VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1721582
Sex: F
Age: 35
State: CA

Vax Date: 08/10/2021
Onset Date: 09/09/2021
Rec V Date: 09/22/2021
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: Received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired vaccine). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.

Other Meds:

Current Illness:

ID: 1721583
Sex: F
Age: 19
State: UT

Vax Date: 08/20/2021
Onset Date:
Rec V Date: 09/22/2021
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: Ten minutes after injection patient started feeling faint/despondenet; Ten minutes after injection patient started feeling faint/despondenet; Cold to the touch, lips were blue; Cold to the touch, lips were blue; Sweating profusely; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Ten minutes after injection patient started feeling faint/despondenet), FEELING OF DESPAIR (Ten minutes after injection patient started feeling faint/despondenet), PARAESTHESIA (Cold to the touch, lips were blue), CYANOSIS (Cold to the touch, lips were blue) and HYPERHIDROSIS (Sweating profusely) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Ten minutes after injection patient started feeling faint/despondenet), FEELING OF DESPAIR (Ten minutes after injection patient started feeling faint/despondenet), PARAESTHESIA (Cold to the touch, lips were blue), CYANOSIS (Cold to the touch, lips were blue) and HYPERHIDROSIS (Sweating profusely). At the time of the report, DIZZINESS (Ten minutes after injection patient started feeling faint/despondenet), FEELING OF DESPAIR (Ten minutes after injection patient started feeling faint/despondenet), PARAESTHESIA (Cold to the touch, lips were blue), CYANOSIS (Cold to the touch, lips were blue) and HYPERHIDROSIS (Sweating profusely) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1721584
Sex: F
Age: 120
State: CA

Vax Date: 07/24/2021
Onset Date:
Rec V Date: 09/22/2021
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: not receiving 2nd dose in time; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose in time) had resolved. No treatment information was reported.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1721585
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: pain which did hurt for few days; round red marks on their arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN and ERYTHEMA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN and ERYTHEMA. At the time of the report, PAIN and ERYTHEMA outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1721586
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) 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. This case was linked to MOD-2021-316015 (Patient Link).

Other Meds:

Current Illness:

ID: 1721587
Sex: F
Age: 73
State: CA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 09/22/2021
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 Date: 20210215; Test Name: Holter monitoring; Result Unstructured Data: atrial flutter; Test Name: Heart rate; Result Unstructured Data: elevated heart rate (120-125)

Allergies:

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

Symptoms: Atrial flutter; Elevated heart rate (120-125); Whole left arm from shoulder to elbow became swollen; Whole left arm from shoulder to elbow became red; Dizziness; foggy headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (Atrial flutter), HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness) in a 73-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 Tachycardia (was hospitalized for that but she was told that it was due to severe anemia (HR then reached 199)). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (foggy headache). On 15-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness). On an unknown date, the patient experienced ATRIAL FLUTTER (Atrial flutter). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jan-2021 for Tachycardia, at an unspecified dose and frequency; METOPROLOL for Adverse event, at a dose of 50 mg,1 1/2 tab AM 1 tab in the evening and WARFARIN SODIUM (COUMADIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ATRIAL FLUTTER (Atrial flutter) had not resolved and HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red), DIZZINESS (Dizziness) and HEADACHE (foggy headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Electrocardiogram ambulatory: abnormal (abnormal) atrial flutter. On an unknown date, Heart rate: 120-125 heart beats per minute (High) elevated heart rate (120-125). No concomitant medication is provided On 2021, Patient had EKG, No results were provided Patient was monitored for 14 days in Holter monitor and it was reported that she would be getting 2D Echocardiogram. She was monitored by an emergency doctor and the vaccine provider after she was given the 2nd dose. This case was linked to MOD-2021-315374 (Patient Link).

Other Meds:

Current Illness:

ID: 1721588
Sex: F
Age: 40
State: NY

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/22/2021
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: tingling in my left arm/tingling in my left hand; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my left arm/tingling in my left hand) and VACCINATION SITE PAIN (pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced PARAESTHESIA (tingling in my left arm/tingling in my left hand) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, PARAESTHESIA (tingling in my left arm/tingling in my left hand) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment medication provided.

Other Meds:

Current Illness:

ID: 1721589
Sex: F
Age: 39
State: CA

Vax Date: 01/13/2021
Onset Date: 09/09/2021
Rec V Date: 09/22/2021
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: Redness in the area of injection; Very hard to the touch in the area of the injection; Swelling at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041l20a and 041l20a) for COVID-19 vaccination. Concurrent medical conditions included Sclerosis multiple. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]), NORTRIPTYLINE, SUMATRIPTAN, OCRELIZUMAB, HYDROXOCOBALAMIN ACETATE (V12) and ZOLPIDEM for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (Fever). On 10-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection). 10-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; MORINDA CITRIFOLIA (MORIN [MORINDA CITRIFOLIA]) 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, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: SERTRALINE [SERTRALINE HYDROCHLORIDE]; NORTRIPTYLINE; SUMATRIPTAN; OCRELIZUMAB; V12; ZOLPIDEM

Current Illness: Sclerosis multiple

ID: 1721590
Sex: F
Age: 56
State: TX

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 09/22/2021
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: 20210909; Test Name: body temperature; Result Unstructured Data: 102 F

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Nose dripping immediately after first shot; Radiating pain after first shot; Felt warm after first shot; Felt achy after first shot; Fever 102F after first shot; Feeling wearied in her body immediately after first shot; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Nose dripping immediately after first shot), PAIN (Radiating pain after first shot), FEELING HOT (Felt warm after first shot), MYALGIA (Felt achy after first shot) and PYREXIA (Fever 102F after first shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heartbeats irregular and COVID-19 in January 2021. Concurrent medical conditions included Immunocompromised and Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Asthma. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (Nose dripping immediately after first shot), PAIN (Radiating pain after first shot), FEELING HOT (Felt warm after first shot), MYALGIA (Felt achy after first shot), PYREXIA (Fever 102F after first shot) and FATIGUE (Feeling wearied in her body immediately after first shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK mg. On 05-Mar-2021, RHINORRHOEA (Nose dripping immediately after first shot), FEELING HOT (Felt warm after first shot), MYALGIA (Felt achy after first shot), PYREXIA (Fever 102F after first shot) and FATIGUE (Feeling wearied in her body immediately after first shot) had resolved. On 06-Mar-2021, PAIN (Radiating pain after first shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: high (High) 102 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-315707, MOD-2021-315706 (Patient Link).

Other Meds: PROAIR HFA; SPIRIVA

Current Illness: Asthma; Immunocompromised

ID: 1721591
Sex: M
Age: 81
State: NJ

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Abnormal

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Afib; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant) and FATIGUE (Tired). At the time of the report, ATRIAL FIBRILLATION (Afib) and FATIGUE (Tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) Abnormal. Concomitant product details were not provided by the reporter. Treatment details were not provided by the reporter. action taken was not applicable. Company comment: This case concerns an 81-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date after an unknown dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns an 81-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date after an unknown dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.

Other Meds:

Current Illness:

ID: 1721592
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/08/2021
Rec V Date: 09/22/2021
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: Fever returned; Headache/having headaches mostly when i lay down; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (Fever returned) and HEADACHE (Headache/having headaches mostly when i lay down) 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 08-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 09-Sep-2021, the patient experienced PYREXIA (Fever returned) and HEADACHE (Headache/having headaches mostly when i lay down). On 08-Sep-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 10-Sep-2021, PYREXIA (Fever returned) had resolved. At the time of the report, HEADACHE (Headache/having headaches mostly when i lay down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment drugs were reported This case was linked to MOD-2021-293439 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow-up information received on 12-09-2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1721593
Sex: U
Age:
State:

Vax Date: 02/08/2021
Onset Date: 08/16/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 20210818; Test Name: Covid-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative on day 2 for COVID; Test Date: 20210826; Test Name: Covid-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative on day 9 for COVID

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Got pretty sick with Covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got pretty sick with Covid like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ILLNESS (Got pretty sick with Covid like symptoms). At the time of the report, ILLNESS (Got pretty sick with Covid like symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Tested negative on day 2 for COVID. On 26-Aug-2021, SARS-CoV-2 test: negative (Negative) Tested negative on day 9 for COVID. No concomitant medications were reported. Treatment information was not provided. Patient reported that she had the second dose of Moderna 08FEB2021. On 16AUG2021 patient got pretty sick with Covid like symptoms. She tested negative on day 2 and day 9 for Covid. Patient and his son were traveling together and he had the J&J vaccine. He tested positive for Covid on his day 6. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1721594
Sex: F
Age:
State:

Vax Date: 06/09/2021
Onset Date: 06/01/2021
Rec V Date: 09/22/2021
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: Constant break through bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Constant break through bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ALPRAZOLAM and TRAZODONE. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Constant break through bleeding). At the time of the report, HEAVY MENSTRUAL BLEEDING (Constant break through bleeding) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-316165 (Patient Link).

Other Meds: ALPRAZOLAM; TRAZODONE

Current Illness:

ID: 1721595
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: received a Moderno vaccine my last shot was on the first I was just told by my position that I have a side effect which is shingles; I am in so much pain it is awful; I am very upset; I cannot sleep; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER, PAIN, FEELING ABNORMAL, and INSOMNIA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER, PAIN, FEELING ABNORMAL, and INSOMNIA. At the time of the report, HERPES ZOSTER, PAIN, FEELING ABNORMAL, and INSOMNIA outcome was unknown. No Treatment medications were provided No Concomitant medications were provided Most recent FOLLOW-UP information incorporated above includes On 11-Sep-2021 a Follow up received with updated events.

Other Meds:

Current Illness:

ID: 1721596
Sex: M
Age: 61
State: FL

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/22/2021
Hospital:

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

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

Allergies:

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

Symptoms: Could not lift his hand over his head; Sweat and Sweating without doing anything; Woke up one hour freezing; Injection site turned black and blue; Dizzy; Lightheaded; Did not feel good. He could not get out of bed until the next day at 3 pm; Arm was really sore/Sore all over; Fever; Injection site was swollen; Headache / Head was pounding and Slight headache; Chills; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not lift his hand over his head), HYPERHIDROSIS (Sweat and Sweating without doing anything), FEELING COLD (Woke up one hour freezing), VACCINATION SITE DISCOLOURATION (Injection site turned black and blue) and DIZZINESS (Dizzy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced MOBILITY DECREASED (Could not lift his hand over his head), HYPERHIDROSIS (Sweat and Sweating without doing anything), FEELING COLD (Woke up one hour freezing), VACCINATION SITE DISCOLOURATION (Injection site turned black and blue), DIZZINESS (Dizzy), DIZZINESS (Lightheaded), FEELING ABNORMAL (Did not feel good. He could not get out of bed until the next day at 3 pm), MYALGIA (Arm was really sore/Sore all over), PYREXIA (Fever), VACCINATION SITE SWELLING (Injection site was swollen), HEADACHE (Headache / Head was pounding and Slight headache), CHILLS (Chills) and FATIGUE (Really tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Could not lift his hand over his head), HYPERHIDROSIS (Sweat and Sweating without doing anything), FEELING COLD (Woke up one hour freezing), VACCINATION SITE DISCOLOURATION (Injection site turned black and blue), DIZZINESS (Dizzy), DIZZINESS (Lightheaded), FEELING ABNORMAL (Did not feel good. He could not get out of bed until the next day at 3 pm), MYALGIA (Arm was really sore/Sore all over), PYREXIA (Fever), VACCINATION SITE SWELLING (Injection site was swollen), HEADACHE (Headache / Head was pounding and Slight headache), CHILLS (Chills) and FATIGUE (Really tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported . Patient reported that he still did not feel good. He took Tylenol at about 1 or 2 pm in the morning, it did not do anything for him. On 11-SEPT-2021 is the 1st day he is feeling good since Tuesday night. He could not do anything on Tuesday night, Wednesday or Thursday. He had a slight headache on Thursday. He could not make his doctor appointment the next day because of his side effects, however he has an appointment on Monday 13SEPT2021. He only took it because he travels a lot.

Other Meds:

Current Illness:

ID: 1721597
Sex: F
Age: 61
State: OH

Vax Date: 08/13/2021
Onset Date: 09/11/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 929901) for COVID-19 vaccination. The patient's past medical history included Hypersensitivity reaction. Concurrent medical conditions included Latex allergy since 01-Jan-1994 and Urticaria. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] for Adverse event, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 11-Sep-2021 to 14-Sep-2021 for Adverse event, at a dose of every 4 hours and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE]) (oral) on 13-Sep-2021 for Adverse event, at a dose of 4 mg. On 13-Sep-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. Concomitant medications were not provided. Additional treatment included-oxygen. Company Comment: This case concerns a 62-year-old female patient with relevant medical history of urticaria and hypersensitivity reaction who experienced serious expected event of anaphylactic reaction. The event occurred approximately one day after the second, most recent dose of Spikevax with first symptoms occurring within 24 hours.. Rechallenge was not applicable since the event occurred after the second dose of Spikevax. The event was consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received on 17-SEP-2021 and patient demographic updated, event were added, product tab information added, medical history added and treatment medicines added.; Sender's Comments: This case concerns a 62-year-old female patient with relevant medical history of urticaria and hypersensitivity reaction who experienced serious expected event of anaphylactic reaction. The event occurred approximately one day after the second, most recent dose of Spikevax with first symptoms occurring within 24 hours.. Rechallenge was not applicable since the event occurred after the second dose of Spikevax. The event was consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.

Other Meds:

Current Illness: Latex allergy; Urticaria

ID: 1721598
Sex: M
Age: 14
State: NY

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 09/22/2021
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: vaccine was administered to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. injection into the deltoid muscle. No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.

Other Meds:

Current Illness:

ID: 1721599
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: fever 102.3 ?F.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: flu; feels really sick; fever 102.3 ?F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ?F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ?F). At the time of the report, INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ?F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever 102.3 ?F.. No concomitant medication details were provided. No treatment medication details were provided.

Other Meds:

Current Illness:

ID: 1721600
Sex: U
Age:
State: TX

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 09/22/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided. Date refrigerated of suspect product was given as 13-APR-2021 and Temperature changes was 41F. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1721601
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/09/2021
Rec V Date: 09/22/2021
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: Severe migraine since having the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine since having the Moderna 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. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MIGRAINE (Severe migraine since having the Moderna vaccine). At the time of the report, MIGRAINE (Severe migraine since having the Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1721602
Sex: M
Age: 60
State: NM

Vax Date: 07/22/2021
Onset Date:
Rec V Date: 09/22/2021
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: extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-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 an unknown date, the patient experienced VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.) outcome was unknown. Patient had no known allergies. Treatment also include Hot and cold compress and massage. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1721603
Sex: F
Age: 38
State: IN

Vax Date: 09/01/2021
Onset Date: 09/03/2021
Rec V Date: 09/22/2021
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: Pain in the left collar bone area.; pain and Inflamation in the Armpit; Pain at the site of the injection (upper left arm).; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication. On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).). At the time of the report, PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported.

Other Meds: ESTROGEN

Current Illness:

ID: 1721604
Sex: F
Age:
State: TN

Vax Date: 09/10/2021
Onset Date: 09/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 103 degrees which continued for the next 2-3 days to varying degrees but never below 100

Allergies:

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

Symptoms: Had a fever of 103 degrees; Swelling continued at the injection site; Vaccination given subcutaneously; Swelling began that afternoon; Inflammation began that afternoon; Tissue had hardened; The area was very warm to touch; The arm pit area is still a little tender; Left arm below the deltoid was extremely red; Lymph nodes in left armpit were very painful for 2-3 days; Woke in middle of night chilling; Lymph nodes in left armpit were swollen; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (The arm pit area is still a little tender), ERYTHEMA (Left arm below the deltoid was extremely red), INFLAMMATION (Inflammation began that afternoon), INDURATION (Tissue had hardened) and FEELING HOT (The area was very warm to touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Leukemia (Reported that no recent change in chronic condition) since 08-Jan-2006, Blood pressure high (HBP) and Seasonal allergy. Concomitant products included TRIAMTERENE for Blood pressure high, MONTELUKAST SODIUM (SINGULAIR) for Seasonal allergy, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 10-Sep-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 10-Sep-2021, the patient experienced INFLAMMATION (Inflammation began that afternoon), SWELLING (Swelling began that afternoon) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccination given subcutaneously). On 10-Sep-2021 at 9:00 PM, the patient experienced VACCINATION SITE SWELLING (Swelling continued at the injection site). On 11-Sep-2021 at 1:00 AM, the patient experienced PYREXIA (Had a fever of 103 degrees). In September 2021, the patient experienced TENDERNESS (The arm pit area is still a little tender), ERYTHEMA (Left arm below the deltoid was extremely red), INDURATION (Tissue had hardened), FEELING HOT (The area was very warm to touch), LYMPH NODE PAIN (Lymph nodes in left armpit were very painful for 2-3 days), CHILLS (Woke in middle of night chilling) and LYMPHADENOPATHY (Lymph nodes in left armpit were swollen). On 10-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccination given subcutaneously) had resolved. On 13-Sep-2021, PYREXIA (Had a fever of 103 degrees) had resolved. In September 2021, LYMPH NODE PAIN (Lymph nodes in left armpit were very painful for 2-3 days) and LYMPHADENOPATHY (Lymph nodes in left armpit were swollen) had resolved. At the time of the report, TENDERNESS (The arm pit area is still a little tender), ERYTHEMA (Left arm below the deltoid was extremely red) and VACCINATION SITE SWELLING (Swelling continued at the injection site) had not resolved and INFLAMMATION (Inflammation began that afternoon), INDURATION (Tissue had hardened), FEELING HOT (The area was very warm to touch), SWELLING (Swelling began that afternoon) and CHILLS (Woke in middle of night chilling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 103 (High) 103 degrees which continued for the next 2-3 days to varying degrees but never below 100. The concomitant medication Protonix was administered by the patient for reflux. The patient was not diagnosed with COVID 19 and had no acute illness at the time of vaccination up to one month before. She was administered with third dose of vaccination due to reduced immune system. The patient experienced swollen lymph nodes in her left armpit and was painful for about 2 ? 3 days. The injection site which was below the deltoid and to the outside of her arm was still swollen and red but not as bad. She had not seeked any medical attention for swelling at injection site and fever. The patient reported that the adverse event was most likely caused by vaccine. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up document received. Patient demographics, medical history, vaccine details, concomitant medication and events were added. On 15-Sep-2021: Follow up document received on 16 Sep 2021 and contains no new information.

Other Meds: PROTONIX [OMEPRAZOLE]; TRIAMTERENE; SINGULAIR

Current Illness: Blood pressure high (HBP); Leukemia (Reported that no recent change in chronic condition); Seasonal allergy

ID: 1721605
Sex: M
Age: 65
State: NJ

Vax Date: 07/14/2021
Onset Date:
Rec V Date: 09/22/2021
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: >35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1721606
Sex: F
Age: 81
State: FL

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
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: Her arm hurt/Soreness in her arm; Hard time breathing/Gasping for air; Feeling cold; Bones were shaking; Feeling she got COVID19 all over again; Extremely ill; Stayed in bed for 5 days/A tight rubber band under her skin squeezing her arm; Bad chills/Teeth was shuddering; A ball of fluids that moved over with the size of a big orange under her arm; Scared; Her arm became red swollen and hot; Her arm became red swollen and hot; On and off headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt/Soreness in her arm), DYSPNOEA (Hard time breathing/Gasping for air), FEELING COLD (Feeling cold), TREMOR (Bones were shaking) and FEELING ABNORMAL (Feeling she got COVID19 all over again) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (during taking "BAM infusion" as treatment patient got infected.) in January 2021. Concurrent medical conditions included Asthma (stated that it was usually under control). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt/Soreness in her arm), DYSPNOEA (Hard time breathing/Gasping for air), FEELING COLD (Feeling cold), TREMOR (Bones were shaking), FEELING ABNORMAL (Feeling she got COVID19 all over again), ILLNESS (Extremely ill), MOBILITY DECREASED (Stayed in bed for 5 days/A tight rubber band under her skin squeezing her arm) and CHILLS (Bad chills/Teeth was shuddering). In August 2021, the patient experienced FEAR (Scared), ERYTHEMA (Her arm became red swollen and hot), PERIPHERAL SWELLING (Her arm became red swollen and hot), HEADACHE (On and off headaches) and LYMPHADENOPATHY (A ball of fluids that moved over with the size of a big orange under her arm). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and Manual therapy (Ice on her arm) for Pain in extremity. On 15-Aug-2021, DYSPNOEA (Hard time breathing/Gasping for air) had resolved. At the time of the report, PAIN IN EXTREMITY (Her arm hurt/Soreness in her arm), FEELING COLD (Feeling cold), TREMOR (Bones were shaking), FEELING ABNORMAL (Feeling she got COVID19 all over again), ILLNESS (Extremely ill), MOBILITY DECREASED (Stayed in bed for 5 days/A tight rubber band under her skin squeezing her arm), FEAR (Scared), ERYTHEMA (Her arm became red swollen and hot), PERIPHERAL SWELLING (Her arm became red swollen and hot), CHILLS (Bad chills/Teeth was shuddering) and LYMPHADENOPATHY (A ball of fluids that moved over with the size of a big orange under her arm) had resolved and HEADACHE (On and off headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications included a puffer for breathing difficulty, and cold compression with ice to her arm. Patient was stay in bed for five days following the appearance of adverse events she experienced after taking the COVID-19 vaccine. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up document contain no new information.

Other Meds: BABY ASPIRIN

Current Illness: Asthma (stated that it was usually under control)

ID: 1721607
Sex: F
Age: 26
State: IN

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
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: Experienced chills and arm pain 12 hours after the injection; Experienced chills and arm pain 12 hours after the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection). In August 2021, PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-316020.

Other Meds:

Current Illness:

ID: 1721608
Sex: U
Age:
State: TX

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/22/2021
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: Administered past the 30 day refrigeration time; Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. First shot info was given that -Expiration date: 31-Oct-2021,Date refrigerated: 20-Apr-2021, Temperature changes (in F): 41.

Other Meds:

Current Illness:

ID: 1721609
Sex: U
Age:
State: TX

Vax Date: 06/11/2021
Onset Date:
Rec V Date: 09/22/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-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 EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications were provided by the reporter No Treatment Information were provided by the reporter

Other Meds:

Current Illness:

ID: 1721610
Sex: U
Age:
State:

Vax Date: 08/14/2021
Onset Date: 09/05/2021
Rec V Date: 09/22/2021
Hospital:

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

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

Allergies:

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

Symptoms: Got Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-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 COVID-19 (Got Covid 19). At the time of the report, COVID-19 (Got Covid 19) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter. It was reported that patient had Covid 19 after on 09/21 and Covid 19 results were positive and then again on 09/05 patient second dosage was schedule for 09/11. Patient still COVID Positive as of today. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1721611
Sex: F
Age:
State: MN

Vax Date: 09/10/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) 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.

Other Meds:

Current Illness:

ID: 1721612
Sex: M
Age:
State:

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/22/2021
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: Sore throat; Fever; 17-year-old received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine). On 07-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 10-SEP-2021 and does not contain any new information On 13-Sep-2021: Follow up received on 13-SEP-2021 and does not contain any new information

Other Meds:

Current Illness:

ID: 1721613
Sex: F
Age: 38
State: CA

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes) 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. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Followup received: Patient details received

Other Meds:

Current Illness:

ID: 1721614
Sex: F
Age: 56
State: FL

Vax Date: 08/13/2021
Onset Date: 09/10/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Fever of 101F

Allergies:

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

Symptoms: pain; fever of 101F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PYREXIA (fever of 101F), CHILLS (Chills) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PAIN (pain), PYREXIA (fever of 101F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, PAIN (pain), PYREXIA (fever of 101F), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 101f (High) Fever of 101F. No concomitant medications were provided

Other Meds:

Current Illness:

ID: 1721615
Sex: F
Age:
State: UT

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 09/22/2021
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: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1721616
Sex: U
Age:
State: NC

Vax Date:
Onset Date: 09/09/2021
Rec V Date: 09/22/2021
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: Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021; 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 EXPIRED PRODUCT ADMINISTERED (Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021) 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 provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Added onset date and stop date for the event.

Other Meds:

Current Illness:

ID: 1721617
Sex: M
Age: 78
State: NY

Vax Date: 02/12/2021
Onset Date: 09/11/2021
Rec V Date: 09/22/2021
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: patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (z-pack (azithromycin)). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ROSUVASTATIN CALCIUM (CRESTOR), VITAMINS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication. 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 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced GAIT DISTURBANCE (patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker). At the time of the report, GAIT DISTURBANCE (patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications was not reported. This case was linked to MOD-2021-316362 (Patient Link).

Other Meds: TOPROL; CRESTOR; VITAMINS NOS; BABY ASPIRIN; STATIN [SIMVASTATIN]

Current Illness: Allergy to antibiotic (z-pack (azithromycin))

ID: 1721618
Sex: M
Age: 78
State: NY

Vax Date: 02/12/2021
Onset Date: 03/12/2021
Rec V Date: 09/22/2021
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: ambulating difficulty; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (ambulating difficulty) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergic to z-pack (azithromycin)). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ROSUVASTATIN CALCIUM (CRESTOR), VITAMINS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication. 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 GAIT DISTURBANCE (ambulating difficulty). At the time of the report, GAIT DISTURBANCE (ambulating difficulty) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication use was not provided by the reporter This case was linked to MOD-2021-316298 (Patient Link).

Other Meds: TOPROL; CRESTOR; VITAMINS NOS; BABY ASPIRIN; STATIN [SIMVASTATIN]

Current Illness: Allergy to antibiotic (Allergic to z-pack (azithromycin))

ID: 1721619
Sex: M
Age: 56
State: OH

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/22/2021
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: cluster head aches; viscious head aches/Headaches after each dose; fatigue/ extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart attack and Stent placement. Concomitant products included LISINOPRIL, METOPROLOL and CLOPIDOGREL for an unknown indication. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired). At the time of the report, CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had reported that he can only be mobile for 5 to 6 hours at a time. No treatment medication was reported This case was linked to MOD-2021-316382 (Patient Link).

Other Meds: LISINOPRIL; METOPROLOL; CLOPIDOGREL

Current Illness:

ID: 1721620
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: bored the next day; a little less perky; This spontaneous case was reported by a consumer and describes the occurrence of BOREDOM and FEELING ABNORMAL in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Arthritis flare up. Previously administered products included for Product used for unknown indication of Flu in 2020. Past adverse reactions to the above products included Swollen joints with Flu. Concurrent medical conditions included Arthritis. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BOREDOM and FEELING ABNORMAL. At the time of the report, BOREDOM and FEELING ABNORMAL outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. No relevant concomitant medications were reported. No treatment information was provided. It was reported that patient has had received pneumonia shot in 2020 and had swollen joints. She stated after receiving the Moderna COVID-19 vaccination, she reported that it wasn't bad at all and she didn't have much going on after the injection. Reporter did not allow further contact.

Other Meds:

Current Illness: Arthritis

ID: 1721621
Sex: M
Age: 49
State:

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 09/22/2021
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: Pain in the arm; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma. On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired). At the time of the report, VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant include Steroids. Treatment information was not reported. This case was linked to MOD-2021-316580, MOD-2021-316581 (Patient Link).

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness: Asthma

ID: 1721622
Sex: M
Age: 49
State:

Vax Date: 01/07/2021
Onset Date: 09/10/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: Antigen test; Test Result: Positive ; Result Unstructured Data: Antigen test(home) - Positive; Test Name: RT-PCR test; Test Result: Negative ; Result Unstructured Data: RT-PCR test - Negative; Test Name: Chest x-ray; Result Unstructured Data: Chest x-ray was clear.; Test Name: Laboratory test; Result Unstructured Data: normal

Allergies:

Symptom List: Pain in extremity

Symptoms: pain in the arm on all doses/arm hurt for 2 days; slight grade fever; stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ4A, 039K20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (stuffy). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever). At the time of the report, NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Chest x-ray was clear.. On an unknown date, Laboratory test: normal (normal) normal. On an unknown date, SARS-CoV-2 test negative: negative (Negative) RT-PCR test - Negative. On an unknown date, SARS-CoV-2 test positive: positive (Positive) Antigen test(home) - Positive. Concomitant medications reported includes, steroids. Treatment information was not provided by the reporter. This case was linked to MOD-2021-316515, MOD-2021-316581 (Patient Link).

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness: Asthma

ID: 1721623
Sex: F
Age: 46
State: CO

Vax Date: 01/26/2021
Onset Date: 09/04/2021
Rec V Date: 09/22/2021
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: not an immunocompromised patient; Hives; Stomach feels like burning and upset; Heart pumping occasionally; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset), PALPITATIONS (Heart pumping occasionally) and OFF LABEL USE (not an immunocompromised patient) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 029L20A and 0251202A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset) and PALPITATIONS (Heart pumping occasionally). On an unknown date, the patient experienced OFF LABEL USE (not an immunocompromised patient). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Adverse event, at a dose of Every 6 hours. At the time of the report, URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset) and PALPITATIONS (Heart pumping occasionally) outcome was unknown and OFF LABEL USE (not an immunocompromised patient) had resolved. Unknown No Concomitant Medications were provided by the reporter

Other Meds:

Current Illness:

ID: 1721624
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 09/22/2021
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: flu like symptoms; headache; shaking; weakness; fever; unbelievable fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness) and PYREXIA (fever) in a 79-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. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided No treatment medications provided No Concomitant medications provided This case was linked to MOD-2021-316889 (Patient Link).

Other Meds:

Current Illness:

ID: 1721625
Sex: F
Age:
State:

Vax Date: 09/07/2021
Onset Date:
Rec V Date: 09/22/2021
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: side effects after the second/ felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; Chest pain on left side; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), CHEST PAIN (Chest pain on left side) and ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), CHEST PAIN (Chest pain on left side), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown and CHEST PAIN (Chest pain on left side) had resolved. Not Provided No concomitant products were reported. Physician suggested couple of Advil should eliminate any pain. This case was linked to MOD-2021-312693, MOD-2021-317608 (Patient Link).

Other Meds:

Current Illness:

ID: 1721626
Sex: F
Age:
State: NY

Vax Date: 08/29/2021
Onset Date: 09/12/2021
Rec V Date: 09/22/2021
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: Less than 25 days since first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days since first shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 052E21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PAROXETINE for an unknown indication. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days since first shot). On 12-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days since first shot) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications includes blood pressure medicine. No treatment medications are provided.

Other Meds: PAROXETINE

Current Illness:

ID: 1721627
Sex: F
Age: 43
State: ID

Vax Date: 09/09/2021
Onset Date:
Rec V Date: 09/22/2021
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: Blood in the urine,urine looked like coffee; Body aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-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 BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) had not resolved. No Concomitant Medication was provided. It was reported that lab results and blood results were all in order and the only thing out of the ordinary was the blood in the urine. This case was linked to MOD-2021-317574 (Patient Link).

Other Meds:

Current Illness:

ID: 1721628
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Sick after vaccination.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after vaccination.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after vaccination.). At the time of the report, ILLNESS (Sick after vaccination.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1721629
Sex: M
Age: 67
State: SC

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 09/22/2021
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: For 3 days, he didn't remember anything; He was cold; Next day after receiving 1st dose, he felt like zombie; The following day, he was sleeping almost all day/ He slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie), SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day), MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0030C21A) for COVID-19 vaccination. Concomitant products included PREGABALIN (LYRICA), ROPINIROLE, GLIMEPIRIDE, PANTOPRAZOLE, ROSUVASTATIN, MAGNESIUM, NICOTINIC ACID (NIACIN) and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for an unknown indication. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie) and SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day). On an unknown date, the patient experienced MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold). At the time of the report, FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie), SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day), MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold) 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 treatment medication reported

Other Meds: LYRICA; ROPINIROLE; GLIMEPIRIDE; PANTOPRAZOLE; ROSUVASTATIN; MAGNESIUM; NIACIN; AMLODIPINE BENAZEPRIL

Current Illness:

ID: 1721630
Sex: F
Age: 47
State: TX

Vax Date: 08/12/2021
Onset Date: 08/19/2021
Rec V Date: 09/22/2021
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: Redness on left arm below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on left arm below injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on left arm below injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness on left arm below injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included unspecified supplements. After first dose, the patient had redness on left arm below injection site and than it disappeared. This case was linked to MOD-2021-317610 (Patient Link).

Other Meds: LEVOTHYROXINE; VITAMINS NOS

Current Illness:

ID: 1721631
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: anaphylactic; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Denied) 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 ANAPHYLACTIC REACTION (anaphylactic) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided. Company comment: This case concerns a female patient with no relevant medical history reported, who experienced the expected event of Anaphylactic reaction after the first dose of mRNA-1273. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient with no relevant medical history reported, who experienced the expected event of Anaphylactic reaction after the first dose of mRNA-1273. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am