VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1766932
Sex: M
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: 3 inch circle at injection site; entire left arm got red; feel hot and has a temp; arm is a little swollen; feels nauseated; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen) and NAUSEA (feels nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1766933
Sex: F
Age:
State: CA

Vax Date: 08/30/2021
Onset Date:
Rec V Date: 10/07/2021
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: pain in the tooth; swollen face; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (pain in the tooth), SWELLING FACE (swollen face) and VACCINATION SITE PAIN (pain in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A1) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (pain in the tooth), SWELLING FACE (swollen face) and VACCINATION SITE PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, TOOTHACHE (pain in the tooth) and SWELLING FACE (swollen face) outcome was unknown and VACCINATION SITE PAIN (pain in the arm) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient also has problems with a tooth. It hurts; but stated that tooth has been bothering patient from before vaccination and after first dose ate something hard which caused pain and swollen face.Patient took Tylenol to treat symptoms and pain started to fade away Patient was taking antibiotics for the tooth situation

Other Meds:

Current Illness:

ID: 1766934
Sex: M
Age: 51
State: PA

Vax Date: 09/27/2021
Onset Date:
Rec V Date: 10/07/2021
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: patient was administered an expired dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Medical history was not provided. On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up On 28-Sep-2021: Significant follow-up-Expiry date updated

Other Meds:

Current Illness:

ID: 1766935
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Rash; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PYREXIA (High Fever) in a 50-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PYREXIA (High Fever). At the time of the report, RASH (Rash) and PYREXIA (High Fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication information was reported. No Treatment medications were provided

Other Meds:

Current Illness:

ID: 1766936
Sex: F
Age: 66
State: PA

Vax Date: 08/20/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient was administered an expired dose of Moderna vaccine; second dose received on day 40; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. There are no treatment or concomitant medications. There is no previous history given Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: fallow up received contains New event updated

Other Meds:

Current Illness:

ID: 1766937
Sex: M
Age: 45
State: GA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 10/07/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and Treatment medications are not provided. This case was linked to MOD-2021-334628, MOD-2021-334629.

Other Meds:

Current Illness:

ID: 1766938
Sex: F
Age:
State: AL

Vax Date: 08/30/2021
Onset Date: 08/31/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: fast heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (fast heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21) for COVID-19 vaccination. Concurrent medical conditions included Tetanus allergy. Concomitant products included CLONIDINE, CARVEDILOL and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced HEART RATE INCREASED (fast heart beat). At the time of the report, HEART RATE INCREASED (fast heart beat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication was reported.

Other Meds: CLONIDINE; CARVEDILOL; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1766939
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Thrombosis after both doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Hyperlipidemia. 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 THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company comment -This case concerns a 65 year old male patient with medical history of Hypertension and Hyperlipidemia, who experienced the unexpected serious event of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine), within unknown days after the dose of mRNA-1273 vaccine. Limited information regarding the event have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report. This case was linked to MOD-2021-334636 (Patient Link).; Sender's Comments: This case concerns a 65 year old male patient with medical history of Hypertension and Hyperlipidemia, who experienced the unexpected serious event of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine), within unknown days after the dose of mRNA-1273 vaccine. Limited information regarding the event have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness: Hyperlipidemia; Hypertension

ID: 1766940
Sex: M
Age: 53
State: FL

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 10/07/2021
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: Very little sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very little sore arm after first dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Very little sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (Very little sore arm after first dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was not on concomitant medication. Treatment information was not provided by reporter. This case was linked to MOD-2021-328618 (Patient Link).

Other Meds:

Current Illness:

ID: 1766941
Sex: F
Age: 76
State: FL

Vax Date: 02/16/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 020M21A and LOT 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1766942
Sex: M
Age: 45
State: GA

Vax Date: 01/22/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: Swollen lymph node under the armpit of the same arm of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the armpit of the same arm of the shot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 023M20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the armpit of the same arm of the shot). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the armpit of the same arm of the shot) outcome was unknown. Patient received third dose due to underlying issues. Patient spoke with doctor and he advised to give it two weeks. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-334583, MOD-2021-334629 (Patient Link).

Other Meds:

Current Illness:

ID: 1766943
Sex: M
Age: 45
State: GA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 10/07/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-334628, MOD-2021-334583 (Patient Link).

Other Meds:

Current Illness:

Date Died:

ID: 1766944
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Three (3) people drying after receiving the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Three (3) people drying after receiving the second dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - This case concerns a female patient of an unknown age with no relevant medical history reported, who experienced serious unexpected event of death. The patient died on an unknown date after the second dose of mRNA-1273 (vaccination date was not reported). The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history reported, who experienced serious unexpected event of death. The patient died on an unknown date after the second dose of mRNA-1273 (vaccination date was not reported). The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1766945
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: thrombosis after both doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Hyperlipidemia. 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. In 2021, the patient experienced THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. Physician stated that she did a literature search and found one case report from June from 29-Jun-2021 where the patient developed thrombosis after receiving both doses of the Moderna COVID-19 vaccine. No treatment information provided. Company Comment: This case concerns a 65-year-old male patient with relevant medical history of Hypertension and Hyperlipidemia , who experienced the unexpected serious event of Thrombosis.The event occurred unknown days after the first and second dose of Spikevax. The rechallenge is unknown since there's no information about the doses. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-334622 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male patient with relevant medical history of Hypertension and Hyperlipidemia , who experienced the unexpected serious event of Thrombosis.The event occurred unknown days after the first and second dose of Spikevax. The rechallenge is unknown since there's no information about the doses. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness: Hyperlipidemia; Hypertension

ID: 1766946
Sex: F
Age: 63
State: OR

Vax Date: 06/03/2021
Onset Date:
Rec V Date: 10/07/2021
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: Felt foggy in the head; Vaccintation site pain; Vaccination site bruising; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt foggy in the head), VACCINATION SITE PAIN (Vaccintation site pain), VACCINATION SITE BRUISING (Vaccination site bruising) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. On 03-Jun-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 FEELING ABNORMAL (Felt foggy in the head), VACCINATION SITE PAIN (Vaccintation site pain), VACCINATION SITE BRUISING (Vaccination site bruising) and FATIGUE (tired). At the time of the report, FEELING ABNORMAL (Felt foggy in the head) and FATIGUE (tired) outcome was unknown and VACCINATION SITE PAIN (Vaccintation site pain) and VACCINATION SITE BRUISING (Vaccination site bruising) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: The follow up document contains no new information.

Other Meds:

Current Illness:

ID: 1766947
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago) 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 (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1766948
Sex: M
Age: 57
State: NY

Vax Date: 09/27/2021
Onset Date:
Rec V Date: 10/07/2021
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: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013A21A and 030M20A) for COVID-19 vaccination. Concurrent medical conditions included HIV infection since 1996. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 27, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. No concomitant drug details or treatment information reported. This case linked to MOD-2021-073142, MOD-2021-073169 (patient link).

Other Meds:

Current Illness: HIV infection

ID: 1766949
Sex: F
Age: 63
State: OR

Vax Date: 07/09/2021
Onset Date:
Rec V Date: 10/07/2021
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: Has not been able to work; Extreme brain fog; Extreme hair loss, Hair loss is continuing through today; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog), ALOPECIA (Extreme hair loss, Hair loss is continuing through today) and FATIGUE (Extreme fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog), ALOPECIA (Extreme hair loss, Hair loss is continuing through today) and FATIGUE (Extreme fatigue). At the time of the report, IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog) and FATIGUE (Extreme fatigue) outcome was unknown and ALOPECIA (Extreme hair loss, Hair loss is continuing through today) had not resolved. No Concomitant medication was reported. No treatment medications were reported. Patient reported that after second dose she felt extreme fatigue, extreme brain fog, extreme hair loss, reactions were so bad she had to drop out of her studies at school, her doctor may have thought she had a stroke but was not sure. Brought in an ambulance to the ER but not hospitalized. This case was linked to MOD-2021-334639 (Patient Link).

Other Meds:

Current Illness:

ID: 1766950
Sex: M
Age: 67
State: FL

Vax Date: 03/01/2021
Onset Date: 09/24/2021
Rec V Date: 10/07/2021
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: Third dose 24Sep2021; expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose 24Sep2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received twelfth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose 24Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose 24Sep2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was mentioned. No treatment medication was mentioned.

Other Meds:

Current Illness:

ID: 1766951
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: 20 days after vaccination: 50U/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 35 days after vaccination: 139 U/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 77 days after vaccination: 41U/L; Test Name: ANA; Test Result: Positive ; Result Unstructured Data: ANA was weakly positive at 1:80; Test Name: Aspartate aminotransferase; Result Unstructured Data: 20 days after vaccination: 40 U/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 35 days after vaccination: 181 U/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 77 days after vaccination: 23 U/L; Test Name: direct bilirubin; Result Unstructured Data: 20 days after vaccination: 0.8 mg/dL; Test Name: direct bilirubin; Result Unstructured Data: 35 days after vaccination: 0.6 mg/dl; Test Name: Albumin; Result Unstructured Data: 20 days after vaccination: 4 g/dl; Test Name: Albumin; Result Unstructured Data: 35 days after vaccination: 4.5 g/dl; Test Name: Albumin; Result Unstructured Data: 77 days after vaccination: 4.1 g/dl; Test Name: Alkaline Phosphatase; Result Unstructured Data: 20 days after vaccination: 70 IU/liter; Test Name: Alkaline Phosphatase; Result Unstructured Data: 35 days after vaccination: 78 IU/liter; Test Name: Alkaline Phosphatase; Result Unstructured Data: 77 days after vaccination: 63 IU/liter; Test Name: Bicarbonate; Result Unstructured Data: 20 days after vaccination: 26 mmol/l; Test Name: Bicarbonate; Result Unstructured Data: 35 days after vaccination: 24 mmol/l; Test Name: Bicarbonate; Result Unstructured Data: 77 days after vaccination: 26 mmol/l; Test Name: Total Bilirubin; Result Unstructured Data: 20 days after vaccination: 3.7 mg/dL; Test Name: Total Bilirubin; Result Unstructured Data: 35 days after vaccination: 3.9 mg/dL; Test Name: Total Bilirubin; Result Unstructured Data: 77 days after vaccination: 0.9 mg/dL; Test Name: Calcium; Result Unstructured Data: 20 days after vaccination: 9 mg/dl; Test Name: Calcium; Result Unstructured Data: 35 days after vaccination: 9 mg/dl; Test Name: Calcium; Result Unstructured Data: 77 days after vaccination: 8.5 mg/dl; Test Name: Chloride; Result Unstructured Data: 20 days after vaccination: 105 mmol/liter; Test Name: Chloride; Result Unstructured Data: 35 days after vaccination: 100 mmol/liter; Test Name: Chloride; Result Unstructured Data: 77 days after vaccination: 103 mmol/liter; Test Name: Creatinine; Result Unstructured Data: 20 days after vaccination: 0.70 mg/dl; Test Name: Creatinine; Result Unstructured Data: 35 days after vaccination: 0.77 mg/dl; Test Name: Creatinine; Result Unstructured Data: 77 days after vaccination: 0.62 mg/dl; Test Name: Glucose; Result Unstructured Data: 20 days after vaccination: 95 mg/dl; Test Name: Glucose; Result Unstructured Data: 35 days after vaccination: 150 mg/dl; Test Name: Glucose; Result Unstructured Data: 77 days after vaccination: 147 mg/dl; Test Name: lactate dehydrogenase (LDH); Result Unstructured Data: 20

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Autoimmune hemolytic anemia; Off label use; This study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Central retinal vein occlusion and Hypertension. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Central retinal vein occlusion, METOPROLOL SUCCINATE for Hypertension. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and OFF LABEL USE (Off label use). The patient was hospitalized on sometime in March 2021 due to AUTOIMMUNE HAEMOLYTIC ANAEMIA. The patient was treated with RITUXIMAB for Autoimmune hemolytic anemia, at a dose of 1000 milligram; RITUXIMAB for Autoimmune hemolytic anemia, at a dose of 1000 mg; PREDNISONE (oral) for Autoimmune hemolytic anemia, at a dose of 1 mg/kg once a day; IMMUNOGLOBULINS NOS (IMMUNE GLOBULIN) (intravenous) for Autoimmune hemolytic anemia, at a dose of 1 gram per kilogram and MYCOPHENOLATE MOFETIL (oral) for Autoimmune hemolytic anemia, at a dose of 1000 milligram twice a day. At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) outcome was unknown and OFF LABEL USE (Off label use) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Haemoglobin (12 g/dl-16 g/dl): 7.3 g/dl (Low) 7.3 g/dL. On an unknown date, Alanine aminotransferase (7 u/l-33 u/l): 50 u/l (High) 20 days after vaccination: 50U/L, 139 u/l (High) 35 days after vaccination: 139 U/L and 41u/l (High) 77 days after vaccination: 41U/L. On an unknown date, Antinuclear antibody: weakly positive at 1:80 (Positive) ANA was weakly positive at 1:80. On an unknown date, Aspartate aminotransferase (9 u/l-32 u/l): 40 u/l (High) 20 days after vaccination: 40 U/L, 181 u/l (High) 35 days after vaccination: 181 U/L and 23 u/l (normal) 77 days after vaccination: 23 U/L. On an unknown date, Bilirubin conjugated (0-0.4 mg/dl): 0.8 mg/dl (High) 20 days after vaccination: 0.8 mg/dL and 0.6mg/dl (High) 35 days after vaccination: 0.6 mg/dl. On an unknown date, Blood albumin (3.3 g/dl-5.0 g/dl): 4 g/dl (normal) 20 days after vaccination: 4 g/dl, 4.5 g/dl (normal) 35 days after vaccination: 4.5 g/dl and 4.1 g/dl (normal) 77 days after vaccination: 4.1 g/dl. On an unknown date, Blood alkaline phosphatase (30 iu/liter-100 iu/liter): 70 iu/liter (normal) 20 days after vaccination: 70 IU/liter, 78 iu/liter (normal) 35 days after vaccination: 78 IU/liter and 63 iu/liter (normal) 77 days after vaccination: 63 IU/liter. On an unknown date, Blood bicarbonate (23 mmol/l-32 mmol/l): 26 mmol/l (normal) 20 days after vaccination: 26 mmol/l, 24 mmol/l (normal) 35 days after vaccination: 24 mmol/l and 26 mmol/l (normal) 77 days after vaccination: 26 mmol/l. On an unknown date, Blood bilirubin (0.0 mg/dl-1.0 mg/dl): 3.7 mg/dl (High) 20 days after vaccination: 3.7 mg/dL, 3.9 mg/dl (High) 35 days after vaccination: 3.9 mg/dL and 0.9 mg/dl, (normal) 77 days after vaccination: 0.9 mg/dL. On an unknown date, Blood calcium (8.5 mg/dl-10.5 mg/dl): 9 mg/dl (normal) 20 days after vaccination: 9 mg/dl, 9 mg/dl (normal) 35 days after vaccination: 9 mg/dl and 8.5 mg/dl (normal) 77 days after vaccination: 8.5 mg/dl. On an unknown date, Blood chloride (98 mmol/liter-108 mmol/liter): 105 mmol/liter (normal) 20 days after vaccination: 105 mmol/liter, 100 mmol/liter (normal) 35 days after vaccination: 100 mmol/liter and 103 mmol/liter (normal) 77 days after vaccination: 103 mmol/liter. On an unknown date, Blood creatinine (0.60 mg/dl-1.50 mg/dl): 0.70 mg/dl (normal) 20 days after vaccination: 0.70 mg/dl, 0.77 mg/dl (normal) 35 days after vaccination: 0.77 mg/dl and 0.62 mg/dl (normal) 77 days after vaccination: 0.62 mg/dl. On an unknown date, Blood glucose (70 mg/dl-100 mg/dl): 95 mg/dl (normal) 20 days after vaccination: 95 mg/dl, 150 mg/dl (High) 35 days after vaccination: 150 mg/dl and 147 mg/dl (High) 77 days after vaccination: 147 mg/dl. On an unknown date, Blood lactate dehydrogenase (100 u/liter-210 u/liter): 746 u/liter (High) 20 days after vaccination: 746 U/liter, 3095 u/liter (High) 35 days after vaccination: 3095 U/liter and 317 u/liter (High) 77 days after vaccination: 317 U/liter. On an unknown date, Blood potassium (3.4 mmol/liter-5.0 mmol/liter): 4.0 mmol/liter (normal) 20 days after vaccination: 4.0 mmol/liter, 4.1 mmol/liter (normal) 35 days after vaccination: 4.1 mmol/liter and 4.1 mmol/liter (normal) 77 days after vaccination: 4.1 mmol/liter. On an unknown date, Blood pressure measurement: 133/78 mm hg (normal) 133/78 mm Hg. On an unknown date, Blood smear test: abnormal (abnormal) A peripheral blood film revealed numerous spherocytes, reticulocytes, and nucleated RBCs.. On an unknown date, Blood sodium (135 mmol/liter-145 mmol/liter): 137 mmol/liter (normal) 20 days after vaccination: 137 mmol/liter, 137 mmol/liter (normal) 35 days after vaccination: 137 mmol/liter and 139 mmol/liter (normal) 77 days after vaccination: 139 mmol/liter. On an unknown date, Blood urea (8 mg/dl-25 mg/dl): 18 mg/dl (normal) 20 days after vaccination: 18 mg/dl, 26 mg/dl (High) 35 days after vaccination: 26 mg/dl and 15 mg/dl (normal) 77 days after vaccination: 15 mg/dl. On an unknown date, Body temperature: 96.9f (Low) 96.9F. On an unknown date, Coombs direct test: negative (Negative) The direct antiglobulin test (DAT) was negative for IgG and C3d, though an eluate prepared from the patient's red blood cells (RBCs) was reactive against all test cells., negative (Negative) Repeat DAT was again negative using routine polyspecific, IgG and C3 reagents in tube testing (Gamma-clone, Immucor, Norcross, GA). Despite the negative DAT, antibody was eluted from the patient's RBCs that demonstrated strong (3+) panreactivity when tested in the gel system. and positive (Positive) A subsequent DAT performed using gel cards?rather than Gamma-clone?was positive (2+) for IgG. Further testing demonstrated the presence of a cold autoantibody that was reactive (3+) at 37 degrees. On an unknown date, Cytomegalovirus test: negative (Negative) Negative. On an unknown date, Epstein-Barr virus test: negative (Negative) Negative. On an unknown date, Flow cytometry: did not reveal a monoclonal b cell or t-cell Flow cytometry did not reveal a monoclonal B cell or T-cell population. On an unknown date, HIV test: negative (Negative) Negative. On an unknown date, Haematocrit (36 %-46 %): 19.5% (Low) 20 days after vaccination: 19.5%, 21.9% (Low) 35 days after vaccination: 21.9% and 31.6% (Low) 77 days after vaccination: 31.6%. On an unknown date, Haemoglobin (12 g/dl-16 g/dl): 14g/dl (normal) Her baseline hemoglobin was 14 g/dL, last assessed two years prior, 7.1 g/dl (Low) 7.1 g/dL, 7.3 g/dl (Low) 7.3 g/dL, 8.0 g/dl (Low) 8.0 g/dL and 10.9 g/dl (Low) 10.9 g/dL. On an unknown date, Haptoglobin (>10 mg/dl-Unknown): <8 mg/dl (Low) 20 days after vaccination: <8 mg/dL, <10?mg/dl (Low) 35 days after vaccination: <10?mg/dL and <10 mg/dl (Low) 77 days after vaccination: <10 mg/dL. On an unknown date, Heart rate: 79 beats/min (normal) 79 beats/min. On an unknown date, Hepatitis B virus test: negative (Negative) Negative. On an unknown date, Immunology test: normal (normal) Normal limit. On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, Mean cell volume (80 fl-100 fl): 93 fl (normal) 20 days after vaccination: 93 fL, 109 fl (High) 35 days after vaccination: 109 fL and 103.9fl (High) 77 days after vaccination: 103.9fL. On an unknown date, Oxygen saturation: 98% (normal) oxygen saturation 98% on room air. On an unknown date, Platelet count (150000 per/?l-400000 per/?l): 20

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL SUCCINATE

Current Illness: Central retinal vein occlusion; Hypertension

ID: 1766952
Sex: F
Age: 58
State: AL

Vax Date: 08/28/2021
Onset Date: 09/26/2021
Rec V Date: 10/07/2021
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: Test Date: 20210926; Test Name: Blood pressure; Result Unstructured Data: was up (could not remember the numbers).; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: at 2 o'clock BP was 140/98; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: a little while ago it was down to 123/87; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: a little while ago it was down to 124/88

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88; Didn't feel good/felt fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88) and FEELING ABNORMAL (Didn't feel good/felt fuzzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A and 020F21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high. On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88) and FEELING ABNORMAL (Didn't feel good/felt fuzzy). At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88) and FEELING ABNORMAL (Didn't feel good/felt fuzzy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Blood pressure measurement: high (High) was up (could not remember the numbers).. On 28-Sep-2021, Blood pressure measurement: 140/98 (High) at 2 o'clock BP was 140/98, 123/87 (High) a little while ago it was down to 123/87 and 124/88 (High) a little while ago it was down to 124/88. No treatment information was provided by the reporter.

Other Meds: AMLODIPINE

Current Illness: Blood pressure high

ID: 1766953
Sex: M
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Got the third shot and felt the same way: It gave him energy too; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too) outcome was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1766954
Sex: F
Age: 66
State: ME

Vax Date: 09/14/2021
Onset Date:
Rec V Date: 10/07/2021
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: lungs started filling up; cough; started having trouble breathing; she might be allergic to it; red arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lungs started filling up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. On 14-Sep-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 PULMONARY CONGESTION (lungs started filling up) (seriousness criterion medically significant), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm). At the time of the report, PULMONARY CONGESTION (lungs started filling up), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PULMONARY CONGESTION (lungs started filling up), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm) to be possibly related. No treatment drug information provided. No concomitant drug information provided. Company Comment: This case concerns a 66 years old female patient, with reported relevant medical history of Chronic Obstructive Pulmonary Disease, who experienced the serious unexpected event of Pulmonary congestion.The event occurred after the first dose of Spikevax vaccination. The rechallenge was unknown for the events, as only the first dose was administered. The medical history of Chronic Obstructive Pulmonary Disease remains a confounders to the event of Pulmonary congestion. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 66 years old female patient, with reported relevant medical history of Chronic Obstructive Pulmonary Disease, who experienced the serious unexpected event of Pulmonary congestion.The event occurred after the first dose of Spikevax vaccination. The rechallenge was unknown for the events, as only the first dose was administered. The medical history of Chronic Obstructive Pulmonary Disease remains a confounders to the event of Pulmonary congestion. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1766955
Sex: F
Age: 29
State: VA

Vax Date: 08/22/2021
Onset Date: 09/19/2021
Rec V Date: 10/07/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210919; Test Name: Body temperature; Result Unstructured Data: 99.8 degree F

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: headache; like a pressure in the frontal lobe of my forehead; mild fever at 99.8?F; chills; was tired/feel tired the rest of the following day; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead), HEADACHE (headache), PYREXIA (mild fever at 99.8?F), CHILLS (chills) and FATIGUE (was tired/feel tired the rest of the following day) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chest pain. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced PYREXIA (mild fever at 99.8?F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches). On 21-Sep-2021, the patient experienced HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, PYREXIA (mild fever at 99.8?F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches) had resolved. At the time of the report, HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead) and HEADACHE (headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 99.8 (High) 99.8 degree F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drug was not reported. The patient was previously diagnosed of potential heart pain. This case was linked to MOD-2021-334971 (Patient Link).

Other Meds:

Current Illness:

ID: 1766956
Sex: F
Age:
State: TX

Vax Date: 09/02/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: not immunocompromised and went to get a booster because of her age and condition; very ill; felt like she was coming down with the flu; weak; tired/fatigued; had nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition). In September 2021, the patient experienced ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea). On 02-Sep-2021, PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition) had resolved. At the time of the report, ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) outcome was unknown. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1766957
Sex: M
Age: 58
State: CA

Vax Date: 07/30/2021
Onset Date: 08/31/2021
Rec V Date: 10/07/2021
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: Couldn't eat for four days because he wasn't hungry; It was like I was sick; Headache, like a migraine; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat for four days because he wasn't hungry), ILLNESS (It was like I was sick), MIGRAINE (Headache, like a migraine) and PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Blood pressure high. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced DECREASED APPETITE (Couldn't eat for four days because he wasn't hungry), ILLNESS (It was like I was sick), MIGRAINE (Headache, like a migraine) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Adverse event, at an unspecified dose and frequency. On 02-Sep-2021, ILLNESS (It was like I was sick), MIGRAINE (Headache, like a migraine) and PYREXIA (Fever) had resolved. On 03-Sep-2021, DECREASED APPETITE (Couldn't eat for four days because he wasn't hungry) had resolved. Concomitant medications included Diabetes medication and High blood pressure medications. Patient was hard to understand and was very confused. Injection was given on upper left arm - non dominant.

Other Meds:

Current Illness: Blood pressure high; Diabetes

ID: 1766958
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: after second dose of moderna Covid-19 vaccine person got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick). At the time of the report, ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick) outcome was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1766959
Sex: F
Age: 29
State: VA

Vax Date: 08/22/2021
Onset Date:
Rec V Date: 10/07/2021
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: Arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The patient's past medical history included Chest pain. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) 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 relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-334946 (Patient Link).

Other Meds:

Current Illness:

ID: 1766960
Sex: F
Age: 60
State: CA

Vax Date: 02/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her; She cannot lift her hand/she cannot lift her arm; sometime it goes numb/she cannot use it; she has to drive with her left arm due to the pain; second shot outside recommended time interval; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it), IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it), IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval) had resolved. At the time of the report, PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it) and IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) had not resolved. Concomitant medications were not provided Patient made an appointment with the doctor.

Other Meds:

Current Illness:

ID: 1766961
Sex: F
Age: 62
State: ME

Vax Date: 03/21/2021
Onset Date: 03/01/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: Blood work; Result Unstructured Data: unknown; Test Name: Computed tomography; Result Unstructured Data: unknown; Test Name: Magnetic resonance imaging scan; Result Unstructured Data: unknown.

Allergies:

Symptom List: Nausea

Symptoms: blood clots in her lungs; getting out of breath; couldn't walk very far; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far). On 01-Apr-2021, the patient experienced PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Apr-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clots in her lungs), DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown unknown. On an unknown date, Computerised tomogram: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown unknown. No concomitant medications were reported. She was admitted to the hospital on 01/Apr/2021 and had many tests which included bloodwork and a magnetic resonance imaging scan (MRI) or computed tomography (CAT) scan. They found blood clots in her lungs. Company Comment: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1766962
Sex: F
Age: 35
State: PR

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 10/07/2021
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: tachycardia; started feeling pressure in her ears that went down to her throat; Decided not to get the second dose; symptoms of an allergic reaction/anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0NCZ1A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Aspirin). On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis). The patient was treated with Benadryl for Adverse event, at an unspecified dose and frequency. On 29-May-2021, TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Patient does not have an history of COVID-19 and myopericarditis .

Other Meds:

Current Illness: Drug allergy (Aspirin)

ID: 1766963
Sex: F
Age: 70
State: ID

Vax Date: 02/11/2021
Onset Date: 03/01/2021
Rec V Date: 10/07/2021
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: sore arm; rash on the arm; little twitching around lip; burning cramping pain that run down from my right thigh to my ankle; burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle), PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode), PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AC1A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis (Patient has multiple sclerosis). Concomitant products included INTERFERON BETA-1A (AVONEX) for Multiple sclerosis, DEXLANSOPRAZOLE (DEXILANT) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm). In March 2021, the patient experienced MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle) and PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode). At the time of the report, MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle), PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode), PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm) outcome was unknown. No treatment information was reported by the reporter. Concomitant product includes blood pressure medication. Dexilant concomitant was used for Reflux. Reporter stated that Patient has multiple sclerosis and takes Avonex, which suppresses her immune system. Patient said she takes a shot once a week, and for both doses of the vaccine she took the Avonex shot half way (meaning, took the shot, waited three days, got Moderna Vaccine, three more days, and then again the Avonex shot).

Other Meds: DEXILANT; AVONEX

Current Illness: Multiple sclerosis (Patient has multiple sclerosis)

ID: 1766964
Sex: F
Age: 59
State: FL

Vax Date: 08/21/2021
Onset Date: 08/27/2021
Rec V Date: 10/07/2021
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: lymph nodes under her left arm became painful; lymph nodes under her left arm became swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015E21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became swollen). In September 2021, LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became swollen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not provided. Treatment details were not provided. This case was linked to MOD-2021-335078 (Patient Link).

Other Meds:

Current Illness:

ID: 1766965
Sex: F
Age:
State: NY

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: patient came down with delta variant after getting both does of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patient came down with delta variant after getting both does of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient came down with delta variant after getting both does of the vaccine). At the time of the report, COVID-19 (patient came down with delta variant after getting both does of the vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had a severe headache, shortness of breath, and lost smell and taste manifested under final diagnosis of COVID-19. However, she was not like "oh! she needs to go to the ER". No concomitant drugs were reported. No treatment drugs were reported. Reporter work at a nursing home where covid-19 cases are surging. Reporter wonder if there is a date set for the approval, also if there is a antibody level range to assure a person is protected still, and whether they should get the available booster from Pfizer or wait for Moderna's. Reporter mentioned a patient came down with delta variant after getting both does of the vaccine. Reporter would like to escalate the question about which range of antibody levels that indicates if a person is still protected, because they feel it would make people feel more confident about getting the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains Significant information-New events added-Severe headache, shortness of breath,lost smell,lost taste.; Sender's Comments: This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the second dose of Spikevax, temporal relationship unknown. The rechallenge is not assessable. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Very limited information has been provided at this time. Vaccination failure was not captured since exact schedule of vaccination and temporal relationship with COVID-19 are unknown.

Other Meds:

Current Illness:

ID: 1766966
Sex: M
Age: 71
State: MA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/07/2021
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: patient passed out and was out for a minute and a half; when patient woke up he was cold; patient complained of soreness after falling from passing out; nausea; patient complained of soreness after falling from passing out; when patient woke up he was shivering; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient passed out and was out for a minute and a half) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Crohn's disease, Bowel discomfort and Immunocompromised. Concomitant products included TEDUGLUTIDE (GATTEX), ASCORBIC ACID, FERROUS FUMARATE (VITRON-C) and FISH OIL (FISH OIL OMEGA 3) for an unknown indication. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient passed out and was out for a minute and a half) (seriousness criterion medically significant), FEELING COLD (when patient woke up he was cold), FALL (patient complained of soreness after falling from passing out), NAUSEA (nausea), MYALGIA (patient complained of soreness after falling from passing out) and CHILLS (when patient woke up he was shivering). On 20-Sep-2021, LOSS OF CONSCIOUSNESS (patient passed out and was out for a minute and a half), FEELING COLD (when patient woke up he was cold), FALL (patient complained of soreness after falling from passing out), NAUSEA (nausea), MYALGIA (patient complained of soreness after falling from passing out) and CHILLS (when patient woke up he was shivering) 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. Other Concomitant medication included were Multivitamin, Omega-3 Fish Oil. No treatment reported. This case concerns a 61-year-old, male patient with relevant medical history of immunocompromised, crohn's disease, and bowel discomfort, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day after the first dose of mRMA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. This patient's underlying disease remains a contributory factor. . The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, male patient with relevant medical history of immunocompromised, crohn's disease, and bowel discomfort, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day after the first dose of mRMA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. This patient's underlying disease remains a contributory factor. . The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.

Other Meds: Gattex; Vitron-C; Fish Oil Omega 3

Current Illness: Bowel discomfort; Crohn's disease; Immunocompromised

ID: 1766967
Sex: F
Age: 69
State: GA

Vax Date: 08/30/2021
Onset Date: 09/02/2021
Rec V Date: 10/07/2021
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: Vaginal discharge; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (Vaginal discharge) and DIARRHEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced DIARRHEA (Diarrhea). On 04-Sep-2021, the patient experienced VAGINAL DISCHARGE (Vaginal discharge). The patient was treated with BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) on 02-Sep-2021 for Diarrhea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) 02-Sep-2021 for Diarrhea, at a dose of one tab. On 02-Sep-2021, DIARRHEA (Diarrhea) had resolved. In September 2021, VAGINAL DISCHARGE (Vaginal discharge) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication of the patient was not reported. Due to vaginal discharge, the patient went to the doctor, who gave her a shot and the discharge went away. She was allergic to the shot and had to take Benadryl. This case was linked to MOD-2021-335094 (Patient Link).

Other Meds:

Current Illness:

ID: 1766968
Sex: F
Age: 55
State: NC

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A and 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Thyroid disorder and Hypertension. Concomitant products included METFORMIN for Diabetes, OLMESARTAN MEDOXOMIL for Hypertension, LEVOTHYROXINE for Thyroid disorder. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache). On 08-Feb-2021, HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. This case was linked to MOD-2021-335151 (Patient Link).

Other Meds: METFORMIN; LEVOTHYROXINE; OLMESARTAN MEDOXOMIL

Current Illness: Diabetes; Hypertension; Thyroid disorder

ID: 1766969
Sex: F
Age: 59
State: FL

Vax Date: 08/21/2021
Onset Date: 09/26/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Area around the injection site very red; Area around the injection site very, very itchy; Lymph nodes under left arm swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 015E21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen). At the time of the report, VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen) outcome was unknown. No Concomitant medication reported. No treatment medication reported This case was linked to MOD-2021-335046 (Patient Link).

Other Meds:

Current Illness:

ID: 1766970
Sex: F
Age: 51
State: DE

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 10/07/2021
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: Numbness in hand; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Chlorathzine for Hypertension. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced FATIGUE (fatigue). On 14-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness in hand). At the time of the report, HYPOAESTHESIA (Numbness in hand) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication use was reported.

Other Meds: Chlorathzine

Current Illness:

ID: 1766971
Sex: F
Age: 75
State: CA

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bleed under skin easily; Taking more naps than usual; Hair stared falling out; Been tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual), ALOPECIA (Hair stared falling out) and FATIGUE (Been tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A, 0U4A21A and 033L20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PREDNISONE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual), ALOPECIA (Hair stared falling out) and FATIGUE (Been tired). At the time of the report, SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual) and FATIGUE (Been tired) outcome was unknown and ALOPECIA (Hair stared falling out) was resolving. No treatment medications were reported. The patient has underlying conditions and got third Moderna boost. The patient tends to bleed under skin easily. The patient reported that a cat bumped leg and blood went all the down front of leg and was black.

Other Meds: LEVOTHYROXINE; PREDNISONE

Current Illness: Thyroid disorder NOS

ID: 1766972
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: EKG; Result Unstructured Data: Abnormal

Allergies:

Symptom List: Pain in extremity

Symptoms: heart palpitations; dying because of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine). At the time of the report, PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (abnormal) Abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1766973
Sex: F
Age: 69
State: GA

Vax Date: 08/30/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 004F21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. No concomitant medications was reported. This case was linked to MOD-2021-335070 (Patient Link).

Other Meds:

Current Illness:

ID: 1766975
Sex: F
Age: 51
State: OK

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 10/07/2021
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: she noted huge hives (3-4 inches) which started at the injection site (left arm); fever; chills; was feeling "fluish"; nauseous; dizzy; vision smoky; light her my eye; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye), INFLUENZA LIKE ILLNESS (was feeling "fluish") and NAUSEA (nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye) and NAUSEA (nauseous). On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills). On 16-Aug-2021, the patient experienced VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Vaccination site urticaria, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site urticaria, at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (dizzy) and NAUSEA (nauseous) outcome was unknown, VISION BLURRED (vision smoky) and PHOTOPHOBIA (light her my eye) had resolved. On 13-Aug-2021, INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills) had resolved. On 18-Aug-2021, VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1766976
Sex: M
Age: 80
State: MA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 10/07/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Minor sore arm). At the time of the report, PAIN IN EXTREMITY (Minor sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was also taken for irritable bowel syndrome. No treatment medication was provided. This case was linked to MOD-2021-335133.

Other Meds: ATORVASTATIN; CITALOPRAM

Current Illness: Irritable bowel syndrome

ID: 1766977
Sex: M
Age: 80
State: MA

Vax Date: 01/26/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
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: Could not get out of bed for 24 hours; Had flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu-like symptoms) and FATIGUE (Could not get out of bed for 24 hours) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu-like symptoms). On 23-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Could not get out of bed for 24 hours). On 23-Feb-2021, FATIGUE (Could not get out of bed for 24 hours) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Had flu-like symptoms) outcome was unknown. Treatment information was not provided. This case was linked to MOD-2021-335120, MOD-2021-335141 (Patient Link).

Other Meds: ATORVASTATIN; CITALOPRAM

Current Illness: Irritable bowel syndrome

ID: 1766978
Sex: M
Age: 33
State: AL

Vax Date: 09/22/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210926; Test Name: Fever; Result Unstructured Data: Patient had fever that got up to 102 F

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: night sweats; felt like he had the flu; swollen lymph nodes; chills; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), PAIN IN EXTREMITY (sore arm), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Sep-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills). At the time of the report, NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), LYMPHADENOPATHY (swollen lymph nodes), CHILLS (chills) and PYREXIA (fever) was resolving and PAIN IN EXTREMITY (sore arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 102 (High) Patient had fever that got up to 102 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported that from the 5th day the side effects started to get better. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1766979
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: got really sick; thinks she might have had the flu as well.; she did not take her second dose; She threw up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), INFLUENZA (thinks she might have had the flu as well), VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), BUPROPION, GABAPENTIN, OXYBUTYNIN, BACLOFEN, TIZANIDINE and MIDODRINE for an unknown indication. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick), INFLUENZA (thinks she might have had the flu as well), VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose). At the time of the report, ILLNESS (got really sick) and INFLUENZA (thinks she might have had the flu as well) outcome was unknown and VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose) 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. Patient got her first dose 3 or 4 months ago from the reporting date. No treatment information was provided. The patient weight provided as 111 without units.

Other Meds: Paxil [Piroxicam]; Bupropion; Gabapentin; Oxybutynin; Baclofen; Tizanidine; Midodrine

Current Illness:

ID: 1766980
Sex: F
Age:
State: NY

Vax Date: 02/13/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: Sore left arm after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after 3rd shot) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore left arm after 3rd shot). On 28-Sep-2021, PAIN IN EXTREMITY (Sore left arm after 3rd shot) had resolved. No concomitant were medications reported. No treatment were medications reported. This case was linked to MOD21-148294 (Patient Link).

Other Meds:

Current Illness:

ID: 1766982
Sex: M
Age: 81
State: MA

Vax Date: 09/27/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he does not feel so great; eyes are aching; malaise; it was very difficult getting out of bed now; it was very difficult sleeping at night; headache after the third dose; fever (not high) after the third dose; aches after the third dose,pains after the third dose; joint stiffness after the third dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), MALAISE (he does not feel so great), EYE PAIN (eyes are aching) and MALAISE (malaise) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication. On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), HEADACHE (headache after the third dose) and PYREXIA (fever (not high) after the third dose). On 28-Sep-2021, the patient experienced MALAISE (he does not feel so great), EYE PAIN (eyes are aching), MALAISE (malaise), MOBILITY DECREASED (it was very difficult getting out of bed now) and INSOMNIA (it was very difficult sleeping at night). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram. At the time of the report, PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), MALAISE (he does not feel so great), EYE PAIN (eyes are aching), MALAISE (malaise), MOBILITY DECREASED (it was very difficult getting out of bed now), INSOMNIA (it was very difficult sleeping at night), HEADACHE (headache after the third dose) and PYREXIA (fever (not high) after the third dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had the third dose yesterday at 3pm and now 21 hours later, did not feel so great, eyes were aching, malaise, it was very difficult getting out of bed and sleeping at night. Unknown immunocompromised status of receiving third dose. This case was linked to MOD-2021-335120, MOD-2021-335133 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information: Unknown immunocompromised status receiving third dose.

Other Meds: ATORVASTATIN; CITALOPRAM

Current Illness:

ID: 1766983
Sex: F
Age: 62
State: MI

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 10/07/2021
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: Really severe reaction; High fever; Fatigue; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in October 2020 and Clot blood (Patient was hospitalized for 7 days (discharged on 02Nov2020) because of a blood clot in the lung.). Concurrent medical conditions included Neurological disorder NOS (neurological ones, as she said COVID affected her spine and has problems with coordination). On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over). On 17-May-2021, VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment information was provided. Patient felt like having covid again. This case was linked to MOD-2021-335178 (Patient Link).

Other Meds:

Current Illness: Neurological disorder NOS (neurological ones, as she said COVID affected her spine and has problems with coordination).

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am