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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1770502
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date: 09/23/2021
Rec V Date: 10/08/2021
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: three days later she got hives, but it was not as bad as the first time.; first vaccine given on 10Feb2021 second vaccination on 23SEPT2021; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (three days later she got hives, but it was not as bad as the first time.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy and Hives (before her first vaccination). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021). On 26-Sep-2021, the patient experienced URTICARIA (three days later she got hives, but it was not as bad as the first time.). On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021) had resolved. At the time of the report, URTICARIA (three days later she got hives, but it was not as bad as the first time.) outcome was unknown. Patient took Benadryl before the second vaccine to keep the hives down. This case was linked to MOD-2021-337927 (Patient Link).

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; HYDROXYZINE; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Hives (before her first vaccination); Penicillin allergy

ID: 1770503
Sex: F
Age: 61
State: OH

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 10/08/2021
Hospital: Y

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: Auto-immune encephalitis; It effects your memory; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) (seriousness criteria hospitalization and medically significant) and MEMORY IMPAIRMENT (It effects your memory). The patient was hospitalized on sometime in March 2021 due to ENCEPHALITIS AUTOIMMUNE. At the time of the report, ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) and MEMORY IMPAIRMENT (It effects your memory) outcome was unknown. Additional concomitant medication included unspecified hypertension medication. Patient had the Moderna vaccine in January and February and ended up with auto immune disease. Patient was admitted to hospital in March for three weeks and was diagnosed with autoimmune encephalitis. Patient stated it affects the memory. Patient was on medical leave from work at the time of this report. Patient's neurologist recommended her to get the third dose. Patient declined to provide further medications due to having memory issue. Treatment medication was not provided by the reporter. Company comment: This case concerns a 61-year-old, female patient with previous relevant medical history of hypertension, who experienced the unexpected event of encephalitis autoimmune. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-337939 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, female patient with previous relevant medical history of hypertension, who experienced the unexpected event of encephalitis autoimmune. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: LIPITOR

Current Illness:

ID: 1770504
Sex: M
Age: 37
State: TX

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/08/2021
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: He started shaking.; He was walking crunched down by his back./He would walk really slow.; He had headaches.; He had chills.; He had fever around 104.; At midnight on same day, he was feeling hot.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (At midnight on same day, he was feeling hot.), TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.) and CHILLS (He had chills.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced FEELING HOT (At midnight on same day, he was feeling hot.). On an unknown date, the patient experienced TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.), CHILLS (He had chills.) and PYREXIA (He had fever around 104.). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING HOT (At midnight on same day, he was feeling hot.), TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.), CHILLS (He had chills.) and PYREXIA (He had fever around 104.) outcome was unknown. Patient wants to know if there is any excuse note that can be provided to his work from moderna for not showing up to work and also wants to know if he should go to doctor if he has fever again. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1770505
Sex: M
Age: 32
State: IA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: Patient received expired first dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment information was provided by reporter. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770506
Sex: F
Age: 31
State: IA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: Patient received first expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine) 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. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770507
Sex: M
Age: 27
State:

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 10/08/2021
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: when he received the vaccine, the liquid in the syringe was light blueish; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT COLOUR ISSUE (when he received the vaccine, the liquid in the syringe was light blueish) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04621A) for COVID-19 vaccination. No medical history was reported. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced PRODUCT COLOUR ISSUE (when he received the vaccine, the liquid in the syringe was light blueish). On 16-Sep-2021, PRODUCT COLOUR ISSUE (when he received the vaccine, the liquid in the syringe was light blueish) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatement of medication was reported. Concomitant medication included supplements.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1770508
Sex: M
Age:
State: AZ

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: Stomach hurts; Arm is sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 29-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1770509
Sex: F
Age: 76
State: IA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: Patient received expired third dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported.

Other Meds:

Current Illness:

ID: 1770510
Sex: M
Age: 30
State: IA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/08/2021
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: Patient received vaccine beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days). In September 2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The vials were in refrigerator for over 30 days. From 24-Aug-2021 the vials were stored in the refrigerator, which were administered on 27-Sep-2021 and 29-Sep-2021. It was stated that the vial did not undergo temperature excursions. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1770511
Sex: M
Age: 37
State: IA

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient received vaccine beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was provided. no treatment information was provided. The vials were in refrigerator for over 30 days. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770512
Sex: F
Age: 68
State: NY

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 10/08/2021
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: injection site was beet red a little painful; injection site was beet red a little painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site was beet red a little painful) and VACCINATION SITE PAIN (injection site was beet red a little painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The patient's past medical history included Connective tissue disorder. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site was beet red a little painful) and VACCINATION SITE PAIN (injection site was beet red a little painful). At the time of the report, VACCINATION SITE ERYTHEMA (injection site was beet red a little painful) and VACCINATION SITE PAIN (injection site was beet red a little painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. patient has a history of cancer twice but only received chemo once. Concomitant medication was not reported. Treatment information was not reported. This case was linked to MOD-2021-338452 (Patient Link).

Other Meds:

Current Illness:

ID: 1770513
Sex: F
Age:
State: MO

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Vials stored in the refrigerator were exposed to temperatures below 36?F; vaccine that had experienced a temperature excursion was given as 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36?F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose) in a 63-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 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36?F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose). On 23-Sep-2021, PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36?F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided. No Treatment medications were provided.

Other Meds:

Current Illness:

ID: 1770514
Sex: F
Age: 62
State: MD

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 10/08/2021
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: first injection "popped" like a trigger mechanism type/weird shot/it almost made her jump after the injection/jolted her/dose went in real fast; left arm was sorer than normal after the injection; left eye bacterial eye infection/ infection moved into her right eye; left eye started swelling/swelled from the top of the eye to the bottom eyelid; left eye started burning; left eyelid started swelling; left eyelid started burning; This spontaneous case was reported by a patient and describes the occurrence of EYE INFECTION BACTERIAL (left eye bacterial eye infection/ infection moved into her right eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Bone disorder (NOS). On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced EYE INFECTION BACTERIAL (left eye bacterial eye infection/ infection moved into her right eye) (seriousness criterion medically significant), EYE SWELLING (left eye started swelling/swelled from the top of the eye to the bottom eyelid), EYE IRRITATION (left eye started burning), SWELLING OF EYELID (left eyelid started swelling) and EYELID IRRITATION (left eyelid started burning). On 16-Jun-2021, the patient experienced FEELING ABNORMAL (first injection "popped" like a trigger mechanism type/weird shot/it almost made her jump after the injection/jolted her/dose went in real fast) and VACCINATION SITE PAIN (left arm was sorer than normal after the injection). The patient was treated with SULFACETAMIDE (ophthalmic) for Eye infection, at an unspecified dose and frequency; PREDNISOLONE (ophthalmic) for Eye infection, at a dose of 0.23 %; DOXYCYCLINE MONOHYDRATE on 23-Sep-2021 for Eye infection, at a dose of 100 milligram; ERYTHROMYCIN (ophthalmic) for Eye infection, at an unspecified dose and frequency and Surgery (Eyelid incision) for Feeling abnormal. At the time of the report, EYE INFECTION BACTERIAL (left eye bacterial eye infection/ infection moved into her right eye) was resolving and EYE SWELLING (left eye started swelling/swelled from the top of the eye to the bottom eyelid), EYE IRRITATION (left eye started burning), EYELID IRRITATION (left eyelid started burning), FEELING ABNORMAL (first injection "popped" like a trigger mechanism type/weird shot/it almost made her jump after the injection/jolted her/dose went in real fast) and VACCINATION SITE PAIN (left arm was sorer than normal after the injection) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had a very bad reaction to the Moderna vaccine. Two to three weeks after the first injection, she started had bacterial eye infections. First, her left eye and eyelid started swelling and burning and was prescribed an ophthalmic ointment. The eye specialist needed to cut her eyelid to alleviate the swelling. She stated just as her left eye started to improve, the infection moved into her right eye. Company Comment: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Eye infection bacterial after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the event occurred approximately 2 to 3 weeks after the first dose of Spikevax. The rechallenge is not applicable, as the events were reported as ongoing prior to dose 2. The benefit-risk relationship of Spikevax vaccine is not affected by this report. This case was linked to MOD-2021-338392 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Eye infection bacterial after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the event occurred approximately 2 to 3 weeks after the first dose of Spikevax. The rechallenge is not applicable, as the events were reported as ongoing prior to dose 2. The benefit-risk relationship of Spikevax vaccine is not affected by this report.

Other Meds: ALENDRONATE

Current Illness:

ID: 1770515
Sex: F
Age: 62
State: MD

Vax Date: 06/16/2021
Onset Date: 08/05/2021
Rec V Date: 10/08/2021
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: similar to chalazion but is behaving differently; the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes; delayed receiving the second dose due to a planned vacation; This spontaneous case was reported by a patient and describes the occurrence of EYE INFECTION BACTERIAL (the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was provided. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Bone disorder NOS. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed receiving the second dose due to a planned vacation). On 30-Sep-2021, the patient experienced EYE INFECTION BACTERIAL (the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes) (seriousness criterion medically significant). On an unknown date, the patient experienced CHALAZION (similar to chalazion but is behaving differently). The patient was treated with DOXYCYCLINE MONOHYDRATE on 23-Sep-2021 for Eye infection, at a dose of 100 mg twice a day and ERYTHROMYCIN for Eye infection, at an unspecified dose and frequency. On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed receiving the second dose due to a planned vacation) had resolved. At the time of the report, EYE INFECTION BACTERIAL (the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes) had not resolved and CHALAZION (similar to chalazion but is behaving differently) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information also included one other different ophthalmic ointment. Company Comment: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Bacterial eye infection after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, inappropriate schedule of vaccine administered was captured. The onset of the event occurred after the first dose without resolution and reoccurred after the second dose of Spikevax. The rechallenge is not applicable, since the vaccination schedule has been completed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. This case was linked to MOD-2021-338356 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Bacterial eye infection after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, inappropriate schedule of vaccine administered was captured. The onset of the event occurred after the first dose without resolution and reoccurred after the second dose of Spikevax. The rechallenge is not applicable, since the vaccination schedule has been completed. The benefit-risk relationship of Spikevax vaccine is not affected by this report.

Other Meds: Alendronate

Current Illness:

ID: 1770516
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-338337 (Patient Link).

Other Meds:

Current Illness:

ID: 1770517
Sex: U
Age:
State: IL

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/08/2021
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: We vaccinated 20 people with vaccine that was out of date since last Friday; 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 (We vaccinated 20 people with vaccine that was out of date since last Friday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were not reported. The 20 patients were vaccinated with the Moderna COVID-19 vaccine that expired on 24-Sep-2021. The vaccinations were administered over 3 days, starting on 27-Sep-2021 and ending on 29-Sep-2021 to all the patients. No treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1770518
Sex: F
Age: 40
State: KY

Vax Date: 09/24/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: Whole body hurts; Diarrhea; Sore arm,soreness in the arm; Tiredness, exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body hurts), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Sore arm,soreness in the arm) and FATIGUE (Tiredness, exhaustion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included METHYLPREDNISOLONE for an unknown indication. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced FATIGUE (Tiredness, exhaustion). On an unknown date, the patient experienced PAIN (Whole body hurts), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Sore arm,soreness in the arm). At the time of the report, PAIN (Whole body hurts), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Sore arm,soreness in the arm) and FATIGUE (Tiredness, exhaustion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment drugs were reported.

Other Meds: METHYLPREDNISOLONE

Current Illness:

ID: 1770519
Sex: F
Age:
State: TX

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: hot flashes; Nausea; vomiting; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches). At the time of the report, HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-338526 (Patient Link).

Other Meds:

Current Illness:

ID: 1770520
Sex: F
Age:
State: TX

Vax Date: 09/29/2021
Onset Date: 09/30/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: tingling in right leg; pain in right leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in right leg) and PAIN IN EXTREMITY (pain in right leg) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced PARAESTHESIA (tingling in right leg) and PAIN IN EXTREMITY (pain in right leg). At the time of the report, PARAESTHESIA (tingling in right leg) and PAIN IN EXTREMITY (pain in right leg) outcome was unknown. Concomitant medication of the patient was not reported. On 30-Sep-2021, the patient woke up and started driving her son to school. She started having tingling and pain in her right leg. It hurt and tingles even when she was sitting still. No treatment information was provided by the reporter. This case was linked to MOD-2021-338511 (Patient Link).

Other Meds:

Current Illness:

ID: 1770521
Sex: M
Age: 27
State: IA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: Expired vaccine used; The vials were in the refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days) 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 product use was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770522
Sex: M
Age: 78
State: NY

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 10/08/2021
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: had troubles hearing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (had troubles hearing) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A8BZ, 026L20A and 172267) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN CALCIUM (LIPITOR), MIDODRINE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), TAMSULOSIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (had troubles hearing). At the time of the report, HYPOACUSIS (had troubles hearing) outcome was unknown. Concomitant medication also includes Supplements. No treatment medication provided. On 24-Sep-2021, patient had blood draw for blood tests, 14 vials of blood were taken due to that patient was worried it might effect the efficacy of the vaccine. It was unknown if the patient was immunocompromised or not. patient took the third dose of the vaccine as his doctor told him to get it. Patient had an unspecified coronary sugary 5 years ago for atrial stimulation. Another unspecified coronary surgery was planned at the end of October. It was planed before prior to getting the vaccines.

Other Meds: XARELTO; LIPITOR; MIDODRINE; VASCEPA; TAMSULOSIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MONTELUKAST

Current Illness: Atrial fibrillation

ID: 1770523
Sex: F
Age:
State: IL

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/08/2021
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: This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine administered to a patient) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 032B21A) for COVID-19 immunization. No medical history reported. On Sep 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 30, 2021, patient administered expired product (expired vaccine administered to a patient). On Sep 30, 2021, administered expired product (expired vaccine administered to a patient) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Originally when the reporter looked-up the expiration date for the Moderna COVID-19 vaccine, it stated it was good until Oct 5, 2021. After administration when the reporter looked-up the expiration date, the website stated the vaccine expired on Sep 24, 2021.

Other Meds:

Current Illness:

ID: 1770524
Sex: F
Age: 61
State:

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 10/08/2021
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: severe pain from her waist down to her thigh; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 023M20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy). At the time of the report, PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (felt dizzy) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient was not aware if she was eligible for booster dose or not. This case was linked to MOD-2021-338524 (Patient Link).

Other Meds:

Current Illness:

ID: 1770525
Sex: F
Age: 61
State:

Vax Date: 08/23/2021
Onset Date:
Rec V Date: 10/08/2021
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: severe pain from her waist down to her thigh; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy). At the time of the report, PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy) outcome was unknown. After the third dose patient was in severe pain from her waist down to her thigh and felt dizzy. No concomitant and treatment medication were provided. This case was linked to MOD-2021-338542, MOD-2021-338524.

Other Meds:

Current Illness:

ID: 1770526
Sex: F
Age: 55
State: IA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications or treatment details were reported. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770527
Sex: F
Age:
State: IA

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/08/2021
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: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). In September 2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) 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. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770528
Sex: F
Age: 71
State: MD

Vax Date: 09/29/2021
Onset Date: 09/30/2021
Rec V Date: 10/08/2021
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: kind of bad; thought she was coming down with a cold; very confused; fatigue/tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concurrent medical conditions included Multiple sclerosis. 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 FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.

Other Meds:

Current Illness: Multiple sclerosis

ID: 1770529
Sex: F
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.; He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.) and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.) 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 INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.) and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.). At the time of the report, INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.) outcome was unknown and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day. And the other person said they had the same thing.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1770530
Sex: M
Age: 65
State: IA

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/08/2021
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: Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The treatment information was not provided. This case was linked to MOD-2021-337484, MOD-2021-337912, MOD-2021-338264, MOD-2021-338266, MOD-2021-338267, MOD-2021-338271, MOD-2021-338277, MOD-2021-338292, MOD-2021-338347, MOD-2021-338355, MOD-2021-338366, MOD-2021-338372, MOD-2021-338375, MOD-2021-338417, MOD-2021-338458, MOD-2021-338530, MOD-2021-338534, MOD-2021-338564, MOD-2021-338578, MOD-2021-338581, MOD-2021-338604, MOD-2021-338607, MOD-2021-338817, MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770531
Sex: M
Age: 21
State: IA

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment reported. This case was linked to MOD-2021-338604 (Patient Link).

Other Meds:

Current Illness:

ID: 1770532
Sex: U
Age:
State:

Vax Date: 09/02/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: They received an expired dose; 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 EXPIRED PRODUCT ADMINISTERED (They received an expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They received an expired dose) had resolved. Not Provided No Concomitant medications were reported. No Treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1770533
Sex: F
Age: 68
State: NJ

Vax Date: 02/04/2021
Onset Date: 03/05/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Osteoarthritis; Arthralgias in their fingers/arthralgias in the hand; Had more arm pain for longer hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had more arm pain for longer hours), OSTEOARTHRITIS (Osteoarthritis) and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 016M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD. Concomitant products included LORAZEPAM for Anxiety and Insomnia, ROSUVASTATIN and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Had more arm pain for longer hours). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis) and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand). At the time of the report, PAIN IN EXTREMITY (Had more arm pain for longer hours) and OSTEOARTHRITIS (Osteoarthritis) outcome was unknown and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient might have had some COPD that flared up, the patient thinks that might not be due to the shot. No treatment information was reported. This case was linked to MOD-2021-338672, MOD-2021-338621 (Patient Link).

Other Meds: ROSUVASTATIN; PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]; LORAZEPAM

Current Illness: COPD

ID: 1770534
Sex: F
Age: 68
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: slight arm pain for few hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain for few hours) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Spinal stenosis NOS. Concomitant products included LORAZEPAM for Insomnia and Anxiety, ROSUVASTATIN CALCIUM (ROSUVASTATIN [ROSUVASTATIN CALCIUM]) and FAMOTIDINE (PEPCID AC) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain for few hours). At the time of the report, PAIN IN EXTREMITY (slight arm pain for few hours) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided This case was linked to MOD-2021-338621, MOD-2021-338659 (Patient Link).

Other Meds: ROSUVASTATIN [ROSUVASTATIN CALCIUM]; PEPCID AC; LORAZEPAM

Current Illness: Spinal stenosis NOS

ID: 1770535
Sex: F
Age: 74
State: KY

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: blood sugar went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L201A, 016M201A and 040C21A) for COVID-19 vaccination. The patient's past medical history included Laser therapy (18 eye laser treatments) and Keratectomy. Concurrent medical conditions included Type 1 diabetes mellitus, Cancer, COPD and Arthritis. Concomitant products included INSULIN for Blood sugar increased. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment drugs were reported. The patient had to take an extra dose that time and adjust the dose of the insulin for a few days before it got controlled. On 15-Feb-2021,The patient received second dose and 03-Sep-2021, received third dose of Moderna vaccine.

Other Meds: INSULIN

Current Illness: Arthritis; Cancer; COPD; Type 1 diabetes mellitus

ID: 1770536
Sex: F
Age: 95
State: AL

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 10/08/2021
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: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042120A and 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had not resolved. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1770537
Sex: F
Age: 41
State: TX

Vax Date: 02/25/2021
Onset Date: 08/24/2021
Rec V Date: 10/08/2021
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: got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 040821A and 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure increased and Overweight (Slightly). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate). On 24-Aug-2021, OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate) had resolved. Concomitant medication details were not provided. Treatment details were not provided.

Other Meds:

Current Illness: Blood pressure increased; Overweight (Slightly)

ID: 1770538
Sex: F
Age: 75
State: NJ

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Soreness at shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at shot site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to codeine.), Drug allergy (allergy to Quinalones), Drug allergy (allergy to sulfa drugs), Drug allergy (allergy to muscle relaxants), Rheumatoid arthritis, Hypothyroidism, Arteriosclerosis, Chronic fatigue and Hypertension. Concomitant products included ENALAPRIL from 10-Feb-2005 to an unknown date, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 12-Mar-2015 to an unknown date, APIXABAN (ELIQUIS) from 15-Jan-2020 to an unknown date, DILTIAZEM (CARDIZEM [DILTIAZEM]) from 15-Jan-2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 20-Feb-2019 to an unknown date for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at shot site). In May 2021, VACCINATION SITE PAIN (Soreness at shot site) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was provided. This case was linked to MOD-2021-029776 (Patient Link).

Other Meds: ENALAPRIL; LEVOTHYROXIN; ELIQUIS; CARDIZEM [DILTIAZEM]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Arteriosclerosis; Chronic fatigue; Drug allergy (allergy to sulfa drugs); Drug allergy (allergy to Quinalones); Drug allergy (allergy to muscle relaxants); Drug allergy (Allergy to codeine.); Hypertension; Hypothyroidism; Penicillin allergy; Rheumatoid arthritis

ID: 1770539
Sex: F
Age:
State: FL

Vax Date: 04/30/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination; Periods are heavier; Periods are more painful; Extremely irregular, worse than when i was teenager; I have gotten my menstrual cycle 4 times since Moderna's vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Menopausal symptoms, Hot flashes and Mood swings. Concomitant products included ESTROVEN for Menopausal symptoms. On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination). At the time of the report, MENSTRUAL DISORDER (Had Menstrual cycle for 30 years and had again at 48 years of age after Moderna vaccination), HEAVY MENSTRUAL BLEEDING (Periods are heavier), DYSMENORRHOEA (Periods are more painful), MENSTRUATION IRREGULAR (Extremely irregular, worse than when i was teenager) and POLYMENORRHOEA (I have gotten my menstrual cycle 4 times since Moderna's vaccination) outcome was unknown. No treatment medications were provided. The periods were heavier, more painful and extremely irregular, worse than when i was an teenager. Had been Menopausal seven months prior to this vaccination.

Other Meds: ESTROVEN

Current Illness:

ID: 1770540
Sex: F
Age: 64
State: IA

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/08/2021
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: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided No treatment medications were provided. This case was linked to MOD-2021-338604, MOD-2021-338616 (Patient Link).

Other Meds:

Current Illness:

ID: 1770541
Sex: F
Age:
State: FL

Vax Date: 04/30/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna; Heavy periods; Painful periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ESTROVEN for an unknown indication. On 30-Apr-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 MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods). At the time of the report, MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was provided Patient reported that it is now September 2021 and she has gotten her menstrual cycle 4 times since Moderna vaccination

Other Meds: Estroven

Current Illness:

ID: 1770542
Sex: M
Age: 53
State: PA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: COVID-19 positive

Allergies:

Symptom List: Pain in extremity

Symptoms: Breakthrough covid infection despite the fact that I was fully vaccinated; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated). At the time of the report, COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Additional information received included reporter information, patient details, route of administration, vaccine indication, and lab data.; Sender's Comments: This case concerns a 54-year-old male patient with no relevant medical history reported, who experienced non serious unexpected event of special interest CVODI-19. The event occurred approximately a month after the second dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of drug is not affected by this report. Lack of efficacy not reported since there are no exact dates of vaccine administration provided.

Other Meds:

Current Illness:

ID: 1770543
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 10/08/2021
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: My entire family of 5 ended up getting COVID; had first vaccine in July, has not yet had her second as of yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet) 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. In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet). At the time of the report, COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product was provided by the reporter. No treatment medication was provided.; Sender's Comments: This case concerns a female with unknown age , with no reported medical history, who experience the unexpected events of Covid 19 and Product dose omission issue . These events occurred on an unknown date after vaccination with the first doe of mRNA- 1273 (Moderna). The rechallenge is not applicable since there is no report yet of a 2nd dose. The benefit -risk relationship of mRNA-1273( Moderna ) is not affected by this report.

Other Meds:

Current Illness:

ID: 1770544
Sex: F
Age: 59
State: MO

Vax Date: 03/21/2021
Onset Date: 09/07/2021
Rec V Date: 10/08/2021
Hospital: Y

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: Biopsy; Result Unstructured Data: rash is due to drug eruption.

Allergies:

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

Symptoms: Drug Eruption / rash all over; Broke out in rash/rash is now all over the body; This spontaneous case was reported by a consumer and describes the occurrence of DRUG ERUPTION (Drug Eruption / rash all over) and RASH (Broke out in rash/rash is now all over the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A, 031B21A and 003B21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder (Lupus Diagnosed in August), Hypertension, Thyroid disorder and Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for Autoimmune disorder NOS, AMLODIPINE for Hypertension, LEVOTHYROXINE for Thyroid disorder, ATORVASTATIN for an unknown indication. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced DRUG ERUPTION (Drug Eruption / rash all over) (seriousness criterion hospitalization) and RASH (Broke out in rash/rash is now all over the body) (seriousness criterion hospitalization). The patient was hospitalized from 20-Sep-2021 to 23-Sep-2021 due to DRUG ERUPTION and RASH. The patient was treated with PREDNISONE on 13-Sep-2021 for Adverse event, at a dose of 40 mg and PREDNISONE on 21-Sep-2021 for Adverse event, at a dose of Increased to 80 mg. At the time of the report, DRUG ERUPTION (Drug Eruption / rash all over) and RASH (Broke out in rash/rash is now all over the body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) rash is due to drug eruption.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported was taken off of amlodipine 2 days ago, patient also stated did not have problems prior to getting the third dose. it described it as drugs being the cause of the rash. patient took generic prednisone as injection and pill form. patient started generic prednisone on 13Sep2021 at 40mg then on 21Sep2021 was increased to 80mg. patient was been on it for 2 weeks. It clears then comes back. patient was concerned and cannot figure out what caused the rash. regular Rheumatologist Reporter3 believes it was due to the medication for Lupus but the Rheumatologist at the hospital Reporter2 thinks it is due to the Moderna vaccine. This case was linked to MOD-2021-339345 (Patient Link).; Sender's Comments: This case concerns a 60 year old female with relevant medical history of autoimmune disease (Lupus) , who experienced the unexpected events of rash and drug eruption . These events occurred 6 days after vacciniaton with the 3rd dose of mRNA 1273(Moderna) . The rechallenge for this case is not applicable. The medical condtion of autoimmune disease, Lupus (since this disease can also present with rashes and predisposition to drug reactions) and medication of Hydroxychloroquine ( recently taken patient just recently diagnosed with lupus noted incidence of rashes can be experienced with the intake of this medicaiton) Amlodipine ( can also cause rashes but very rare incidence) are confounders for this case. The benefit-risk relationship of mRNA-1273(Moderna) is not affected by this report.

Other Meds: HYDROXYCHLOROQUINE; AMLODIPINE; ATORVASTATIN; LEVOTHYROXINE

Current Illness: Autoimmune disorder (Lupus Diagnosed in August); Autoimmune disorder; Hypertension; Thyroid disorder

ID: 1770545
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: Funkiness; She had a little reaction of a fever for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Funkiness) and PYREXIA (She had a little reaction of a fever for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. 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 FEELING ABNORMAL (Funkiness) and PYREXIA (She had a little reaction of a fever for 24 hours). At the time of the report, FEELING ABNORMAL (Funkiness) outcome was unknown and PYREXIA (She had a little reaction of a fever for 24 hours) had resolved. Its been past 7 months of her first vaccination. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-339365 (Patient Link).

Other Meds:

Current Illness: Blood pressure high

ID: 1770546
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No medical history was provided by the reporter. . Concurrent medical conditions included Autoimmune disorder NOS. Concomitant products included ATENOLOL (TENORMIN) for an unknown indication. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself). In 2021, EXPIRED PRODUCT ADMINISTERED (second vaccine given yesterday, caller reports it is expired, when she looks up lot# herself) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. Medical conditions includes Cardiac.

Other Meds: TENORMIN

Current Illness: Autoimmune disorder NOS

ID: 1770547
Sex: M
Age: 66
State: CA

Vax Date: 01/14/2021
Onset Date: 09/29/2021
Rec V Date: 10/08/2021
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: has a lump under his left arm in the arm pit area; he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (has a lump under his left arm in the arm pit area) and OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 011J20A and 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised). On an unknown date, the patient experienced AXILLARY MASS (has a lump under his left arm in the arm pit area). On 29-Sep-2021, OFF LABEL USE (he received the 3rd dose (lot # 037C21A) for immunocompromised patients on 29Sep2021 in his left arm despite not being immunocompromised) had resolved. At the time of the report, AXILLARY MASS (has a lump under his left arm in the arm pit area) outcome was unknown. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1770548
Sex: F
Age: 54
State: FL

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 10/08/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days) and PAIN IN EXTREMITY (Very sore arm for a week) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radiation therapy (Did radiation for Rosai-Dorfman Disease in July and August.). Concurrent medical conditions included Rosai-Dorfman syndrome (A histiocytosis disease, which is a non malignant blood cancer, but it is not present in the blood stream.) and Diabetic. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week), PYREXIA (Slight fever) and HEADACHE (Bad headache for a day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week) and HEADACHE (Bad headache for a day) had resolved and PYREXIA (Slight fever) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-339411 (Patient Link).

Other Meds:

Current Illness: Diabetic; Rosai-Dorfman syndrome (A histiocytosis disease, which is a non malignant blood cancer, but it is not present in the blood stream.)

ID: 1770549
Sex: F
Age: 73
State: FL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 10/08/2021
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: vaccination site pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L0A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included L-THYROXINE [LEVOTHYROXINE] and ALENDRONATE SODIUM for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 09-Jan-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported by reporter. This case was linked to MOD-2021-339522, MOD-2021-322828 (Patient Link). Reporter did not allow further contact; Sender's Comments: This case concerns a 74-year-old, female patient with no relevant medical history, who experienced the expected event of vaccination site pain. The event occurred during the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative since the event did not re-occur after the administration of the remaining doses of the vaccine. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds: L-THYROXINE [LEVOTHYROXINE]; ALENDRONATE SODIUM

Current Illness:

ID: 1770550
Sex: U
Age:
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/08/2021
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: Expired vaccine was administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to patients). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1770551
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: sore left injection site arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am