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: 1775939
Sex: F
Age:
State: FL

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 10/11/2021
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: left arm became red like the size of her palm; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm became red like the size of her palm) and FEELING HOT (Hot to the touch) in a 54-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 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left arm became red like the size of her palm) and FEELING HOT (Hot to the touch). At the time of the report, ERYTHEMA (left arm became red like the size of her palm) and FEELING HOT (Hot to the touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was stated it been 2 weeks since she got her 1st shot and this the first time she has seen it. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1775940
Sex: F
Age: 32
State: TX

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/11/2021
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: 2nd dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided. The vaccine vial was on refrigerator from 25-Aug-2021 (8 days prior). Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up contains patient's demographics and product details.

Other Meds:

Current Illness:

ID: 1775941
Sex: U
Age:
State: AL

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/11/2021
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: 20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021; 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 (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021). In September 2021, EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter stated that dose of expired was vaccine received between 02-Sep-2021 and 24-Sep-2021. Concomitant medications were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received contains non significant information updated reporter contact details. On 05-Oct-2021: follow-up includes no new information.

Other Meds:

Current Illness:

ID: 1775942
Sex: F
Age: 63
State: NJ

Vax Date: 08/04/2021
Onset Date: 09/09/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Vaccination site swelling; Hot to the touch right arm from elbow to shoulder; Could not lift right arm; Felt tightness in right arm; Vaccination site pain; Vaccination site pruritus; Unusual taste; tingling; flushing; with the skin being tight; it started to get real hot and red; rash; Vaccination site itching; vaccination site redness; vaccination site rash; chills; I started to feel soreness at the site then my arm was hurting me so; with swelling in mid arm area between injection site and elbow; It was itchy and feverish; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), FEELING HOT (Hot to the touch right arm from elbow to shoulder), MOBILITY DECREASED (Could not lift right arm), MUSCULOSKELETAL STIFFNESS (Felt tightness in right arm) and VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting, Hives, Urticaria, Drug allergy (Sulfar drug and pen v k), Drug allergy (synthetic vit a), Drug allergy (breakthrough idonine contrast), Labile blood pressure, Arrhythmia and Tinnitus. On 04-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) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), FEELING HOT (Hot to the touch right arm from elbow to shoulder), MOBILITY DECREASED (Could not lift right arm), MUSCULOSKELETAL STIFFNESS (Felt tightness in right arm), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus), TASTE DISORDER (Unusual taste), PARAESTHESIA (tingling), FLUSHING (flushing), SKIN TIGHTNESS (with the skin being tight), ERYTHEMA (it started to get real hot and red), RASH (rash), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE RASH (vaccination site rash), CHILLS (chills), VACCINATION SITE PAIN (I started to feel soreness at the site then my arm was hurting me so), VACCINATION SITE SWELLING (with swelling in mid arm area between injection site and elbow), PYREXIA (It was itchy and feverish) and HYPERSENSITIVITY (Hypersensitivity reaction). On 13-Sep-2021, TASTE DISORDER (Unusual taste), PARAESTHESIA (tingling), FLUSHING (flushing), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site rash) had not resolved, CHILLS (chills) and PYREXIA (It was itchy and feverish) had resolved. On 20-Sep-2021, VACCINATION SITE SWELLING (Vaccination site swelling), FEELING HOT (Hot to the touch right arm from elbow to shoulder), MOBILITY DECREASED (Could not lift right arm) and MUSCULOSKELETAL STIFFNESS (Felt tightness in right arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus), SKIN TIGHTNESS (with the skin being tight), ERYTHEMA (it started to get real hot and red), RASH (rash), VACCINATION SITE PAIN (I started to feel soreness at the site then my arm was hurting me so), VACCINATION SITE SWELLING (with swelling in mid arm area between injection site and elbow) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medicine were reported by the reporter Treatment: Medications included Cold press Patient is having lot of cytotoxins in her body Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up appended Included Reporter Information, Medical history & Events updated

Other Meds:

Current Illness: Arrhythmia; Bee sting; Drug allergy (synthetic vit a); Drug allergy (Sulfar drug and pen v k); Drug allergy (breakthrough idonine contrast); Hives; Labile blood pressure; Tinnitus; Urticaria

ID: 1775943
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/11/2021
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: Bells Palsy; 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 BELL'S PALSY (Bells Palsy) 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 BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication listed. No treatment information provided. Company comment: This case concerns a patient of unknown age and gender, with no previous relevant medical history reported, who experienced the unexpected event of Bell?s palsy. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a patient of unknown age and gender, with no previous relevant medical history reported, who experienced the unexpected event of Bell?s palsy. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.

Other Meds:

Current Illness:

ID: 1775944
Sex: F
Age: 22
State: GA

Vax Date: 09/07/2021
Onset Date: 09/01/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data: Test Name: Chest x-ray; Result Unstructured Data: myocarditis and pericarditis; Test Name: Echocardiogram; Result Unstructured Data: diagnosed with pericarditiss; Test Name: EKG; Result Unstructured Data: diagnosed with myocarditis. Also diagnosed pericarditis as well after looking at the same echocardiogram by 2nd cardiologist.

Allergies:

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

Symptoms: told her not to get the 2nd dose; chest pain in heart; shortness of breath; extreme fatigue; Myocarditis; staying in bed the whole time; inflammation; she wasn't feeling better; pericarditis; started feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (chest pain in heart), DYSPNOEA (shortness of breath), ASTHENIA (started feeling weak), FATIGUE (extreme fatigue), PERICARDITIS (pericarditis) and MYOCARDITIS (Myocarditis) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient had Covid 19 over the summer and her symptoms began on 1st week of July with a positive Covid test on July-2021) in July 2021. Previously administered products included for Fever: Advil and Tylenol. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced ANGINA PECTORIS (chest pain in heart) (seriousness criteria disability and medically significant), DYSPNOEA (shortness of breath) (seriousness criterion disability), FATIGUE (extreme fatigue) (seriousness criterion disability) and MYOCARDITIS (Myocarditis) (seriousness criteria disability and medically significant). In September 2021, the patient experienced ASTHENIA (started feeling weak) (seriousness criterion disability), PERICARDITIS (pericarditis) (seriousness criteria disability and medically significant), BEDRIDDEN (staying in bed the whole time), INFLAMMATION (inflammation) and MALAISE (she wasn't feeling better). The patient was treated with COLCHICINE for Inflammation, at a dose of .6 milligram twice a day. At the time of the report, ANGINA PECTORIS (chest pain in heart), DYSPNOEA (shortness of breath), ASTHENIA (started feeling weak), FATIGUE (extreme fatigue), PERICARDITIS (pericarditis), MYOCARDITIS (Myocarditis), BEDRIDDEN (staying in bed the whole time), INFLAMMATION (inflammation) and MALAISE (she wasn't feeling better) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) myocarditis and pericarditis. On an unknown date, Echocardiogram: abnormal (abnormal) diagnosed with pericarditiss. On an unknown date, Electrocardiogram: abnormal (abnormal) diagnosed with myocarditis. Also diagnosed pericarditis as well after looking at the same echocardiogram by 2nd cardiologist.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was reported that on 08-Sep-2021, 18 to 20 hours after the 1st dose, patient started having chest pain in her heart, shortness of breath, extreme fatigue. She went to urgent care on 08-Sep-2021, the doctor diagnosed her with myocarditis and prescribed steroids. About a week and half after the symptoms began, she wasn't feeling better even after staying in bed the whole time, started feeling weak and went to see the 1st cardiologist who diagnosed her with pericarditis after doing an echocardiogram and EKG. Three days later she went to a 2nd cardiologist to get a 2nd opinion. He diagnosed pericarditis as well after looking at the same echocardiogram and prescribed treatment to alleviate the inflammation. The 2nd cardiologist also did 2 blood tests to check for damage and blood clotting. The 2nd cardiologist also told her not to get the 2nd dose and that it would take about 6 months for the inflammation to go away. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received and included no newinformation; Sender's Comments: This case concerns a 22 year-old female patient with reported history of covid-19, who experienced the unexpected serious events of dyspnoea and angina pectoris, and the expected but serious events of pericarditis and myocarditis. The event occurred 2 days after the first dose of mRNA-1273 vaccine for all the reported events, whit the exception of pericarditis, which occurred a week and a half after vaccination. The rechallenge was unknown for all the events, since they are not recovered/not resolved, and no information about second dose is provided. The medical history of Covid-19 infection remains as a confounder and a risk factor for the events of myocarditis and pericarditis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1775945
Sex: F
Age: 72
State: WI

Vax Date: 03/01/2021
Onset Date: 09/30/2021
Rec V Date: 10/11/2021
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: Mild soreness at the injection site; I was really, really tired & fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Rheumatic fever (as a kid). In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued). At the time of the report, VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided. Patient hip replacement surgery scheduled in October and doctors had recommended it. the patient experiencing mild soreness at the injection site and was really, really tired and fatigued. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Upon follow-up source document contain future surgery details updated in Inarrative supplement.

Other Meds:

Current Illness:

ID: 1775946
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/11/2021
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: received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) 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 PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door). At the time of the report, PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1775947
Sex: F
Age:
State: FL

Vax Date: 09/02/2021
Onset Date:
Rec V Date: 10/11/2021
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 felt sick all over again; felt dizzy immediately following the dose (10-15 min later); did not feel good; left arm as being warm to the touch; a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose; left arm was very painful for day,rolling over on that arm hurt (she would jump up); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Sep-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 ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch), THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)). At the time of the report, ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs were reported. No treatment drugs were reported.

Other Meds:

Current Illness:

ID: 1775948
Sex: F
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient received vaccine beyond 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Second dose and first dose details were not reported Expired doses of the Moderna vaccine was administered to 25 patients. The vials were in refrigerator for over 30 days. Number of doses per vials on 27-Sep-2021 1 vials of 14 doses and on 29-Sep-2021, 1 vial, 11 doses. Date the vial was initially stored in the refrigerator is on 24-Aug-2021. Dates of administration of vaccine on 27-Sep-2021 and 29-Sep-2021. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1775949
Sex: F
Age: 56
State: IA

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/11/2021
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: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received vaccine beyond 30 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037F21A) for COVID-19 immunization. No medical history reported. On Sep 27, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 27, 2021, patient administered expired product (received vaccine beyond 30 days). At the time of the report, administered expired product (received vaccine beyond 30 days) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-338604 (patient link).

Other Meds:

Current Illness:

ID: 1775950
Sex: M
Age: 72
State: MI

Vax Date: 02/12/2021
Onset Date: 03/12/2021
Rec V Date: 10/11/2021
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: Left shoulder burned; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Left shoulder burned) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced THERMAL BURN (Left shoulder burned) and HEADACHE (Headache). At the time of the report, THERMAL BURN (Left shoulder burned) and HEADACHE (Headache) outcome was unknown. No treatment information was provided. No concomitant medication was provided This case was linked to MOD-2021-338314, MOD-2021-338407 (Patient Link).

Other Meds:

Current Illness:

ID: 1775951
Sex: U
Age:
State: OR

Vax Date:
Onset Date: 05/22/2021
Rec V Date: 10/11/2021
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: expired vaccine used; Patients received vaccines that went through excursions twice; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Patients received vaccines that went through excursions twice) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) 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 22-May-2021, the patient experienced PRODUCT STORAGE ERROR (Patients received vaccines that went through excursions twice). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 03-Sep-2021, PRODUCT STORAGE ERROR (Patients received vaccines that went through excursions twice) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1775952
Sex: F
Age:
State: TX

Vax Date: 02/01/2021
Onset Date: 03/19/2021
Rec V Date: 10/11/2021
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: Lower body weakness; Neck pain; legs couldn't stand; Inability to walk; Weakness of legs; terrified of the BOOSTER.; Head pain; Fever; Body pain/Severe body aches; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk) and MUSCULAR WEAKNESS (Weakness of legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 8077727399) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Tested positive.). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), ANXIETY (terrified of the BOOSTER.), HEADACHE (Head pain), PYREXIA (Fever) and MYALGIA (Body pain/Severe body aches). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASTHENIA (Lower body weakness), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), HEADACHE (Head pain) and PYREXIA (Fever) had not resolved and NECK PAIN (Neck pain), ANXIETY (terrified of the BOOSTER.) and MYALGIA (Body pain/Severe body aches) outcome was unknown. Patient height was 5'2" and weight was 220. No treatment medications were reported. This case was linked to MOD-2021-338873 (RA Linked Report). This case was linked to MOD-2021-023159 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains Updated suspect product details. Added new events and concomitant medications and patient medical history. On 05-Oct-2021: Follow up received on 06 oct 2021 contains NNI.; Sender's Comments: MOD-2021-338873:Dose 2

Other Meds: LEVOTHYROXINE

Current Illness: Thyroid disorder

ID: 1775953
Sex: F
Age: 63
State: GA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/11/2021
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: Administration of expired vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient reported- administered vaccine one day after past expiry date. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains Pregnancy data, Race, Ethnic Group, Vaccine Route & body site updated.

Other Meds:

Current Illness:

ID: 1775954
Sex: F
Age: 26
State: IL

Vax Date: 02/26/2021
Onset Date: 03/25/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Fever of 100 degrees Farenheight; Test Date: 20210930; Test Name: COVID-19 Virus test; Test Result: Positive ; Result Unstructured Data: Patient tested positive for Covid-19 on 30 Sep 2021

Allergies:

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

Symptoms: Lack of drug effect; Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result; I felt miserable after my second Moderna covid-19 vaccination; Lying in bed in the fetal position; Chills; Fever/Fever of 100 degrees Farenheight; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result), FEELING ABNORMAL (I felt miserable after my second Moderna covid-19 vaccination), BEDRIDDEN (Lying in bed in the fetal position), DRUG INEFFECTIVE (Lack of drug effect) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FEELING ABNORMAL (I felt miserable after my second Moderna covid-19 vaccination), BEDRIDDEN (Lying in bed in the fetal position), CHILLS (Chills), PYREXIA (Fever/Fever of 100 degrees Farenheight) and HEADACHE (Headache). On 30-Sep-2021, the patient experienced COVID-19 (Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result). 30-Sep-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result), FEELING ABNORMAL (I felt miserable after my second Moderna covid-19 vaccination), BEDRIDDEN (Lying in bed in the fetal position), DRUG INEFFECTIVE (Lack of drug effect), CHILLS (Chills), PYREXIA (Fever/Fever of 100 degrees Farenheight) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for Covid-19 on 30 Sep 2021. On an unknown date, Body temperature: 100 (High) Fever of 100 degrees Farenheight. Concomitant medication were not reported. Treatment medication was not reported. Patient reported that she had no adverse reaction with the first dose and she received her second dose in left arm shoulder deltoid muscle and experienced a loss of smell and taste but she regain smell and taste on day 8 of covid-19 infection. patient experienced another episode of headache on an unknown date in SEP-2021 and another episode of Pyrexia on an unknown date in SEP-2021. Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up Updated reporter contact information includes reporter's address and email. On 05-Oct-2021: Added patient demographics(gender, date of birth, weight, pregnant information), lab data, suspect product details(dose one and dose two) and new events(case upgraded from non serious to serious as per follow up document- other medically important condition for a few events).; Sender's Comments: This case of drug ineffective concerns a 27-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest COVID-19. The event occurred approximately 5 months after the second dose of Spikevax. Rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of drug is not affected by this report

Other Meds:

Current Illness:

ID: 1775955
Sex: F
Age: 20
State: FL

Vax Date: 09/05/2021
Onset Date: 09/05/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048f21a) for COVID-19 vaccination. The patient's past medical history included Panic attack. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Myalgia, at an unspecified dose and frequency. On 06-Sep-2021, MYALGIA (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant was not specified. This case was linked to MOD-2021-339110.

Other Meds:

Current Illness:

ID: 1775956
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/11/2021
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: has a scab where the needle was introduced/ like a pimple where the needle was introduced; headache; tiredness; fever; had "the red arm"; itchy where the needle was introduced; Possibly getting first and second dose too close; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (had "the red arm") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In April 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 an unknown date, the patient experienced VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm"), VACCINATION SITE PRURITUS (itchy where the needle was introduced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close). At the time of the report, VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm") and VACCINATION SITE PRURITUS (itchy where the needle was introduced) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. treatment medications were not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1775957
Sex: M
Age: 62
State:

Vax Date: 08/25/2021
Onset Date: 09/22/2021
Rec V Date: 10/11/2021
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: shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath"; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 038c21a) for COVID-19 vaccination. Concurrent medical conditions included Asthma (Patient added that he can't do things without running out of breath). Concomitant products included PARACETAMOL (TYLENOL) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath"). At the time of the report, DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath") outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment details were reported. Patient reported being on Sedatives medication and Stomach medication.

Other Meds: TYLENOL; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE.]

Current Illness: Asthma (Patient added that he can't do things without running out of breath.)

ID: 1775958
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 06/05/2021
Rec V Date: 10/11/2021
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: received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021). On 05-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021) had resolved. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Patient states that she received her first Moderna vaccine in what she thinks was January but possibly February of 2021.

Other Meds:

Current Illness:

ID: 1775959
Sex: U
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 10/11/2021
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: ask people if they lost their hair after getting the vaccine they tell her that hey have; 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 ALOPECIA (ask people if they lost their hair after getting the vaccine they tell her that hey have) 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 ALOPECIA (ask people if they lost their hair after getting the vaccine they tell her that hey have). At the time of the report, ALOPECIA (ask people if they lost their hair after getting the vaccine they tell her that hey have) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No Treatment informations were reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Non-significant Follow-up -NNI On 05-Oct-2021: Follow up received on 06-Oct-2021 contained No New Information.

Other Meds:

Current Illness:

ID: 1775960
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: I was pretty sick for the first two shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was pretty sick for the first two shots) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cancer. In January 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 ILLNESS (I was pretty sick for the first two shots). At the time of the report, ILLNESS (I was pretty sick for the first two shots) outcome was unknown. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness: Cancer

ID: 1775961
Sex: F
Age: 69
State: NJ

Vax Date: 08/25/2021
Onset Date: 09/22/2021
Rec V Date: 10/11/2021
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: Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash; Little rash on their lower right arm; It is itching so bad/ they started itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash), VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site) and VACCINATION SITE RASH (Little rash on their lower right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site). On 23-Sep-2021, the patient experienced RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash) and VACCINATION SITE RASH (Little rash on their lower right arm). At the time of the report, RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash), VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site) and VACCINATION SITE RASH (Little rash on their lower right arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: SYNTHROID.

Current Illness:

ID: 1775962
Sex: M
Age: 72
State: WA

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 10/11/2021
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: Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad") in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Concurrent medical conditions included COPD in July 1968. Concomitant products included TIMOLOL for Glaucoma. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad"). At the time of the report, VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad") had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Patient reported that it felt better. This case was linked to MOD-2021-339295 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Patients race, ethnicity, Relevant medical history, concomitant medications, Event outcome and event assessment updated.

Other Meds: TIMOLOL

Current Illness: COPD

ID: 1775963
Sex: F
Age:
State: FL

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 10/11/2021
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: Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine; Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot) 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 01-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 COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot). At the time of the report, COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Non-significant follow-up: Reporters email address updated; Sender's Comments: This case concerns a female patient, age unknown with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (event onset date unknown). The rechallenge was not applicable since only information about first dose was disclosed. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.

Other Meds:

Current Illness:

ID: 1775964
Sex: F
Age:
State: FL

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling at the injection site after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site after second vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site after second vaccine). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site after second vaccine) outcome was unknown. Concomitant medications were not reported. treatment medications were not reported.

Other Meds:

Current Illness:

ID: 1775965
Sex: U
Age:
State: WI

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Expired vaccine given last 30 Sept; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given last 30 Sept) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given last 30 Sept). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given last 30 Sept) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Added drug start date and updated event verbatim.

Other Meds:

Current Illness:

ID: 1775966
Sex: F
Age:
State:

Vax Date: 10/01/2021
Onset Date:
Rec V Date: 10/11/2021
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: Swelling in her hands; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-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 PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1775967
Sex: M
Age: 54
State:

Vax Date: 09/29/2021
Onset Date: 09/30/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore in his left arm which moved to his right breast; underneath arm lymph nodes are swollen; sore in his left arm; severe joint pain; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), BREAST PAIN (sore in his left arm which moved to his right breast), ARTHRALGIA (severe joint pain), LYMPHADENOPATHY (underneath arm lymph nodes are swollen) and VACCINATION SITE PAIN (sore in his left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (believed he already had COVID 2 1/2 months ago.). On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced LETHARGY (lethargic) and ARTHRALGIA (severe joint pain). On 01-Oct-2021, the patient experienced BREAST PAIN (sore in his left arm which moved to his right breast), LYMPHADENOPATHY (underneath arm lymph nodes are swollen) and VACCINATION SITE PAIN (sore in his left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), BREAST PAIN (sore in his left arm which moved to his right breast), ARTHRALGIA (severe joint pain), LYMPHADENOPATHY (underneath arm lymph nodes are swollen) and VACCINATION SITE PAIN (sore in his left arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported not being on any medications prior to getting vaccine.

Other Meds:

Current Illness:

ID: 1775968
Sex: F
Age: 64
State: CA

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 10/11/2021
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: Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again; Hadaches every now and then; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047b21a and 041b21a) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis (Always had psoriasis in her neck for 4 years) and Herpes infection (Used to get herpes in her lips or on her gluteus). On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then) outcome was unknown. No concomitant medication were reported. It was reported that 3 days after receiving the vaccine her underlying burning diminished and the psoriasis disappeared.Patient also stated that sometimes she used to get herpes in her lips or on her gluteus and after vaccination she didn't had another episode of herpes again.

Other Meds:

Current Illness: Herpes infection (Used to get herpes in her lips or on her gluteus); Psoriasis (Always had psoriasis in her neck for 4 years.)

ID: 1775969
Sex: M
Age: 44
State: FL

Vax Date: 04/26/2021
Onset Date: 08/13/2021
Rec V Date: 10/11/2021
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: Can not really move; Lack of energy; Tired/ fatigue; Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021) and FATIGUE (Tired/ fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 048B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021). On an unknown date, the patient experienced MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy) and FATIGUE (Tired/ fatigue). On 13-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021) had resolved. At the time of the report, MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy) and FATIGUE (Tired/ fatigue) outcome was unknown. 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. Pharmacist reports that the patient reported after the second dose,he has been experiencing tired, fatigue, lack of energy, and was unable to move.

Other Meds:

Current Illness:

ID: 1775970
Sex: F
Age:
State: MD

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data: Test Date: 20211001; Test Name: Body temperature; Result Unstructured Data: 100.5-100.7 Deg. F

Allergies:

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

Symptoms: Fever of 100.5-100.7 Deg. F; Swollen axillary adenopathy that is 5cm; Redness of injection site of 4cm.; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 100.5-100.7 Deg. F), LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PYREXIA (Fever of 100.5-100.7 Deg. F), LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Oct-2021, PYREXIA (Fever of 100.5-100.7 Deg. F) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 100.5-100.7 (High) 100.5-100.7 Deg. F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1775971
Sex: F
Age: 62
State: PA

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/11/2021
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: a little clammy; I slept all day probably for about 18 hours; l was hot and cold; I couldn't eat; couldn't get up; felt like I am going to fall down; A little nauseated; pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm), COLD SWEAT (a little clammy), SOMNOLENCE (I slept all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold) and FEEDING DISORDER (I couldn't eat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). On 02-Oct-2021, the patient experienced SOMNOLENCE (I slept all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold), FEEDING DISORDER (I couldn't eat), MOBILITY DECREASED (couldn't get up ), FEELING ABNORMAL (felt like I am going to fall down) and NAUSEA (A little nauseated). On 03-Oct-2021, the patient experienced COLD SWEAT (a little clammy). The patient was treated with IBUPROFEN for Adverse event, at a dose of 2 Tab every six hours. At the time of the report, PAIN IN EXTREMITY (pain in my arm) and COLD SWEAT (a little clammy) had not resolved and SOMNOLENCE (I slept all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold), FEEDING DISORDER (I couldn't eat), MOBILITY DECREASED (couldn't get up ), FEELING ABNORMAL (felt like I am going to fall down) and NAUSEA (A little nauseated) was resolving. Concomitant medication information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1775972
Sex: M
Age: 16
State: FL

Vax Date: 07/08/2021
Onset Date: 08/13/2021
Rec V Date: 10/11/2021
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: Both feet are a little numb; Numbness in middle right toe; Cramping in left foot; Tingling (numbness) in his right foot; 16 year old given vaccine; Patient received second dose 36 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingling (numbness) in his right foot), HYPOAESTHESIA (Numbness in middle right toe), MUSCLE SPASMS (Cramping in left foot), HYPOAESTHESIA (Both feet are a little numb) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 36 days after the first dose). On 15-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling (numbness) in his right foot). On 19-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness in middle right toe) and MUSCLE SPASMS (Cramping in left foot). On 22-Aug-2021, the patient experienced HYPOAESTHESIA (Both feet are a little numb). On 13-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 36 days after the first dose) had resolved. On 25-Aug-2021, PARAESTHESIA (Tingling (numbness) in his right foot), HYPOAESTHESIA (Numbness in middle right toe), MUSCLE SPASMS (Cramping in left foot) and HYPOAESTHESIA (Both feet are a little numb) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Tingling in his right foot started on 15-AUG-2021. On 19-AUG-2021 reported numbness in middle right toe and cramping in left foot. On 22-AUG-2021, both feet are a little numb. Patient race is On 25-AUG-2021 reported no numbness or any other symptoms. No concomitant product reported by reporter. No treatment medication reported by reporter. This case was linked to MOD-2021-280894 (Patient Link).

Other Meds:

Current Illness:

ID: 1775973
Sex: F
Age: 64
State: NC

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/11/2021
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: welt at the injection site; big red circle at the injection site; itching at the injection site; hives at injection site; arm being kind of sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (welt at the injection site), MYALGIA (arm being kind of sore), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes, SIMVASTATIN, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and FISH OIL for an unknown indication. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced MYALGIA (arm being kind of sore). On 27-Sep-2021, the patient experienced INJECTION SITE URTICARIA (welt at the injection site), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE URTICARIA (welt at the injection site), MYALGIA (arm being kind of sore), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Patient reported that she won't get the second shot. Patient also reported that she has an appointment with her doctor on 16October2021. treatment medication include antibiotic,vaseline

Other Meds: SIMVASTATIN; METFORMIN; LISINOPRIL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; FISH OIL

Current Illness: Blood pressure high; Diabetes

ID: 1775974
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 10/11/2021
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: my shoulder, the joint is really hurting/ my neck and behind my back hurts; I have extra pain/ patient states all this is on the left arm were the vaccine was administrated; swelling around the injection site, the shoulder joint; a bad administration of the vaccine; 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 SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (my shoulder, the joint is really hurting/ my neck and behind my back hurts), VACCINATION SITE PAIN (I have extra pain/ patient states all this is on the left arm were the vaccine was administrated), VACCINATION SITE SWELLING (swelling around the injection site, the shoulder joint) and PRODUCT ADMINISTRATION ERROR (a bad administration of the vaccine) 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 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (a bad administration of the vaccine). On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (my shoulder, the joint is really hurting/ my neck and behind my back hurts), VACCINATION SITE PAIN (I have extra pain/ patient states all this is on the left arm were the vaccine was administrated) and VACCINATION SITE SWELLING (swelling around the injection site, the shoulder joint). On 25-Sep-2021, PRODUCT ADMINISTRATION ERROR (a bad administration of the vaccine) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (my shoulder, the joint is really hurting/ my neck and behind my back hurts), VACCINATION SITE PAIN (I have extra pain/ patient states all this is on the left arm were the vaccine was administrated) and VACCINATION SITE SWELLING (swelling around the injection site, the shoulder joint) had not resolved. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1775975
Sex: F
Age:
State: WA

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 10/11/2021
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: sick for about a week/ felt crappy for longer like almost a month; arms hurt; flu-like symptoms; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sick for about a week/ felt crappy for longer like almost a month), PAIN IN EXTREMITY (arms hurt), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024172OA and 028L2OA) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sick for about a week/ felt crappy for longer like almost a month), PAIN IN EXTREMITY (arms hurt), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (sick for about a week/ felt crappy for longer like almost a month), PAIN IN EXTREMITY (arms hurt), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. No concomitant medications were not reported. She is nervous about taking the booster vaccine and will discuss with her Oncologist No treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: TCR was received on 6-OCT-2021 and contains significant information: address, age , current condition , events ,were added.

Other Meds:

Current Illness: Cancer

ID: 1775976
Sex: F
Age: 24
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 10/11/2021
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: Body aches; Covid toes( feet hurting, red/purple coloration); Covid toes( feet hurting, red/purple coloration); Low energy/fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Post-traumatic stress disorder. Concomitant products included TRAZODONE for Post-traumatic stress disorder. On 27-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 PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication were provided. Patient reported that she was experiencing an intense rash in the scalp that is causing hair loss and it got worse since last two months. She also reported that her Dermatologist thinks this is dermatitis or psoriasis and prescribed, whit Clobetasol (steroid medication), propionate shampoo and a ciclopirox shampoo. This case was linked to MOD-2021-339457 (Patient Link).

Other Meds: TRAZODONE

Current Illness: Post-traumatic stress disorder

ID: 1775977
Sex: F
Age: 67
State: FL

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 10/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Unsteady on feet; Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills). On 20-Sep-2021, GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Patient took appointment on 8 Oct 2021 to take second dose and said that no rash was experienced as a side effect. treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Removed event Rash.

Other Meds:

Current Illness:

ID: 1775978
Sex: M
Age:
State: TN

Vax Date: 03/25/2021
Onset Date: 04/19/2021
Rec V Date: 10/11/2021
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: Almost debilitating; Inappropriate schedule of vaccine administered; EYE TWITCHING; OCCASIONAL STRONG HEARTBEAT; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), EYE IRRITATION (EYE TWITCHING), HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT), ASTHENIA (Almost debilitating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 048F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Amoxicillin, Amoxicillin, Pseudoephedrine and Caffeine. Past adverse reactions to the above products included Abdominal discomfort with Amoxicillin; Heart racing with Caffeine and Pseudoephedrine; and Vomiting with Amoxicillin. Concurrent medical conditions included Drug allergy (Augmentin), Heart racing and Ear infection (Bacterial , Fungal Ear infections.) in December 2020. Concomitant products included L-METHYLFOLATE from 15-Jun-2021 to an unknown date for Anxiety. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANXIETY (Anxiety). On 22-Sep-2021, the patient experienced EYE IRRITATION (EYE TWITCHING) and HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT). On an unknown date, the patient experienced ASTHENIA (Almost debilitating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ANXIETY (Anxiety), EYE IRRITATION (EYE TWITCHING), HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT) and ASTHENIA (Almost debilitating) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had anxiety on a daily basis as that happend once thirty years ago due to OTC pseudophedrine, Afrin use and caffeine. Lasted a few weeks and also happend a second time a couple weeks after flu vaccine several years ago and lasted 2- 3 weeks. Treatment information does not provided. This case was linked to MOD-2021-291669 (Patient Link).

Other Meds: L-METHYLFOLATE.

Current Illness: Drug allergy (Augmentin); Heart racing.

ID: 1775979
Sex: F
Age: 30
State: AL

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/11/2021
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: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (administration of an expired dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 048F21A) for COVID-19 immunization. No medical history reported. On Oct 3, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 3, 2021, patient administered expired product (administration of an expired dose). On Oct 3, 2021, administered expired product (administration of an expired dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated the dose administered after 30-day use by date or after manufacturer date of expiry. Storage details provide by reporter included: Date the vial was initially stored in the refrigerator: Sep 1, 2021 with a use by date of Oct 1, 2021. This case linked to MOD-2021-339392 (patient link).

Other Meds:

Current Illness:

ID: 1775980
Sex: F
Age: 70
State:

Vax Date: 09/27/2021
Onset Date:
Rec V Date: 10/11/2021
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: runny nose; sinus issues; throat discomfort; weakness in her arms; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-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 RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache). At the time of the report, RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was provided by the reporter. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1775981
Sex: F
Age: 42
State: IL

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 10/11/2021
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: Coldness; Joints being painful/It comes and goes, knees feel painful, and elbows; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows). At the time of the report, FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1775982
Sex: F
Age:
State: CA

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 10/11/2021
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: Next day arm sore at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hay fever, Penicillin allergy (Severe itching on back) since 1957 and Sulfonamide allergy (Itching) since 2003. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Patient partial date of birth was reported as the year 1942. No concomitant medications were provided. No treatment information was provided by the reporter. This case was linked to MOD-2021-016765 (Patient Link).

Other Meds:

Current Illness: Hay fever; Penicillin allergy (Severe itching on back); Sulfonamide allergy (Itching)

ID: 1775983
Sex: F
Age: 77
State:

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 10/11/2021
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: cannot move it; hand is swollen / Fingers are so swollen they look like sausages; in great pain; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (cannot move it) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 024M(Zor2)0A and 041L(Zor2)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MONOPLEGIA (cannot move it) (seriousness criterion medically significant), PERIPHERAL SWELLING (hand is swollen / Fingers are so swollen they look like sausages), PAIN IN EXTREMITY (in great pain) and VACCINATION SITE REACTION (COVID arm). At the time of the report, MONOPLEGIA (cannot move it), PERIPHERAL SWELLING (hand is swollen / Fingers are so swollen they look like sausages), PAIN IN EXTREMITY (in great pain) and VACCINATION SITE REACTION (COVID arm) had not resolved. The patient stated that she had a condition for that she went to the emergency room for yesterday (at the time of report). She was told it could be a reaction, but it was an uncommon reaction to getting the Moderna booster. She stated her doctor has even indicated there can be swelling in parts of the body after the injection because of other things like rheumatoid arthritis in the body. The patient could not move her hand quick enough as she was trying to answer questions regarding the adverse event she was reporting. She had gone to her physician and they took X-rays and blood work, but she was continuing to have symptoms and went to the emergency room yesterday on 03-Oct-2021. The patient stated her physician gave her a brace to keep the swelling down. She will be talking with a rheumatologist. She had no underlying medical conditions. Concomitant medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Follow up received and Reporter's contact information updated, added dosing information, events outcome updated as not recovered and emergency room visit ticked and lab data was added in I-narrative.

Other Meds:

Current Illness:

ID: 1775984
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/11/2021
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: Hand is swollen, cannot move it, in great pain; Hand is swollen, cannot move it, in great pain; Hand is swollen, cannot move it, in great pain; Moderna Arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm). At the time of the report, LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm) outcome was unknown. No concomitant medications were provided. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Follow-up received contains reporter details, patient details,events were updated.; Sender's Comments: This case concerns a unknown-year-old, female patient with no reported medical history. The patient experienced unlisted non-serious events of Limb discomfort peripheral swelling pain in extremity and vaccination site reaction unspecified days after third dose (booster dose) of spikevax. Patient experienced AEs after the third dose and no information about first and second dose is available rechallenge not applicable. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1775985
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/11/2021
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: Believe having side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Believe having side effects) 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 (Believe having side effects). At the time of the report, VACCINATION COMPLICATION (Believe having side effects) 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 provided.

Other Meds:

Current Illness:

ID: 1775986
Sex: F
Age: 36
State: AL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/11/2021
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: administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1775987
Sex: F
Age: 30
State: AL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/11/2021
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: Received an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1775988
Sex: F
Age: 73
State: FL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/11/2021
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: Red hot hard lump on the right of the injection site/hot/still warm to the touch; Red hot hard lump on the right of the injection site; Red hot hard lump on the right of the injection site/hardness; Red hot hard lump on the right of the injection site/redness/still red; Soreness in the arm of the injection/her arm was more sore than before; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch), VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness), VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red) and VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, FOLIC ACID and VITAMINS NOS for an unknown indication. On 02-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before). On 03-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch), VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness) and VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red). At the time of the report, VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch) and VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red) had not resolved and VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness) and VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before) was resolving. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up was received and contains significant information; suspect product details, concomitant details, additional events were added.

Other Meds: LEVOTHYROXINE; FOLIC ACID; VITAMINS NOS

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am