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: 1734002
Sex: F
Age: 69
State: AZ

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/25/2021
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: Little bruising [from first dose]; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Little bruising [from first dose]) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-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 VACCINATION SITE BRUISING (Little bruising [from first dose]). At the time of the report, VACCINATION SITE BRUISING (Little bruising [from first dose]) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient took the second shot on 16-sep-2021 with lot number 037F21A, taken in left arm. patient states that her HCP is new, but she has an appointment coming up on 28Sep2021. Treatment information was not provided. concomitant medication were not provided. This case was linked to MOD-2021-324943.

Other Meds:

Current Illness:

ID: 1734003
Sex: F
Age: 49
State: NJ

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/25/2021
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: Severe stomach cramping; Toxic diarrhea; Arm was very sore after the shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach cramping), DIARRHEA (Toxic diarrhea) and PAIN IN EXTREMITY (Arm was very sore after the shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore after the shot). On 31-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach cramping) and DIARRHEA (Toxic diarrhea). The patient was treated with SIMETICONE (GAS-X) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In September 2021, ABDOMINAL PAIN UPPER (Severe stomach cramping) and DIARRHEA (Toxic diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was very sore after the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Approximately 24 hours after receiving the injection, the patient developed severe stomach cramping and toxic diarrhea which continued for five days. The patient drank Gatorade, ate soup, slept and took Tylenol and Gas-X. The patient suspected it as food poisoning but, when it continued for more than a day and a half, the patient knew it was not. The patient consulted with the physician who advised to consult if it continued. The patient was considering about not receiving the second shot.

Other Meds:

Current Illness:

ID: 1734004
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: tested positive for covid after my first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid after my first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid after my first shot). At the time of the report, COVID-19 (tested positive for covid after my first shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1734005
Sex: U
Age:
State: NY

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 09/25/2021
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: redness at the injection site; itching at the injection site; rash at the injection site/rash up to elbow; shingles in the eye; COVIDARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash at the injection site/rash up to elbow), HERPES ZOSTER (shingles in the eye) and VACCINATION COMPLICATION (COVIDARM) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash at the injection site/rash up to elbow), HERPES ZOSTER (shingles in the eye) and VACCINATION COMPLICATION (COVIDARM). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash at the injection site/rash up to elbow), HERPES ZOSTER (shingles in the eye) and VACCINATION COMPLICATION (COVIDARM) outcome was unknown. No concomitant medications was reported No Treatment medications was reported This case was linked to MOD-2021-322897 (Patient Link).

Other Meds:

Current Illness:

ID: 1734006
Sex: F
Age:
State: AZ

Vax Date: 08/20/2021
Onset Date:
Rec V Date: 09/25/2021
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: Red bumps on the hands and feet; Mild burning and itching on the red bumps; Moderate pain; Patient's feet has mild swelling; Mild burning and itching on the red bumps; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (Red bumps on the hands and feet), BURNING SENSATION (Mild burning and itching on the red bumps), PAIN (Moderate pain), PERIPHERAL SWELLING (Patient's feet has mild swelling) and PRURITUS (Mild burning and itching on the red bumps) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LEVOTHYROXINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 20-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 RASH ERYTHEMATOUS (Red bumps on the hands and feet), BURNING SENSATION (Mild burning and itching on the red bumps), PAIN (Moderate pain), PERIPHERAL SWELLING (Patient's feet has mild swelling) and PRURITUS (Mild burning and itching on the red bumps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency and MENTHOL (ICE [MENTHOL]) for Red rash, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red bumps on the hands and feet), BURNING SENSATION (Mild burning and itching on the red bumps), PAIN (Moderate pain), PERIPHERAL SWELLING (Patient's feet has mild swelling) and PRURITUS (Mild burning and itching on the red bumps) 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.

Other Meds: LEVOTHYROXINE; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1734007
Sex: M
Age: 73
State: TX

Vax Date: 08/09/2021
Onset Date: 09/01/2021
Rec V Date: 09/25/2021
Hospital: Y

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: heart function is down to 35%; clot in heart; he started having chest pains; consumer had a heart attack, died, and "brought me back"; coded; he was sick; He states he is still tired from all the events; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (consumer had a heart attack, died, and "brought me back"), CARDIAC DYSFUNCTION (heart function is down to 35%), THROMBOSIS (clot in heart), ILLNESS (he was sick), CHEST PAIN (he started having chest pains), FATIGUE (He states he is still tired from all the events) and CARDIO-RESPIRATORY ARREST (coded) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 939902) for COVID-19 vaccination. The patient's past medical history included Thyroid disorder and Hypercholesterolemia. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (he was sick) (seriousness criteria hospitalization, medically significant and life threatening). On 09-Sep-2021, the patient experienced MYOCARDIAL INFARCTION (consumer had a heart attack, died, and "brought me back") (seriousness criteria hospitalization, medically significant and life threatening), THROMBOSIS (clot in heart) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (he started having chest pains) (seriousness criteria hospitalization, medically significant and life threatening) and CARDIO-RESPIRATORY ARREST (coded) (seriousness criteria hospitalization, medically significant and life threatening). In September 2021, the patient experienced FATIGUE (He states he is still tired from all the events) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced CARDIAC DYSFUNCTION (heart function is down to 35%) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized from 09-Sep-2021 to 13-Sep-2021 due to CARDIAC DYSFUNCTION, CARDIO-RESPIRATORY ARREST, CHEST PAIN, FATIGUE, ILLNESS, MYOCARDIAL INFARCTION and THROMBOSIS. At the time of the report, MYOCARDIAL INFARCTION (consumer had a heart attack, died, and "brought me back"), CARDIAC DYSFUNCTION (heart function is down to 35%), THROMBOSIS (clot in heart), ILLNESS (he was sick), CHEST PAIN (he started having chest pains), FATIGUE (He states he is still tired from all the events) and CARDIO-RESPIRATORY ARREST (coded) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included thyroid and cholesterol medication. Treatment information not provided. Consumer states that 2 days after vaccination, consumer had a heart attack, died, and brought back. Consumer repeated that pattern twice heart attack, died and brought back. Consumer also reports he had clot in heart and heart function was down to 35%. Consumer states that on 07 Sep 2021 he was sick and part of 08 Sep 2021. On 09 Sep 2021, around 4:45 AM he started having chest pains and was transported to hospital via helicopter. Consumer was hospitalized from 09Sep2021 to 13Sep2021. Consumer cannot confirm for sure if any surgery was done, he mentioned might be a stent was put in. Consumer states they started 8 new pills for him including blood thinners. Company comment: This case concerns a 73 year-old male subject with no reported medical history who experienced the unexpected events of myocardial infarction, cardiac dysfunction, thrombosis, illness, chest pain, cardiopulmonary arrest, and fatigue. The events myocardial infarction, cardiac dysfunction, thrombosis, illness, chest pain, cardiopulmonary arrest occurred approximately 30 to 31 days after the second dose of mRNA-1273. The event fatigue occurred at an unknown date. The rechallenge was unknown as information on the first dose and subsequent events are not provided. The medical history hypercholesterolemia and thyroid disorder remain confounders. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.; Sender's Comments: This case concerns a 73 year-old male subject with no reported medical history who experienced the unexpected events of myocardial infarction, cardiac dysfunction, thrombosis, illness, chest pain, cardiopulmonary arrest, and fatigue. The events myocardial infarction, cardiac dysfunction, thrombosis, illness, chest pain, cardiopulmonary arrest occurred approximately 30 to 31 days after the second dose of mRNA-1273. The event fatigue occurred at an unknown date. The rechallenge was unknown as information on the first dose and subsequent events are not provided. The medical history hypercholesterolemia and thyroid disorder remain confounders. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.

Other Meds:

Current Illness:

ID: 1734008
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Frozen shoulder; COVID arm/adverse reaction; Red patch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PERIARTHRITIS (Frozen shoulder), VACCINATION SITE REACTION (COVID arm/adverse reaction) and ERYTHEMA (Red patch) in an adult patient of an unknown 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 PERIARTHRITIS (Frozen shoulder), VACCINATION SITE REACTION (COVID arm/adverse reaction) and ERYTHEMA (Red patch). At the time of the report, PERIARTHRITIS (Frozen shoulder), VACCINATION SITE REACTION (COVID arm/adverse reaction) and ERYTHEMA (Red patch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1734009
Sex: F
Age: 60
State: FL

Vax Date: 12/29/2020
Onset Date: 01/27/2021
Rec V Date: 09/25/2021
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: Felt like I had the flu; A racing heart beat and a pounding heart that lasted all day.; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA (Felt like I had the flu) and PALPITATIONS (A racing heart beat and a pounding heart that lasted all day.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Arrhythmia (Arrhythmia problem). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA (Felt like I had the flu) and PALPITATIONS (A racing heart beat and a pounding heart that lasted all day.). At the time of the report, INFLUENZA (Felt like I had the flu) outcome was unknown and PALPITATIONS (A racing heart beat and a pounding heart that lasted all day.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Dose date captured as per narrative No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-322729 (Patient Link).

Other Meds:

Current Illness: Arrhythmia (Arrhythmia problem)

ID: 1734010
Sex: M
Age: 27
State:

Vax Date: 09/14/2021
Onset Date:
Rec V Date: 09/25/2021
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: pain in the arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and PYREXIA (fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (pain in the arm) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Scheduled for second dose on 12Oct2021. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1734011
Sex: F
Age: 40
State: TX

Vax Date: 01/22/2021
Onset Date: 09/16/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210916; Test Name: body temperature; Result Unstructured Data: fever of 101.; Test Date: 20210916; Test Name: heart rate; Result Unstructured Data: 113 beats per minute for past 8-9 hours 95-102 beats per minute which is fluctuations

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: couldn't sleep all night; palpitations; severe migraine; eye pain in left eye which radiates down to the ear; achiness; pain on arm; pain on lymph node; chills; fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep all night), PALPITATIONS (palpitations), MIGRAINE (severe migraine), EYE PAIN (eye pain in left eye which radiates down to the ear) and PAIN (achiness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autoimmune disorder (unknown). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INSOMNIA (couldn't sleep all night), PALPITATIONS (palpitations), MIGRAINE (severe migraine), EYE PAIN (eye pain in left eye which radiates down to the ear), PAIN (achiness), PAIN IN EXTREMITY (pain on arm), LYMPH NODE PAIN (pain on lymph node), CHILLS (chills) and PYREXIA (fever of 101). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 17-Sep-2021, PYREXIA (fever of 101) had resolved. At the time of the report, INSOMNIA (couldn't sleep all night), PALPITATIONS (palpitations), MIGRAINE (severe migraine), EYE PAIN (eye pain in left eye which radiates down to the ear), PAIN (achiness), PAIN IN EXTREMITY (pain on arm), LYMPH NODE PAIN (pain on lymph node) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Body temperature: 101 (High) fever of 101.. On 16-Sep-2021, Heart rate: 113 (High) 113 beats per minute for past 8-9 hours 95-102 beats per minute which is fluctuations. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported.

Other Meds:

Current Illness: Autoimmune disorder (unknown)

ID: 1734012
Sex: F
Age: 61
State: GA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 09/25/2021
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: Bumps on their scalp; Losing hair; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Bumps on their scalp) and ALOPECIA (Losing hair) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Bumps on their scalp) and ALOPECIA (Losing hair). At the time of the report, SKIN MASS (Bumps on their scalp) and ALOPECIA (Losing hair) outcome was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1734013
Sex: M
Age: 26
State: TX

Vax Date: 08/19/2021
Onset Date: 08/30/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210831; Test Name: Blood work; Result Unstructured Data: normal; Test Date: 20210831; Test Name: X-Ray; Result Unstructured Data: normal

Allergies:

Symptom List: Rash, Urticaria

Symptoms: hasn't even been to work the last two weeks/not capable of working; I get out of breath; feel like a tingling, numbness in my chest; feel anxious; feel like a tingling, numbness in my chest/ sometimes the tingling is in my neck or head; chest has been feeling tight/tightness in my chest constantly/all day long it feels tight; weird episode/ like panic attack; felt weird/ Felt off/Since then, every day I have been having the same feeling; thought I was having a heart attack or a stroke/happened in the morning/I feel like I'm about to have a heart attack; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest has been feeling tight/tightness in my chest constantly/all day long it feels tight), PANIC ATTACK (weird episode/ like panic attack), FEELING ABNORMAL (felt weird/ Felt off/Since then, every day I have been having the same feeling), CARDIAC DISCOMFORT (thought I was having a heart attack or a stroke/happened in the morning/I feel like I'm about to have a heart attack) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't even been to work the last two weeks/not capable of working) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced CHEST DISCOMFORT (chest has been feeling tight/tightness in my chest constantly/all day long it feels tight), PANIC ATTACK (weird episode/ like panic attack), FEELING ABNORMAL (felt weird/ Felt off/Since then, every day I have been having the same feeling) and CARDIAC DISCOMFORT (thought I was having a heart attack or a stroke/happened in the morning/I feel like I'm about to have a heart attack). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't even been to work the last two weeks/not capable of working), DYSPNOEA (I get out of breath), HYPOAESTHESIA (feel like a tingling, numbness in my chest), ANXIETY (feel anxious) and PARAESTHESIA (feel like a tingling, numbness in my chest/ sometimes the tingling is in my neck or head). At the time of the report, CHEST DISCOMFORT (chest has been feeling tight/tightness in my chest constantly/all day long it feels tight), PANIC ATTACK (weird episode/ like panic attack), FEELING ABNORMAL (felt weird/ Felt off/Since then, every day I have been having the same feeling), CARDIAC DISCOMFORT (thought I was having a heart attack or a stroke/happened in the morning/I feel like I'm about to have a heart attack), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't even been to work the last two weeks/not capable of working), DYSPNOEA (I get out of breath), HYPOAESTHESIA (feel like a tingling, numbness in my chest), ANXIETY (feel anxious) and PARAESTHESIA (feel like a tingling, numbness in my chest/ sometimes the tingling is in my neck or head) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Blood test: normal (normal) normal. On 31-Aug-2021, X-ray: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient went to emergency room on 31-AUG-2021 but they did not give him any medication. Patient rarely took medications. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1734014
Sex: F
Age: 82
State: NY

Vax Date: 01/11/2021
Onset Date: 02/12/2021
Rec V Date: 09/25/2021
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: leg did have to get stitches; fainted in the shower; felt a little dizzy; fell to the ground/collapsed/fell over again; hit my knee on the tile; beyond dizzy/took me a half hour to get up; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainted in the shower) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SYNCOPE (fainted in the shower) (seriousness criterion medically significant), DIZZINESS (felt a little dizzy), FALL (fell to the ground/collapsed/fell over again), JOINT INJURY (hit my knee on the tile) and DIZZINESS POSTURAL (beyond dizzy/took me a half hour to get up). On an unknown date, the patient experienced LIMB INJURY (leg did have to get stitches). At the time of the report, SYNCOPE (fainted in the shower), DIZZINESS (felt a little dizzy), FALL (fell to the ground/collapsed/fell over again), JOINT INJURY (hit my knee on the tile), DIZZINESS POSTURAL (beyond dizzy/took me a half hour to get up) and LIMB INJURY (leg did have to get stitches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The first shot she didn't have a reaction. On 12Feb2021, she felt a little dizzy after she got up in the morning. Then she fainted in the shower. She collapsed and fell to the ground. She never fainted in her life. She hit her knee on the tile and crawled out of the shower. But she fell over again because she was beyond dizzy. It took her a half hour to get up. She states it was a very weird fainting experience. The leg did have to get stitches. She states she lives alone. She states she has no major illnesses. She goes to the gym all the time. She doesn't take any medications, except one for thyroid. The patient states that she doesn't know what to do now. She is concerned about taking the booster shot. She wants to know if she can take a Pfizer vaccine. Consent given for safety to contact the patient and her HCP. Treatment details were not provided.; Sender's Comments: This case concerns a 83 year-old, female with no relevant medical history, who experienced the unexpected events of syncope (and other non serious events). The event occurred approximately 1month and 2 days after the first dose and 2 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Event "syncope" Was auto-upgraded to serious by Auto-IME tool, but based on info avail and medical judgment the event was reassessed as non-serious.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1734015
Sex: F
Age: 59
State: NC

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 09/25/2021
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: Sluggish; Slight achiness; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and PAIN (Slight achiness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The patient's past medical history included Cancer (Had cancer 10 year ago). Concomitant products included METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) for Blood pressure high, MELATONIN for Sleep disorder therapy. On 05-May-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 SLUGGISHNESS (Sluggish) and PAIN (Slight achiness). At the time of the report, SLUGGISHNESS (Sluggish) and PAIN (Slight achiness) 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 included Armor thyroid 30mg for thyroid, sleep tea for sleeping aid and melatonin to help sleep. Treatment medication was not provided for dose 1. This case was linked to MOD-2021-322989 (Patient Link).

Other Meds: METOPROLOL [METOPROLOL SUCCINATE]; MELATONIN

Current Illness:

ID: 1734016
Sex: F
Age:
State: IA

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/25/2021
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: heart palpitation for the last 20 minutes; difficulty in breathing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitation for the last 20 minutes) and DYSPNOEA (difficulty in breathing) 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 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PALPITATIONS (heart palpitation for the last 20 minutes) and DYSPNOEA (difficulty in breathing). At the time of the report, PALPITATIONS (heart palpitation for the last 20 minutes) and DYSPNOEA (difficulty in breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported

Other Meds:

Current Illness:

ID: 1734017
Sex: U
Age:
State: FL

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 09/25/2021
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: His memory was affected, he could not remember things; Arm pain; Muscle sore and pain; Headache; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (His memory was affected, he could not remember things), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle sore and pain), HEADACHE (Headache) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Immunocompromised. On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (His memory was affected, he could not remember things), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle sore and pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tired). At the time of the report, MEMORY IMPAIRMENT (His memory was affected, he could not remember things), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle sore and pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tired) had resolved. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-323126 (Patient Link).

Other Meds:

Current Illness: Diabetes; Immunocompromised

ID: 1734018
Sex: F
Age: 71
State: FL

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 09/25/2021
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: felt rotten/ have woken up almost as rotten as last week; I just don't feel very well at all; very lethargic; arthritis has bothered me quite a bit this week; very sore arm/body aches; headache; a little queasy; fatigue/very tired/more tired than usual; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt rotten/ have woken up almost as rotten as last week), MALAISE (I just don't feel very well at all), LETHARGY (very lethargic), ARTHRITIS (arthritis has bothered me quite a bit this week) and MYALGIA (very sore arm/body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 031M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included POTASSIUM CITRATE, VITAMINS NOS, METFORMIN and ROSUVASTATIN for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt rotten/ have woken up almost as rotten as last week), MALAISE (I just don't feel very well at all), LETHARGY (very lethargic), ARTHRITIS (arthritis has bothered me quite a bit this week), MYALGIA (very sore arm/body aches), HEADACHE (headache), NAUSEA (a little queasy) and FATIGUE (fatigue/very tired/more tired than usual). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt rotten/ have woken up almost as rotten as last week), MALAISE (I just don't feel very well at all), LETHARGY (very lethargic), ARTHRITIS (arthritis has bothered me quite a bit this week), MYALGIA (very sore arm/body aches), HEADACHE (headache), NAUSEA (a little queasy) and FATIGUE (fatigue/very tired/more tired than usual) outcome was unknown.

Other Meds: POTASSIUM CITRATE; VITAMINS NOS; METFORMIN; ROSUVASTATIN

Current Illness:

ID: 1734019
Sex: M
Age:
State: FL

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 09/25/2021
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: fever (temperature) 99? F; His memory was affected, he could not remember things; Arm pain; Muscle sore/muscle pain; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (His memory was affected, he could not remember things), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle sore/muscle pain), FATIGUE (Tired) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (His memory was affected, he could not remember things), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle sore/muscle pain), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (fever (temperature) 99? F). At the time of the report, MEMORY IMPAIRMENT (His memory was affected, he could not remember things), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle sore/muscle pain), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (fever (temperature) 99? F) had resolved. Patient is immunocompromised and received the third dose of vaccine. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-323101 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness: Diabetes

ID: 1734020
Sex: F
Age: 44
State: NY

Vax Date: 09/02/2021
Onset Date: 09/08/2021
Rec V Date: 09/25/2021
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: Minor pins and needles all over the body/Random pins and needles all over the body; Right arm pit got fat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Minor pins and needles all over the body/Random pins and needles all over the body) and VACCINATION SITE SWELLING (Right arm pit got fat) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Right arm pit got fat). On 17-Sep-2021, the patient experienced PARAESTHESIA (Minor pins and needles all over the body/Random pins and needles all over the body). At the time of the report, PARAESTHESIA (Minor pins and needles all over the body/Random pins and needles all over the body) outcome was unknown and VACCINATION SITE SWELLING (Right arm pit got fat) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1734021
Sex: M
Age: 80
State: FL

Vax Date: 02/01/2021
Onset Date: 08/19/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: contracted Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) outcome was unknown. No concomitant medication was reported by the reporter. No treatment was reported by the reporter.

Other Meds:

Current Illness:

ID: 1734022
Sex: M
Age: 16
State: AL

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Inappropriate age at vaccine administration; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 19-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided.

Other Meds:

Current Illness:

ID: 1734023
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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 covid 4 months after a second shot of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid 4 months after a second shot of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. Concurrent medical conditions included Diabetic and Immunocompromised. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got covid 4 months after a second shot of vaccine). At the time of the report, COVID-19 (got covid 4 months after a second shot of vaccine) outcome was unknown. No Treatment informations were reported.

Other Meds:

Current Illness: Diabetic; Immunocompromised

ID: 1734024
Sex: M
Age: 48
State: PA

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/25/2021
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: Gout flared up, both knees; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flared up, both knees) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical history information was reported. Concurrent medical conditions included Borderline diabetes. On 19-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 GOUT (Gout flared up, both knees). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout flare, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Gout flare, at an unspecified dose and frequency. At the time of the report, GOUT (Gout flared up, both knees) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medication of the patient was not reported. The patient had no known allergies. This case was linked to MOD-2021-323257 (Patient Link).

Other Meds:

Current Illness: Borderline diabetes

ID: 1734025
Sex: M
Age: 48
State: PA

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: gout flared up, both knees; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout flared up, both knees) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination. The patient had no known allergies. Concurrent medical conditions included Borderline diabetes. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GOUT (gout flared up, both knees). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout flare, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Gout flare, at an unspecified dose and frequency. At the time of the report, GOUT (gout flared up, both knees) outcome was unknown. Concomitant medication of the patient was not reported. This case was linked to MOD-2021-323228 (Patient Link).

Other Meds:

Current Illness: Borderline diabetes

ID: 1734026
Sex: M
Age: 76
State: CA

Vax Date: 09/08/2021
Onset Date: 09/09/2021
Rec V Date: 09/25/2021
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: Blurry vision; Arm soreness; Swollen lymph node in neck; Felt achy and sore; Itchiness on the injection site; Redness on the injection site; Headache; Severe tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), PAIN IN EXTREMITY (Arm soreness), LYMPHADENOPATHY (Swollen lymph node in neck), MYALGIA (Felt achy and sore) and VACCINATION SITE PRURITUS (Itchiness on the injection site) in a 76-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 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VISION BLURRED (Blurry vision), PAIN IN EXTREMITY (Arm soreness), LYMPHADENOPATHY (Swollen lymph node in neck), VACCINATION SITE PRURITUS (Itchiness on the injection site), VACCINATION SITE ERYTHEMA (Redness on the injection site), HEADACHE (Headache) and FATIGUE (Severe tiredness). 09-Sep-2021, the patient experienced MYALGIA (Felt achy and sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurry vision), PAIN IN EXTREMITY (Arm soreness), LYMPHADENOPATHY (Swollen lymph node in neck), MYALGIA (Felt achy and sore), VACCINATION SITE PRURITUS (Itchiness on the injection site), VACCINATION SITE ERYTHEMA (Redness on the injection site), HEADACHE (Headache) and FATIGUE (Severe tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1734027
Sex: M
Age:
State: GA

Vax Date: 03/15/2021
Onset Date: 08/06/2021
Rec V Date: 09/25/2021
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: like "getting a punch in the arm or something"/ went away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away). At the time of the report, VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away) had resolved. No relevant concomitant medications were reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1734028
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/25/2021
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: patient did not get the second dose yet; patient under 18 got the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient did not get the second dose yet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 got the first dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 got the first dose of the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not get the second dose yet). In March 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 got the first dose of the vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not get the second dose yet) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. Patient is under 18 but over 12 years of age, got the first dose of the vaccine back in Mar-2021 in Portugal and was inquiring about getting the second dose.

Other Meds:

Current Illness:

ID: 1734029
Sex: U
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: ongoing dizzy spells since they received their Covid 19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (ongoing dizzy spells since they received their Covid 19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy and Meniere's disease. 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 DIZZINESS (ongoing dizzy spells since they received their Covid 19 vaccine). At the time of the report, DIZZINESS (ongoing dizzy spells since they received their Covid 19 vaccine) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness: Allergy; Meniere's disease

ID: 1734030
Sex: M
Age: 80
State: TX

Vax Date: 01/20/2021
Onset Date: 09/17/2021
Rec V Date: 09/25/2021
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: Received third dose , not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399243, 041L20A and 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-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 17-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised). On 17-Sep-2021, EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised) had resolved. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1734031
Sex: M
Age:
State: PA

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Sore Injection Site Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site Arm) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Injection Site Arm). At the time of the report, VACCINATION SITE PAIN (Sore Injection Site 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. No concomitant medications reported. No treatment reported.

Other Meds:

Current Illness:

ID: 1734032
Sex: M
Age: 73
State: MI

Vax Date: 02/18/2021
Onset Date: 03/08/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Name: CT scan; Result Unstructured Data: blood clots; Test Name: ultrasound; Result Unstructured Data: blood clots

Allergies:

Symptom List: Injection site pain

Symptoms: blood clots; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clots) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 08-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clots) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Adverse event, at a dose of 20 milligram. At the time of the report, DEEP VEIN THROMBOSIS (blood clots) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: blood clots blood clots. On an unknown date, Ultrasound scan: blood clots blood clots. Concomitant product usage were not provided. This case concerns a 73 year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event occurred approximately 19 days after the first dose of Spikevax. The rechallenge was unknown since no information regarding second dose. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 73 year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event occurred approximately 19 days after the first dose of Spikevax. The rechallenge was unknown since no information regarding second dose. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds:

Current Illness:

ID: 1734033
Sex: M
Age: 36
State: WA

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/25/2021
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: Got an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1734034
Sex: M
Age: 62
State: CA

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 09/25/2021
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: felt so lazy he could not even do anything; could not work, it took away 3 days from work from him; COVID-19; feeling bad; feeling not able to focus; dizzy; chest pain; sore throat; chills for a few days; fever; just by simply talking to somebody he starts tiring; sore arm; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt so lazy he could not even do anything), IMPAIRED WORK ABILITY (could not work, it took away 3 days from work from him), COVID-19 (COVID-19), FEELING ABNORMAL (feeling bad) and DISTURBANCE IN ATTENTION (feeling not able to focus) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN for Cholesterol, FENOFIBRATE for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (felt so lazy he could not even do anything), IMPAIRED WORK ABILITY (could not work, it took away 3 days from work from him), COVID-19 (COVID-19), FEELING ABNORMAL (feeling bad), DISTURBANCE IN ATTENTION (feeling not able to focus), DIZZINESS (dizzy), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills for a few days), PYREXIA (fever), FATIGUE (just by simply talking to somebody he starts tiring), MYALGIA (sore arm) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with FAMOTIDINE for Stomach ache, at an unspecified dose and frequency. At the time of the report, LETHARGY (felt so lazy he could not even do anything), IMPAIRED WORK ABILITY (could not work, it took away 3 days from work from him), COVID-19 (COVID-19), FEELING ABNORMAL (feeling bad), DISTURBANCE IN ATTENTION (feeling not able to focus), DIZZINESS (dizzy), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills for a few days), PYREXIA (fever), FATIGUE (just by simply talking to somebody he starts tiring), MYALGIA (sore arm) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. The patient's concomitant d rug also includes blood pressure medications. The patient received monoclonal antibodies and is now feeling better. The treatment drug includes promethazine has not taken for the last days.; Sender's Comments: This case concerns a 63 year-old, male patient, who experienced the non serious expected/unexpected event of COVID-19, lethargy, impaired work ability, feeling abnormal, disturbance in attention, dizziness, chest pain, oropharyngeal pain, chills, pyrexia, fatigue and myalgia. Drug ineffective was considered as an additional event. The events occurred on an unknown date after the second dose of Spikevax/Moderna COVID-19 vaccine (more than 14 days according to information provided in narrative). The rechallenge was not applicable, as the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

Other Meds: ATORVASTATIN; FENOFIBRATE

Current Illness:

ID: 1734035
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Is pain in my arm after getting the shot normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal). At the time of the report, VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided.

Other Meds:

Current Illness:

ID: 1734036
Sex: F
Age: 74
State: VA

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 09/25/2021
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: fatigued; high temperature/temperature of 102 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight). At the time of the report, FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight) had resolved. No treatment medication was reported. No Concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1734037
Sex: M
Age: 42
State: HI

Vax Date: 08/15/2021
Onset Date: 09/13/2021
Rec V Date: 09/25/2021
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: head ache / massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head ache / massive headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced HEADACHE (head ache / massive headache). On 14-Sep-2021, HEADACHE (head ache / massive headache) had resolved. No concomitant treatment was provided. No treatment medication was provided. The patient had reported started maybe one day after got the second dose, had a head ache on the 13th and then on the 14th figured it would have go away by now.

Other Meds:

Current Illness:

ID: 1734038
Sex: U
Age:
State:

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 09/25/2021
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: Moderna has destroyed my body; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna has destroyed my body) and HEADACHE (headaches) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna has destroyed my body) and HEADACHE (headaches). At the time of the report, VACCINATION COMPLICATION (Moderna has destroyed my body) and HEADACHE (headaches) outcome was unknown. No Concomitant medications were reported. No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1734039
Sex: F
Age: 57
State: CA

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210604; Test Name: COVID-19 Antibody test; Test Result: Positive ; Result Unstructured Data: Positive; Comments: tested positive for natural antibodies to COVID-19; Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210422; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Drooping of the left side of my face; numbness on the left side of my face; severe weakness of both of my legs and left arm; brain fog; severe lethargy; heaviness in my left eye; swelling in my left eye; I was in bed Wednesday and Thursday.; flu like symptoms; could not lift my head up; headache; started having a lot of mucus; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Drooping of the left side of my face) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Sever e Asthmatic.). On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SECRETION DISCHARGE (started having a lot of mucus). On 08-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSKINESIA (could not lift my head up) and HEADACHE (headache). On 09-Sep-2021, the patient experienced OCULAR DISCOMFORT (heaviness in my left eye), EYE SWELLING (swelling in my left eye) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was in bed Wednesday and Thursday.). On 10-Sep-2021, the patient experienced BELL'S PALSY (Drooping of the left side of my face) (seriousness criterion medically significant), HYPOAESTHESIA (numbness on the left side of my face), MUSCULAR WEAKNESS (severe weakness of both of my legs and left arm), FEELING ABNORMAL (brain fog) and LETHARGY (severe lethargy). At the time of the report, BELL'S PALSY (Drooping of the left side of my face), SECRETION DISCHARGE (started having a lot of mucus), INFLUENZA LIKE ILLNESS (flu like symptoms), DYSKINESIA (could not lift my head up), OCULAR DISCOMFORT (heaviness in my left eye), EYE SWELLING (swelling in my left eye), HYPOAESTHESIA (numbness on the left side of my face), MUSCULAR WEAKNESS (severe weakness of both of my legs and left arm), FEELING ABNORMAL (brain fog), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was in bed Wednesday and Thursday.), LETHARGY (severe lethargy) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not provided. Treatment medication were not reported. This case concerns a 57-year-old male patient with relevant medical history of severe Asthma who experienced the unexpected event of Bell's palsy. The event occurred 3 days after first dose of mRNA-1273. The rechallenge was not applicable as the patient had the first dose and not eligible for second dose at the time of the report base on dosing schedule. Causality assessment for the event was not provided by the reporter. The event is consistent with the current understanding of the mechanism of action of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and event is a medical important event.; Sender's Comments: This case concerns a 57-year-old male patient with relevant medical history of severe Asthma who experienced the unexpected event of Bell's palsy. The event occurred 3 days after first dose of mRNA-1273. The rechallenge was not applicable as the patient had the first dose and not eligible for second dose at the time of the report base on dosing schedule. Causality assessment for the event was not provided by the reporter. The event is consistent with the current understanding of the mechanism of action of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and event is a medical important event.

Other Meds:

Current Illness: Asthma (Sever e Asthmatic.)

ID: 1734040
Sex: F
Age: 50
State: AL

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210909; Test Name: BLOOD PRESSURE; Result Unstructured Data: blood pressure was 110/60 when headache started; Test Date: 20210909; Test Name: BLOOD PRESSURE; Result Unstructured Data: within 45 minutes,shot up to 155/99.

Allergies:

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

Symptoms: chest pain; numbness in left ear and left cheek; tingling in left ear and left cheek; could not close joints / could not use her hand; nausea; fatigue; weird headache starts in back of head and is burning / The headache completely incapacitates her when it starts. She feels it move to the frontal lobe, and it vanishes just as quickly as it comes; body aches severe on left arm; severe burning/cooling sensation; hazy vision starts in left eye and it moves to the right eye; pupils constricted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (severe burning/cooling sensation), VISION BLURRED (hazy vision starts in left eye and it moves to the right eye), MIOSIS (pupils constricted), HYPOAESTHESIA (numbness in left ear and left cheek) and PARAESTHESIA (tingling in left ear and left cheek) in a 50-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 Hysterectomy. Concurrent medical conditions included Heart disorder (have heart problems), Sleep disorder, Neuropathy, Knee replacement and Blood pressure fluctuation (Emergency blood pressure). Concomitant products included METOPROLOL for Blood pressure fluctuation, AMLODIPINE for Blood pressure high, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Knee replacement, PREGABALIN (LYRICA) for Neuropathy, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, ESTRADIOL for an unknown indication. On 08-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (severe burning/cooling sensation), VISION BLURRED (hazy vision starts in left eye and it moves to the right eye), MIOSIS (pupils constricted), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (weird headache starts in back of head and is burning / The headache completely incapacitates her when it starts. She feels it move to the frontal lobe, and it vanishes just as quickly as it comes) and MYALGIA (body aches severe on left arm). On 09-Sep-2021, the patient experienced MOBILITY DECREASED (could not close joints / could not use her hand). On 16-Sep-2021, the patient experienced HYPOAESTHESIA (numbness in left ear and left cheek) and PARAESTHESIA (tingling in left ear and left cheek). On an unknown date, the patient experienced CHEST PAIN (chest pain). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (severe burning/cooling sensation), VISION BLURRED (hazy vision starts in left eye and it moves to the right eye), MIOSIS (pupils constricted), HYPOAESTHESIA (numbness in left ear and left cheek), PARAESTHESIA (tingling in left ear and left cheek), CHEST PAIN (chest pain), MOBILITY DECREASED (could not close joints / could not use her hand), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (weird headache starts in back of head and is burning / The headache completely incapacitates her when it starts. She feels it move to the frontal lobe, and it vanishes just as quickly as it comes) and MYALGIA (body aches severe on left arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Blood pressure measurement: 110/60 (normal) blood pressure was 110/60 when headache started and 155/99 (High) within 45 minutes,shot up to 155/99.. Patient experiences nausea, 12 hours later followed by fatigue, weird headache that starts in back of the head, and burning, with a severe burning cooling sensation. Patient feels headache moving to the frontal lobe, and disappearing just as quickly as it comes. Patient also have hazy vision which started in the left eye, moving to the right eye. Numbness and tingling in the left ear and left cheek, in the 8th day after the third dose of vaccine . This case was linked to MOD-2021-323605.

Other Meds: AMBIEN; ESTRADIOL; METOPROLOL; LYRICA; NORCO; AMLODIPINE

Current Illness: Blood pressure fluctuation (Emergency blood pressure); Heart disorder (have heart problems); Knee replacement; Neuropathy; Sleep disorder

ID: 1734041
Sex: F
Age: 49
State: AL

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Name: low grade fever; Result Unstructured Data: High

Allergies:

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

Symptoms: low grade fever 100.1; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever 100.1) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included METOPROLOL and AMLODIPINE for Blood pressure, ZOLPIDEM TARTRATE (AMBIEN) for Disorder sleep, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Knee replacement, PREGABALIN (LYRICA) for Neuropathy, ESTRADIOL (ESTRADIOL 2 1 A PHARMA) for an unknown indication. On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever 100.1). At the time of the report, PYREXIA (low grade fever 100.1) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) High. No treatment medications are provided. This case was linked to MOD-2021-323594 (Patient Link).

Other Meds: AMBIEN; ESTRADIOL 2 1 A PHARMA; METOPROLOL; LYRICA; NORCO; AMLODIPINE

Current Illness:

ID: 1734042
Sex: F
Age: 63
State: NV

Vax Date: 09/14/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: swollen left arm around her injection site area; itchy rash around her injection site area; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The medical history was not provided by the reporter. 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 VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills) 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 medication was not provided.

Other Meds:

Current Illness:

ID: 1734043
Sex: F
Age: 75
State: CA

Vax Date: 01/07/2021
Onset Date: 08/28/2021
Rec V Date: 09/25/2021
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: Increased asthma attacks; Severe runny nose; This spontaneous case was reported by a physician and describes the occurrence of RHINORRHOEA (Severe runny nose) and ASTHMA (Increased asthma attacks) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 031M20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder, Asthma and Drug allergy (Gabapentin makes her nauseated and have vertigo). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced RHINORRHOEA (Severe runny nose). On an unknown date, the patient experienced ASTHMA (Increased asthma attacks). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] for Adverse event, at a dose of unk, Nebulizer; ITRACONAZOLE (ITRACONAZOLE EG) for Sinus infection, at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Severe runny nose) and ASTHMA (Increased asthma attacks) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient thought that might had react more to the vaccine this time around, felt like faucet, patient was checking a box of Kleenex everyday. Other treatment medication included antihistamines. This case was linked to MOD-2021-323634, MOD-2021-323615 (Patient Link).

Other Meds: ADVAIR

Current Illness: Asthma; Autoimmune disorder; Drug allergy (Gabapentin makes her nauseated and have vertigo)

ID: 1734044
Sex: M
Age: 69
State: HI

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore left injection site arm; some swelling in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm) 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. No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-323677 (Patient Link).

Other Meds:

Current Illness:

ID: 1734045
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: multiple heart attack patients (4 to 5); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (multiple heart attack patients (4 to 5)) 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 MYOCARDIAL INFARCTION (multiple heart attack patients (4 to 5)) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (multiple heart attack patients (4 to 5)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications are provided by reporter. No treatment medications are provided by reporter. company comment: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected event of myocardial infarction. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-323647, MOD21-144997, MOD-2021-323647 (Patient Link).; Sender's Comments: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected event of myocardial infarction. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1734046
Sex: M
Age: 69
State: HI

Vax Date: 09/14/2021
Onset Date:
Rec V Date: 09/25/2021
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: Very tired like the Flu; Very tired/ Spent the day after the second vaccine in bed.; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-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 INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided No treatment medication information was provided This case was linked to MOD-2021-323655 (Patient Link).

Other Meds:

Current Illness:

ID: 1734047
Sex: F
Age: 40
State: TX

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Could not sleep last night; Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm; Red Injection site (2 quarters size); Swelling on the injection site; Itchiness on the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep last night), VACCINATION SITE PRURITUS (Itchiness on the Injection site), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness on the Injection site). On 17-Sep-2021, the patient experienced INSOMNIA (Could not sleep last night), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 17-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Could not sleep last night), VACCINATION SITE PRURITUS (Itchiness on the Injection site), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient states that she could not sleep last night from the pain and she can not pick up her baby using her left arm. No concomitant medication details were reported.

Other Meds:

Current Illness:

ID: 1734048
Sex: M
Age: 63
State: GA

Vax Date: 01/15/2021
Onset Date: 03/01/2021
Rec V Date: 09/25/2021
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: Test Name: BLOOD TEST; Result Unstructured Data: SLIGHT ANEMIA; Test Name: BLOOD TEST; Result Unstructured Data: the blood work showed that the anemia is doing better, closer to normal ranges.; Test Name: ENDOSCOPY; Result Unstructured Data: no bleeding

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: slight anemia.; Hair loss is everywhere on his body((eyebrows, chest, arms, legs); hair is so thin and light; he started losing hair on his head first./hair loss is progressively worse; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included SIMVASTATIN, LISINOPRIL, COLLAGEN, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERENOA REPENS (PROSTATE HEALTH [SERENOA REPENS]), TURMERIC [CURCUMA LONGA RHIZOME] and BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]) for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse). At the time of the report, ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: slight anemia (abnormal) SLIGHT ANEMIA and the blood work showed that the anemia is doing bet (normal) the blood work showed that the anemia is doing better, closer to normal ranges.. On an unknown date, Endoscopy: no bleeding (normal) no bleeding. The patient was also taking Acu vitamin concomitantly. No treatment information was provided.

Other Meds: SIMVASTATIN; LISINOPRIL; COLLAGEN; BABY ASPIRIN; PROSTATE HEALTH [SERENOA REPENS]; TURMERIC [CURCUMA LONGA RHIZOME]; PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]

Current Illness:

ID: 1734049
Sex: U
Age:
State:

Vax Date: 09/09/2021
Onset Date:
Rec V Date: 09/25/2021
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: Loss of my sense of smell/ experiencing anosmia after receiving vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of my sense of smell/ experiencing anosmia after receiving vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of my sense of smell/ experiencing anosmia after receiving vaccine). At the time of the report, ANOSMIA (Loss of my sense of smell/ experiencing anosmia after receiving vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1734050
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: very sick; Every time she stands, bends, or changes position she has breathing problems; Cardiac disorder / Every time she stands, bends, or changes position she has heart problems; lost all of her energy / hard to get up everyday; very bad joint pain; chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday) and ARTHRALGIA (very bad joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue) outcome was unknown. No treatment medications provided. No Concomitant medications provided. Spike protient antibody test was done with a score over 4000, of which passing score was 1.00 or 0.8.

Other Meds:

Current Illness:

ID: 1734051
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: received a dose of the vaccine more than 12 hs after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture) 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 medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am