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: 1711010
Sex: F
Age: 61
State: NJ

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 09/18/2021
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: I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness; Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before; I got a rash over my torso neck and chest; I cant go on long walks, having brain fog; having brain fog/ I do not usually feel this way; second vaccine gave covid arm lasting 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog) and FEELING ABNORMAL (having brain fog/ I do not usually feel this way) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE for an unknown indication. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog), FEELING ABNORMAL (having brain fog/ I do not usually feel this way) and VACCINATION SITE REACTION (second vaccine gave covid arm lasting 2 weeks). At the time of the report, DIZZINESS (I'm having a lot of dizziness and Lightheadedness/I had to go to urgent care for dizziness), HOT FLUSH (Extreme hot flashes which I didn't even have during menopause/I am experiencing extreme hot flashes that i never felt before), RASH (I got a rash over my torso neck and chest), GAIT DISTURBANCE (I cant go on long walks, having brain fog), FEELING ABNORMAL (having brain fog/ I do not usually feel this way) and VACCINATION SITE REACTION (second vaccine gave covid arm lasting 2 weeks) outcome was unknown. Treatment information was not provided. This case was linked to MOD-2021-311001 (Patient Link).

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1711011
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Moderna side effects after a week; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not reported. Relevant concomitant medications were not provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1711012
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/28/2021
Rec V Date: 09/18/2021
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: diagnosed with COVID (wait to take him to get his third vaccination); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)). At the time of the report, COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided.

Other Meds:

Current Illness: Immunocompromised

ID: 1711013
Sex: F
Age:
State: AR

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210903; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Throat hurts; Tired; Nauseous; smell loss; still sleeping a lot; 14 year old administered first dose; loss of taste; Congestion; Stomach pain; started to feel sick 6 hours after getting first dose/ sounds sick/not feeling well; runny nose; cough; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), NASAL CONGESTION (Congestion), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (started to feel sick 6 hours after getting first dose/ sounds sick/not feeling well) and RHINORRHOEA (runny nose) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy and Drug allergy (Versed allergy). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from December 2019 to an unknown date for ADHD. On 01-Sep-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced AGEUSIA (loss of taste), NASAL CONGESTION (Congestion), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (started to feel sick 6 hours after getting first dose/ sounds sick/not feeling well), RHINORRHOEA (runny nose), COUGH (cough) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old administered first dose). On 02-Sep-2021, the patient experienced ANOSMIA (smell loss) and SOMNOLENCE (still sleeping a lot). On 03-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Throat hurts), FATIGUE (Tired) and NAUSEA (Nauseous). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 01-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old administered first dose) had resolved. At the time of the report, AGEUSIA (loss of taste), NASAL CONGESTION (Congestion), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (started to feel sick 6 hours after getting first dose/ sounds sick/not feeling well), RHINORRHOEA (runny nose), COUGH (cough), ANOSMIA (smell loss), SOMNOLENCE (still sleeping a lot), OROPHARYNGEAL PAIN (Throat hurts), FATIGUE (Tired) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications included OTC stomach medication Patient received Moderna accidentally instead of Pfizer Patient was advised to take over the counter pain medicine and cold medicine. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Vaccine lot number was added. On 13-Sep-2021: Patient demographics updated, Added allergy, Added dose 1 timing, added events runny nose, cough, loss of smell, throat pain, nose is stuffy, tired and nauseous

Other Meds: ADDERALL

Current Illness: Drug allergy (Versed allergy); Penicillin allergy

ID: 1711014
Sex: F
Age: 19
State: FL

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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: Hives which look like raised looking bug bites; Itchiness in her lower back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back). At the time of the report, URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back) outcome was unknown. 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: 1711015
Sex: F
Age:
State:

Vax Date: 09/04/2021
Onset Date:
Rec V Date: 09/18/2021
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: chest pain; diarrhea; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache). At the time of the report, CHEST PAIN (chest pain), DIARRHOEA (diarrhea), CHILLS (chills) and HEADACHE (Headache) outcome was unknown. Patient felts throwing up and hit by a truck after getting her third dose Concomitant product was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-311093 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1711016
Sex: F
Age: 36
State: PA

Vax Date: 08/08/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
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: sickness; capsulitis; fever; tiredness; injection was "higher" than it should have been, was not in the deltoid; shoulder feels hot; jolt of pain into her shoulder; pain and hot burning at the injection site; lymph nodes in my arm are swollen; arm feels stiff; hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm) and PERIARTHRITIS (capsulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced JOINT WARMTH (shoulder feels hot), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen) and ARTHRALGIA (jolt of pain into her shoulder). On an unknown date, the patient experienced ILLNESS (sickness), PERIARTHRITIS (capsulitis), PYREXIA (fever), FATIGUE (tiredness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid). At the time of the report, JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), PERIARTHRITIS (capsulitis), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen), PYREXIA (fever), FATIGUE (tiredness), ARTHRALGIA (jolt of pain into her shoulder) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid) outcome was unknown. The patient treatment medication included Tylenol and advil, also using ice for shoulder pain. Also prescribed steroid for 5 days but she had not taken yet. This case was linked to MOD-2021-311116 (Patient Link).

Other Meds:

Current Illness:

ID: 1711017
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Someone told her that a magnet would stick to the injection site after taking the first injection, and it did; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did). At the time of the report, VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported.

Other Meds:

Current Illness:

ID: 1711018
Sex: F
Age: 80
State: MO

Vax Date: 08/04/2021
Onset Date: 09/04/2021
Rec V Date: 09/18/2021
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: She has tingling and numbness in fingers of both hands.; She has tingling and numbness in fingers of both hands.; Stiffness in both hands; 2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.; 2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She has tingling and numbness in fingers of both hands.), HYPOAESTHESIA (She has tingling and numbness in fingers of both hands.), MUSCULOSKELETAL STIFFNESS (Stiffness in both hands), MYALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) and ARTHRALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma (Eye drops for glaucoma.). Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) and ARTHRALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.). On an unknown date, the patient experienced PARAESTHESIA (She has tingling and numbness in fingers of both hands.), HYPOAESTHESIA (She has tingling and numbness in fingers of both hands.) and MUSCULOSKELETAL STIFFNESS (Stiffness in both hands). The patient was treated with IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and PREDNISONE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (She has tingling and numbness in fingers of both hands.), HYPOAESTHESIA (She has tingling and numbness in fingers of both hands.), MUSCULOSKELETAL STIFFNESS (Stiffness in both hands), MYALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) and ARTHRALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications includes Eye drops for glaucoma. Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Added treatment medication (Prednisone) and new event (Stiffness in both hands).

Other Meds: PREMARIN

Current Illness: Glaucoma (Eye drops for glaucoma.)

ID: 1711019
Sex: M
Age: 70
State: CA

Vax Date: 01/26/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
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: Blood Pressure; Result Unstructured Data: 88/70; Test Name: Blood Pressure; Result Unstructured Data: 115/75; Test Date: 20210906; Test Name: Blood Pressure; Result Unstructured Data: 110/75

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: lethargy; a very severe reaction; sore arm; not feeling well; trouble with balance; Systolic blood pressure <90 mmHg; Diarrhoea; really bad fatigue; bouts of nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy) and BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BALANCE DISORDER (trouble with balance), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea) and VOMITING (vomited). 01-Sep-2021, the patient experienced BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) and DIARRHOEA (Diarrhoea). On 07-Sep-2021, the patient experienced MALAISE (not feeling well). On an unknown date, the patient experienced VACCINATION COMPLICATION (a very severe reaction), LETHARGY (lethargy) and MYALGIA (sore arm). At the time of the report, VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), DIARRHOEA (Diarrhoea), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea), VOMITING (vomited) and MYALGIA (sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Blood pressure measurement: 110/75 (normal) 110/75. On an unknown date, Blood pressure measurement: 88/70 (Low) 88/70 and 115/75 (normal) 115/75. Concomitant medications were not provided. No Treatment information was provided This case was linked to MOD-2021-311336, MOD-2021-311337 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow-up adr form received,events added

Other Meds:

Current Illness:

ID: 1711020
Sex: F
Age: 51
State: TX

Vax Date: 02/23/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
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 use; Tenderness; Vaccination adverse reaction; myalgia; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia), PAIN (pain), TENDERNESS (Tenderness) and OFF LABEL USE (off label use) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia) and PAIN (pain). On 07-Sep-2021, the patient experienced TENDERNESS (Tenderness). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia), PAIN (pain), TENDERNESS (Tenderness) and OFF LABEL USE (off label use) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received her first dose of Moderna COVID19 Vaccine on 23Feb2021 and second dose on 24Mar2021. She received her third dose on 05Sep2021. The patient asks if getting the booster was too early. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1711021
Sex: M
Age: 57
State: NC

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
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: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date the vial was initially stored in the refrigerator was 31-Aug-2021. Date first punctured: 05-Sep-2021 at 11AM Kept in Refrigerator Date of administration of vaccine when applicable: 06-Sep-2021 4:30PM Room Temperature on 06-Sep-2021 then discarded the vial. The vial did not undergo any previous temperature excursions. Total amount of time the vial was exposed to room temperature range (46? to 77? F): From 06-Sep-2021 9:00AM and discarded vial after 4:30PM. This case was linked to MOD-2021-311383 (Patient Link).

Other Meds:

Current Illness:

ID: 1711022
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Got covid-19 11 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid-19 11 days after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid-19 11 days after 1st dose). At the time of the report, COVID-19 (Got covid-19 11 days after 1st dose) 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. This case was linked to MOD-2021-311244 (Patient Link).

Other Meds:

Current Illness:

ID: 1711023
Sex: F
Age:
State: GA

Vax Date: 03/01/2021
Onset Date: 08/20/2021
Rec V Date: 09/18/2021
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: Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine; Horrendous cough; Went to ER with high fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine), COUGH (Horrendous cough) and PYREXIA (Went to ER with high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Obesity and Pancreatitis. Concurrent medical conditions included Diabetes. In March 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 20-Aug-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine), COUGH (Horrendous cough) and PYREXIA (Went to ER with high fever). On 07-Sep-2021, COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine) and COUGH (Horrendous cough) had resolved. At the time of the report, PYREXIA (Went to ER with high fever) had resolved. It was reported that the patient had Hormone Replacement Therapy , also Concomitant medications include chronic hormones, as patient is transgender. on 27-Aug-2021 the patient received monoclonal antibody treatment. This case was linked to MOD-2021-311283 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Followup document contain no new information.

Other Meds:

Current Illness: Diabetes

ID: 1711024
Sex: M
Age: 68
State: TX

Vax Date: 01/12/2021
Onset Date: 08/18/2021
Rec V Date: 09/18/2021
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: tired and sleepy; tired and sleepy; received third dose but he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received third dose but he is not immunocompromised), SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 039K20A and 030M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension since 15-Jan-1992 and High cholesterol since 15-Jan-2015. Concomitant products included EPLERENONE from 15-Jan-2015 to an unknown date, AMLODIPINE from 15-Jan-1992 to an unknown date and HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) from 15-Jan-1992 to an unknown date for Blood pressure, ATORVASTATIN from 15-Jan-2011 to an unknown date for Cholesterol, MELOXICAM from 10-Oct-2011 to an unknown date for an unknown indication. On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced OFF LABEL USE (received third dose but he is not immunocompromised). On an unknown date, the patient experienced SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy). At the time of the report, OFF LABEL USE (received third dose but he is not immunocompromised) had resolved and SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication use was reported. Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: follow-up Information Included patient demographic details, Concomitant medication, concurrent condition and new event added.

Other Meds: EPLERENONE; AMLODIPINE; ATORVASTATIN; MELOXICAM; MAXZIDE

Current Illness: High cholesterol; Hypertension

ID: 1711025
Sex: F
Age: 61
State: MA

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 09/18/2021
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: Fatigue [after second dose]; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue [after second dose]) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032L20VT) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 FATIGUE (Fatigue [after second dose]). At the time of the report, FATIGUE (Fatigue [after second dose]) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-311231 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional document received with no new information.

Other Meds:

Current Illness:

ID: 1711026
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Pulse rate; Result Unstructured Data: 130's; Test Name: Oxygen Saturation; Result Unstructured Data: low 80's

Allergies:

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

Symptoms: I actually thought I was going to die; I'm not better yet; I almost went blind in my right eye; My heart feels like it could explode after climbing a flight of stairs; I can't catch myb reath when I walk any distance at all.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I actually thought I was going to die), MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.) 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, the patient experienced FEELING ABNORMAL (I actually thought I was going to die), MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I actually thought I was going to die) had not resolved and MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.) outcome was unknown. Unknown DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) 130's. On an unknown date, Oxygen saturation: low (Low) low 80's. The consumer stated that he received second Moderna shot and felt like he was going to die and he is not better yet. during reporting. The consumer stated that he almost went blind in his right eye and his heart feels like it could explode after climbing a flight of stairs. He also stated that he can't catch his breath when he walk any distance at all. His blood oxygen would drop to the low 80's and his pulse could go to into the 130's. The consumer stated that he underwent a biopsy on his right temple artery. The consumer stated that he was on a high dose of prednisone treatment medication. The consumer stated that he was scheduled to see a specialist at in October. No concomitant product use was provided by the reporter.

Other Meds:

Current Illness:

ID: 1711027
Sex: M
Age: 74
State: NC

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
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: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided Treatment information was not provided Action taken with mRNA-1273 in response to the events was not applicable. The vial was first punctured on 05-Sep-2021 11am Kept in Refrigerator.Total amount of time the vial was exposed to room temperature range (46? to 77? F) from 06-Sep-2021 9:00AM and discarded vial after 4:30PM. This case was linked to MOD-2021-311383 (Patient Link).

Other Meds:

Current Illness:

ID: 1711028
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/18/2021
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: when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain; having calf pain, muscle pains in my calf. It's gotten worse; having calf pain, muscle pains in my calf. It's gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain), PAIN IN EXTREMITY (having calf pain, muscle pains in my calf. It's gotten worse) and MYALGIA (having calf pain, muscle pains in my calf. It's gotten worse) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included CREST syndrome (autoimmune disease.). In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain), PAIN IN EXTREMITY (having calf pain, muscle pains in my calf. It's gotten worse) and MYALGIA (having calf pain, muscle pains in my calf. It's gotten worse). At the time of the report, PAIN (when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain), PAIN IN EXTREMITY (having calf pain, muscle pains in my calf. It's gotten worse) and MYALGIA (having calf pain, muscle pains in my calf. It's gotten worse) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness: CREST syndrome (autoimmune disease.)

ID: 1711029
Sex: M
Age: 70
State: CA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. No concomitant medications provided. No treatment medications provided. This case was linked to MOD-2021-311336, MOD-2021-311212 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non-Significant Follow up on 13-SEP-2021 contain Race information and Ethnicity were added

Other Meds:

Current Illness:

ID: 1711030
Sex: F
Age: 59
State: FL

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: >35 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days from the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days from the first dose) had resolved. No concomitant medications reported. The patient reported that a few things had happened that prevented her from going to get the second vaccine. No treatment medications reported.

Other Meds:

Current Illness:

ID: 1711031
Sex: M
Age: 50
State: NC

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
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: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. On 31 Aug 2021 , the vial was initially stored in the refrigerator and on 05 Sep 2021 11 AM vial was first punctured and kept in refrigerator. The vial did not undergo any previous temperature excursions. The total amount of time the vial was exposed to room temperature was from 06 Sep 2021 9.00 AM until the vial was discarded after 4.30 PM. This case was linked to MOD-2021-311383 (Patient Link).

Other Meds:

Current Illness:

ID: 1711032
Sex: F
Age: 56
State: NC

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
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: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021 at 4:30 PM, 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 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 31-Aug-2021 , the vial was initially stored in refrigerator. On 05-Sep-2021 at 11 A.M the vial was first punctured and kept in refrigerator. On 06-Sep-2021 vial was discarded after 4:30 P.M. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-311145, MOD-2021-311380, MOD-2021-311249, MOD-2021-311257, MOD-2021-311374, MOD-2021-311226, MOD-2021-311286 (Patient Link).

Other Meds:

Current Illness:

ID: 1711033
Sex: F
Age: 76
State: FL

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 09/18/2021
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: Felt a little off for one day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little off for one day) in a 76-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. In January 2021, the patient experienced MALAISE (Felt a little off for one day). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. In January 2021, MALAISE (Felt a little off for one day) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications were not reported. Treatment includes Ice also. Patient had second dose on 26 Feb 2021 and also a third booster dose due to her comorbidities. She experienced various side effects after each dose. This case was linked to MOD-2021-014607, MOD-2021-311452 (Patient Link).

Other Meds:

Current Illness:

ID: 1711034
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia) 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 FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia). At the time of the report, FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: FU received on 13 Sep 2021 include no new information. On 13-Sep-2021: Follow-up received contains no new information

Other Meds:

Current Illness:

ID: 1711035
Sex: F
Age: 36
State: NC

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 202012; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Fatigue; Pain at the left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (No hospitalization due to COVID-19. No treatment received.) in December 2020, Anxiety and Irregular periods. Concomitant products included FLUOXETINE for Anxiety. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. This case was linked to MOD-2021-311611 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received contains no new information. On 13-Sep-2021: Follow-up received contains no new information.

Other Meds: FLUOXETINE

Current Illness:

ID: 1711036
Sex: F
Age: 36
State: NC

Vax Date: 05/20/2021
Onset Date: 07/14/2021
Rec V Date: 09/18/2021
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: Test Name: Blood pressure; Result Unstructured Data: normal; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: F; Test Name: Hear rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Name: oxygen; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Name: respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 202012; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210802; Test Name: ultrasound; Result Unstructured Data: Two blood clots right arm were found on Ultrasound, One was a fully occluded blood clot right subclavian vein. partial blood clot in my right axillary vein. occlusive deep vein thrombosis involving the subclavian vein. Non-occlusive thrombus in the right axillary vein

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: DVT; Greater then 35 days between Moderna Covid-19 injections.; Could feel a very strong pulse in my right hand.; Pain under my right collarbone; Chest pain right sternum; Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein; Headache; Right arm turned red; Right arm was actively swelling; Right arm discolored; Skin became tight; pain down right arm; Pain in right arm pit; Tingling in right arm and in armpit; Generalized pain in my neck and in my right shoulder; Back pain; pain at the left arm injection site; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein) and DEEP VEIN THROMBOSIS (DVT) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020, Irregular periods and Anxiety. Concomitant products included FLUOXETINE for Anxiety, APIXABAN (ELIQUIS) for an unknown indication. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced VACCINATION SITE PAIN (pain at the left arm injection site). On 15-Jul-2021, the patient experienced PERIPHERAL SWELLING (Right arm was actively swelling), SKIN DISCOLOURATION (Right arm discolored), SKIN TIGHTNESS (Skin became tight), PAIN IN EXTREMITY (pain down right arm), AXILLARY PAIN (Pain in right arm pit), PARAESTHESIA (Tingling in right arm and in armpit), PAIN (Generalized pain in my neck and in my right shoulder), BACK PAIN (Back pain), ERYTHEMA (Right arm turned red) and HEADACHE (Headache). On 02-Aug-2021, the patient experienced THROMBOSIS (Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein) (seriousness criterion medically significant), RADIAL PULSE (Could feel a very strong pulse in my right hand.), BONE PAIN (Pain under my right collarbone) and CHEST PAIN (Chest pain right sternum). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Moderna Covid-19 injections.). At the time of the report, THROMBOSIS (Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein), DEEP VEIN THROMBOSIS (DVT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Moderna Covid-19 injections.), PERIPHERAL SWELLING (Right arm was actively swelling), SKIN DISCOLOURATION (Right arm discolored), SKIN TIGHTNESS (Skin became tight), PAIN IN EXTREMITY (pain down right arm), AXILLARY PAIN (Pain in right arm pit), PARAESTHESIA (Tingling in right arm and in armpit), PAIN (Generalized pain in my neck and in my right shoulder), BACK PAIN (Back pain), RADIAL PULSE (Could feel a very strong pulse in my right hand.), BONE PAIN (Pain under my right collarbone), ERYTHEMA (Right arm turned red), CHEST PAIN (Chest pain right sternum), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at the left arm injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. On 02-Aug-2021, Ultrasound scan: abnormal (abnormal) Two blood clots right arm were found on Ultrasound, One was a fully occluded blood clot right subclavian vein. partial blood clot in my right axillary vein. occlusive deep vein thrombosis involving the subclavian vein. Non-occlusive thrombus in the right axillary vein. On an unknown date, Blood pressure measurement: 110/67 mmHg (normal) normal. On an unknown date, Body temperature: 98.2 (Inconclusive) F. On an unknown date, Heart rate: 64 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 98 (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 17 (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After the ultrasound patient reported, having severe aching pain under the right collarbone. Patient was prescribed Eliquis 10mg twice daily times 7 days, then took Eliquis 5mg twice daily and patient continued to take Eliquis for 3months. After 15JUL2021 the patient experienced back pain and headache. The patient went to see a chiropractor and had multiple visits with the Chiropractor Treatment information was not provided. Action taken was not applicable. Company Comment This case concerns 36-year-old female patient who experienced the events of deep vein thrombosis and thrombosis. The events occurred approximately 54 days after the first dose of mRNA-1273 and 19 days subsequent after the second dose of mRNA-1273. The rechallenge was not applicable for the events. The event was considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-311474. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: follow up received on 13-sep-2021 is Significant follow up Appended - New event (Deep Vein Thrombosis) Was updated; Sender's Comments: This case concerns 36-year-old female patient who experienced the events of deep vein thrombosis and thrombosis. The events occurred approximately 54 days after the first dose of mRNA-1273 and 19 days subsequent after the second dose of mRNA-1273. The rechallenge was not applicable for the events. The event was considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: ELIQUIS; FLUOXETINE

Current Illness:

ID: 1711037
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: she knows of people who have received a mix of the Pfizer and Moderna vaccines; 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 INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines) 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 INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines) had resolved. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1711038
Sex: F
Age: 55
State: OH

Vax Date: 04/03/2021
Onset Date: 09/02/2021
Rec V Date: 09/18/2021
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: 20210906; Test Name: Covid-19 virus test; Test Result: Positive ; Result Unstructured Data: Tested positive on Sunday, 06/Sep/2021

Allergies:

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

Symptoms: Symptoms of COVID-19 /COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Symptoms of COVID-19 /COVID-19 positive) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Symptoms of COVID-19 /COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Symptoms of COVID-19 /COVID-19 positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Tested positive on Sunday, 06/Sep/2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported Treatment medication were not reported

Other Meds:

Current Illness:

ID: 1711039
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: received a 100-mcg dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received a 100-mcg dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL OVERDOSE (received a 100-mcg dose). At the time of the report, ACCIDENTAL OVERDOSE (received a 100-mcg dose) outcome was unknown.

Other Meds:

Current Illness:

ID: 1711040
Sex: U
Age:
State:

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Open heart surgery eight weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC OPERATION (Open heart surgery eight 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 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC OPERATION (Open heart surgery eight weeks ago). At the time of the report, CARDIAC OPERATION (Open heart surgery eight weeks ago) outcome was unknown. wondering if the vaccination is still effective because it is now been seven months since the second shot. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1711041
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: They got something flipped up the heart.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (They got something flipped up the heart.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRASYSTOLES (They got something flipped up the heart.). At the time of the report, EXTRASYSTOLES (They got something flipped up the heart.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1711042
Sex: M
Age: 64
State: TX

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 09/18/2021
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: His symptoms felt more like the flu than anything else; Fever; Chills; felt like crap; area where he received the shot was hot to the touch; little painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 092D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE WARMTH (area where he received the shot was hot to the touch) and VACCINATION SITE PAIN (little painful). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (felt like crap), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at a dose of 1 dosage form. On 04-Aug-2021, FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (little painful) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were provided.

Other Meds:

Current Illness:

ID: 1711043
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Soreness throughout her entire body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness throughout her entire body) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 PAIN (Soreness throughout her entire body) and HEADACHE (Headache). At the time of the report, PAIN (Soreness throughout her entire body) and HEADACHE (Headache) had not resolved. No concomitant medications were reported by reporter. No treatment information was provided by reporter.

Other Meds:

Current Illness:

ID: 1711044
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: So weak; Watery stools; Crying uncontrollably; Suicidal thoughts; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts) 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 ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts). At the time of the report, ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts) outcome was unknown. No concomitant medications were reported. No treatment was provided.

Other Meds:

Current Illness:

ID: 1711045
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I am very tired almost all the time; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I am very tired almost all the time) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 FATIGUE (I am very tired almost all the time). At the time of the report, FATIGUE (I am very tired almost all the time) outcome was unknown. concomitant and treatment drugs were not provided

Other Meds:

Current Illness:

ID: 1711046
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Flu like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. No concomitant medications reported. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1711047
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Pretty bad spine pain; Migraine; Leg numbness; Leg weakness; Ocular migraines; Seeing shapesand has difficulty seeing; Muscle weakness; Could not get up; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness) and OPHTHALMIC MIGRAINE (Ocular migraines) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (CUTAQUIG), ATENOLOL, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), AMITRIPTYLINE, DIAZEPAM and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication. 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 SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting) outcome was unknown. Treatment information was not provided.

Other Meds: CUTAQUIG; ATENOLOL; DEPO PROVERA; AMITRIPTYLINE; DIAZEPAM; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]

Current Illness:

ID: 1711048
Sex: U
Age:
State:

Vax Date: 05/03/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: abnormal

Allergies:

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

Symptoms: Blood pressure issues; Fainting; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and BLOOD PRESSURE ABNORMAL (Blood pressure issues). At the time of the report, SYNCOPE (Fainting) and BLOOD PRESSURE ABNORMAL (Blood pressure issues) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) abnormal. Concomitant product use was not provider by the reporter. Treatment information was not provided. Company comment: Very limited information regarding these events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is not expected

Other Meds:

Current Illness:

ID: 1711049
Sex: M
Age:
State: TX

Vax Date: 09/05/2021
Onset Date:
Rec V Date: 09/18/2021
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: General body pain; body aches/ muscle aches and pains; headache; fatigue; chills; Fever; Vaccination site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever). At the time of the report, MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. No Concomitant drugs were reported. No Treatment information were reported. The patient reported "I have COVID arm. Delayed reaction".

Other Meds:

Current Illness:

ID: 1711050
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Exposed to the virus; 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 Exposed to Covid19 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 Exposed to Covid19. At the time of the report, EXPOSURE TO SARS-COV-2 Exposed to Covid19 outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. No concomitant product use was provided by the reporter. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1711051
Sex: F
Age: 73
State: CA

Vax Date: 08/05/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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: Fever; Chills; She's been throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VOMITING (She's been throwing up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 006D21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included ZINC for an unknown indication. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VOMITING (She's been throwing up). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VOMITING (She's been throwing up) outcome was unknown. Concomitant medications include Blood pressure medicines. Treatment information was not provided by reporter.

Other Meds: ZINC

Current Illness: Blood pressure

ID: 1711052
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over body) 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 RASH (Rash all over body). At the time of the report, RASH (Rash all over body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication is not provided by the reporter. Treatment information was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1711053
Sex: U
Age:
State:

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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: administered expired doses to some patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1711054
Sex: F
Age: 73
State: IL

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
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: adverse reaction; injection site had turned red after 1st dose; headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer (for 10 years ). Concomitant products included TIMOLOL for Glaucoma, ATORVASTATIN CALCIUM, ZOLPIDEM and LATANOPROST for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose). At the time of the report, ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information reported as Denlafaxine (substitute drug). Unknown treatment medication was reported for nausea. This case was linked to MOD-2021-313718, MOD21-140857, MOD-2021-313629 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up contains significant information, reporter information added, Patient information and medical history information added, Product information added, Concomitant medication information added, Adverse event added.

Other Meds: ATORVASTATIN CALCIUM; ZOLPIDEM; TIMOLOL; LATANOPROST

Current Illness: Cancer (for 10 years)

ID: 1711055
Sex: U
Age:
State:

Vax Date: 08/08/2021
Onset Date:
Rec V Date: 09/18/2021
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: Multiple large puss filled pimples on upper body area; Skin rashes; This spontaneous case was reported by a consumer and describes the occurrence of ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes) 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 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes). At the time of the report, ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were provided by the reporter. No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1711056
Sex: M
Age:
State:

Vax Date: 09/07/2021
Onset Date:
Rec V Date: 09/18/2021
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: Pain in my chest/slight chest pain on the left side; Experiencing side effects; night sweating; increase in feelings of arthritis in our arthritic areas; joint pain; aching everywhere; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHEST PAIN (Pain in my chest/slight chest pain on the left side) had resolved and VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever) outcome was unknown. It was reported that patient received the Booster dose of Moderna and experienced chest pain that came for five seconds and then departed for period as long as fifteen minutes. Concomitant medications were not reported. Treatment information was not provided. This case was linked to MOD-2021-316965, MOD-2021-317608 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up document received contained: Updated reporter details- Phone number; Dose number; Additional events; Outcome of event- From unknown to recovered;

Other Meds:

Current Illness:

ID: 1711057
Sex: F
Age: 73
State: TN

Vax Date: 03/12/2021
Onset Date: 04/01/2021
Rec V Date: 09/18/2021
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: Retaining fluid; Affecting my legs/circulation in legs; Fatigued; Less than 35 days since first dose; Losing hair; Still fatigued with no energy; Lost my taste; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Losing hair), AGEUSIA (Lost my taste), FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs) and ASTHENIA (Still fatigued with no energy ) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PARACETAMOL (TYLENOL) for Arthritic-like pain, LOSARTAN for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGEUSIA (Lost my taste). In May 2021, the patient experienced ASTHENIA (Still fatigued with no energy ). In July 2021, the patient experienced ALOPECIA (Losing hair). On an unknown date, the patient experienced FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs), FATIGUE (Fatigued) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 35 days since first dose). The patient was treated with HYDROCHLOROTHIAZIDE on 14-Jul-2021 for Adverse event, at a dose of UNK, one time dose. At the time of the report, ALOPECIA (Losing hair), AGEUSIA (Lost my taste), FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs) and ASTHENIA (Still fatigued with no energy ) outcome was unknown, FATIGUE (Fatigued) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 35 days since first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter stated he did not experienced any adverse events after first dose of Moderna vaccine which was done on 12-MAR-2021 On 03-SEP-2021 patient had undergone some bloodwork which results were not yet disclosed. On 14-SEP-2021 his primary care provider ordered for ultrasound of legs. Reporter also mentioned that after taking Hydrochlorothiazide 12.5mg/1day but it did not work.

Other Meds: LOSARTAN; TYLENOL

Current Illness:

ID: 1711058
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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 aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient's consent to follow-up was given. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1711059
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.). At the time of the report, VACCINATION COMPLICATION (What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am