), ILLNESS (Sick), SPEECH DISORDER (Cant get words out), FALL (She stood up and went down on the floor) and VOMITING (Throwing up sick). At the time of the report, SYNCOPE (Passed right out), VEIN RUPTURE (my veins broke/broken veins), DIZZINESS (Immediately after I stood up I passed right out/when I would go to take a step I get a little dizzy/put my foot down and nothing is there making me feel wobbly/dizzy spells/stood up and went down on the floor/cant get my words out), INFLUENZA (Flu symptoms), CONTUSION (bruises on my forehead on the tip of my eyebrows/got one two weeks ago and it has not faded/bruises inside of my arms and legs/bruises on the ankle part of my legs look like bands/bruised so bad my veins broke/broken veins and bruises is what bothere), CHEST DISCOMFORT (heaviness on the left side of my chest/like someone is pushing on it/), FEELING ABNORMAL (Weird stuff/Bad), VERTIGO (like vertigo where I felt nauseated/felt wobbly/vertigo), CHEST PAIN (Chest pain in the middle of my chest), GAIT DISTURBANCE (when she takes big steps she feels it still), ILLNESS (Sick), SPEECH DISORDER (Cant get words out), FALL (She stood up and went down on the floor), VOMITING (Throwing up sick), CHILLS (Chilly) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) 3-4 times per week as the disease progresses.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Company Comment: This case concerns a 64-year-old, female subject with a history of Lupus syndrome, who experienced the unexpected event of VEIN RUPTURE. The event occurred on an unknown date after the second dose of Spikevax. The rechallenge was unknown since no information about the third dose was disclosed. The medical history of Lupus syndrome and use of concomitant medication metoprolol and acetylsalicylic acid remains confounders. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-341161 (Patient Link).; Sender's Comments: This case concerns a 64-year-old, female subject with a history of Lupus syndrome, who experienced the unexpected event of VEIN RUPTURE. The event occurred on an unknown date after the second dose of Spikevax. The rechallenge was unknown since no information about the third dose was disclosed. The medical history of Lupus syndrome and use of concomitant medication metoprolol and acetylsalicylic acid remains confounders. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: Vitamin D3; Biotin; Amlodipine; Metoprolol; Estradiol; Protonix [omeprazole]; Aspirin (E.C.); Singulair; hydroxychloroquine; Percocet [Oxycodone Hydrochloride; Oxycodone Terephthalate; Paracetamol]

Current Illness: COPD; Drug allergy; Lupus pneumonitis (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs); Lupus syndrome; Nonsmoker; Pneumonia.

ID: 1790230
Sex: M
Age: 14
State: UT

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: vaccine administered to an underage patient of 14 years old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage patient of 14 years old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage patient of 14 years old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage patient of 14 years old) 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. It was reported that the patient had not experienced any other symptoms after vaccination.

Other Meds:

Current Illness:

ID: 1790231
Sex: U
Age:
State: TX

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: covid-19; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: 14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (After vaccination, he told the pharmacist that he was COVID positive). On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot). On 04-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, COVID-19: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and Treatment was not specified. Patient stated that after vaccination, he told the pharmacist that he was COVID positive and received Monoclonal antibodies 14 days ago.

Other Meds:

Current Illness:

ID: 1790232
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1790233
Sex: M
Age: 76
State: VA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 10/16/2021
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: Knees give out when walking; Slight tremors,tremors,whole body shakes quickly; Pain/aches; Feeling inflamed,like lightening from buttocks down legs across groins; Painful to walk; Can't move left shoulder without excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins) and GAIT DISTURBANCE (Painful to walk) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), AMIODARONE, CLOPIDOGREL and QUETIAPINE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins), GAIT DISTURBANCE (Painful to walk) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move left shoulder without excruciating pain). The patient was treated with DICLOFENAC SODIUM (topical) for Analgesic therapy, at a dose of 1 percent and ACETAMINOPHEN for Analgesic therapy, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins), GAIT DISTURBANCE (Painful to walk) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move left shoulder without excruciating pain) had not resolved. Patient had visited the doctor who prescribed him a steroid which didn't totally work and two creams Diclofenac sodium topical 1% rugby pain relieving cream. Patient reported taking acetaminophen as well. This case was linked to MOD-2021-341049 (Patient Link).

Other Meds: PRADAXA; AMIODARONE; CLOPIDOGREL; QUETIAPINE

Current Illness:

ID: 1790234
Sex: F
Age:
State:

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables) 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 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables). At the time of the report, DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was mentioned. No treatment medication was mentioned.

Other Meds:

Current Illness:

ID: 1790235
Sex: F
Age: 63
State: IN

Vax Date: 02/04/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
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: 20210908; Test Name: SARS-Cov2 antibody; Result Unstructured Data: antibody levels SARS-Cov2 antibody IgG nucleocap and IgM spike were reported as zero.

Allergies:

Symptom List: Nausea

Symptoms: diagnosed with uterine cancer; This spontaneous case was reported by a physician and describes the occurrence of UTERINE CANCER in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21, 040C21A, and 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced UTERINE CANCER (seriousness criterion medically significant). The patient was treated with Surgery (Underwent emergency surgery of hysterectomy was done by mid Apr 2021) for Uterine cancer. At the time of the report, UTERINE CANCER outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 08-Sep-2021, SARS-CoV-2 antibody test 0 antibody levels SARS-Cov2 antibody IgG nucleocap and IgM spike were reported as zero. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reported stated the patient was not on any medications before she got the vaccine. The patient had a radiation therapy post six weeks of vaccine administration and not chemotherapy. Treatment information was not provided. This case concerns a 64 year-old female patient with no reported medical history, who experienced the unexpected serious event of Uterine cancer. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790236
Sex: M
Age: 77
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 10/16/2021
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: felt kind of sick; sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt kind of sick) and PAIN (sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ILLNESS (felt kind of sick) and PAIN (sore). On 22-Jan-2021, ILLNESS (felt kind of sick) and PAIN (sore) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. It was reported that the patient had second dose of vaccine on 15Feb2021 in the same facility with lot number 013M20A. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1790237
Sex: F
Age: 14
State: MO

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: 1st dose administered to 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Pharmacy accidentally administered a 1st Moderna dose to a 14 year old

Other Meds:

Current Illness:

ID: 1790238
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: PCR test; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

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

Symptoms: breakthrough scare--flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms) 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 INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790239
Sex: F
Age: 54
State: NJ

Vax Date: 03/01/2021
Onset Date: 07/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Endoscopy; Result Unstructured Data: endoscopy showed inflammation of the lining in her stomach

Allergies:

Symptom List: Tremor

Symptoms: All the sudden she didn't feel well intestinally/still not feeling right; Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping; Has some nausea in the morning; Little bit of constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Little bit of constipation), GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right), GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONSTIPATION (Little bit of constipation). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right), GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning). The patient was treated with ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) ongoing since an unknown date for Gastritis, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (Little bit of constipation) and GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right) had not resolved and GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: abnormal (abnormal) endoscopy showed inflammation of the lining in her stomach. No concomitant medication was reported by reporter.

Other Meds:

Current Illness:

ID: 1790240
Sex: F
Age: 63
State: NC

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 10/16/2021
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 Name: Blood Work; Result Unstructured Data: 3-4 times per week as the disease progresses; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Arm hurt but it didn't bother me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt but it didn't bother me) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs.), Drug allergy (Aspirin), Pneumonia, COPD and Non-tobacco user. Concomitant products included BIOTIN for Dry skin, AMLODIPINE for Hypertension, HYDROXYCHLOROQUINE for Lupus syndrome, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort, COLECALCIFEROL (VITAMIN D3), METOPROLOL, ESTRADIOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST SODIUM (SINGULAIR) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt but it didn't bother me). At the time of the report, VACCINATION SITE PAIN (Arm hurt but it didn't bother me) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) 3-4 times per week as the disease progresses. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medications were reported. This case was linked to MOD-2021-341062 (Patient Link).

Other Meds: VITAMIN D3; BIOTIN; AMLODIPINE; METOPROLOL; ESTRADIOL; PROTONIX [OMEPRAZOLE]; ASPIRIN (E.C.); SINGULAIR; HYDROXYCHLOROQUINE; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]

Current Illness: COPD; Drug allergy (Aspirin); Lupus syndrome (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs.); Pneumonia

ID: 1790241
Sex: M
Age: 76
State: PA

Vax Date: 02/22/2021
Onset Date: 09/23/2021
Rec V Date: 10/16/2021
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: couldn't make a whole sentences,couldnt respond to my wife,babbling bascillay,lost ability to complete a sentences; hands were shaking ,could not hold the fork without shaking; sweated all night; slept from Friday noon to Saturday noon, 24 hours; Off label use/could receive a third shot. Later found out that it was for immunocompromised but I was not an immunocompromised patient; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (couldn't make a whole sentences,couldnt respond to my wife,babbling bascillay,lost ability to complete a sentences), MOBILITY DECREASED (Difficulty zipping water from a bottle), TREMOR (hands were shaking ,could not hold the fork without shaking), HYPERHIDROSIS (sweated all night) and SOMNOLENCE (slept from Friday noon to Saturday noon, 24 hours) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 030L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced OFF LABEL USE (Off label use/could receive a third shot. Later found out that it was for immunocompromised but I was not an immunocompromised patient). On 24-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SPEECH DISORDER (couldn't make a whole sentences,couldnt respond to my wife,babbling bascillay,lost ability to complete a sentences), MOBILITY DECREASED (Difficulty zipping water from a bottle), TREMOR (hands were shaking ,could not hold the fork without shaking), HYPERHIDROSIS (sweated all night) and SOMNOLENCE (slept from Friday noon to Saturday noon, 24 hours). On 23-Sep-2021, OFF LABEL USE (Off label use/could receive a third shot. Later found out that it was for immunocompromised but I was not an immunocompromised patient) had resolved. On 25-Sep-2021, SPEECH DISORDER (couldn't make a whole sentences,couldnt respond to my wife,babbling bascillay,lost ability to complete a sentences), MOBILITY DECREASED (Difficulty zipping water from a bottle), TREMOR (hands were shaking ,could not hold the fork without shaking), HYPERHIDROSIS (sweated all night) and SOMNOLENCE (slept from Friday noon to Saturday noon, 24 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Patient was not an immunocompromised. Patient was told by the HCP to put it as immunocompromised which allowed the patient to get the third dose. This case was linked to MOD-2021-341194 (Patient Link).

Other Meds:

Current Illness:

ID: 1790242
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Very bad headache; Progressed into tinnitus; Didn't receive a 2nd 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 HEADACHE (Very bad headache), TINNITUS (Progressed into tinnitus) and PRODUCT DOSE OMISSION ISSUE (Didn't receive a 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Very bad headache), TINNITUS (Progressed into tinnitus) and PRODUCT DOSE OMISSION ISSUE (Didn't receive a 2nd shot). At the time of the report, HEADACHE (Very bad headache), TINNITUS (Progressed into tinnitus) and PRODUCT DOSE OMISSION ISSUE (Didn't receive a 2nd shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were mentioned. No treatment details were reported. Reporter stated that the patient didn't receive a 2nd shot, because it was not mandated to receive a shot. Reporter stated that the patient has not got COVID.

Other Meds:

Current Illness:

ID: 1790243
Sex: F
Age: 54
State: TX

Vax Date: 01/20/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: Ears are ringing / tinnitus /ears are so loud some days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears are ringing / tinnitus /ears are so loud some days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Ears are ringing / tinnitus /ears are so loud some days). At the time of the report, TINNITUS (Ears are ringing / tinnitus /ears are so loud some days) outcome was unknown. The patient would like to get the booster, her gynecologist recommended it but she was afraid of it. No concomitant medications were reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1790244
Sex: F
Age:
State: FL

Vax Date: 10/03/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: Feels like she has tonsillitis; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (Feels like she has tonsillitis) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced TONSILLITIS (Feels like she has tonsillitis). At the time of the report, TONSILLITIS (Feels like she has tonsillitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1790245
Sex: M
Age: 69
State: FL

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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: Test Name: CT scan; Result Unstructured Data: CT scan showed the cancer.

Allergies:

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

Symptoms: Colon cancer; Cramping with sit ups/ The crunches or sit-ups aggravated the mass in his colon, and this went on for 2-3 weeks; Aggravated the mass in his colon; Pain; This spontaneous case was reported by a consumer and describes the occurrence of Colon cancer in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLON CANCER (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS, MASS, and PAIN. The patient was hospitalized for 14 days due to COLON CANCER. The patient was treated with Surgery for Colon cancer. At the time of the report, COLON CANCER, MUSCLE SPASMS, MASS, and PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Computerised tomogram (abnormal) CT scan showed the cancer. No concomitant medications and treatment medications were provided. This case concerns a 70-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected even of colon cancer. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1790246
Sex: M
Age: 42
State: KY

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 10/16/2021
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: Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced TINNITUS (Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing). At the time of the report, TINNITUS (Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Patient takes concomitant medication but not willing to disclose. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1790247
Sex: M
Age: 76
State: PA

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 10/16/2021
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: stomach a little bit upset/ stomach was a little upset for a little bit.; soreness in the arm; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported. This case was linked to MOD-2021-341167, MOD-2021-341203 (Patient Link).

Other Meds:

Current Illness:

ID: 1790248
Sex: M
Age: 76
State: PA

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: little bit

Allergies:

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

Symptoms: stomach a little bit upset; Typical side effects; soreness in the arm; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 027C21A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, 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 experienced ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other little bit. 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 details were not reported by the reporter. Treatment details was not reported by the reporter. This case was linked to MOD-2021-341194, MOD-2021-341167 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: TCR attached-significant patient age, event added, out come of the events provided.

Other Meds:

Current Illness:

ID: 1790249
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: not feeling well /feel a little bit off; feel sort of in a cloud; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud). At the time of the report, MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud) outcome was unknown. No concomitant medication details was reported. No treatment medication details was reported. Patient has heard from several places that Moderna will recommend a booster shot which is half dose. Patient has not been feeling well lately and he would like to know if a third full dose can affect him adversely. Patient feels a little off and sort of in a cloud.

Other Meds:

Current Illness:

ID: 1790250
Sex: F
Age: 46
State: PA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
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: Received dose from vial punctured days before; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reporter reported number of doses/vials was 1 vial, 1 dose. Date the vial was initially stored in the refrigerator was 03 Sep 2021. Date and time vial was first punctured was 07 Sep 2021 at 3.20pm. The vial did not under gone to temperature excursion. No concomitant medications were mentioned. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1790251
Sex: F
Age: 57
State: GA

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 10/16/2021
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: suspected cellulitis at left arm injection site; been quite unwell since getting my 3rd Moderna covid shot; localized reactions with alot of redness that went down her arm.; bed bound for a month.; She felt so sick; severe fatigue; had left arm inflammation and redness; had left arm redness; feeling of tired; mistakenly gave it to me subcutaneously/3rd dose was administered incorrect route by subcutaneous injection; This spontaneous case was reported by a nurse and describes the occurrence of CELLULITIS (suspected cellulitis at left arm injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 028B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]) for lupus. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CELLULITIS (suspected cellulitis at left arm injection site) (seriousness criterion medically significant), MALAISE (been quite unwell since getting my 3rd Moderna covid shot), ERYTHEMA (localized reactions with alot of redness that went down her arm.), BEDRIDDEN (bed bound for a month.), ILLNESS (She felt so sick), FATIGUE (severe fatigue), VACCINATION SITE INFLAMMATION (had left arm inflammation and redness), VACCINATION SITE ERYTHEMA (had left arm redness), FATIGUE (feeling of tired) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (mistakenly gave it to me subcutaneously/3rd dose was administered incorrect route by subcutaneous injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 30-Sep-2021, FATIGUE (feeling of tired) had resolved. At the time of the report, CELLULITIS (suspected cellulitis at left arm injection site), MALAISE (been quite unwell since getting my 3rd Moderna covid shot), ERYTHEMA (localized reactions with alot of redness that went down her arm.), BEDRIDDEN (bed bound for a month.), ILLNESS (She felt so sick), FATIGUE (severe fatigue), VACCINATION SITE INFLAMMATION (had left arm inflammation and redness) and VACCINATION SITE ERYTHEMA (had left arm redness) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (mistakenly gave it to me subcutaneously/3rd dose was administered incorrect route by subcutaneous injection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Company comment: This is a case of incorrect route of product administration and concerns a 57-year-old, female patient with medical history of lupus and concomitant use of imuran, who experienced the unexpected serious event of cellulitis. The event occurred on an unknown number of days after the third dose of mRNA 1273. The rechallenge is not applicable, since the vaccination schedule has been completed. The medical history of lupus and concomitant use of imuran, remain a confounder. The benefit-risk relationship of the vaccine is not affected by this report. This case was linked to MOD-2021-341218, MOD-2021-341229 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Significant Follow-up appended.; Sender's Comments: This is a case of incorrect route of product administration and concerns a 57-year-old, female patient with medical history of lupus and concomitant use of imuran, who experienced the unexpected serious event of cellulitis. The event occurred on an unknown number of days after the third dose of mRNA 1273. The rechallenge is not applicable, since the vaccination schedule has been completed. The medical history of lupus and concomitant use of imuran, remain a confounder. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds: IMURAN [AZATHIOPRINE SODIUM]

Current Illness:

ID: 1790252
Sex: M
Age: 53
State: VA

Vax Date: 08/24/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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: 202109; Test Name: MRI; Result Unstructured Data: MRI confirmed diagnosis of stroke.

Allergies:

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

Symptoms: small stroke clarified as his right arm went totally numb and he could move his arm or his fingers; "small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers; "small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (small stroke clarified as his right arm went totally numb and he could move his arm or his fingers), HYPOAESTHESIA ("small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers) and HYPOKINESIA ("small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040CZ1A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced CEREBROVASCULAR ACCIDENT (small stroke clarified as his right arm went totally numb and he could move his arm or his fingers) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA ("small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers) (seriousness criterion hospitalization) and HYPOKINESIA ("small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers) (seriousness criterion hospitalization). At the time of the report, CEREBROVASCULAR ACCIDENT (small stroke clarified as his right arm went totally numb and he could move his arm or his fingers), HYPOAESTHESIA ("small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers) and HYPOKINESIA ("small stroke" clarified as his right arm went totally numb and he could move his arm or his fingers) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) MRI confirmed diagnosis of stroke.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided Treatment medication was not provided Company Comment: This case concerns a 53-year-old, male patient, with no disclosed medical history, who experienced the serious, unexpected, AESI event of cerebrovascular accident and other serious, unexpected events of hypoaesthesia and hypokinesia. The events occurred approximately 3 weeks after first dose of Moderna vaccine. The rechallenge is not applicable as only one dose have been received by the patient. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 53-year-old, male patient, with no disclosed medical history, who experienced the serious, unexpected, AESI event of cerebrovascular accident and other serious, unexpected events of hypoaesthesia and hypokinesia. The events occurred approximately 3 weeks after first dose of Moderna vaccine. The rechallenge is not applicable as only one dose have been received by the patient. The benefit-risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790253
Sex: F
Age: 57
State: GA

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 10/16/2021
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: sore arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore arm) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No medical history for patient was reported. Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]) for Lupus anticoagulant. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (sore arm) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (tired) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient taken medication for suspected cellulitis it was not cellulitis at injection site and steroid cream. This case was linked to MOD-2021-341229, MOD-2021-341213 (Patient Link).

Other Meds: IMURAN [AZATHIOPRINE SODIUM]

Current Illness:

ID: 1790254
Sex: F
Age: 57
State: GA

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 10/16/2021
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: sore arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Systemic lupus erythematosus. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Systemic lupus erythematosus. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-341218, MOD-2021-341213 (Patient Link).

Other Meds: IMURAN [AZATHIOPRINE]

Current Illness: Systemic lupus erythematosus

ID: 1790255
Sex: F
Age: 80
State: NM

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 10/16/2021
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: Blood clots; a pain in leg near right knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Baker's cyst (Right knee), Clot blood (in lower leg), and Factor V Leiden mutation. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (seriousness criterion medically significant) and PAIN IN EXTREMITY (in leg near right knee). The patient was treated with XARELTO at an unspecified dose and frequency and WARFARIN at an unspecified dose and frequency. At the time of the report, THROMBOSIS and PAIN IN EXTREMITY (in leg near right knee) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. Patient had received a cortisone shot in her knee a month or 2 earlier for Baker's cyst in her right knee. This case concerns a 80-year-old, female patient with relevant medical history of Baker's cyst, Clot blood, and Factor V Leiden mutation, who experienced the unexpected events of Thrombosis and Pain in extremity. The events occurred on an unknown date after a dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of Baker's cyst, Clot blood, and Factor V Leiden mutation remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Case is assessed as Serious since Thrombosis is on the list and the outcome of the events is still unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am