VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1820462
Sex: U
Age: 88
State: PA

Vax Date: 03/09/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. This case was linked to MOD-2021-357274, MOD-2021-357572, MOD-2021-356768 (Patient Link).

Other Meds:

Current Illness: Immunocompromised

ID: 1820463
Sex: U
Age: 41
State: PA

Vax Date: 01/15/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) 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: 1820464
Sex: F
Age: 73
State: TX

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/27/2021
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: 1 or 2 days of feeling crummy after 3rd dose; blurry mind stuff; can't think clearly at times; a lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (1 or 2 days of feeling crummy after 3rd dose), DAYDREAMING (blurry mind stuff), THINKING ABNORMAL (can't think clearly at times) and FATIGUE (a lot of fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO) and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced FEELING ABNORMAL (1 or 2 days of feeling crummy after 3rd dose), DAYDREAMING (blurry mind stuff), THINKING ABNORMAL (can't think clearly at times) and FATIGUE (a lot of fatigue). At the time of the report, FEELING ABNORMAL (1 or 2 days of feeling crummy after 3rd dose), DAYDREAMING (blurry mind stuff), THINKING ABNORMAL (can't think clearly at times) and FATIGUE (a lot of fatigue) outcome was unknown. No treatment information was provided by the reporter. Other concomitant medications: acidophilus ,Airborne gummies ,Aller-Flo nasal spray ,doxapin , Move Free Daily, multivitamin , Premarin cream, zolpidem 5mg ,Prolia injection This case was linked to MOD-2021-356901, MOD-2021-356856 (Patient Link).

Other Meds: ALLEGRA; ALPRAZOLAM; AREDS; KLONOPIN; LIVALO; VITAMIN D3

Current Illness:

ID: 1820465
Sex: U
Age: 55
State: PA

Vax Date: 01/22/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1820466
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: Tingling sensation on the arm where injection was given; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (Tingling sensation on the arm where injection was given) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PARAESTHESIA (Tingling sensation on the arm where injection was given). At the time of the report, INJECTION SITE PARAESTHESIA (Tingling sensation on the arm where injection was given) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1820467
Sex: U
Age: 68
State: PA

Vax Date: 02/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported.

Other Meds:

Current Illness:

ID: 1820468
Sex: U
Age: 64
State: PA

Vax Date: 09/20/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. This is a case of expired product administered for this 64-year, male patient with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 64-year, male patient with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1820469
Sex: U
Age: 81
State: PA

Vax Date: 02/06/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A.) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Totally 28 doses were administered on 18-OCT-2021 after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals. No relevant concomitant medications were reported. No treatment information was reported. This is a case of expired product administered for this 82-year old patient of an unknown gender, with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after third dose and no more dosing is expected. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 82-year old patient of an unknown gender, with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after third dose and no more dosing is expected. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1820470
Sex: U
Age: 72
State: PA

Vax Date: 02/09/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Second dose after 38 days of first vaccine; Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1820471
Sex: M
Age: 50
State: NC

Vax Date: 08/24/2021
Onset Date: 09/28/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: "Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE ("Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced DEVICE CONNECTION ISSUE ("Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage). On 28-Sep-2021, DEVICE CONNECTION ISSUE ("Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1820472
Sex: F
Age:
State: NY

Vax Date: 10/04/2021
Onset Date: 10/01/2021
Rec V Date: 10/27/2021
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: Irritated Injected Arm the first 24 hours; Localized allergic reaction on the vaccinated arm; Redness lasted a month/Red Injected Arm; Injected Arm got bigger and bigger the first 24 hours; Had an immediate reaction on my arm/that increased over that past 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours), VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours), ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm), VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours), ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm), VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours). In October 2021, the patient experienced VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours). On 10-Oct-2021, VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours) had resolved. In October 2021, VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours) had resolved. At the time of the report, ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm) and VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) outcome was unknown. 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. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: updated reporter details, patient age, vaccine start date and batch number and added new events and outcome.

Other Meds:

Current Illness:

ID: 1820473
Sex: F
Age: 33
State: WA

Vax Date: 09/29/2021
Onset Date: 09/30/2021
Rec V Date: 10/27/2021
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: 20210930; Test Name: BLOOD PRESSURE; Result Unstructured Data: lower number of blood pressure was high.; Test Date: 20210930; Test Name: HEART RATE; Result Unstructured Data: lower heart rate (56 bpm) for 2 weeks.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Serious palpitations; Lower number of blood pressure was high; Lower heart rate; Muscle ache; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Blood pressure measurement: high (High) lower number of blood pressure was high.. On 30-Sep-2021, Heart rate: 56 (Low) lower heart rate (56 bpm) for 2 weeks.. 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. It was reported that the patient had serious palpitations, lower number of blood pressure was high, headache, muscle ache, and lower heart rate (56 bpm) for 2 weeks. The headache and muscle ache were coming and going. And all the symptoms started together the next day after first shot. No Concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1820474
Sex: F
Age: 22
State: WA

Vax Date: 10/15/2021
Onset Date: 10/17/2021
Rec V Date: 10/27/2021
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: Both legs became swollen; Skin on legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both legs became swollen) and PAIN OF SKIN (Skin on legs hurt) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PERIPHERAL SWELLING (Both legs became swollen) and PAIN OF SKIN (Skin on legs hurt). The patient was treated with SODIUM CHLORIDE for Swelling of legs, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Both legs became swollen) was resolving and PAIN OF SKIN (Skin on legs hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Treatment included sodium chloride, for the adverse event and then the patient was feeling better. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow-up included treatment medication sodium chloride and Event swelling of legs outcome were updated

Other Meds:

Current Illness:

ID: 1820475
Sex: U
Age:
State: MA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/27/2021
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 dose of the vaccine from a vial that was left 30 hs out of the fridge; received a dose of the vaccine from a vial that was left 30 hs out of the fridge; 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 (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) 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 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1820476
Sex: U
Age: 66
State: PA

Vax Date: 03/11/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant products were reported. No Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1820477
Sex: F
Age: 45
State: CA

Vax Date: 09/14/2021
Onset Date: 10/19/2021
Rec V Date: 10/27/2021
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: Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. This case was linked to MOD-2021-357526, MOD-2021-357788, MOD-2021-357978, MOD-2021-357980, MOD-2021-358415 (Patient Link).

Other Meds:

Current Illness:

ID: 1820478
Sex: U
Age: 71
State: PA

Vax Date: 02/03/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1820479
Sex: U
Age: 62
State:

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 10/27/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I am currently under the care of my doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.; headaches but now in the form of extreme pressure.; 102 temp; Nausea; Muscle pain; extreme crushing headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I am currently under the care of my Doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache). In April 2021, the patient experienced HEAD DISCOMFORT (headaches but now in the form of extreme pressure.). On an unknown date, the patient experienced MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) (seriousness criterion hospitalization). On 18-Mar-2021, PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache) had resolved. At the time of the report, MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) and HEAD DISCOMFORT (headaches but now in the form of extreme pressure.) had not resolved. No concomitant medication information was provided. No treatment product information was provided. patient had MRI of brain, cervical spine x-ray and numerous blood tests.; Sender's Comments: This case concerns a 63-year-old patient of an unknown gender with no medical history who experienced the unexpected event of migraine. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the event occurred after the second dose. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting due to hospitalization.

Other Meds:

Current Illness:

ID: 1820480
Sex: F
Age: 33
State: WA

Vax Date: 03/20/2021
Onset Date: 05/01/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: CT scans; Result Unstructured Data: but nothing was found then; Test Date: 2021; Test Name: Her oxygen level gets low; Result Unstructured Data: oxygen level got low; Test Date: 202105; Test Name: X-rays; Result Unstructured Data: but nothing was found then

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: scarring in her lungs; hemiplegic migraines; severe breathing problems / she struggles to breath when doing anything; pleural effusion; migraines; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion) and MIGRAINE (migraines). In August 2021, the patient experienced SCAR (scarring in her lungs) and HEMIPLEGIC MIGRAINE (hemiplegic migraines). At the time of the report, SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: but nothing was found then (normal) but nothing was found then. In May 2021, X-ray: but nothing was found then (normal) but nothing was found then. In 2021, Oxygen saturation: low (Low) oxygen level got low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter Treatment included Oral steroids & steroid inhalers. The patient developed scarring in her lungs in August-2021 after visiting the ER and getting x-rays & CT scans.

Other Meds:

Current Illness:

ID: 1820481
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: The dose was administered to the patient after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1820482
Sex: F
Age:
State: WV

Vax Date: 02/05/2021
Onset Date: 03/04/2021
Rec V Date: 10/27/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/achy), CHILLS (chills for 24 hrs) and HEADACHE (headache for 6 hours) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Azithromycin) and Drug allergy (Ceftin (rash)). On 05-Feb-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 8:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021 at 9:00 AM, the patient experienced PAIN IN EXTREMITY (sore arm/achy), CHILLS (chills for 24 hrs) and HEADACHE (headache for 6 hours). On 05-Mar-2021, PAIN IN EXTREMITY (sore arm/achy), CHILLS (chills for 24 hrs) and HEADACHE (headache for 6 hours) had resolved. Not Provided concomitant medication include :Vitamins Women's Complete (oral,once a day) No treatment information provided. This case was linked to MOD-2021-304545 (Patient Link).

Other Meds:

Current Illness: Drug allergy (Ceftin (rash)); Drug allergy (Azithromycin)

ID: 1820483
Sex: U
Age: 51
State: PA

Vax Date: 04/07/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was provided The vaccine was administered after being stored in a refrigerator for 33 days.

Other Meds:

Current Illness:

ID: 1820484
Sex: U
Age: 67
State: PA

Vax Date: 02/21/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported No treatment medication was reported

Other Meds:

Current Illness:

ID: 1820485
Sex: U
Age: 72
State: PA

Vax Date: 09/20/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 28 doses of vaccine were administered (18OCT2021) after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals. All doses were administered by intramuscular injection from lot number 005C21A. None of these patients had reported symptoms to the contact or received any known treatments. 2 doses 20SEP2021 18OCT2021 Concomitant medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1820486
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: He stated 2 patients reported being tired, fatigue and had ache and pain; He stated 2 patients reported being tired, fatigue and had ache and pain; Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/ He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female; This spontaneous case was reported by a physician and describes the occurrence of PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain), FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/ He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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 (He stated 2 patients reported being tired, fatigue and had ache and pain), FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/ He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female). At the time of the report, PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain) and FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/ He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was reported by the reporter.

Other Meds:

Current Illness:

ID: 1820487
Sex: U
Age: 65
State: PA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) 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. 28 doses of vaccine were administered on 18OCT2021 after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals.

Other Meds:

Current Illness:

ID: 1820488
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: Tingling sensation; 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 PARAESTHESIA (Tingling sensation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation). At the time of the report, PARAESTHESIA (Tingling sensation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1820489
Sex: F
Age: 37
State: TN

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/27/2021
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: Expired dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided This case was linked to MOD-2021-357985 (Patient Link).

Other Meds:

Current Illness:

ID: 1820490
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (Feeling really crappy/feeling overwhelmed) and MALAISE (Feeling really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling really crappy/feeling overwhelmed) and MALAISE (Feeling really sick). At the time of the report, FEELING ABNORMAL (Feeling really crappy/feeling overwhelmed) and MALAISE (Feeling really sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Reporters husband said that his company reported multiple people feeling sick after taking the vaccine but not specified the company. This case was linked to MOD-2021-357737 (Patient Link).

Other Meds:

Current Illness:

ID: 1820491
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Name: SAlb; Result Unstructured Data: serum albumin 4.1 g/dl; Test Name: Baseline SCr/SCr; Result Unstructured Data: baseline SCr 1.1(mg/dl); Test Name: Baseline SCr/SCr; Result Unstructured Data: SCr 1.5(g/dl); Test Name: Baseline SCr/SCr; Result Unstructured Data: SCr 1.4(g/dl); Test Name: Urine protein; Result Unstructured Data: 1.2 g/d; Test Name: Urine protein; Result Unstructured Data: 0.3 g/d; Test Name: Urine rbc; Result Unstructured Data: 51-100 (/HPF); Test Name: Urine rbc; Result Unstructured Data: 3 ? 10 (/HPF)

Allergies:

Symptom List: Nausea

Symptoms: IgA nephropathy; Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy) in a 66-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. 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 IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant). an unknown date, the patient experienced PERICARDITIS (Pericarditis). The patient was treated with PREDNISONE for Pericarditis, at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 4.1 g/dl serum albumin 4.1 g/dl. On an unknown date, Blood creatine: normal (normal) baseline SCr 1.1(mg/dl), 1.5 g/dl SCr 1.5(g/dl) and 1.4 g/dl SCr 1.4(g/dl). On an unknown date, Protein urine: 1.2 g/d 1.2 g/d and 0.3 g/d 0.3 g/d. On an unknown date, Red blood cells urine: 51-100 (/hpf) 51-100 (/HPF) and 3 ? 10 (/hpf) 3 ? 10 (/HPF). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) to be possibly related. Patient responded to Prednisone treatment Follow up time was reported as 5 months Presenting symptom included Gross Hematuria Concomitant product use was not provided by the reporter. Company Comment: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-357261, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety on 22-Oct-2021 included an Email with Agency received from team and does not contain any new information; Sender's Comments: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1820492
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Name: Serum albumin; Result Unstructured Data: Laboratories during presentation was 2.0 g/dl; Test Name: Serum albumin; Result Unstructured Data: Laboratories during last follow up was 2.7 g/dl; Test Name: Serum creatinine; Result Unstructured Data: Baseline was 1.19 mg/dl; Test Name: Serum creatinine; Result Unstructured Data: Laboratories during presentation was 2.19 g/dl; Test Name: Serum creatinine; Result Unstructured Data: Laboratories during last follow up was 1.2 mg/dl; Test Name: Urine protein; Result Unstructured Data: Laboratories during presentation was 18 g/d; Test Name: Urine protein; Result Unstructured Data: Laboratories during last follow up was 2 g/d; Test Name: Urine RBC; Result Unstructured Data: Laboratories during presentation was less than (<) HPF; Test Name: Urine RBC; Result Unstructured Data: Laboratories during presentation was less than (<) 3 /HPF

Allergies:

Symptom List: Injection site pain

Symptoms: acute tubular necrosis; Minimal change disease; This literature-non-study case was reported in a literature article and describes the occurrence of RENAL TUBULAR NECROSIS (acute tubular necrosis) and GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL TUBULAR NECROSIS (acute tubular necrosis) (seriousness criterion medically significant) and GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) (seriousness criterion medically significant). At the time of the report, RENAL TUBULAR NECROSIS (acute tubular necrosis) and GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 2.0 g/dl Laboratories during presentation was 2.0 g/dl and 2.7 g/dl Laboratories during last follow up was 2.7 g/dl. On an unknown date, Blood creatinine: 1.19 mg/dl Baseline was 1.19 mg/dl, 2.19 g/dl Laboratories during presentation was 2.19 g/dl and 1.2 g/dl Laboratories during last follow up was 1.2 mg/dl. On an unknown date, Protein urine: 18 g/d Laboratories during presentation was 18 g/d and 2 g/d Laboratories during last follow up was 2 g/d. On an unknown date, Red blood cells urine: less than (<) high power field (hpf) Laboratories during presentation was less than (<) HPF and less than (<) high power field (hpf) Laboratories during presentation was less than (<) 3 /HPF. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RENAL TUBULAR NECROSIS (acute tubular necrosis) and GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) to be possibly related. This article reports a case series of patients who developed new or relapsing GN post vaccination. This patient was newly diagnosed with GN post Moderna COVID-19 vaccination. Patient presented with symptom of Acute kidney injury(AKI). Patient was treated with high dose steroids Concomitant medications were not reported This is a literature non study case concerning a 83-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant) events of Acute tubular necrosis and Minimal change disease. The events occurred approximately 4 weeks after the second dose of Spikevax with unknown information regarding the first dose. Patient received high dose of steroids and was reported to have respond to treatment on follow up. The rechallenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-357261, MOD-2021-357609, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety 21-Oct-2021 included an Email and does not contain any new information; Sender's Comments: This is a literature non study case concerning a 83-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant) events of Acute tubular necrosis and Minimal change disease. The events occurred approximately 4 weeks after the second dose of Spikevax with unknown information regarding the first dose. Patient received high dose of steroids and was reported to have respond to treatment on follow up. The rechallenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1820493
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: SAlb; Result Unstructured Data: Laboratories during presentation was 2.5 g/dl; Test Name: SAlb; Result Unstructured Data: Laboratories during last follow up was 4.4 g/dl; Test Name: SCr; Result Unstructured Data: base line SCr 1 mg/dl; Test Name: SCr; Result Unstructured Data: Laboratories during presentation was 1.6 g/dl; Test Name: SCr; Result Unstructured Data: Laboratories during last follow up was 1.5g/dl; Test Name: Urine protein; Result Unstructured Data: Laboratories during presentation was 19 g/d; Test Name: Urine protein; Result Unstructured Data: Laboratories during last follow up was 0.07 g/d; Test Name: Urine RBC; Result Unstructured Data: Laboratories during presentation was less than (<) 3 /HPF; Test Name: Urine RBC; Result Unstructured Data: Laboratories during last follow up was 0-2/HPF

Allergies:

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

Symptoms: Minimal change disease; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Glomerulonephritis minimal lesion. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) (seriousness criterion medically significant). The patient was treated with RITUXIMAB for Minimal change disease, at an unspecified dose and frequency. At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 2.5g/dl Laboratories during presentation was 2.5 g/dl and 4.4g/dl Laboratories during last follow up was 4.4 g/dl. On an unknown date, Blood creatinine: base line scr 1 mg/dl base line SCr 1 mg/dl, 1.6g/dl Laboratories during presentation was 1.6 g/dl and 1.5g/dl Laboratories during last follow up was 1.5g/dl. On an unknown date, Protein urine: 19g/d Laboratories during presentation was 19 g/d and 0.07g/d Laboratories during last follow up was 0.07 g/d. On an unknown date, Red blood cells urine: lessthan(<)3 /high power field(hpf) Laboratories during presentation was less than (<) 3 /HPF and 0-2/hpf Laboratories during last follow up was 0-2/HPF. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) to be possibly related. Concomitant medications were not reported. This article reports a case series of patients who developed new or relapsing GN post vaccination. Patient was presented with symptom of edema. She was also treated with High dose steroid Duration of remission before relapse was 1 month and Follow up was taken after 02 month. This literature-non-study case concerns a 67-year-old female patient with relevant medical history of glomerulonephritis minimal lesion who experienced serious unexpected event of glomerulonephritis minimal lesion relapse. The event occurred approximately 3 weeks after the second dose of Spikevax. The patient presented with the symptom of edema and the patient was in remission for one month prior to relapse. The patient received high dose steroid therapy and Rituximab as a corrective treatment for the event with positive response. Rechallenge was not applicable since the event occurred after the second dose so no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report. Causal or contributing role of Spikevax in triggering relapse of pre-existing condition cannot be excluded based on the information provided. This case was linked to MOD-2021-357261, MOD-2021-357609, MOD-2021-357610, MOD-2021-357611, MOD-2021-357613, MOD-2021-357614 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety 22-Oct-2021 included an Email and does not contain any new information; Sender's Comments: This literature-non-study case concerns a 67-year-old female patient with relevant medical history of glomerulonephritis minimal lesion who experienced serious unexpected event of glomerulonephritis minimal lesion relapse. The event occurred approximately 3 weeks after the second dose of Spikevax. The patient presented with the symptom of edema and the patient was in remission for one month prior to relapse. The patient received high dose steroid therapy and Rituximab as a corrective treatment for the event with positive response. Rechallenge was not applicable since the event occurred after the second dose so no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report. Causal or contributing role of Spikevax in triggering relapse of pre-existing condition cannot be excluded based on the information provided.

Other Meds:

Current Illness: Glomerulonephritis minimal lesion

ID: 1820494
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Name: Serum albumin; Result Unstructured Data: Laboratories during presentation was 2.7g/dl; Test Name: Serum creatinine; Result Unstructured Data: Baseline 1.7 mg/dl; Test Name: Serum creatinine; Result Unstructured Data: Laboratories during last follow up was 2.1 g/dl; Test Name: Urine protein; Result Unstructured Data: Laboratories during presentation was 16.6 g/d; Test Name: Urine RBC; Result Unstructured Data: Laboratories during presentation was less than (<) 3 /HPF

Allergies:

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

Symptoms: Phospholipase A2 receptor membranous nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Phospholipase A2 receptor membranous nephropathy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Glomerulonephritis membranous. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Phospholipase A2 receptor membranous nephropathy) (seriousness criterion medically significant). The patient was treated with OBINUTUZUMAB for Membranous nephropathy, at an unspecified dose and frequency. At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Phospholipase A2 receptor membranous nephropathy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 2.7g/dl Laboratories during presentation was 2.7g/dl. On an unknown date, Blood creatinine: 1.7 mg/dl Baseline 1.7 mg/dl and 2.1 g/dl Laboratories during last follow up was 2.1 g/dl. On an unknown date, Protein urine: 16.6 g/d Laboratories during presentation was 16.6 g/d. On an unknown date, Red blood cells urine: than (<) 3 / high power field (hpf) Laboratories during presentation was less than (<) 3 /HPF. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MEMBRANOUS (Phospholipase A2 receptor membranous nephropathy) to be possibly related. This article reports a case series of patients who developed new or relapsing GN post vaccination. This patient developed relapse of GN post Moderna COVID-19 vaccination. Patient presented with symptom of edema Duration of remission before relapse was 8 months. Concomitant medications were not reported This is a literature non study case concerning a 70-year-old, male patient with medical history of previous membranous nephropathy, who experienced the unexpected serious (medically significant) event of relapsed Phospholipase A2 receptor membranous nephropathy. The event occurred approximately 4 weeks after the second dose of Spikevax with unknown information regarding the first dose. Patient presented with edema and was diagnosed with a relapsed membranous nephropathy and received Obinutuzumab with no further information regarding the follow up. The rechallenge is not applicable. Patient?s medical history of previous membranous nephropathy is a confounder for the event. Patient was in remission for 8 months before relapse. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-357261, MOD-2021-357609, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357614. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety 21-Oct-2021 included an Email with Agency received from team and does not contain any new information; Sender's Comments: This is a literature non study case concerning a 70-year-old, male patient with medical history of previous membranous nephropathy, who experienced the unexpected serious (medically significant) event of relapsed Phospholipase A2 receptor membranous nephropathy. The event occurred approximately 4 weeks after the second dose of Spikevax with unknown information regarding the first dose. Patient presented with edema and was diagnosed with a relapsed membranous nephropathy and received Obinutuzumab with no further information regarding the follow up. The rechallenge is not applicable. Patient?s medical history of previous membranous nephropathy is a confounder for the event. Patient was in remission for 8 months before relapse. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1820495
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Name: serum albumin; Result Unstructured Data: Laboratories during presentation was 4.5 g/dl; Test Name: serum creatinine; Result Unstructured Data: Baseline 0.96 mg/dl; Test Name: serum creatinine; Result Unstructured Data: Laboratories during presentation was 0.76 g/dl; Test Name: Urine Protein; Result Unstructured Data: Laboratories during presentation was 0.61 g/d; Test Name: Urine RBC; Result Unstructured Data: Laboratories during presentation was 11 ?20/HPF

Allergies:

Symptom List: Tremor

Symptoms: IgA nephropathy; Microscopic hematuria; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy) in a 19-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. The patient's past medical history included Microscopic hematuria (Underlying disease). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant) and HAEMATURIA (Microscopic hematuria). At the time of the report, IGA NEPHROPATHY (IgA nephropathy) outcome was unknown and HAEMATURIA (Microscopic hematuria) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 4.5g/dl Laboratories during presentation was 4.5 g/dl. On an unknown date, Blood creatinine: 0.96mg/dl Baseline 0.96 mg/dl and 0.76g/dl Laboratories during presentation was 0.76 g/dl. On an unknown date, Protein urine: 0.61 g/d Laboratories during presentation was 0.61 g/d. On an unknown date, Red blood cells urine: 11 ?20 /high power field (hpf) Laboratories during presentation was 11 ?20/HPF. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA nephropathy) and HAEMATURIA (Microscopic hematuria) to be possibly related. No relevant concomitant medications were reported. Treatment was reported as conservative. Patient was presented with Gross hematuria symptom after 2 days after second dose and it resolved in 2 days. Duration of remission before relapse was of 6 months. Follow up time was unknown. , Blood albumin, Blood creatinine, Protein urine and Red blood cells urine lab results were unknown. This is a regulatory case concerning a 19 year-old, male patient with clinical history of Microscopic hematuria who experienced the unexpected serious event of IgA NEPHROPATHY and other non-serious event. The events occurred unknown days after two doses of COVID-19 vaccine. The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-357261, MOD-2021-357609, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety 22-Oct-2021 included an Email and does not contain any new information; Sender's Comments: This is a regulatory case concerning a 19 year-old, male patient with clinical history of Microscopic hematuria who experienced the unexpected serious event of IgA NEPHROPATHY and other non-serious event. The events occurred unknown days after two doses of COVID-19 vaccine. The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1820496
Sex: F
Age: 39
State: FL

Vax Date: 10/17/2021
Onset Date:
Rec V Date: 10/27/2021
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: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided. This case was linked to US-MODERNATX, INC.-MOD-2021-357638, MOD21-144365 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-357638:mother case MOD21-144365:mother dose 1 case

Other Meds:

Current Illness:

ID: 1820497
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: The dose was administered to the patient after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitants are provided No treatments are provided. The caller had a vaccine documented as expiring in November but the system had the lot number incorrect by one letter. The actual expiry date was October 10th 2021. Lot: 006C21A

Other Meds:

Current Illness:

ID: 1820498
Sex: M
Age: 68
State: OH

Vax Date: 02/26/2021
Onset Date: 10/03/2021
Rec V Date: 10/27/2021
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: 202110; Test Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: Lack of drug effect; Post Vaccination caught Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Post Vaccination caught Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B01A and 012A21) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced COVID-19 (Post Vaccination caught Covid-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Post Vaccination caught Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive Positive. No concomitant medication information was provided. No treatment product information was provided. Patient tested positive for Covid-19 two weeks ago Monday.3OCT2021. Patient was not hospitalized.; Sender's Comments: This is a spontaneous case concerning a 68 -year-old male patient with no relevant medical history reported who experienced The non serious and AESI event of COVID-19 approximately 6 month after the second dose of a proper vaccination schedule with spikevax. Additional event of drug ineffective was added. Rechallenge is not applicable for these events. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.

Other Meds:

Current Illness:

ID: 1820499
Sex: F
Age: 67
State: OH

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: patient was told that she was perfect.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: tingling sensation on her left knee down and her left elbow down/tingling on her right side; a little bit of tiredness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side), VACCINATION SITE PAIN (sore arm) and FATIGUE (a little bit of tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Sep-2021, the patient experienced FATIGUE (a little bit of tiredness). On 06-Oct-2021, the patient experienced PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side). On 08-Oct-2021, PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (a little bit of tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) patient was told that she was perfect.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1820500
Sex: U
Age:
State: TN

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/27/2021
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: Vaccine given after use date/Expired vaccine given; 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 (Vaccine given after use date/Expired vaccine given) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given) 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. It was reported that the HCP was trying to figure out whether the patient should be re-administered with another dose. The HCP did not know if the vial had undergone any temperature excursions and regarding date of vial initially stored in the refrigerator.

Other Meds:

Current Illness:

ID: 1820501
Sex: M
Age: 56
State: CA

Vax Date: 10/16/2021
Onset Date: 10/17/2021
Rec V Date: 10/27/2021
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: Test Date: 20211017; Test Name: EKG; Result Unstructured Data: results presented Brugada

Allergies:

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

Symptoms: Patient blacked out, twice, and had to go to the Emergency Room; Patient's EKG test results presented Brugada; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) (seriousness criterion medically significant) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, Electrocardiogram: abnormal (abnormal) results presented Brugada. 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 listed. No treatment information provided. Company Comment : This case concerns a 56-year-old male patient with no reported medical history who experienced the unexpected event of loss of consciousness and Brugada syndrome. The event occurred 1day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was nunknoen as details pertaining to second dose was not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting. Both events are important medical events; Sender's Comments: This case concerns a 56-year-old male patient with no reported medical history who experienced the unexpected event of loss of consciousness and Brugada syndrome. The event occurred 1day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was nunknoen as details pertaining to second dose was not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting. Both events are important medical events

Other Meds:

Current Illness:

ID: 1820502
Sex: U
Age:
State: TX

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). In October 2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. The vaccine was administered to an unknown number of patients over the weekend (16-Oct-2021 to 17-Oct-2021). The vaccine was only moved from the freezer to the refrigerator 2 weeks ago

Other Meds:

Current Illness:

ID: 1820503
Sex: U
Age:
State: PA

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/27/2021
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: Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients). In October 2021, EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were reported. The dates of administration of vaccine are 15-Oct-2021 to 8 or 9 patient and 18-Oct-2021 to 8 or 9 patient.

Other Meds:

Current Illness:

ID: 1820504
Sex: F
Age: 66
State: MA

Vax Date: 02/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/27/2021
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: Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Lymphoma (she was diagnosed with lymphoma in perhaps in February2021/March 2021.) since 2021. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) outcome was unknown. Concomitant medications not reported by the reporter. This case was linked to MOD-2021-357742 (Patient Link).

Other Meds:

Current Illness: Lymphoma (she was diagnosed with lymphoma in perhaps in February2021/March 2021.)

ID: 1820505
Sex: F
Age: 71
State: CO

Vax Date: 01/13/2021
Onset Date: 02/10/2021
Rec V Date: 10/27/2021
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: every bone in my body was hurting/my face bones hurt; my skull hurt; I thought I was going to die; I hurt so much I couldn't talk; violent chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk) and CHILLS (violent chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. 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) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, BONE PAIN (every bone in my body was hurting/my face bones hurt), HEAD DISCOMFORT (my skull hurt), FEAR OF DEATH (I thought I was going to die), APHASIA (I hurt so much I couldn't talk), CHILLS (violent chills) and NAUSEA (nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details was reported. This case was linked to MOD-2021-357771 (Patient Link).

Other Meds:

Current Illness:

ID: 1820506
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: may have only received one COVID-19 dose; caller thinks 1st dose Moderna, 2nd dose Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer) 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 PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer) had resolved. Patient thinks she received Moderna for the first dose and Pfizer for the second dose but is unsure. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1820507
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Leg cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Leg cramps). At the time of the report, RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Leg cramps) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1820508
Sex: F
Age: 65
State: NJ

Vax Date: 01/20/2021
Onset Date: 02/24/2021
Rec V Date: 10/27/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 032L20A.) for COVID-19 vaccination. The patient's past medical history included Surgery (Abdominal surgery) on 19-Aug-2021. Previously administered products included for Influenza immunisation: flu shot (Patient was reported to take the flu shot after the abdominal surgery). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 26-Feb-2021, PYREXIA (Fever) had resolved. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1820509
Sex: M
Age: 30
State: TN

Vax Date: 09/19/2021
Onset Date: 10/01/2021
Rec V Date: 10/27/2021
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: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot on head and eyebrows) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 047C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced RASH MACULAR (Red spot on head and eyebrows). At the time of the report, RASH MACULAR (Red spot on head and eyebrows) outcome was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided. The patient confirmed it was not itching or burning and it was just there. There were no pre-existing condition and no allergic to many medications or food.

Other Meds:

Current Illness:

ID: 1820510
Sex: U
Age: 67
State: PA

Vax Date: 03/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. The patient did not report any symptoms or received any known treatments.

Other Meds:

Current Illness: Immunocompromised

ID: 1820511
Sex: F
Age: 55
State:

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/27/2021
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: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am