VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1672417
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: cannot sit due to back pain and his kidneys; cannot sit due to back pain and his kidneys; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (cannot sit due to back pain and his kidneys) and RENAL PAIN (cannot sit due to back pain and his kidneys) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (cannot sit due to back pain and his kidneys) and RENAL PAIN (cannot sit due to back pain and his kidneys). At the time of the report, BACK PAIN (cannot sit due to back pain and his kidneys) and RENAL PAIN (cannot sit due to back pain and his kidneys) outcome was unknown. No concomitant medications were reported. No treatment information was reported. Patient had both doses and had side effects such as he cannot sit due to back pain and his kidneys.

Other Meds:

Current Illness:

ID: 1672418
Sex: M
Age: 57
State: NY

Vax Date: 02/11/2021
Onset Date: 03/01/2021
Rec V Date: 09/04/2021
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: Elbow and wrist hurt; Could not lift anything up with his left arm; Was on light duty at work; Fingertips were burning; Fingertips were numb; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Elbow and wrist hurt), MOBILITY DECREASED (Could not lift anything up with his left arm), IMPAIRED WORK ABILITY (Was on light duty at work), BURNING SENSATION (Fingertips were burning) and HYPOAESTHESIA (Fingertips were numb) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination. The patient's past medical history included Testicular cancer (Left testes was removed) from 1998 to 1999 and Pneumonectomy (Had a black spot, because of cancer) on 04-May-2020. Concurrent medical conditions included Knee swelling (Got hurt years ago and was still swollen). On 11-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 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Elbow and wrist hurt) and MOBILITY DECREASED (Could not lift anything up with his left arm). In March 2021, the patient experienced IMPAIRED WORK ABILITY (Was on light duty at work), BURNING SENSATION (Fingertips were burning) and HYPOAESTHESIA (Fingertips were numb). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. In March 2021, BURNING SENSATION (Fingertips were burning) and HYPOAESTHESIA (Fingertips were numb) had resolved. At the time of the report, PAIN IN EXTREMITY (Elbow and wrist hurt) had not resolved and MOBILITY DECREASED (Could not lift anything up with his left arm) and IMPAIRED WORK ABILITY (Was on light duty at work) outcome was unknown. No concomitant medication information was provided. This case was linked to MOD-2021-288150 (Patient Link).

Other Meds:

Current Illness: Knee swelling (Got hurt years ago and was still swollen)

ID: 1672419
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: First dose 4-5 months ago, no second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 4-5 months ago, no second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 4-5 months ago, no second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 4-5 months ago, no second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment and concomitant medication information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1672420
Sex: F
Age: 61
State: SC

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: Glucose; Result Unstructured Data: WBC count as well as glucose was high; Test Date: 20210816; Test Name: WBC count; Result Unstructured Data: WBC count as well as glucose was high

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Slight infection; I was constipated; This morning I was kneeling over because of stomach pain; Pain was horrible; I was tired; Chills; Headache that would come and go in waves on Sunday; Brain fog; Stress induced because she was anxious in receiving the vaccine; I could feel my heart palpitating that night; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (I could feel my heart palpitating that night), INFECTION (Slight infection), CONSTIPATION (I was constipated), ABDOMINAL PAIN UPPER (This morning I was kneeling over because of stomach pain) and FEELING ABNORMAL (Brain fog) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: GLUTATHIONE and Vitamin C. Concomitant products included LISINOPRIL for an unknown indication. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced PALPITATIONS (I could feel my heart palpitating that night) and STRESS (Stress induced because she was anxious in receiving the vaccine). On 15-Aug-2021, the patient experienced FEELING ABNORMAL (Brain fog), FATIGUE (I was tired), CHILLS (Chills) and HEADACHE (Headache that would come and go in waves on Sunday). On 16-Aug-2021, the patient experienced INFECTION (Slight infection), CONSTIPATION (I was constipated), ABDOMINAL PAIN UPPER (This morning I was kneeling over because of stomach pain) and PAIN (Pain was horrible). On 15-Aug-2021, CHILLS (Chills) had resolved. On 16-Aug-2021, ABDOMINAL PAIN UPPER (This morning I was kneeling over because of stomach pain), FEELING ABNORMAL (Brain fog) and HEADACHE (Headache that would come and go in waves on Sunday) had resolved. At the time of the report, PALPITATIONS (I could feel my heart palpitating that night), INFECTION (Slight infection), STRESS (Stress induced because she was anxious in receiving the vaccine), PAIN (Pain was horrible) and FATIGUE (I was tired) outcome was unknown and CONSTIPATION (I was constipated) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Blood glucose: high (High) WBC count as well as glucose was high. On 16-Aug-2021, White blood cell count: high (High) WBC count as well as glucose was high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication included was Antibiotics for the increased WBC count.

Other Meds: LISINOPRIL

Current Illness:

ID: 1672421
Sex: M
Age: 55
State: CA

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 09/04/2021
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: ringing in the ears (tinnitus) that started in July; headache that lasted for about 4 to 5 months; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (ringing in the ears (tinnitus) that started in July) and HEADACHE (headache that lasted for about 4 to 5 months) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in the ears (tinnitus) that started in July) and HEADACHE (headache that lasted for about 4 to 5 months). The patient was treated with PARACETAMOL (TYLENOL A) for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in the ears (tinnitus) that started in July) and HEADACHE (headache that lasted for about 4 to 5 months) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: XANAX

Current Illness:

ID: 1672422
Sex: F
Age: 68
State: TX

Vax Date: 08/06/2021
Onset Date: 08/15/2021
Rec V Date: 09/04/2021
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: Arm was a little bit sore after the shot; Her arm where she got the shot in is red; Her arm where she got the shot in is inflamed; Her arm where she got the shot in is a little bit itchy; Her arm where she got the shot in was a little bit tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Her arm where she got the shot in is inflamed), VACCINATION SITE PRURITUS (Her arm where she got the shot in is a little bit itchy), VACCINATION SITE PAIN (Her arm where she got the shot in was a little bit tender), VACCINATION SITE ERYTHEMA (Her arm where she got the shot in is red) and MYALGIA (Arm was a little bit sore after the shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced VACCINATION SITE PAIN (Her arm where she got the shot in was a little bit tender). On 16-Aug-2021, the patient experienced VACCINATION SITE INFLAMMATION (Her arm where she got the shot in is inflamed), VACCINATION SITE PRURITUS (Her arm where she got the shot in is a little bit itchy) and VACCINATION SITE ERYTHEMA (Her arm where she got the shot in is red). On an unknown date, the patient experienced MYALGIA (Arm was a little bit sore after the shot). At the time of the report, VACCINATION SITE INFLAMMATION (Her arm where she got the shot in is inflamed), VACCINATION SITE PRURITUS (Her arm where she got the shot in is a little bit itchy), VACCINATION SITE PAIN (Her arm where she got the shot in was a little bit tender), VACCINATION SITE ERYTHEMA (Her arm where she got the shot in is red) and MYALGIA (Arm was a little bit sore after the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication provided. Patient was concerned as her events started 8 days after the shot.

Other Meds:

Current Illness:

ID: 1672423
Sex: F
Age:
State: TX

Vax Date: 08/15/2021
Onset Date: 08/15/2021
Rec V Date: 09/04/2021
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: Aches and pains; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pains), PYREXIA (Fever) and VOMITING (Throwing up) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MYALGIA (Aches and pains), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, MYALGIA (Aches and pains), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1672424
Sex: F
Age: 76
State: CA

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 09/04/2021
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: Tinnitus, mostly white noise but sometimes ringing; she had flu feeling for one day after the second dose .; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA LIKE ILLNESS (she had flu feeling for one day after the second dose .) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-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 TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA LIKE ILLNESS (she had flu feeling for one day after the second dose .). At the time of the report, TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA LIKE ILLNESS (she had flu feeling for one day after the second dose .) outcome was unknown. No concomitant medication reported. No treatment information was provided. This case was linked to MOD-2021-288321 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1672425
Sex: F
Age: 57
State: NJ

Vax Date: 12/24/2020
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Covid arm 7 days after each dose/Localized allergic reaction; Very hot; Red; Throbbing; Localized allergic reaction; A little bit lightheaded; Rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing) and HYPERSENSITIVITY (Localized allergic reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), HYPERSENSITIVITY (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash). The patient was treated with Manual therapy for Pain. At the time of the report, VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), HYPERSENSITIVITY (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment Medications details were provided. This case was linked to MOD-2021-288347 (Patient Link). Reporter did not allow further contact

Other Meds: ASPIRIN 81

Current Illness:

ID: 1672426
Sex: M
Age:
State:

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

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

Lab Data: Test Name: COVID test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No treatment medication information was provided. No concomitant medication information was provided.

Other Meds:

Current Illness:

ID: 1672427
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Off label dosing (vaccine given to underage patient); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Off label dosing (vaccine given to underage patient)) 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 OFF LABEL USE (Off label dosing (vaccine given to underage patient)). At the time of the report, OFF LABEL USE (Off label dosing (vaccine given to underage patient)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant drugs were reported. No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1672428
Sex: F
Age: 84
State: FL

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 09/04/2021
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: she was too ill to get the second dose due to her underlying conditions; she was too ill; her arm hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (her arm hurt), ILLNESS (she was too ill) and PRODUCT DOSE OMISSION ISSUE (she was too ill to get the second dose due to her underlying conditions) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included Open heart surgery (2 open heart surgeries). Concurrent medical conditions included Diabetic. Concomitant products included METOPROLOL, BUMETANIDE (BUMEX), CLOPIDOGREL BISULFATE (PLAVIX), GLIPIZIDE and OMEPRAZOLE 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 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt). In April 2021, the patient experienced ILLNESS (she was too ill). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she was too ill to get the second dose due to her underlying conditions). On 21-Mar-2021, PAIN IN EXTREMITY (her arm hurt) had resolved. At the time of the report, ILLNESS (she was too ill) was resolving and PRODUCT DOSE OMISSION ISSUE (she was too ill to get the second dose due to her underlying conditions) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was provided by reporter.

Other Meds: METOPROLOL; BUMEX; PLAVIX; GLIPIZIDE; OMEPRAZOLE

Current Illness: Diabetic

ID: 1672429
Sex: M
Age: 74
State: WY

Vax Date: 02/01/2021
Onset Date: 07/26/2021
Rec V Date: 09/04/2021
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: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Shingles: shingrix (he got the shingles vaccine 5 years ago). In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. No concomitant medications was provided by the reporter. Patient got the first Moderna dose in his left arm in Feb-2021. He had the second vaccine in his left arm in Mar-2021. On 26-JUL-2021, he got shingles.

Other Meds:

Current Illness:

ID: 1672430
Sex: F
Age: 72
State: CA

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hematoma on her lower arms and lower legs.; ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (hematoma on her lower arms and lower legs.) and RASH (ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HAEMATOMA (hematoma on her lower arms and lower legs.) and RASH (ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.). At the time of the report, HAEMATOMA (hematoma on her lower arms and lower legs.) outcome was unknown and RASH (ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.) had not resolved. Patient went to see a dermatologist who prescribed her Keflex and an anti rash cream. Concomitants medications are reported as Vitamins.

Other Meds:

Current Illness:

ID: 1672431
Sex: M
Age: 74
State: GA

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now; Pain in the shoulder at the shot area; Some discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Some discomfort), RASH (Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now) and INJECTION SITE PAIN (Pain in the shoulder at the shot area) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SB21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced DISCOMFORT (Some discomfort) and INJECTION SITE PAIN (Pain in the shoulder at the shot area). On 15-Aug-2021, the patient experienced RASH (Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now). On 09-Aug-2021, DISCOMFORT (Some discomfort) and INJECTION SITE PAIN (Pain in the shoulder at the shot area) had resolved. At the time of the report, RASH (Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1672432
Sex: F
Age: 47
State: IN

Vax Date: 08/10/2021
Onset Date: 08/16/2021
Rec V Date: 09/04/2021
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: Redness of the face; Tightness of the face; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness of the face) and MUSCLE TIGHTNESS (Tightness of the face) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LOSARTAN for an unknown indication. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced ERYTHEMA (Redness of the face) and MUSCLE TIGHTNESS (Tightness of the face). At the time of the report, ERYTHEMA (Redness of the face) and MUSCLE TIGHTNESS (Tightness of the face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient took a medication that causes angioedema (Losartan for more than a year). No treatment information was provided.

Other Meds: LOSARTAN

Current Illness:

ID: 1672433
Sex: U
Age:
State: CA

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/04/2021
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: expired dose was given to a patient; vial was moved from the freezer to the refrigerator on 13Aug2021; 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 (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non significant Follow up

Other Meds:

Current Illness:

ID: 1672434
Sex: F
Age: 32
State: CA

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: sore throat; Pressure on the right side of neck; Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included TERBINAFINE and METOCLOPRAMIDE for an unknown indication. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). In August 2021, NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved. Concomitant medication included Birth control. No treatment medication was reported. Patient had confirmed she has not visited her primary care yet.

Other Meds: TERBINAFINE; METOCLOPRAMIDE

Current Illness: Sulfonamide allergy

ID: 1672435
Sex: F
Age: 120
State: TX

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 09/04/2021
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: called in to ask if she can still have 2nd dose of Moderna vaccine; Rashes all over body; my arm is still numb; cant even lay on that arm that had injection; my legs feel floppy its like totally numb; could not remember simple words; i got really tired; giant lymph nodes on my chest; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words) and FATIGUE (i got really tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scarlet fever. Concurrent medical conditions included Seasonal allergy, Allergic to cats and Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLLAGEN for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest) and PYREXIA (Fever). In July 2021, the patient experienced RASH (Rashes all over body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine). At the time of the report, HYPOAESTHESIA (my arm is still numb) had not resolved and LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest), PYREXIA (Fever), RASH (Rashes all over body) and PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Caller also reported that she had fever and rashes all of the body 3 weeks ago. It was like she had Scarlet Fever which she had before. No treatment medication were reported.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; COLLAGEN

Current Illness: Allergic to cats; Penicillin allergy; Seasonal allergy

ID: 1672436
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (wrist on that same side seems very swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (wrist on that same side seems very swollen). At the time of the report, JOINT SWELLING (wrist on that same side seems very swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by the reporter. No information on treatment is provided by the reporter.

Other Meds:

Current Illness:

ID: 1672437
Sex: F
Age: 28
State: GA

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/04/2021
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: Test Date: 20210816; Test Name: Heart Rate; Result Unstructured Data: 110 BPM

Allergies:

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

Symptoms: heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No medical history was provided by reporter. . Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening). At the time of the report, HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: 110 bpm (High) 110 BPM. No medical history was provided by reporter. Other concomitant includes blood pressure pills. No treatment medication reported.

Other Meds: ADDERALL

Current Illness:

ID: 1672438
Sex: U
Age:
State:

Vax Date: 07/18/2021
Onset Date:
Rec V Date: 09/04/2021
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: I got the ovid 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got the ovid 3 weeks ago) 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 18-Jul-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 COVID-19 (I got the ovid 3 weeks ago). At the time of the report, COVID-19 (I got the ovid 3 weeks ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1672439
Sex: M
Age:
State: MI

Vax Date: 03/15/2021
Onset Date: 04/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: General disconfort; Loss of strength; Leg Aches; Slowed thinking; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General disconfort), ASTHENIA (Loss of strength), PAIN IN EXTREMITY (Leg Aches) and BRADYPHRENIA (Slowed thinking) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DISCOMFORT (General disconfort), ASTHENIA (Loss of strength), PAIN IN EXTREMITY (Leg Aches) and BRADYPHRENIA (Slowed thinking). At the time of the report, DISCOMFORT (General disconfort), ASTHENIA (Loss of strength), PAIN IN EXTREMITY (Leg Aches) and BRADYPHRENIA (Slowed thinking) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No Concomitant medication information was reported. No treatment medications were provided. Three weeks after the first shoot of the Moderna vaccine he started to feel leg aches, loss of strength and a slower thinking speed. A general felling of discomfort was reported. His doctor told him that this events were not related to the vaccine. Second dose 26Apr2021

Other Meds:

Current Illness:

ID: 1672440
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-288836 (Patient Link).

Other Meds:

Current Illness:

ID: 1672441
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours) 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 THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1672442
Sex: M
Age:
State: GA

Vax Date: 08/12/2021
Onset Date: 08/15/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), TACHYCARDIA (increased heart rate), ANXIETY (anxiety) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shortness of breath (Patient used a CPAP machine for shortness of breath (prior to Moderna COVID-19 vaccination)) and Heart rate increased. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced DYSPNOEA (shortness of breath), TACHYCARDIA (increased heart rate), ANXIETY (anxiety) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), TACHYCARDIA (increased heart rate), ANXIETY (anxiety) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1672443
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: developing digestive issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (developing digestive issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (developing digestive issues). At the time of the report, DYSPEPSIA (developing digestive issues) outcome was unknown. Concomitant medications were not provided. No treatment information was provided. This case was linked to MOD-2021-288736 (Patient Link).

Other Meds:

Current Illness:

ID: 1672444
Sex: M
Age: 76
State: TX

Vax Date: 01/02/2021
Onset Date: 01/07/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: COVID-19 positive

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Intentional deviation from dosage regimen; Received second dose more than 36 days after first dose; Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine; Never really felt bad and if so, it was subtle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Never really felt bad and if so, it was subtle), COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine), INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SL20A and 027B21A) for COVID-19 vaccination. Concurrent medical conditions included Barrett's esophagus, Blood pressure high and Diabetes (Diabeties Patient take injection for diabeties.). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Barrett's esophagus, CLOPIDOGREL BISULFATE (PLAVIX) for Blood count abnormal, METFORMIN and INSULIN for Diabetes. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Never really felt bad and if so, it was subtle). On 14-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine). On 12-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose). On 12-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) had resolved. At the time of the report, FEELING ABNORMAL (Never really felt bad and if so, it was subtle) and COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) COVID-19 positive. Lab data includes - Patient tested COVID-19 positive on 7-jan-2021 or 8-jan-2021 Concomitant medications also included unknown blood thinner and heart medications. Treatment medication include antibody infusion for COVID-19 received around 12-JAN-2021

Other Meds: PLAVIX; METFORMIN; INSULIN; NEXIUM [ESOMEPRAZOLE MAGNESIUM]

Current Illness: Barrett's esophagus; Blood pressure high; Diabetes (Diabeties Patient take injection for diabeties.)

ID: 1672445
Sex: F
Age: 66
State: TX

Vax Date: 12/26/2020
Onset Date: 01/12/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 202101; Test Name: COVID-19 test; Test Result: Positive; Result Unstructured Data: Positive.

Allergies:

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

Symptoms: diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine; very ill; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 after first dose of Moderna vaccine and ILLNESS 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 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ILLNESS. On 14-Jan-2021, the patient experienced COVID-19 diagnosed after first dose of Moderna vaccine. At the time of the report, COVID-19 diagnosed after first dose of Moderna COVID-19 vaccine had resolved and ILLNESS (very ill) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test Positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient did not take any concomitant medications. Patient received antibody infusion for COVID-19.

Other Meds:

Current Illness:

ID: 1672446
Sex: M
Age:
State: FL

Vax Date: 08/13/2021
Onset Date: 08/15/2021
Rec V Date: 09/04/2021
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: 20210815; Test Name: I had 102.3?F; Result Unstructured Data: 102.3?F

Allergies:

Symptom List: Nausea

Symptoms: I've been in bed for two days; It literally feels like my brain is splitting in two; I had 102.3?F; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (I've been in bed for two days), FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3?F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, GABAPENTIN, LEVETIRACETAM, TAMSULOSIN, TOPIRAMATE, CELECOXIB and CHLORZOXAZONE for an unknown indication. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced BEDRIDDEN (I've been in bed for two days), FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3?F). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, BEDRIDDEN (I've been in bed for two days) had resolved. At the time of the report, FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3?F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, Body temperature: 102.3?f (High) 102.3?F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter mentioned that he had seen to a neurologist.

Other Meds: GABAPENTIN; LEVETIRACETAM; TAMSULOSIN; TOPIRAMATE; CELECOXIB; CHLORZOXAZONE; IMITREX [SUMATRIPTAN]

Current Illness: Migraine

ID: 1672447
Sex: M
Age: 71
State: NY

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: low grade fever of 100 degrees F

Allergies:

Symptom List: Injection site pain

Symptoms: Sore Arm; low grade fever of 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) low grade fever of 100 degrees F. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. After first dose, the patient did not get sick.

Other Meds:

Current Illness:

ID: 1672448
Sex: F
Age: 44
State: NC

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210812; Test Name: Fever; Result Unstructured Data: Fever of 102.5

Allergies:

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

Symptoms: Stomach problems; Intestinal problems flared up /Diarrhea; Two Autoimmune diseases flared up; Fibromyalgia flared up; Heard swooshing sounds in her head during fever; Headache; Fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up) and TINNITUS (Heard swooshing sounds in her head during fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fibromyalgia (Autoimmune diseases flared up indicated fibromyalgia) and Intestinal functional disorder NOS (Autoimmune diseases flared up indicated intestinal problems(Diarrhea)). On 12-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 102.5 (High) Fever of 102.5. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness: Fibromyalgia (Autoimmune diseases flared up indicated fibromyalgia); Intestinal functional disorder NOS (Autoimmune diseases flared up indicated intestinal problems(Diarrhea))

ID: 1672449
Sex: U
Age:
State: CA

Vax Date: 08/16/2021
Onset Date: 08/15/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.; The vial was left out at room temperature Sunday night into Monday (16Aug2021); 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 PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)). On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.). At the time of the report, PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Suspect details included: Manufacture date: 21Apr2021 Original refrigeration date: 14Aug2021 (In freezer/frozen prior to that) Temperature stored in fridge: 38?F Stored at room temperature at 2:30p on 15Aug2021. 1st puncture: 15Aug2021 at 2:54pm. At room temp prior to her getting off work Left out at room temperature from 2:30pm 15Aug2021 through 3:00pm on Mon 16Aug2021.

Other Meds:

Current Illness:

ID: 1672450
Sex: F
Age: 18
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not reported. Patient who received the Moderna vaccine 30 minute ago and now has hives, but not all over the body.

Other Meds:

Current Illness:

ID: 1672451
Sex: U
Age:
State:

Vax Date: 12/01/2020
Onset Date: 08/17/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided No treatment information was provided.

Other Meds:

Current Illness:

ID: 1672452
Sex: M
Age:
State: GA

Vax Date: 08/16/2021
Onset Date: 08/17/2021
Rec V Date: 09/04/2021
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: Test Date: 20210817; Test Name: BODY TEMPERATURE; Result Unstructured Data: -0 degree temperature

Allergies:

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

Symptoms: his body started shaking so much; His whole body was "very very cold" and "extremely cold."; He said his body is in -0 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (his body started shaking so much), FEELING COLD (His whole body was "very very cold" and "extremely cold.") and BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature) 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 16-Aug-2021 at 6:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced TREMOR (his body started shaking so much) and FEELING COLD (His whole body was "very very cold" and "extremely cold."). 17-Aug-2021, the patient experienced BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature). At the time of the report, TREMOR (his body started shaking so much), FEELING COLD (His whole body was "very very cold" and "extremely cold.") and BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature decreased: decreased (Low) -0 degree temperature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment medication information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1672453
Sex: M
Age:
State: FL

Vax Date: 03/12/2021
Onset Date: 03/25/2021
Rec V Date: 09/04/2021
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: 20210325; Test Name: positive for COVID-19; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: He hasn't received his 2nd dose.; He became positive for covid after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He became positive for covid after receiving 1st dose) and PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (He became positive for covid after receiving 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.). At the time of the report, COVID-19 (He became positive for covid after receiving 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No Concomitant medications were reported. No Treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1672454
Sex: F
Age: 46
State: MI

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 09/04/2021
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: an episode of athlete foot on hands and feet; She has so many allergies; her hands dry out; Her hands still react to the sun, they burn and itch /itched and it burned it was worse when she was in the sun.; was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned; was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned; a rash that was in her arms, legs and face; was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned; was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned; This spontaneous case was reported by a consumer and describes the occurrence of TINEA PEDIS (an episode of athlete foot on hands and feet), MULTIPLE ALLERGIES (She has so many allergies), DRY SKIN (her hands dry out), PHOTOSENSITIVITY REACTION (Her hands still react to the sun, they burn and itch /itched and it burned it was worse when she was in the sun.) and VACCINATION SITE MASS (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concurrent medical conditions included Allergy (burn and itch, her hands dry out) and Allergy. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ALPRAZOLAM (XANAX), IBUPROFEN, ATENOLOL, ALBUTEROL [SALBUTAMOL] and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-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 TINEA PEDIS (an episode of athlete foot on hands and feet), MULTIPLE ALLERGIES (She has so many allergies), DRY SKIN (her hands dry out), PHOTOSENSITIVITY REACTION (Her hands still react to the sun, they burn and itch /itched and it burned it was worse when she was in the sun.), VACCINATION SITE MASS (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned), VACCINATION SITE DYSAESTHESIA (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned), RASH (a rash that was in her arms, legs and face), VACCINATION SITE PRURITUS (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned) and VACCINATION SITE SWELLING (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, TINEA PEDIS (an episode of athlete foot on hands and feet), MULTIPLE ALLERGIES (She has so many allergies), DRY SKIN (her hands dry out), PHOTOSENSITIVITY REACTION (Her hands still react to the sun, they burn and itch /itched and it burned it was worse when she was in the sun.), VACCINATION SITE MASS (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned), VACCINATION SITE DYSAESTHESIA (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned), RASH (a rash that was in her arms, legs and face), VACCINATION SITE PRURITUS (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned) and VACCINATION SITE SWELLING (was huge and swollen where she had the shot, but not like the COVID arm, it was a solid round mass. It itched and it burned) outcome was unknown. This case was linked to MOD-2021-289155 (Patient Link).

Other Meds: CYMBALTA; XANAX; IBUPROFEN; ATENOLOL; ALBUTEROL [SALBUTAMOL]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Allergy (burn and itch, her hands dry out); Allergy

ID: 1672455
Sex: M
Age: 71
State: OH

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 09/04/2021
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: mild nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (mild nauseousness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Immunocompromised. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (mild nauseousness). At the time of the report, NAUSEA (mild nauseousness) outcome was unknown. No treatment medications were provided This case was linked to MOD-2021-289526.

Other Meds: MYCOPHENOLATE

Current Illness: Immunocompromised

ID: 1672456
Sex: M
Age: 31
State: CA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: He has not received the second dose; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRODUCT DOSE OMISSION ISSUE (He has not received the second dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He has not received the second dose). On 15-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (He has not received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1672457
Sex: F
Age:
State: NY

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/04/2021
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: off label- extended time between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses) 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 16-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 PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided.

Other Meds:

Current Illness:

ID: 1672458
Sex: F
Age: 61
State: CA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 09/04/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 3 and Spinal stenosis. Concomitant products included TRAMADOL for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches). At the time of the report, ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches) outcome was unknown. Treatment details were provided by reporter. She did not take any medications for her symptoms but limited her diet to applesauce, bananas, and rice. She watched her diet to try and help with those symptoms as well. This case was linked to MOD-2021-289553.

Other Meds: TRAMADOL

Current Illness:

ID: 1672459
Sex: F
Age: 56
State: FL

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Leg was swollen; Abnormal blood work; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer (Breast cancer), Lymph node biopsy (Cut lymph nodes), Cancer (cancer.) and Immunodeficiency (Immunodeficiency.). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work) outcome was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter This case was linked to MOD-2021-289568 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Significant Follow up appended on 18-AUG-2021- Patient age & age group updated

Other Meds:

Current Illness: Breast cancer (Breast cancer); Cancer (cancer.); Immunodeficiency (Immunodeficiency.); Lymph node biopsy (Cut lymph nodes)

ID: 1672460
Sex: F
Age: 42
State: OH

Vax Date: 01/01/2021
Onset Date: 02/04/2021
Rec V Date: 09/04/2021
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: knot in my right arm where I took my vaccine; tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired). At the time of the report, SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired) outcome was unknown. Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. Knot stayed there, never got bigger and never got smaller.

Other Meds:

Current Illness:

ID: 1672461
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: mild soreness at the site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness at the site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild soreness at the site). At the time of the report, VACCINATION SITE PAIN (mild soreness at the site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided by the reporter.

Other Meds: ESBRIET

Current Illness:

ID: 1672462
Sex: F
Age: 62
State: FL

Vax Date: 01/06/2021
Onset Date: 02/08/2021
Rec V Date: 09/04/2021
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: Bursitis; acute case of bronchitis and laryngitis; Frozen shoulder in non vaccinated arm; Severe brain fog; Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia; Dizziness; Dizziness Vertigo; Six days after each vaccine I experienced exhaustion I slept for two days; Headache; body ache; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Dizziness Vertigo), FEELING ABNORMAL (Severe brain fog), BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), DIZZINESS (Dizziness) and BURSITIS (Bursitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D NOS, MAGNESIUM, FISH OIL, ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VERTIGO (Dizziness Vertigo), DIZZINESS (Dizziness), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days), HEADACHE (Headache), MYALGIA (body ache) and FATIGUE (Fatigue extreme). On an unknown date, the patient experienced FEELING ABNORMAL (Severe brain fog), BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), BURSITIS (Bursitis), LARYNGITIS (acute case of bronchitis and laryngitis) and PERIARTHRITIS (Frozen shoulder in non vaccinated arm). On 17-Feb-2021, VERTIGO (Dizziness Vertigo), DIZZINESS (Dizziness), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days), HEADACHE (Headache) and MYALGIA (body ache) had resolved. At the time of the report, FEELING ABNORMAL (Severe brain fog) had resolved, BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), BURSITIS (Bursitis), LARYNGITIS (acute case of bronchitis and laryngitis) and PERIARTHRITIS (Frozen shoulder in non vaccinated arm) outcome was unknown and FATIGUE (Fatigue extreme) was resolving. No treatment medication were provided by the reporter This case was linked to MOD-2021-289558 (Patient Link).

Other Meds: VITAMIN D NOS; MAGNESIUM; FISH OIL; LEXAPRO; BUPROPION; VITAMIN B12 [CYANOCOBALAMIN]; FIORICET

Current Illness:

ID: 1672463
Sex: U
Age:
State: AR

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

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

Lab Data:

Allergies:

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

Symptoms: it has made a couple of people really sick; 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 ILLNESS (it has made a couple of people really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (it has made a couple of people really sick). At the time of the report, ILLNESS (it has made a couple of people really sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-276849 (Patient Link).

Other Meds:

Current Illness:

ID: 1672464
Sex: M
Age: 13
State: CA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/04/2021
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: Inadvertently gave a 1st Moderna dose to a 13 year old today; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently gave a 1st Moderna dose to a 13 year old today) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently gave a 1st Moderna dose to a 13 year old today). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently gave a 1st Moderna dose to a 13 year old today) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1672465
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Body pain; Run a low fever; Vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting) 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 PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting). At the time of the report, PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1672466
Sex: F
Age: 28
State: WI

Vax Date: 07/24/2021
Onset Date:
Rec V Date: 09/04/2021
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: didn't actually have a fever but went between cold and warm; her arm was hurting; she wasn't feeling great; neuropathic side effects; electrical tingling shock that goes up in her feet and sometimes into her leg; her nerves spazzing out; it's really painful; electrical tingling shock that goes up in her feet and sometimes into her leg; a headache which was described as "not a severe one, a minor one"; more tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), NEURALGIA (neuropathic side effects) and ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression, Bipolar disorder and Social anxiety disorder. On 24-Jul-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 OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), NEURALGIA (neuropathic side effects), ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg), MUSCLE SPASMS (her nerves spazzing out), PAIN (it's really painful), PARAESTHESIA (electrical tingling shock that goes up in her feet and sometimes into her leg), HEADACHE (a headache which was described as "not a severe one, a minor one") and FATIGUE (more tired than usual). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), HEADACHE (a headache which was described as "not a severe one, a minor one") and FATIGUE (more tired than usual) had resolved and NEURALGIA (neuropathic side effects), ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg), MUSCLE SPASMS (her nerves spazzing out), PAIN (it's really painful) and PARAESTHESIA (electrical tingling shock that goes up in her feet and sometimes into her leg) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported by reporter It was reported that the caller did not know the name of medications of the top of her head. Patient's physician stated that she would be fine to receive the second dose and patient had a physical examination scheduled in a few weeks

Other Meds:

Current Illness: Bipolar disorder; Depression; Social anxiety disorder

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am