VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1718088
Sex: F
Age: 26
State: IN

Vax Date: 09/09/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: pain in arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) had not resolved. Concomitant medications were not provided. Treatment medications were not provided. This case was linked to MOD-2021-315977 (Patient Link).

Other Meds:

Current Illness:

ID: 1718089
Sex: M
Age: 56
State: IL

Vax Date: 08/04/2021
Onset Date:
Rec V Date: 09/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Tenderness in the armpit on the shoulder; Did not notice the pain until he touched the arm.; General soreness; It really hurt for a while, right in the muscle below the armpit.; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.) outcome was unknown. No concomitant medication was provided. Ice bag was used to treat symptoms.

Other Meds:

Current Illness:

ID: 1718090
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit). At the time of the report, INSOMNIA (been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1718091
Sex: U
Age:
State:

Vax Date: 09/09/2021
Onset Date: 09/01/2021
Rec V Date: 09/21/2021
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: throat feels really dry; Dry mouth; 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 DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth) 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 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth). At the time of the report, DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications, Lab data details and Treatment informations were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718092
Sex: F
Age:
State: MN

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718093
Sex: F
Age: 26
State: UT

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/21/2021
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: Patient was cold to the touch; Sweating profusely; Became pale; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING COLD (Patient was cold to the touch), HYPERHIDROSIS (Sweating profusely) and PALLOR (Became pale) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced FEELING COLD (Patient was cold to the touch), HYPERHIDROSIS (Sweating profusely) and PALLOR (Became pale). At the time of the report, FEELING COLD (Patient was cold to the touch) and HYPERHIDROSIS (Sweating profusely) outcome was unknown and PALLOR (Became pale) was resolving. 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 medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718094
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Leg cramps in both legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps in both legs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Leg cramps in both legs). At the time of the report, MUSCLE SPASMS (Leg cramps in both legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1718095
Sex: U
Age:
State: TX

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vaccine temperature reported as temperature changes 40-41 F. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1718096
Sex: M
Age:
State: NY

Vax Date: 09/08/2021
Onset Date:
Rec V Date: 09/21/2021
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 got a dose from a vial punctured more than 12 hours before; slight fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided by the reporter. no treatment information provided by the reporter

Other Meds:

Current Illness:

ID: 1718097
Sex: U
Age:
State: TX

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1718098
Sex: M
Age:
State: MN

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1718099
Sex: F
Age: 57
State: PA

Vax Date: 08/25/2021
Onset Date: 09/09/2021
Rec V Date: 09/21/2021
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: Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side). At the time of the report, PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included sugar pill and cholesterol pill (unspecified). Patient did not take medication to treat symptoms.

Other Meds:

Current Illness:

ID: 1718100
Sex: U
Age:
State: FL

Vax Date: 08/27/2021
Onset Date: 09/09/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 20210909; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: tested positive for COVID-19; 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 SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) 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 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided. Treatment information was not provided. The patient will take second shot on 24-Sep-2021

Other Meds:

Current Illness:

ID: 1718101
Sex: U
Age:
State: TX

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). At the time of the report, PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information reported.

Other Meds:

Current Illness:

ID: 1718102
Sex: F
Age:
State: TX

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/21/2021
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: Had adverse reaction; More than 36 days from fist vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination) 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 January 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 ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination). At the time of the report, ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1718103
Sex: F
Age: 56
State: IL

Vax Date: 04/01/2021
Onset Date: 06/01/2021
Rec V Date: 09/21/2021
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: She started with hot flashes very badly/She still experiences hot flashes; In June, she started having menopausal symptoms; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms). At the time of the report, HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) had not resolved and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1718104
Sex: F
Age:
State: MN

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date) 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 medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718105
Sex: U
Age:
State: TX

Vax Date: 07/23/2021
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) to be not applicable. No concomitant medication was provided No treatment received by the patient

Other Meds:

Current Illness:

ID: 1718106
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: did have a kind of a long term reaction / that's the way my body reacts.; i'm fine, it is nothing serious, just not feeling that great; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great) 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 ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great). At the time of the report, ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. She stated that's she had bad reaction to shots and that the way her body reacts. Concomitant medications were not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718107
Sex: F
Age: 75
State: FL

Vax Date: 08/12/2021
Onset Date: 09/11/2021
Rec V Date: 09/21/2021
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: Painful urination; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Painful urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. Concomitant products included LOVASTATIN, GABAPENTIN, DULOXETINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSURIA (Painful urination). At the time of the report, DYSURIA (Painful urination) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were provided. it was reported patient had painful urination few minutes earlier. This case was linked to MOD-2021-316173 (Patient Link).

Other Meds: LOVASTATIN; GABAPENTIN; DULOXETINE; ALDACTONE [SPIRONOLACTONE]

Current Illness: Drug allergy

ID: 1718108
Sex: F
Age: 65
State: IN

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 09/21/2021
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: Patient received first dose on 10Feb2021/second dose on 18Mar2021; couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.; arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021), PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.). The patient was treated with CORTISONE for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021) outcome was unknown and PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.) had not resolved. She does not have a diagnose yet although she has consulted doctors, the X-Ray did not show injuries or anything, and they are going to do a MRI in about 4 weeks. She started going to the Orthopedist and now is doing physical therapy. No concomitant medications were reported This case was linked to MOD-2021-024087 (Patient Link).

Other Meds:

Current Illness:

ID: 1718109
Sex: F
Age:
State: TX

Vax Date: 06/09/2021
Onset Date:
Rec V Date: 09/21/2021
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: The bleeding continued after the second dose and is not stopping even with treatment by physicians; Dizziness; three days of being in bed with bad fever and nausea; three days of being in bed with bad fever and nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ALPRAZOLAM and TRAZODONE for an unknown indication. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea). At the time of the report, HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea) had not resolved. The patient did not provide her age but reported that she was in her 20s. After receiving the first dose, upon the end of the cycle of first period after the patient was having constant breakthrough bleeding. The bleeding continued after the second dose and was not stopping even with treatment by physicians. The bleeding episodes have never occurred prior to the vaccine according to the patient. No treatment information was provided by the reporter. This case was linked to MOD-2021-315665 (Patient Link).

Other Meds: ALPRAZOLAM; TRAZODONE

Current Illness:

ID: 1718110
Sex: F
Age: 69
State: CA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 20210607; Test Name: Thyroid gland scan; Result Unstructured Data: Very small nodules bilaterally in the thyroid, nonspecific appearing and difficult to characterize further because of small size. No surrounding adenopathy noted.

Allergies:

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

Symptoms: Became ill after first dose; fatigue; high fever; dizziness; sweating; glands swollen and achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: TYPHOID VACCINE (In 1983 and Experienced similar events) in 1983. Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Allergy to antibiotic (Dicloxacillin), Allergy to antibiotic (Levofloxacin), Hypertension, Lymphadenopathy, Drug allergy (Compazine), Drug allergy (Statins) and Drug allergy (Prochlorperazine). Concomitant products included CITALOPRAM from 07-Jul-2021 to an unknown date for Anxiety, TELMISARTAN from 24-Aug-2021 to an unknown date for Hypertension, AMITRIPTYLINE and MELATONIN from 17-Jul-2021 to an unknown date for Sleep disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN) from 16-Mar-2021 to an unknown date for an unknown indication. On 05-Feb-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and PYREXIA (high fever). On an unknown date, the patient experienced ILLNESS (Became ill after first dose) and FATIGUE (fatigue). At the time of the report, ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Thyroid gland scan abnormal: abnormal (abnormal) Very small nodules bilaterally in the thyroid, nonspecific appearing and difficult to characterize further because of small size. No surrounding adenopathy noted.. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) to be possibly related. No treatment medications were provided This case was linked to MOD-2021-300020 (Patient Link).

Other Meds: AMITRIPTYLINE; TELMISARTAN; CITALOPRAM; ASPIRIN; MELATONIN

Current Illness: Allergy to antibiotic (Tetracycline); Allergy to antibiotic (Levofloxacin); Allergy to antibiotic (Dicloxacillin); Drug allergy (Statins); Drug allergy (Prochlorperazine); Drug allergy (Compazine); Hypertension; Lymphadenopathy

ID: 1718111
Sex: F
Age: 75
State: FL

Vax Date: 08/12/2021
Onset Date: 09/11/2021
Rec V Date: 09/21/2021
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: she had with the first dose was a sore arm that went away after 2 days; Painful urination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days) and DYSURIA (Painful urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LOVASTATIN, GABAPENTIN, DULOXETINE and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (ALDACTONE 50 HCT) for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced DYSURIA (Painful urination). On an unknown date, the patient experienced PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days). At the time of the report, PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days) had resolved and DYSURIA (Painful urination) 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 treatment medication details provided. This case was linked to MOD-2021-316145 (Patient Link).

Other Meds: LOVASTATIN; GABAPENTIN; DULOXETINE; ALDACTONE 50 HCT

Current Illness: Drug allergy (Codeine)

ID: 1718112
Sex: U
Age:
State: TX

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/21/2021
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: Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information reported.

Other Meds:

Current Illness:

ID: 1718113
Sex: U
Age:
State:

Vax Date: 09/03/2021
Onset Date: 09/01/2021
Rec V Date: 09/21/2021
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: My arm is now very red and warm.; It is starting to feel like my arm is weak and achy; My arm is now very red and warm.; It is starting to feel like my arm is weak and achy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My arm is now very red and warm.), PAIN IN EXTREMITY (It is starting to feel like my arm is weak and achy), SKIN WARM (My arm is now very red and warm.) and MUSCULAR WEAKNESS (It is starting to feel like my arm is weak and achy) 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 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ERYTHEMA (My arm is now very red and warm.), PAIN IN EXTREMITY (It is starting to feel like my arm is weak and achy), SKIN WARM (My arm is now very red and warm.) and MUSCULAR WEAKNESS (It is starting to feel like my arm is weak and achy). At the time of the report, ERYTHEMA (My arm is now very red and warm.), PAIN IN EXTREMITY (It is starting to feel like my arm is weak and achy), SKIN WARM (My arm is now very red and warm.) and MUSCULAR WEAKNESS (It is starting to feel like my arm is weak and achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication reported.

Other Meds:

Current Illness:

ID: 1718114
Sex: U
Age:
State: TX

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. 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 medications were reported. Date refrigerated: 13-Apr-2021. Temperature changes (in F): 37-40. No treatment medications were reported This case was linked to MOD-2021-316323 (Patient Link).

Other Meds:

Current Illness:

ID: 1718115
Sex: U
Age:
State: TX

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Administered past the 30 day refrigeration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product details were provided by the reporter. No Treatment information was provided. Linked to master case: MOD-2021-315260

Other Meds:

Current Illness:

ID: 1718116
Sex: F
Age: 45
State: TX

Vax Date: 07/11/2021
Onset Date: 07/11/2021
Rec V Date: 09/21/2021
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: Pain for a couple days; Hard to get up; All muscles hurt; Received second dose almost 8 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up), MYALGIA (All muscles hurt) and INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient had COVID in August 2020.) and Pericarditis (Patient has a past history of Pericarditis that happened 4 years ago during an autoimmune attack.). Concurrent medical conditions included ADD, Thyroid disorder, Ulcerative colitis, Blood sugar decreased and Blood pressure abnormal (Patient's blood pressure has been going up and down.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, HYDROXYCHLOROQUINE for Blood sugar decreased, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MESALAZINE (LIALDA) for Ulcerative colitis. On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up), MYALGIA (All muscles hurt) and INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose). On 03-Sep-2021, INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose) had resolved. At the time of the report, PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up) and MYALGIA (All muscles hurt) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was reported. Patient had COVID 19 in August 2020. Since then, her blood pressure has been going up and down, so patient takes some drug that helps BP remain constant. This case was linked to MOD-2021-316301 (Patient Link).

Other Meds: ADDERALL; SYNTHROID; LIALDA; HYDROXYCHLOROQUINE

Current Illness: ADD; Blood pressure abnormal (Patient's blood pressure has been going up and down.); Blood sugar decreased; Thyroid disorder; Ulcerative colitis

ID: 1718117
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: have diarrhea and nausea over a week after getting 1st dose; have diarrhea and nausea over a week after getting 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose). At the time of the report, DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718118
Sex: F
Age: 45
State: TX

Vax Date: 07/11/2021
Onset Date: 09/03/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: COVID-19 Test; Test Result: Negative

Allergies:

Symptom List: Injection site pain

Symptoms: Sinus congestion; Like hay fever symptoms; Coughing; Stuff coming out while she cough like phlegm; Shortness of breath when walking, A little shortness of breath at rest; Lot more pain than with the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing) and PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pericarditis. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit hyperactivity disorder, HYDROXYCHLOROQUINE for Diabetes mellitus, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MESALAZINE (LIALDA) for Ulcerative colitis. On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Lot more pain than with the first shot). On 04-Sep-2021, the patient experienced SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest). At the time of the report, PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, COVID-19 Test: negative Negative. No treatment information was provided. This case was linked to MOD-2021-316241 (Patient Link).

Other Meds: ADDERALL; SYNTHROID; LIALDA; HYDROXYCHLOROQUINE

Current Illness:

ID: 1718119
Sex: U
Age:
State: TX

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Per reporter,the Moderna COVID Vaccine was refrigerated on 20-APR-2021, and administered to the patient on 27-AUG-2021. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718120
Sex: U
Age:
State: TX

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. This case was linked to MOD-2021-316219 (Patient Link).

Other Meds:

Current Illness:

ID: 1718121
Sex: F
Age: 28
State: IL

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/21/2021
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: Mixed Moderna and Pfizer dose; first dose of Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed Moderna and Pfizer dose) and PRODUCT ADMINISTRATION ERROR (first dose of Pfizer) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 20-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (first dose of Pfizer). On 10-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed Moderna and Pfizer dose). On 20-Aug-2021, PRODUCT ADMINISTRATION ERROR (first dose of Pfizer) had resolved. On 10-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Mixed Moderna and Pfizer dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1718122
Sex: M
Age: 59
State: FL

Vax Date: 08/13/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: left sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 05ZE21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (left sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 2 dosage form. At the time of the report, VACCINATION SITE PAIN (left sore arm) outcome was unknown. The concomitant medications information was not reported. The patient had no known allergies.

Other Meds:

Current Illness:

ID: 1718123
Sex: M
Age: 56
State: OH

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/21/2021
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: Fatigue; Headaches after each dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headaches after each dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart attack (History of 3 heart attacks) and Stent placement. Concomitant products included LISINOPRIL, METOPROLOL and CLOPIDOGREL for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headaches after each dose). At the time of the report, FATIGUE (Fatigue) had not resolved and HEADACHE (Headaches after each dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-316410 (Patient Link).

Other Meds: LISINOPRIL; METOPROLOL; CLOPIDOGREL

Current Illness:

ID: 1718124
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: running high fever; chills; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided No Treatment medication was provided.

Other Meds:

Current Illness:

ID: 1718125
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment and concomitant medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718126
Sex: F
Age: 74
State: FL

Vax Date: 12/29/2020
Onset Date: 01/28/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: SARS Cov 2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: sick for 3 days; weakness; low grade fever; chills but not that bad; terrible muscle pain during the night; he next day felt better and by the third day felt tired but was able to do her activities; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad) and MYALGIA (terrible muscle pain during the night) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy (seasonal allergies), Drug allergy (Phenergan) and Drug allergy (Sulfa drug). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN and ALPRAZOLAM (XANAX) for an unknown indication. On 29-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 28-Jan-2021, the patient experienced ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad), MYALGIA (terrible muscle pain during the night) and FATIGUE (he next day felt better and by the third day felt tired but was able to do her activities). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg four times per day. At the time of the report, ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad) and MYALGIA (terrible muscle pain during the night) had resolved and FATIGUE (he next day felt better and by the third day felt tired but was able to do her activities) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant medications was reported as Metoprolol extender release 25mg daily, Lamictol 12.5mg/day. Treatment medications reported by reporter are Zinc 1 tab for the first two days Amoxicillin 875mg twice a day started yesterday (10Sept)

Other Meds: CYMBALTA; GABAPENTIN; XANAX

Current Illness: Drug allergy (Sulfa drug); Drug allergy (Phenergan); Seasonal allergy (seasonal allergies)

ID: 1718127
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; Improper storage of unused product; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are provided. No treatment medications are provided. Third shot info of patient includes Date administered: 18AUG2021, Lot number: 008C21A , Expiration date: 31OCT2021 , Date refrigerated: 20APR2021, Temperature changes (in F): 41

Other Meds:

Current Illness:

ID: 1718128
Sex: M
Age:
State: NJ

Vax Date: 01/16/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: soreness in the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site.) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21O, #013L20A and #021M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (soreness in the injection site.). At the time of the report, VACCINATION SITE PAIN (soreness in the injection site.) outcome was unknown. No Concomitant use were reported. No Treatment were reported Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-Significant F/U Case.

Other Meds:

Current Illness:

ID: 1718129
Sex: M
Age: 49
State: NJ

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 09/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Name: x-ray chest; Result Unstructured Data: normal

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: pain in the arm on all doses; feeling tired on 1st 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses). At the time of the report, VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. Concomitant products also included Steroids. No treatment medication provided. RT-PCR test which came back negative. This case was linked to MOD-2021-316580, MOD-2021-316515 (Patient Link).

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness: Asthma

ID: 1718130
Sex: U
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1718131
Sex: F
Age: 25
State: IL

Vax Date: 08/20/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Patient is currently pregnant with an unknown due date; Mixed Moderna + Pfizer vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is currently pregnant with an unknown due date) and PRODUCT PREPARATION ERROR (Mixed Moderna + Pfizer vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. Co-suspect product included non-company product BNT162B2 for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient started BNT162B2 (unknown route) 1 dosage form. On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, BNT162B2 (unknown route) dosage was changed to at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 10-Sep-2021, the patient experienced PRODUCT PREPARATION ERROR (Mixed Moderna + Pfizer vaccine). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is currently pregnant with an unknown due date). On 10-Sep-2021, PRODUCT PREPARATION ERROR (Mixed Moderna + Pfizer vaccine) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is currently pregnant with an unknown due date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment drugs were reported. The pharmacist reported that the patient is currently pregnant with an unknown due date, possibly in November 2021. This case concerns a 25 year old pregnant female, who experienced Maternal exposure during pregnancy and Product Preparation error on the day of receiving vaccine. The rechallenge is not applicable since this is the firt time patient received Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 25 year old pregnant female, who experienced Maternal exposure during pregnancy and Product Preparation error on the day of receiving vaccine. The rechallenge is not applicable since this is the firt time patient received Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1718132
Sex: M
Age:
State: MA

Vax Date: 03/13/2021
Onset Date: 05/01/2021
Rec V Date: 09/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 202108; Test Name: body temperature; Result Unstructured Data: Fever

Allergies:

Symptom List: Vomiting

Symptoms: After 2 shots, had bumpy health; Could barely walk; Allergic reaction to Lovastatin, has been on it for 15 years; Muscles in legs tightened; Face got burned from MRI; Pain on left side of temple, had MRI; some mineral make up; Temperature 100.1; Beginning of August, got COVID-19; Got Covid, head feels foggy; COVID-19; Mild sore throat; Sneezed around 1 in the afternoon; Runny nose; sinusitis; Head was swollen; Head foggy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Mild sore throat), SNEEZING (Sneezed around 1 in the afternoon), RHINORRHOEA (Runny nose) and SINUSITIS (sinusitis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LOVASTATIN for an unknown indication. On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced SINUSITIS (sinusitis), SWELLING (Head was swollen) and FEELING ABNORMAL (Head foggy). In August 2021, the patient experienced COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Mild sore throat), SNEEZING (Sneezed around 1 in the afternoon), RHINORRHOEA (Runny nose), DRUG INEFFECTIVE (Beginning of August, got COVID-19), FEELING ABNORMAL (Got Covid, head feels foggy) and PYREXIA (Temperature 100.1). On an unknown date, the patient experienced MUSCLE TIGHTNESS (Muscles in legs tightened), GENERAL PHYSICAL HEALTH DETERIORATION (After 2 shots, had bumpy health), GAIT DISTURBANCE (Could barely walk), DRUG HYPERSENSITIVITY (Allergic reaction to Lovastatin, has been on it for 15 years), THERMAL BURN (Face got burned from MRI) and PAIN (Pain on left side of temple, had MRI; some mineral make up). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) in August 2021 for Fever, at an unspecified dose and frequency and AMOXICILLIN in May 2021 for Sinusitis, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Mild sore throat), SNEEZING (Sneezed around 1 in the afternoon), RHINORRHOEA (Runny nose), SINUSITIS (sinusitis), SWELLING (Head was swollen), FEELING ABNORMAL (Head foggy), MUSCLE TIGHTNESS (Muscles in legs tightened), DRUG INEFFECTIVE (Beginning of August, got COVID-19), GENERAL PHYSICAL HEALTH DETERIORATION (After 2 shots, had bumpy health), GAIT DISTURBANCE (Could barely walk), DRUG HYPERSENSITIVITY (Allergic reaction to Lovastatin, has been on it for 15 years), FEELING ABNORMAL (Got Covid, head feels foggy), THERMAL BURN (Face got burned from MRI), PAIN (Pain on left side of temple, had MRI; some mineral make up) and PYREXIA (Temperature 100.1) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 100.1f (High) Fever. The patient reported that following both shots, they had "bumpy health". They reported having had sinusitis in May 2021 for 3 weeks (head was swollen, foggy) that was treated with an antibiotic. The muscles in their legs tightened and they could barely walk. They further reported having had an allergic reaction (details not provided) to Lovastatin (statin drug; treats high cholesterol) despite being on it for 15 years. The patient subsequently developed COVID-19 in the beginning of August 2021 and was quarantined for 14 days. Symptoms included head feeling foggy, mild sore throat, sneezing, runny nose and a temperature of 100.1. The patient believes they got COVID-19 at the grocery store but reported that is was a very, very mild case. On an unknown date, they developed pain on the left side of their temple and had an MRI which showed "some mineral make up". They further reported that their face got burned from the MRI. They do not want another shot. This case was linked to MOD-2021-038156 (Patient Link).; Sender's Comments: This case concerns a male patient with non-serious COVID-19, oropharyngeal pain, sneezing, rhinorrhoea, sinusitis, swelling, feeling abnormal, muscle tightness, drug ineffective, general physical health deterioration, gait disturbance, drug hypersensitivity, feeling abnormal, thermal burn, pyrexia, and pain in temple. Latency unknown after 2nd dose. Outcomes unknown. Rechallenge unknown. Reporter causality not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: LOVASTATIN

Current Illness:

ID: 1718133
Sex: F
Age: 55
State: FL

Vax Date: 04/06/2021
Onset Date: 09/07/2021
Rec V Date: 09/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210907; Test Name: COVID-19 virtus test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Tested positive for COVID-19; Tested positive for COVID-19 on September 7th; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Overweight and Smoker (former smoker). Concurrent medical conditions included Hypertension. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) positive. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.; Sender's Comments: This case concerns a 55-year-old female patient, former smoker, overweight and hypertensive, who experienced the unexpected event of COVID-19, vaccination failure was considered as an additional event. The event occurred approximately 4 months after the second dose of Spikevax. The event was considered related to the product per the reporter's assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds:

Current Illness: Hypertension

ID: 1718134
Sex: M
Age: 61
State: NC

Vax Date: 05/12/2021
Onset Date:
Rec V Date: 09/21/2021
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: kidneys' and sick; my side starting hurting; and hard to breathe; fever; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (kidneys' and sick) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-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 KIDNEY INFECTION (kidneys' and sick) (seriousness criterion medically significant), DISCOMFORT (my side starting hurting), DYSPNOEA (and hard to breathe) and PYREXIA (fever). At the time of the report, KIDNEY INFECTION (kidneys' and sick), DISCOMFORT (my side starting hurting), DYSPNOEA (and hard to breathe) and PYREXIA (fever) outcome was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 62-year-old male subject who experienced the serious event of kidney infection, and non-serious events of discomfort, dyspnoea, and pyrexia. The events occurred after the administration of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up appended as live follow up included events added; Sender's Comments: This case concerns a 62-year-old male subject who experienced the serious event of kidney infection, and non-serious events of discomfort, dyspnoea, and pyrexia. The events occurred after the administration of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1718135
Sex: F
Age:
State: ME

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: This spontaneous case reported by a healthcare professional, describes the occurrence of product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 003C21A and 014C21A) for COVID-19 immunization. Concurrent medical conditions included prediabetes since Jan 28, 2021. Concomitant products included Zyrtec (cetirizine hydrochloride) for allergy. On Aug 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 12, 2021, product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA). On Sep 10, 2021, product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA) resolved. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-284575 (patient link).

Other Meds: Zyrtec (cetirizine hydrochloride)

Current Illness: Prediabetes

ID: 1718136
Sex: M
Age: 66
State: FL

Vax Date: 02/20/2021
Onset Date: 09/08/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Fever of 101 degrees Fahrenheit

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: felt really bad; nauseated; fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. No medical History was reported. Concomitant products included MELOXICAM, VERAPAMIL, TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) and PRAVASTATIN for an unknown indication. On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 101 (High) Fever of 101 degrees Fahrenheit. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient had no known allergy. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received significant information - Events Outcome updated.

Other Meds: MELOXICAM; VERAPAMIL; COENZYME Q10+; PRAVASTATIN

Current Illness:

ID: 1718137
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 01/01/2021
Rec V Date: 09/21/2021
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 arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, 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. No concomitant medication is provided by reporter. No treatment information is provided by reporter. Patient medical history include some medical training and a pre -existing medical condition. This case was linked to MOD-2021-316913 (Patient Link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am