VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1644844
Sex: M
Age:
State: TX

Vax Date: 06/26/2021
Onset Date: 07/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210725; Test Name: Blood pressure; Result Unstructured Data: High blood pressure.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Rapid pulse; Blood in urine; Night sweat; Cough; Swollen lymph node; Chills; Fever; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced PALPITATIONS (Rapid pulse) (seriousness criterion medically significant), BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph node) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN (ZITHROMYCIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE (DOXYCYCLIN [DOXYCYCLINE]) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Blood pressure measurement: high blood pressure (High) High blood pressure. The concomitant medications on use were not provided. Patient was on three different antibiotics for the adverse events, he was not getting rather getting worse. His doctor was checking for tuberculosis and lymphoma. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. This case was linked to MOD-2021-284085 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644845
Sex: F
Age: 50
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: administered 4 doses of an affected vial; received dose of Moderna vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No medical history is reported by reporter. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial) 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 information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1644846
Sex: M
Age: 31
State: OH

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
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: received dose of Moderna vaccine after excursion; reported that he administered 4 doses of an affected vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial). On 09-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and treatment drugs were not provided. The vaccine was actually delivered by McKesson on Thursday, 05-Aug-2021 and kept in the cooler box. On the evening of 08-Aug-2021, the pharmacist realized the vaccines were still in the shipping packaging and contacted the pharmacist on duty. The pharmacist on duty opened the packaging and visually observed that the vials were in a liquid state. When she clicked the tag alert, it showed a red X. She did not note the condition of the Phase Change Gelpack material in the shipping container. The pharmacist on duty put a glycol thermometer in the empty cooler overnight which showed the temperature range was 32-37 F, however the vaccine had already been moved to the refrigerator. The pharmacist also checked the Moderna excursion tool, which said to quarantine the vials. Due to the fact that the vaccine was in liquid state upon opening the packaging, the pharmacist used the Moderna Excursion Tool and labeled the vaccine 30 Day Use by Date as 03Sep2021 based on the results. Referred to Walmart's home office and Moderna for guidance.

Other Meds:

Current Illness:

ID: 1644847
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Patient was administered expired Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Pharmacist reported that she administered expired vaccine to three patients on 10-AUG-2021 and later it was discarded. She mentioned that punctured vial was left out all the day on 09-AUG-2021 for about 12 hours at room temperature.

Other Meds:

Current Illness:

ID: 1644848
Sex: F
Age: 58
State: NY

Vax Date: 02/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210317; Test Name: blood sample; Result Unstructured Data: anemic; Test Date: 2021; Test Name: blood sample; Result Unstructured Data: she became more anemic; Test Date: 20210317; Test Name: Body temperature; Result Unstructured Data: 102; Test Date: 20210317; Test Name: HGB; Result Unstructured Data: Anemic; Test Date: 2021; Test Name: HGB; Result Unstructured Data: down; Test Date: 20210317; Test Name: Platelet; Result Unstructured Data: 80; Test Date: 2021; Test Name: Platelet; Result Unstructured Data: 30; Test Date: 2021; Test Name: Platelet; Result Unstructured Data: 93 from 250; Test Date: 2021; Test Name: Platelet; Result Unstructured Data: Low; Test Date: 2021; Test Name: Platelet; Result Unstructured Data: dropped more; Test Date: 2021; Test Name: Platelet; Result Unstructured Data: platelet kept on dropping; Test Date: 20210317; Test Name: WBC; Result Unstructured Data: 2; Test Date: 2021; Test Name: WBC; Result Unstructured Data: 1.5.; Test Date: 2021; Test Name: WBC; Result Unstructured Data: came back up.

Allergies:

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

Symptoms: Had trouble moving around; When patient was discharged her WBC was 2 and then 2 days later she started getting fever of 102 degrees F; Anemic; Extremely fatigued, which never went away; Diagnosed with HLH; This spontaneous case was reported by a non-health professional and describes the occurrence of HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (Diagnosed with HLH), FATIGUE (Extremely fatigued, which never went away), MOBILITY DECREASED (Had trouble moving around), ANAEMIA (Anemic) and PYREXIA (When patient was discharged her WBC was 2 and then 2 days later she started getting fever of 102 degrees F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 048A21A) for COVID-19 vaccination. The patient's past medical history included Bone marrow biopsy (bone marrow biopsy procedures) since an unknown date, Chemotherapy, Blood transfusion and Platelet transfusion. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Extremely fatigued, which never went away) (seriousness criteria hospitalization and life threatening). On 17-Mar-2021, the patient experienced ANAEMIA (Anemic) (seriousness criteria hospitalization and life threatening). On an unknown date, the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (Diagnosed with HLH) (seriousness criteria hospitalization, medically significant and life threatening), MOBILITY DECREASED (Had trouble moving around) (seriousness criteria hospitalization and life threatening) and PYREXIA (When patient was discharged her WBC was 2 and then 2 days later she started getting fever of 102 degrees F) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 30 days due to HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. At the time of the report, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (Diagnosed with HLH), FATIGUE (Extremely fatigued, which never went away), MOBILITY DECREASED (Had trouble moving around), ANAEMIA (Anemic) and PYREXIA (When patient was discharged her WBC was 2 and then 2 days later she started getting fever of 102 degrees F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood test: abnormal (abnormal) anemic. On 17-Mar-2021, Body temperature: 102 (abnormal) 102. On 17-Mar-2021, Haemoglobin: 8 (Low) Anemic. On 17-Mar-2021, Platelet disorder: 80 (abnormal) 80. On 17-Mar-2021, White blood cell count: 2 (abnormal) 2. On an unknown date, Blood test: abnormal (abnormal) she became more anemic. On an unknown date, Haemoglobin: low (Low) down. On an unknown date, Platelet disorder: 30 (abnormal) 30, 93 from 250 (abnormal) 93 from 250, low (Low) Low, low (Low) dropped more and low (Low) platelet kept on dropping. On an unknown date, White blood cell count: 1.5. (abnormal) 1.5. and came back up (normal) came back up. Patient was hospitalized 3 times and had undergone chemotherapy. She was given with WBC injection (multiple shots) and her WBC came back up. She was treated with steroids also. Few days later she needed blood transfusion again. During hospitalization hematology department had done test like bone marrow biopsy multiple times, CT scans. And then was diagnosed with HLH, which was a super rare and aggressive immune response disease. She had blood tests daily and more transfusions. At certain point she needed platelet transfusion also. Treatment included Chemotherapy and a drug named JAKAFI, which is not yet approved by FDA for HLH. On 17 Jun 2021, She had chemo for 7 weeks and she responded well. Company Comment :Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected.

Other Meds:

Current Illness: Bone marrow biopsy (bone marrow biopsy procedures).

ID: 1644849
Sex: F
Age: 50
State: AL

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
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: under my arm, where I put on deodorant, is a little swollen.; injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.) and VACCINATION SITE PAIN (injection site arm was sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for an unknown indication. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PAIN (injection site arm was sore). On 11-Aug-2021, the patient experienced PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at a dose of 2. At the time of the report, PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.) and VACCINATION SITE PAIN (injection site arm was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by the reporter.

Other Meds:

Current Illness:

ID: 1644850
Sex: F
Age: 78
State: NH

Vax Date: 03/10/2021
Onset Date: 04/08/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: bloodwork; Result Unstructured Data: normal

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: rash was getting progressively brighter red; looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water; rash around her bronchial/chest area; bruising at the injection site; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water), ERYTHEMA (rash was getting progressively brighter red), VACCINATION SITE BRUISING (bruising at the injection site), HEADACHE (headache) and FATIGUE (tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD (Chronic Obstructive Pulmonary Disorders.) since 11-Aug-2021. Concomitant products included Zatidor eye drops for Allergy, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE FUROATE (ARNUITY ELLIPTA), MONTELUKAST, CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) and LORATADINE for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruising at the injection site), HEADACHE (headache) and FATIGUE (tiredness). On 05-May-2021, the patient experienced ACNE (looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water) and RASH (rash around her bronchial/chest area). On 20-May-2021, the patient experienced ERYTHEMA (rash was getting progressively brighter red). In April 2021, VACCINATION SITE BRUISING (bruising at the injection site), HEADACHE (headache) and FATIGUE (tiredness) had resolved. At the time of the report, ACNE (looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water), ERYTHEMA (rash was getting progressively brighter red) and RASH (rash around her bronchial/chest area) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. She was allergic to thimerosal and also She had numerous allergies. She was prescribed a steroidal cream by the dermatologist on 05/Aug/2021. She was only to use it for 2 weeks. Since starting the cream, a lot of the deep redness was going away. No one knew what caused the rash or exactly what it was. They described the diagnosis to her as little baby spider veins that when touched explode and become a red dot. patient saw the pulmonologist yesterday and he poked the rash and created a red spot. Her next step was a biopsy. This case was linked to MOD-2021-283915 (Patient Link). Reporter did not allow further contact

Other Meds: SPIRIVA; ARNUITY ELLIPTA; MONTELUKAST; CETIRIZINE HCL; LORATADINE

Current Illness: COPD (Chronic Obstructive Pulmonary Disorders.)

ID: 1644851
Sex: U
Age:
State: NH

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: lips swelling; ankles swelling; still hasn't gotten his second shot 6 months after the first; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (lips swelling), JOINT SWELLING (ankles swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL and BIMATOPROST (LUMIGAN) for an unknown indication. 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 LIP SWELLING (lips swelling), JOINT SWELLING (ankles swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first). At the time of the report, LIP SWELLING (lips swelling) and JOINT SWELLING (ankles swelling) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were provided.

Other Meds: LISINOPRIL; LUMIGAN

Current Illness:

ID: 1644852
Sex: M
Age: 39
State: OH

Vax Date: 08/09/2021
Onset Date: 08/08/2021
Rec V Date: 08/28/2021
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: pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered; received dose of Moderna vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion). On 09-Aug-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered). On 09-Aug-2021, POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) 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 provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1644853
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) 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.

Other Meds:

Current Illness:

ID: 1644854
Sex: F
Age:
State: WV

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/28/2021
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: Her left arm as very week needing help from other arm to use it in the morning.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20a and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.). At the time of the report, MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.) outcome was unknown. No concomitant medications were provided. No treatments were provided.

Other Meds:

Current Illness:

ID: 1644855
Sex: M
Age: 27
State: TN

Vax Date: 07/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
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: 5-6 times coughing out bloody mucous; breathing as a bit painful, stabbing pain; urge to cough always; trouble sleeping; throat pain; difficulty of breathing; slight nausea; almost puking; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping) and OROPHARYNGEAL PAIN (throat pain) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ1A and 638C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Fruit allergy. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking). At the time of the report, SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking) outcome was unknown. No concomitant medications were provided The patient was trying to get an appointment with his doctor but he is on the verge of retiring and the license has expired already. Patient did not take any medication with the symptoms, just increased water intake. The patient confirmed not taking any regular prescribed medications or any supplements. This case was linked to MOD-2021-285176 (Patient Link).

Other Meds:

Current Illness: Drug allergy; Fruit allergy; Penicillin allergy

ID: 1644856
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Positive Covid test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Positive Covid test; I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars). At the time of the report, COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. No Concomitant medications were reported. No Treatment medications were reported. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1644857
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Outbreak with eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Outbreak with eczema) 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 ECZEMA (Outbreak with eczema). At the time of the report, ECZEMA (Outbreak with eczema) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1644858
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: body aches; fever with chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever) outcome was unknown. No concomitant information was reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644859
Sex: M
Age: 86
State: MD

Vax Date: 02/21/2021
Onset Date: 08/10/2021
Rec V Date: 08/28/2021
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: Erythema multiforme; little itchy; very red rash; extreme rash around both ankles; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M90A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant), RASH PRURITIC (little itchy), RASH ERYTHEMATOUS (very red rash) and RASH (extreme rash around both ankles). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme), RASH PRURITIC (little itchy), RASH ERYTHEMATOUS (very red rash) and RASH (extreme rash around both ankles) outcome was unknown. Concomitant medications included blood thinner medicine. Treatment information not provided. "Patient had a very red and a little itchy, a few months after he completed his 2 doses of the Moderna Covid-19 vaccine. He got the second dose in March and the rash only started 2 days ago. Patient says he did not have symptoms right after the shots, however he never had this kind of rash before. Patient confirms he did not have fever. Patients says that he looked it up online and says the rash is called Erythema multiforme as the images looked exactly what his rashes are. Patient says he only used a rash ointment and he will see his doctor tomorrow." Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.

Other Meds:

Current Illness:

ID: 1644860
Sex: M
Age: 61
State: KY

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 08/28/2021
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: hasn't received second shot (>42 days following first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasn't received second shot (>42 days following first dose)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, 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 (hasn't received second shot (>42 days following first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasn't received second shot (>42 days following first dose)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1644861
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Pain in arm; Shakiness; Feeling out of sorts; 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 PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts) 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 PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts). At the time of the report, PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644862
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided 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 information was provided; Sender's Comments: This is a case of product exposure during pregnancy 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1644863
Sex: M
Age: 27
State: NC

Vax Date: 07/30/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
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: Popping up on feet, like blisters with no fluid; Tender and sore; Welts on hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts on hands and feet), BLISTER (Popping up on feet, like blisters with no fluid) and TENDERNESS (Tender and sore) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced URTICARIA (Welts on hands and feet). On an unknown date, the patient experienced BLISTER (Popping up on feet, like blisters with no fluid) and TENDERNESS (Tender and sore). At the time of the report, URTICARIA (Welts on hands and feet), BLISTER (Popping up on feet, like blisters with no fluid) and TENDERNESS (Tender and sore) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1644864
Sex: F
Age: 47
State:

Vax Date: 07/28/2021
Onset Date:
Rec V Date: 08/28/2021
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: hives; it's itching; like a rash in the arm; red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder). At the time of the report, URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644865
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination). At the time of the report, vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Patient continued to have side effects six months later. No concomitant products or treatment information reported.

Other Meds:

Current Illness:

ID: 1644866
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Third dose of Moderna COVID-19 vaccine inadvertently; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently) 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 EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently). At the time of the report, EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644867
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: dizziness; arm pain; muscular tightness throughout my neck and back; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea) 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 DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea). At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant drugs were reported. No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1644868
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/28/2021
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: mild pain at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain at the shot site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild pain at the shot site). At the time of the report, VACCINATION SITE PAIN (mild pain at the shot site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1644869
Sex: M
Age:
State: SC

Vax Date: 01/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: pretty bad case of COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 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. In July 2021, the patient experienced COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown. No concomitant medications were provided by the reporter. No treatment Information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1644870
Sex: F
Age: 51
State: OH

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 08/28/2021
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: itching / It's still itching now; redness; I developed skin irritation; was sore at the injection site; I felt extremely tired, & was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching / It's still itching now), ERYTHEMA (redness), SKIN IRRITATION (I developed skin irritation), VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site). On 15-Jul-2021, the patient experienced PRURITUS (itching / It's still itching now), ERYTHEMA (redness) and SKIN IRRITATION (I developed skin irritation). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching / It's still itching now) had not resolved and ERYTHEMA (redness), SKIN IRRITATION (I developed skin irritation), VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by reporter. This case was linked to MOD-2021-284638 (Patient Link).

Other Meds:

Current Illness:

ID: 1644871
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: Covid-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect) 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.

Other Meds:

Current Illness:

ID: 1644872
Sex: F
Age: 63
State: VA

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
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: Neck was getting stiff; Extremely tired; Red, raised area about the size of a quarter; Vaccine stung really bad when injected; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Vaccine stung really bad when injected). On 11-Aug-2021, the patient experienced ERYTHEMA (Red, raised area about the size of a quarter). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck was getting stiff) and FATIGUE (Extremely tired). At the time of the report, ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1644873
Sex: F
Age: 13
State: ME

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
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: accidentally administered the vaccine to a 13-year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered the vaccine to a 13-year-old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered the vaccine to a 13-year-old) (seriousness criterion medically significant). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered the vaccine to a 13-year-old) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. This is a case of inappropriate age (13yrs) at vaccine administration with no adverse events. Additional information is requested. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received and contains no new information; Sender's Comments: This is a case of inappropriate age (13yrs) at vaccine administration with no adverse events. Additional information is requested. MOD21-129585:cross linked

Other Meds:

Current Illness:

ID: 1644874
Sex: F
Age: 66
State: TX

Vax Date: 08/11/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: a terrible diarrhea; nauseated/nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (a terrible diarrhea) and NAUSEA (nauseated/nausea) in a 66-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 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced NAUSEA (nauseated/nausea). On 14-Aug-2021, the patient experienced DIARRHOEA (a terrible diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of 1 dosage form, 2 tablets. On 15-Aug-2021, DIARRHOEA (a terrible diarrhea) had resolved. At the time of the report, NAUSEA (nauseated/nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient mentioned of taking 2 tablets of Imodium that was given by a nurse from her doctor's office, and it helped to treat her diarrhea. Patient took doctor pepper and another medication for nausea. Patient is on some concomitant medications like: Medication for Epilepsy. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: additional info received with updated event information

Other Meds:

Current Illness:

ID: 1644875
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: took the Moderna COVID-19 vaccine and was having a reaction 6 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later) 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 VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later). At the time of the report, VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644876
Sex: F
Age: 61
State: KY

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 08/28/2021
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: my immune system became suppressed,I had some issues with that (immune system); it was very itchy; rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body; didn't receive second shot yet (>42 days following first dose); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)) (seriousness criterion medically significant), RASH PRURITIC (it was very itchy), RASH (rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body) and PRODUCT DOSE OMISSION ISSUE (didn't receive second shot yet (>42 days following first dose)). At the time of the report, IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)), RASH PRURITIC (it was very itchy) and RASH (rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't receive second shot yet (>42 days following first dose)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient does not take any medication regularly and no treatment medications were reported Patient has seen three doctors, and still has some of the rash. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1644877
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Tension; This spontaneous case was reported by a consumer and describes the occurrence of TENSION (Tension) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by reporter. 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 TENSION (Tension). At the time of the report, TENSION (Tension) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1644878
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 03/03/2021
Rec V Date: 08/28/2021
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: more than 36 days since received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days since received the first dose) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since received the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since received the first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter

Other Meds:

Current Illness:

ID: 1644879
Sex: F
Age: 48
State: MS

Vax Date: 07/22/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: patient experienced SARS-CoV2 infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patient experienced SARS-CoV2 infection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced COVID-19 (patient experienced SARS-CoV2 infection). At the time of the report, COVID-19 (patient experienced SARS-CoV2 infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1644880
Sex: F
Age: 74
State: DE

Vax Date: 07/26/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: High; Test Name: EKG; Result Unstructured Data: normal

Allergies:

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

Symptoms: Both legs and feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both legs and feet swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Cholesterol medicines causes shortness of breath) and Allergy NOS (Allergic to a lot of things). On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Both legs and feet swollen). At the time of the report, PERIPHERAL SWELLING (Both legs and feet swollen) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Electrocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. The patient was prescribed with hydrocortisone (thrice weekly) but the patient was yet to start the medications. The patient received first dose of vaccine, lot number was 0a1B21A or 091B21A. The patient had so side effects until a few days later when both legs and feet started to swell. The patient's blood pressure was also raising, so the patient consulted with the physician as the patient thought about having some kind of reaction to the vaccine. The physician suspected that it was probably not related to the vaccine and prescribed hydrocortisone to take three times a week. The patient was scheduled for second dose on 23-Aug-2021.

Other Meds:

Current Illness: Allergy NOS (Allergic to a lot of things); Drug allergy (Cholesterol medicines causes shortness of breath)

ID: 1644881
Sex: M
Age:
State: IA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Anti-glomerular basement membrane antibody; Test Result: Negative; Result Unstructured Data: negative; Test Date: 2021; Test Name: cytoplasmic ANC-A; Test Result: Positive; Result Unstructured Data: positive; Test Date: 2021; Test Name: Myeloperoxidase-O antibody; Test Result: Negative; Result Unstructured Data: negative; Test Date: 2021; Test Name: kidney biopsy; Result Unstructured Data: revealed cellular crescents and fibrinoid necrosis in 38 of 46 glomeruli, with some tubular injury. A diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made; Test Date: 2021; Test Name: bicarbonate; Result Unstructured Data: 21 mEq/l; Test Date: 2021; Test Name: creatinine; Result Unstructured Data: 10.42 mg/dl; Test Date: 2021; Test Name: creatinine; Result Unstructured Data: 8.41 mg/dl (baseline 1.11 mg/dl, 8 months prior; Test Date: 2021; Test Name: potassium; Result Unstructured Data: 5.0 mEq/l; Test Date: 2021; Test Name: sodium; Result Unstructured Data: 129 mEq/l; Test Date: 2021; Test Name: blood urea nitrogen; Result Unstructured Data: 82 mg/dl; Test Date: 2021; Test Name: C3/C4 levels; Result Unstructured Data: normal; Test Date: 2021; Test Name: C3/C4 levels; Result Unstructured Data: normal; Test Date: 2021; Test Name: hemoglobin; Result Unstructured Data: 14.6 g/dl; Test Date: 2021; Test Name: Immunofluorescence test; Result Unstructured Data: segmental fibrin staining the glomerular capillary loops, confirming fibrinoid necrosis; Test Date: 2021; Test Name: electron microscopy; Result Unstructured Data: No immune complex?mediated deposits, interstitial fibrosis and tubular atrophy were mild; Test Date: 2021; Test Name: serologic workup; Test Result: Positive ; Result Unstructured Data: positive cytoplasmic A NCA titers and antibodies to proteinase-3 (PR3).; Test Date: 2021; Test Name: serologic workup; Result Unstructured Data: a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made; Test Date: 2021; Test Name: Toxicology screen; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 2021; Test Name: Renal ultrasound; Result Unstructured Data: no hydronephrosis; Test Date: 2021; Test Name: Urinalysis; Result Unstructured Data: 'had 1+ proteinuria and microscopic hematuria with dysmorphic red blood cells.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Glomerulonephritis after Moderna COVID-19 Vaccination. Kidney Int. 2021;100 (2):473-4 Concurrent medical conditions included Hypertension (he was treated with amlodipine). Concomitant products included AMLODIPINE for Hypertension. On 15-Apr-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 16-Apr-2021, the patient experienced ASTHENIA (Weakness) and HEADACHE (Headache). On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis) (seriousness criterion medically significant). The patient was treated with RITUXIMAB for Glomerulonephritis, at a dose of 375 mg/m2; PREDNISONE for Glomerulonephritis, at an unspecified dose and frequency and CYCLOPHOSPHAMIDE for Pauci-immune glomerulonephritis and Crescentic glomerulonephritis, at a dose of 7.5 mg/kg once. At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis), ASTHENIA (Weakness) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Anti-glomerular basement membrane antibody: negative (Negative) negative. In 2021, Antineutrophil cytoplasmic antibody: positive (Positive) positive and negative (Negative) negative. In 2021, Biopsy kidney: abnormal (abnormal) revealed cellular crescents and fibrinoid necrosis in 38 of 46 glomeruli, with some tubular injury. , a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made. In 2021, Blood bicarbonate: 21 meq/l (Low) 21 mEq/l. In 2021, Blood creatinine: 10.42 mg/dl (High) 10.42 mg/dl and 8.41 mg/dl (High) 8.41 mg/dl (baseline 1.11 mg/dl, 8 months prior. In 2021, Blood potassium: 5.0 meq/l (normal) 5.0 mEq/l. In 2021, Blood sodium: 129 meq/l (Low) 129 mEq/l. In 2021, Blood urea: 82 mg/dl (High) 82 mg/dl. In 2021, Complement factor C3: normal (normal) normal. In 2021, Complement factor C4: normal (normal) normal. In 2021, Haemoglobin: 14.6 g/dl (normal) 14.6 g/dl. In 2021, Immunology test: abnormal (abnormal) segmental fibrin staining the glomerular capillary loops, confirming fibrinoid necrosis. In 2021, Microscopy: abnormal (abnormal) No immune complex?mediated deposits, interstitial fibrosis and tubular atrophy were mild. In 2021, Serology test: positive (Positive) positive cytoplasmic A NCA titers and antibodies to proteinase-3 (PR3). and abnormal (abnormal) a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made. In 2021, Toxicologic test: negative (Negative) negative. In 2021, Ultrasound kidney: no hydronephrosis (normal) no hydronephrosis. In 2021, Urine analysis: abnormal (abnormal) 'had 1+ proteinuria and microscopic hematuria with dysmorphic red blood cells. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis) to be possibly related. No further causality assessments were provided for ASTHENIA (Weakness) and HEADACHE (Headache). The patient was presented with headache and weakness 2 weeks after receiving his second dose of the Moderna (mRNA-1273) vaccine on 15-Apr-2021. Headache started the day after his second vaccination and was associated with weakness. Vitals were stable, and physical examination was unremarkable. Intravenous (IV) hydration was initiated. Interstitial fibrosis and tubular atrophy were mild. Rituximab was initiated at 375 mg/m2, but the patient developed severe dyspnea and declined further doses. One dose of cyclophosphamide 7.5 mg/kg (per CYCIDPS trial dosing) was given; however, hemodialysis was initiated for hyperkalemia and worsening renal function. Currently, he continues to require dialysis, while on prednisone, and with a plan to repeat cyclophosphamide 2 weeks after the first dose. On the basis of serologic and biopsy findings, a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's medical history of Hypertension is a confounding factor that may play a possible contributory role. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received by safety 28-Jul-2021 included an email from the ? team with an abstract and no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's medical history of Hypertension is a confounding factor that may play a possible contributory role.

Other Meds: AMLODIPINE

Current Illness: Hypertension (he was treated with amlodipine).

ID: 1644882
Sex: F
Age: 59
State: FL

Vax Date: 04/06/2021
Onset Date: 05/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This itchiness is not comfortable, she cannot function correctly.; different types of stuff coming out of her skin/it's ugly; shortness of breath; chest pain; rash; lack of drug effect; severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable), DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by the reporter. Concomitant products included INSULIN, METFORMIN, TORASEMIDE (TORSEMIDE), BISOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), GABAPENTIN, LOSARTAN, ROSUVASTATIN, EZETIMIBE and LORATADINE for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable). On an unknown date, the patient experienced DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), RASH (rash) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable), DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), RASH (rash) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. Patient lab data includes blood test. Patient went to dermatologist but they are treating this topically and patient felt this is not topical but internal. Concomitant over the counter medication unspecified was taken by patient. Treatment information was not provided.

Other Meds: INSULIN; METFORMIN; TORSEMIDE; BISOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]; INVOKANA [CANAGLIFLOZIN]; GABAPENTIN; LOSARTAN; ROSUVASTATIN; EZETIMIBE; LORATADINE

Current Illness:

ID: 1644883
Sex: F
Age: 69
State: VT

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: covid 19 pcr test; Test Result: Negative ; Result Unstructured Data: NEGATIVE

Allergies:

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

Symptoms: Severe pain; more hardness at injection site; Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included Vaccination adverse reaction (severe swelling after flu vaccine, yellow fever. And passed out. ) and Osteoporosis. Previously administered products included for an unreported indication: YELLOW FEVER and flu vaccine. Concurrent medical conditions included Contrast media allergy and Lactose intolerant. Concomitant products included TRANEXAMIC ACID (TYRODIN [TRANEXAMIC ACID]) and VITAMINS NOS for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 16-Mar-2021, VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) NEGATIVE. No treatment medication were provided by the reporter Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-285153 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: TYRODIN [TRANEXAMIC ACID]; VITAMINS NOS

Current Illness: Contrast media allergy; Lactose intolerant

ID: 1644884
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: CD4 count; Result Unstructured Data: 234

Allergies:

Symptom List: Pain in extremity

Symptoms: Immune compromised; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immune compromised) 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 09-Mar-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 IMMUNODEFICIENCY (Immune compromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immune compromised) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CD4 lymphocytes: 234 (abnormal) 234. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No medical history was provided. The reporter reported that his CD4 COUNT was 234 when he received his COVID-19 vaccine on march 9, 2021. Also patient was immune compromised. Company Comment: Very limited information regarding this event has been provided at this time. Further information is not to be expected. The patient stated that at the time of vaccination the CD4 count was 234. Therefore, a causal association of immunocompromization and vaccination appears rather unlikely. Implied causality of a spontaneous report applies, however. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not to be expected. The patient stated that at the time of vaccination the CD4 count was 234. Therefore, a causal association of immunocompromization and vaccination appears rather unlikely. Implied causality of a spontaneous report applies, however.

Other Meds:

Current Illness:

ID: 1644885
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: skin reactions from the vaccine> This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin reactions from the vaccine>) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 SKIN REACTION (skin reactions from the vaccine>). At the time of the report, SKIN REACTION (skin reactions from the vaccine>) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1644886
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Patient received an expired vaccine; Possible temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No information on concomitant medications were reported. No Treatment medications were reported. The vaccines were received to nurse on 30-July-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge. The nurse was unaware that the vaccines were initially received and placed in the fridge 08-July-2021. The max temperature reached was 41.4F and min 40.6F.

Other Meds:

Current Illness:

ID: 1644887
Sex: F
Age: 66
State: NY

Vax Date: 07/06/2021
Onset Date:
Rec V Date: 08/28/2021
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: Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-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 BLOOD BLISTER (Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red). At the time of the report, BLOOD BLISTER (Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red) outcome was unknown. No relevant concomitant product were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644888
Sex: F
Age: 53
State: CA

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: more pain all over the left side of their body; whole left arm hurts; pain in their kidney; pain in their chest; pain under their left arm; left wrist hurts/left elbow hurts; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest) and VACCINATION SITE PAIN (pain at the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 12-Aug-2021, the patient experienced PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest), AXILLARY PAIN (pain under their left arm) and ARTHRALGIA (left wrist hurts/left elbow hurts). At the time of the report, PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest), VACCINATION SITE PAIN (pain at the injection site), AXILLARY PAIN (pain under their left arm) and ARTHRALGIA (left wrist hurts/left elbow hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated they did not take any medications regularly. No Treatment information was provided. After six days of vaccine administration, patient developed more pain all over the left side of their body, their whole left arm hurts, left elbow, left wrist, they have pain under their left arm, in their kidney and their chest.

Other Meds:

Current Illness:

ID: 1644889
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Patient received an expired vaccine past 30 days in the fridge; A possible temperature excursion at her facility; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment medications reported. Nurse reported that the vaccines were received on 08-Jul-2021 and was placed in the refrigerator, later was received to her on 30-Jul-2021 with the expiration label missing. The nurse was unaware that vaccines were placed in the fridge on 08-Jul-2021.The max temperature reached was 41.4F and min 40.6F. 4 vials (Lot# 038C21A)of them were affected and 3 of the vials were used to administer vaccinations to 9 patients over 3 days 09-Aug-2021 to11-Aug-2021.

Other Meds:

Current Illness:

ID: 1644890
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Two dots of blood; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Two dots of blood) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Two dots of blood). At the time of the report, VACCINATION SITE PAIN (Two dots of blood) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644891
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) 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 EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) to be not applicable. No concomitant and treatment medications provided by reporter.

Other Meds:

Current Illness:

ID: 1644892
Sex: F
Age: 49
State: IN

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 08/28/2021
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: 20210429; Test Name: Body temperature; Result Unstructured Data: low grade fever of 100

Allergies:

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

Symptoms: lupus flare up; condition aggravated; felt worse than flu; low grade fever of 100; body aches; extreme fatigue (down and out); injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus. Concomitant products included MESALAZINE (DELZICOL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant), FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 800 milligram and PREDNISONE ongoing since an unknown date for SLE flare, at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown and FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 100 (abnormal) low grade fever of 100. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Ibuprofen for vaccine related adverse events and Prednisolone for lupus flare up are the treatment medication reported by reporter. Patient states that adverse events lasted 3-4 days. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-285120 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: DELZICOL; ADVAIR; PROAIR [FLUTICASONE PROPIONATE]; CLARITIN-D; VITAMIN D3

Current Illness: Lupus erythematosus

ID: 1644893
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Patient received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am