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: 1645246
Sex: M
Age: 78
State: OR

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Hemoglobin; Result Unstructured Data: hemoglobin was down to 5

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Pulmonary embolism/blood clot in his lungs; Hiatal hernia; Hemoglobin was down to 5; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hip surgery and Blood transfusion. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs) (seriousness criteria medically significant and life threatening), HIATUS HERNIA (Hiatal hernia) and HAEMOGLOBIN DECREASED (Hemoglobin was down to 5). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs), HIATUS HERNIA (Hiatal hernia) and HAEMOGLOBIN DECREASED (Hemoglobin was down to 5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 5 (Low) hemoglobin was down to 5. Concomitant product use was not provided by the reporter. The patient stated that he had a pulmonary embolism after his hip surgery and was placed on Eliquis. After 6 months while taking Eliquis he developed a blood clot in his lungs and was placed on Eliquis for life. This last week he went in for some blood tests and his hemoglobin was down to 5. He was given 3 units of blood by transfusion. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Thromboembolic events are one of the AESI in the use of the product Patient will continue to be monitored. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Thromboembolic events are one of the AESI in the use of the product Patient will continue to be monitored. Further information is expected.

Other Meds:

Current Illness:

ID: 1645247
Sex: F
Age:
State: AL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Pneumonia; Bronchitis; COVID-19 Positive; Missed the recommended interval between doses; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), BRONCHITIS (Bronchitis), COVID-19 (COVID-19 Positive) and PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses). At the time of the report, PNEUMONIA (Pneumonia), BRONCHITIS (Bronchitis) and COVID-19 (COVID-19 Positive) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information reported that, the patient got infusion in the hospital. Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1645248
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: People that died; 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 DEATH (People that died) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medications were not reported. The treatment information was not provided. Company Comment : This case cannot be evaluated, it seems invalid. More info has been required to assess its validity.; Sender's Comments: This case cannot be evaluated, it seems invalid. More info has been required to assess its validity.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1645249
Sex: F
Age: 45
State: NJ

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: sore arm; mild body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A /) for COVID-19 vaccination. No Medical History information was reported. On 21-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 arm) and MYALGIA (mild body aches). At the time of the report, VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. This case was linked to MOD-2021-289960 (Patient Link).

Other Meds:

Current Illness:

ID: 1645250
Sex: F
Age: 69
State:

Vax Date: 03/03/2021
Onset Date: 03/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore right injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site shoulder). At the time of the report, VACCINATION SITE PAIN (sore right injection site shoulder) outcome was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient received her vaccine in the right arm shoulder deltoid muscle. This case was linked to MOD-2021-289814 (Patient Link).

Other Meds:

Current Illness:

ID: 1645251
Sex: M
Age: 70
State: CO

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012Y20A and 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away). At the time of the report, URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away) had not resolved. Concomitant product use was not provided by the reporter. The patient developed hives 3 1/2 months ago after the second dose. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1645252
Sex: M
Age: 65
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: body ache; started to feel real fatigued; muscle aches; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The patient's past medical history included COVID-19 in September 2020. Concomitant products included VITAMINS NOS and KRILL OIL for an unknown indication. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache). On 17-Aug-2021, PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds: VITAMINS NOS; KRILL OIL

Current Illness:

ID: 1645253
Sex: F
Age:
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: flared up her autoimmune disorder; Inflammation for a couple of weeks after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (flared up her autoimmune disorder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Polymyalgia rheumatica (She is an immunocompromised patient who has Polymyalgia Rheumatica). Concomitant products included PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Polymyalgia rheumatica. 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 AUTOIMMUNE DISORDER (flared up her autoimmune disorder) (seriousness criterion medically significant) and INFLAMMATION (Inflammation for a couple of weeks after the second dose). At the time of the report, AUTOIMMUNE DISORDER (flared up her autoimmune disorder) and INFLAMMATION (Inflammation for a couple of weeks after the second dose) outcome was unknown. Treatment medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PREDNISONE [PREDNISONE ACETATE]

Current Illness: Polymyalgia rheumatica (She is an immunocompromised patient who has Polymyalgia Rheumatica)

ID: 1645254
Sex: M
Age:
State: LA

Vax Date: 03/18/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: tested positive for COVID/ no symptoms; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Hepatitis B and Fracture. Concomitant products included TENOFOVIR DISOPROXIL FUMARATE (VIREAD), CLONIDINE (CATAPRESS) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown. The patient was very pleased with the vaccine. Treatment information was not provided.

Other Meds: VIREAD; CATAPRESS; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]

Current Illness: Fracture; Hepatitis B

ID: 1645255
Sex: F
Age: 45
State: NJ

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: High

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Delirious; Can barely move; arm, foot, hand and toe has been ach; Sweats; body aches; hip has been achy; Nausea; Fatigue/extreme exhaustion; 102 Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirious) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 DELIRIUM (Delirious) (seriousness criterion medically significant), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever). At the time of the report, DELIRIUM (Delirious), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information. This case was linked to MOD-2021-289827 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.

Other Meds:

Current Illness:

ID: 1645256
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: possible unset of dementia following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (possible unset of dementia following vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (possible unset of dementia following vaccination) (seriousness criterion medically significant). At the time of the report, DEMENTIA (possible unset of dementia following vaccination) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient lost his vaccination card because of him suffering dementia. He had received two doses of the Moderna COVID19 vaccine and she was looking for assistance on how to get the booster dose. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1645257
Sex: F
Age: 66
State: FL

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210513; Test Name: Heart rate; Result Unstructured Data: Increased

Allergies:

Symptom List: Rash, Urticaria

Symptoms: has not received her 2nd dose; blur vision; heart was racing; her chest hurt; fluttering heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering heart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer. Concomitant products included OMEPRAZOLE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), METOPROLOL, VALSARTAN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CARDIAC FLUTTER (fluttering heart) (seriousness criterion medically significant), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose). On 13-May-2021, CARDIAC FLUTTER (fluttering heart), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Heart rate: increased (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.

Other Meds: OMEPRAZOLE; NORCO; METOPROLOL; VALSARTAN; NEURONTIN; SYNTHROID; XANAX; VITAMINS NOS

Current Illness: Cancer

ID: 1645258
Sex: M
Age: 59
State: FL

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works; His whole side of the face is numb; got headache like crazy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Liver transplant and Immunosuppressant drug therapy since an unknown date. Concurrent medical conditions included Bell's palsy (He has Bell's palsy last July. He went on therapy and was getting better) since July 2020. Concomitant products included TACROLIMUS (PROGRAF), LISINOPRIL and GABAPENTIN for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works) (seriousness criterion medically significant), HYPOAESTHESIA (His whole side of the face is numb) and HEADACHE (got headache like crazy). At the time of the report, FACIAL PARALYSIS (It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works) had not resolved and HYPOAESTHESIA (His whole side of the face is numb) and HEADACHE (got headache like crazy) outcome was unknown. Concomitant medication included Etdir. Treatment information included Gabapentin. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested. This case was linked to MOD-2021-289533 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.

Other Meds: PROGRAF; LISINOPRIL; GABAPENTIN

Current Illness: Bell's palsy (He has Bell's palsy last July. He went on therapy and was getting better); Immunosuppressant drug therapy

ID: 1645259
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Possible heart inflammation; injection sight supposed to swell; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDITIS (Possible heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 MYOCARDITIS (Possible heart inflammation) (seriousness criterion medically significant) and VACCINATION SITE SWELLING (injection sight supposed to swell). At the time of the report, MYOCARDITIS (Possible heart inflammation) and VACCINATION SITE SWELLING (injection sight supposed to swell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment history was reported. Very limited information regarding the events has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1645260
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Laryngeal swelling with laryngitis; extreme fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of LARYNGITIS (Laryngeal swelling with laryngitis), FATIGUE (extreme fatigue) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Milk allergy, Fruit allergy (Allergic to pineapple) and Seasonal allergy. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced LARYNGITIS (Laryngeal swelling with laryngitis) (seriousness criterion medically significant), FATIGUE (extreme fatigue) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LARYNGITIS (Laryngeal swelling with laryngitis), FATIGUE (extreme fatigue) and PYREXIA (fever) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication was reported by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded The case was reported as serious but on an event level described as non-serious for each criterion.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded The case was reported as serious but on an event level described as non-serious for each criterion.

Other Meds:

Current Illness: Fruit allergy (Allergic to pineapple); Milk allergy; Seasonal allergy

ID: 1645261
Sex: F
Age: 35
State: OH

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: I was diagnosed with Thyroid Eye Disease; I had been having bulging eyes; I had been having dryness; I had been having eye pain; I had a sore arm at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) and EXOPHTHALMOS (I had been having bulging eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Graves' disease since 2019. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Graves' disease. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm at injection site). On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) (seriousness criterion medically significant), EXOPHTHALMOS (I had been having bulging eyes) (seriousness criterion medically significant), DRY EYE (I had been having dryness) and EYE PAIN (I had been having eye pain). At the time of the report, ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease), EXOPHTHALMOS (I had been having bulging eyes), DRY EYE (I had been having dryness), EYE PAIN (I had been having eye pain) and VACCINATION SITE PAIN (I had a sore arm at injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Lab data was not provided Treatment product was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Graves disease could be a confounder of the events. Vaccination site pain is consistent with the Known safety profile of the product. This case was linked to MOD-2021-290495 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Graves disease could be a confounder of the events. Vaccination site pain is consistent with the Known safety profile of the product.

Other Meds: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]

Current Illness: Graves' disease

ID: 1645262
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: I was sick; I summinestred the fist dosis on april, but don`t the second; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second). At the time of the report, ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided. The patient needed to start the process of second vaccine.

Other Meds:

Current Illness:

ID: 1645263
Sex: F
Age: 35
State: OH

Vax Date: 01/14/2021
Onset Date: 02/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I was diagnosed with Thyroid Eye Disease; I had been having bulging eyes; I had been having dryness; I had been having pain; I had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) and EXOPHTHALMOS (I had been having bulging eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Graves' disease since 2019. Concomitant products included LEVOTHYROXINE for Graves' disease. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). On 17-May-2021, the patient experienced ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) (seriousness criterion medically significant), EXOPHTHALMOS (I had been having bulging eyes) (seriousness criterion medically significant), DRY EYE (I had been having dryness) and EYE PAIN (I had been having pain). At the time of the report, ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease), EXOPHTHALMOS (I had been having bulging eyes), DRY EYE (I had been having dryness), EYE PAIN (I had been having pain) and VACCINATION SITE PAIN (I had a sore arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that she experienced Thyroid Eye Disease.she'd been experiencing eye dryness, pain, & bulging. She reports that she'd been using over the counter eye drops On 20-May-2021 she saw an ophthalmologist and On 10-Jun-2021 saw an eye surgeon. "My Dr recently told me I need to have a hysterectomy." Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient?s history of Grave?s disease could be a confounding factor for the event Endocrine ophthalmopathy. This case was linked to MOD-2021-290469 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient?s history of Grave?s disease could be a confounding factor for the event Endocrine ophthalmopathy.

Other Meds: LEVOTHYROXINE

Current Illness: Graves' disease

ID: 1645264
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Being able to talk with dead people, hearing ?people drumming outside his house' and the constant voice of a co-worker whom he believed to be a paramour- it was later confirmed that there was no romantic relationship/ auditory hallucinations; Superficial and grandiose/ grandiose delusions of becoming clairvoyant; Erotomaniac delusions; Anxious; This literature-non-study case was reported in a literature article and describes the occurrence of HALLUCINATION, AUDITORY (Being able to talk with dead people, hearing ?people drumming outside his house' and the constant voice of a co-worker whom he believed to be a paramour- it was later confirmed that there was no romantic relationship/ auditory hallucinations) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Can new onset psychosis occur after mRNA based COVID-19 vaccine administration? A case report. Psychiatry Res. 2021;304:114165 Concurrent medical conditions included Schizotypal personality disorder (strongly associated with the development of schizophrenia). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION, AUDITORY (Being able to talk with dead people, hearing ?people drumming outside his house' and the constant voice of a co-worker whom he believed to be a paramour- it was later confirmed that there was no romantic relationship/ auditory hallucinations) (seriousness criterion medically significant), DELUSION OF GRANDEUR (Superficial and grandiose/ grandiose delusions of becoming clairvoyant), DELUSIONAL DISORDER, EROTOMANIC TYPE (Erotomaniac delusions) and ANXIETY (Anxious). At the time of the report, HALLUCINATION, AUDITORY (Being able to talk with dead people, hearing ?people drumming outside his house' and the constant voice of a co-worker whom he believed to be a paramour- it was later confirmed that there was no romantic relationship/ auditory hallucinations), DELUSION OF GRANDEUR (Superficial and grandiose/ grandiose delusions of becoming clairvoyant), DELUSIONAL DISORDER, EROTOMANIC TYPE (Erotomaniac delusions) and ANXIETY (Anxious) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HALLUCINATION, AUDITORY (Being able to talk with dead people, hearing ?people drumming outside his house' and the constant voice of a co-worker whom he believed to be a paramour- it was later confirmed that there was no romantic relationship/ auditory hallucinations), DELUSION OF GRANDEUR (Superficial and grandiose/ grandiose delusions of becoming clairvoyant), DELUSIONAL DISORDER, EROTOMANIC TYPE (Erotomaniac delusions) and ANXIETY (Anxious) to be possibly related. Concomitant medications were not provided. Previously, he was asymptomatic, working full-time as an office manager. Although functional adolescence and adulthood, he described himself as a loner, with an inclination to overly spiritual ideas, and able to communicate directly with God. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD. Events seriousness per provided list. This case was linked to MOD-2021-291121 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD. Events seriousness per provided list.

Other Meds:

Current Illness: Schizotypal personality disorder (strongly associated with the development of schizophrenia).

ID: 1645265
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: memory issues; focus; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus) in a patient of an unknown age and gender 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 an unknown date, the patient experienced AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus). At the time of the report, AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by reporter. No treatment details were provided by reporter. Follow thru and losing 30-60 mins of time were reported as adverse events.

Other Meds:

Current Illness:

ID: 1645266
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: 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: mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (mild fever). At the time of the report, PYREXIA (mild fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1645267
Sex: F
Age: 37
State: MD

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: itching on the right side of the back/Itching at the vaccination site; sensation prevented her for sleeping; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The patient's past medical history included Back surgery (An inserted metal in the spine and right shoulder blade). On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced PRURITUS (itching on the right side of the back/Itching at the vaccination site). In August 2021, the patient experienced INSOMNIA (sensation prevented her for sleeping). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) 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. Concomitant medications were not reported. The sensation started after vaccination, but it shortly disappeared, then started at the shoulder blade. She also commented that the sensation prevented her for sleeping. Patient also took steroid cream to alleviate the symptoms.

Other Meds:

Current Illness:

ID: 1645268
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Numbness to face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness to face) 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 HYPOAESTHESIA (Numbness to face). At the time of the report, HYPOAESTHESIA (Numbness to face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant drugs were reported. No Treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1645269
Sex: F
Age: 78
State: FL

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202101; Test Name: GFR; Result Unstructured Data: 62; Test Date: 20210726; Test Name: GFR; Result Unstructured Data: eGFR was down to 48.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: nephritis; Very very unusual drop in kidney function; Stage 3 kidney disease; This spontaneous case was reported by a consumer and describes the occurrence of NEPHRITIS (nephritis), RENAL IMPAIRMENT (Very very unusual drop in kidney function) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 NEPHRITIS (nephritis) (seriousness criterion medically significant), RENAL IMPAIRMENT (Very very unusual drop in kidney function) (seriousness criterion medically significant) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) (seriousness criterion medically significant). At the time of the report, NEPHRITIS (nephritis), RENAL IMPAIRMENT (Very very unusual drop in kidney function) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Glomerular filtration rate: 62 (normal) 62. On 26-Jul-2021, Glomerular filtration rate: 48 (Low) eGFR was down to 48. No concomitant medical information were reported. No treatment information was reported. Company Comment: Very limited information regarding these events have been provided at this time. Other factors may have contributed to the low eGFR as 5 months have passed since patient received last dose of vaccine. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Other factors may have contributed to the low eGFR as 5 months have passed since patient received last dose of vaccine. Further information has been requested.

Other Meds:

Current Illness:

ID: 1645270
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: worser cough than I had the day before I got the modrna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (worser cough than I had the day before I got the modrna 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 Cough. 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 COUGH (worser cough than I had the day before I got the modrna vaccine). At the time of the report, COUGH (worser cough than I had the day before I got the modrna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided by the reporter.

Other Meds:

Current Illness: Cough

ID: 1645271
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: had a side effect with my two doses of vaccine other than sore arm/; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm) 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 VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm). At the time of the report, VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications was provided. No Treatment medications was provided. This case was linked to MOD-2021-290688 (Patient Link).

Other Meds:

Current Illness:

ID: 1645272
Sex: F
Age: 72
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: lost the eye sight in the right eye/ patient said the left eye that had a recent transplant have been settle down and been ok, the right eye no, have lost my vision; severe inflammation (both eyes ); edema (both eyes); Destroyed the surface of the cornea. The cornea literally felt apart; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (lost the eye sight in the right eye/ patient said the left eye that had a recent transplant have been settle down and been ok, the right eye no, have lost my vision) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Corneal transplant (2 corneal transplants (left eye and is still recovering)) and Cataract (right) (glaucoma cataract (right eye).). Concurrent medical conditions included Colitis. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for Hypothyroidism, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), LOTEPREDNOL ETABONATE (LOTEMAX), LATANOPROSTENE BUNOD (VYZULTA), PREDNISONE, VALACICLOVIR HYDROCHLORIDE (VALTREX), ACETAZOLAMIDE SODIUM (DIAMOX [ACETAZOLAMIDE SODIUM]), ESCITALOPRAM OXALATE (LEXAPRO), BIFIDOBACTERIUM INFANTIS (ALIGN), CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, 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 BLINDNESS UNILATERAL (lost the eye sight in the right eye/ patient said the left eye that had a recent transplant have been settle down and been ok, the right eye no, have lost my vision) (seriousness criterion medically significant), EYE INFLAMMATION (severe inflammation (both eyes )), EYE OEDEMA (edema (both eyes)) and INJURY CORNEAL (Destroyed the surface of the cornea. The cornea literally felt apart). The patient was treated with PREDNISONE at a dose of increase the prednisone up until 5 times a day.. At the time of the report, BLINDNESS UNILATERAL (lost the eye sight in the right eye/ patient said the left eye that had a recent transplant have been settle down and been ok, the right eye no, have lost my vision), EYE INFLAMMATION (severe inflammation (both eyes )), EYE OEDEMA (edema (both eyes)) and INJURY CORNEAL (Destroyed the surface of the cornea. The cornea literally felt apart) outcome was unknown. Concomitant medication : Clanex, nasal Spray, Straviol, Xerotear(fish oil), pressure visions. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's underlying history of glaucoma cataract and corneal transplants remains a contributory factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's underlying history of glaucoma cataract and corneal transplants remains a contributory factor.

Other Meds: Combigan; Lotemax; Vyzulta; Prednisone; Valtrex; Diamox [Acetazolamide Sodium]; Levoxyl; Lexapro; Align; Calcium; Vitamin D [Colecalciferol]

Current Illness: Colitis

ID: 1645273
Sex: F
Age: 61
State: VA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall; the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall; chills; a low grade fever today of 99.5 F/She had a fever last night with shakes; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), CHILLS (chills), PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced CHILLS (chills), PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall) and VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall). At the time of the report, VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), CHILLS (chills) and PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. No concomitant medication was provided. No treatment information was provided. This case was linked to MOD-2021-290761 (Patient Link).

Other Meds:

Current Illness:

ID: 1645274
Sex: F
Age:
State: MA

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

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: Coronary Angiogram/ angiography; Test Result: Inconclusive; Result Unstructured Data: LC 100%; Test Name: Coronary Angiogram/ angiography; Result Unstructured Data: Emergency occluded proximal segment of the left circumflex (LC) artery with a globular thrombus and TIMI 0 flow; Test Name: angiogram; Test Result: Inconclusive ; Result Unstructured Data: TIMI III flow; Test Name: BMI; Test Result: Inconclusive; Result Unstructured Data: 46.6 kg/m2; Test Name: Ischemic Changes on ECG; Result Unstructured Data: Inferior ST elevation; Test Name: cardiac ultrasound; Result Unstructured Data: hypokinesis of the anterolateral and inferolateral walls; Test Name: cardiac ultrasound; Result Unstructured Data: mild hypokinesis of the anterolateral and inferolateral walls; Test Name: LVEF; Test Result: Inconclusive; Result Unstructured Data: 50 percent; Test Name: LVEF; Test Result: Inconclusive; Result Unstructured Data: 60 percent; Test Name: Sars- CoV-2 PCR; Test Result: Negative ; Result Unstructured Data: negative, on 2 separate nasopharyngeal aspirates; Test Name: Peak Troponin; Test Result: Inconclusive; Result Unstructured Data: 4714 ng/L.

Allergies:

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

Symptoms: Acute myocardial infarction; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Acute myocardial infarction within 24 hours after COVID-19 vaccination. 2021;S0002-9149(21):00631-7 The patient's past medical history included Nasopharyngeal aspiration (2 separate) and Percutaneous coronary intervention (performed to the LC artery, the patient was free of chest pain after PCI). Concurrent medical conditions included Smoker, Hypertension, Hyperlipidemia and Coronary artery disease (Prior, with no Family History of Premature Coronary Artery Disease). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to ACUTE MYOCARDIAL INFARCTION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiocardiogram: LC 100% (Inconclusive) LC 100% and artery with a globular thrombus and TIMI 0 flow (abnormal) Emergency occluded proximal segment of the left circumflex (LC) artery with a globular thrombus and TIMI 0 flow. On an unknown date, Angiogram: TIMI iii flow (Inconclusive) TIMI III flow. On an unknown date, Body mass index: 46.6 kg/m2 (Inconclusive) 46.6 kg/m2. On an unknown date, ECG signs of myocardial infarction: inferior ST elevation (abnormal) Inferior ST elevation. On an unknown date, Echocardiogram: hypokinesis of the anterolateral and inferolateral (abnormal) hypokinesis of the anterolateral and inferolateral walls and mild hypokinesis (abnormal) mild hypokinesis of the anterolateral and inferolateral walls. On an unknown date, Ejection fraction: 50 (Inconclusive) 50 percent and 60 (Inconclusive) 60 percent. On an unknown date, SARS-CoV-2 test: negative (Negative) negative, on 2 separate nasopharyngeal aspirates. On an unknown date, Troponin: 4714 ng/l (Inconclusive) 4714 ng/L. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) to be possibly related. Concomitant medications were not provided by the reporter. No treatment was provided. It was reported that acute myocardial infarction with onset less than 24 hours after the first dose of a COVID-19 vaccine. The angiographic features of case was suggestive of acute thrombotic events as the underlying mechanism. Patient was discharged 1 week after admission. This case concerned of patients 1 and attributed the chest pain to local effects of the vaccine injection. Based on the current available information and temporal association between the use of the product and the start of events (1 day after vaccination), a causal relationship cannot be excluded. However, patient's age, smoking habit and previous history of hypertension, hyperlipidemia and prior coronary artery disease can be relevant confounders. This case was linked to MOD-2021-290649 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of events (1 day after vaccination), a causal relationship cannot be excluded. However, patient's age, smoking habit and previous history of hypertension, hyperlipidemia and prior coronary artery disease can be relevant confounders.

Other Meds:

Current Illness: Coronary artery disease (Prior, with no Family History of Premature Coronary Artery Disease); Hyperlipidemia; Hypertension; Smoker.

ID: 1645275
Sex: M
Age:
State: GA

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

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

Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: getting less oxygen; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive with the virus

Allergies:

Symptom List: Nausea

Symptoms: peripheral neuropathy got worst by 10 times/neuropathy and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down; feeling freezing; arthritis got worst by 50 times and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down; migraine that constantly were on -going for the next 5 days; lack of breathing; only can sleep left side just for 5-10 minutes; feels like he is getting suffocating; body temperature of 93.1 degree; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy got worst by 10 times/neuropathy and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down but remain un-change on his left hip and thigh side) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis and Peripheral neuropathy. Concomitant products included NORTRIPTYLINE HYDROCHLORIDE (PAMELOR) and CLONAZEPAM (KLONOPIN) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy got worst by 10 times/neuropathy and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down but remain un-change on his left hip and thigh side) (seriousness criterion medically significant), FEELING COLD (feeling freezing), ARTHRITIS (arthritis got worst by 50 times and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down but remain un-change on his left hip and thigh side), MIGRAINE (migraine that constantly were on -going for the next 5 days), DYSPNOEA (lack of breathing), SLEEP DISORDER (only can sleep left side just for 5-10 minutes), SUFFOCATION FEELING (feels like he is getting suffocating) and BODY TEMPERATURE ABNORMAL (body temperature of 93.1 degree). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 325 milligram,(doubled) then normally take in middle of the day and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy got worst by 10 times/neuropathy and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down but remain un-change on his left hip and thigh side), FEELING COLD (feeling freezing), ARTHRITIS (arthritis got worst by 50 times and arthritis went down but remain un-change on his left hip and thigh sideneuropathy and arthritis went down but remain un-change on his left hip and thigh side), MIGRAINE (migraine that constantly were on -going for the next 5 days), DYSPNOEA (lack of breathing), SLEEP DISORDER (only can sleep left side just for 5-10 minutes), SUFFOCATION FEELING (feels like he is getting suffocating) and BODY TEMPERATURE ABNORMAL (body temperature of 93.1 degree) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: less oxygen (Low) getting less oxygen. On an unknown date, SARS-CoV-2 test: positive (Positive) positive with the virus. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant includes supplement for arthritis was reported. Patient does not know the exact date but believes received the 1st dose in Mid or late-april or may was reported. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds: PAMELOR; KLONOPIN

Current Illness:

ID: 1645276
Sex: M
Age: 23
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: second dose after day 42; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-May-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up information received on 21-Aug-2021 and Included No new information.

Other Meds:

Current Illness:

ID: 1645277
Sex: F
Age: 56
State:

Vax Date: 05/15/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Seizure; Broke her teeth; 1st dose 15-May-2021 and then the second dose on 30-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Root canal procedure (Root canal). Previously administered products included for Product used for unknown indication: Restylane kysse in November 2020. Concurrent medical conditions included Seizure (Seizure disorder) since November 2020. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-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 SEIZURE (Seizure) (seriousness criterion medically significant), TOOTH FRACTURE (Broke her teeth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-May-2021 and then the second dose on 30-May-2021). The patient was treated with TOPIRAMATE (TOPAMAX) in July 2021 for Seizure, at a dose of 50 milligram. At the time of the report, SEIZURE (Seizure) and TOOTH FRACTURE (Broke her teeth) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-May-2021 and then the second dose on 30-May-2021) had resolved. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Seizure (Seizure disorder)

ID: 1645278
Sex: F
Age: 24
State: AZ

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

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

Lab Data:

Allergies:

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

Symptoms: Bottom lip keeps getting inflamed; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Bottom lip keeps getting inflamed) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088921A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEILITIS (Bottom lip keeps getting inflamed). At the time of the report, CHEILITIS (Bottom lip keeps getting inflamed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1645279
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Just got 1st shot is my nose suppose to run; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Just got 1st shot is my nose suppose to run) 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 RHINORRHOEA (Just got 1st shot is my nose suppose to run). At the time of the report, RHINORRHOEA (Just got 1st shot is my nose suppose to run) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1645280
Sex: F
Age: 13
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: 1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.). On 10-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication was provided Treatment medication was not provided by the reporter

Other Meds:

Current Illness:

ID: 1645281
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bell's Palsy; jaundice; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In April 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 BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and JAUNDICE (jaundice). At the time of the report, BELL'S PALSY (Bell's Palsy) and JAUNDICE (jaundice) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. No concomitant medication was provided by the reporter. Company Comment: Very limited information regarding these events has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Additional initial.; Sender's Comments: Very limited information regarding these events has been provided at this time

Other Meds:

Current Illness:

ID: 1645282
Sex: F
Age: 54
State: UT

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

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

Lab Data:

Allergies:

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

Symptoms: She still has bumps but they are not as raised and itchy; On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy) and PAPULE (She still has bumps but they are not as raised and itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. Medical history was not reported. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. 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 RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy). On an unknown date, the patient experienced PAPULE (She still has bumps but they are not as raised and itchy). The patient was treated with LORATADINE at a dose of UNK dosage form and ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy) and PAPULE (She still has bumps but they are not as raised and itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication was provided. Treatment information was not provided.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1645283
Sex: U
Age:
State:

Vax Date: 07/15/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210801; Test Name: COVID-19 Test; Test Result: Positive; Result Unstructured Data: Positive.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: I now have covid pneumonia; I was covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (I now have Covid pneumonia) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (I was covid positive). On an unknown date, the patient experienced COVID-19 PNEUMONIA (I now have covid pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (I now have covid pneumonia) and COVID-19 (I was covid positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Reporter did not allow further contact; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1645284
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: had a side effect with my two doses of vaccine other than sore arm/; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/). At the time of the report, PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/) outcome was unknown. No concomitant medication was reported. No treatment information was reported. This case was linked to MOD-2021-290599 (Patient Link).

Other Meds:

Current Illness:

Date Died: 08/16/2021

ID: 1645285
Sex: M
Age: 67
State: CA

Vax Date: 01/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: very low; Test Name: Oxygen saturation; Result Unstructured Data: oxygen was not going to the blood; Test Name: COVID-19 virus test; Test Result: Positive; Result Unstructured Data: positive.

Allergies:

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

Symptoms: He was placed in the ICU and passed on 16Aug2021; COVID-19; High grade fever; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He was placed in the ICU and passed on 16Aug2021), COVID-19 (COVID-19) and PYREXIA (High grade fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (COVID-19) (seriousness criteria death and life threatening), PYREXIA (High grade fever) (seriousness criterion life threatening) and DRUG INEFFECTIVE (Lack of drug effect). On 16-Aug-2021, PYREXIA (High grade fever) outcome was unknown. The patient died on 16-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DRUG INEFFECTIVE (Lack of drug effect) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: very low (Low) very low. On an unknown date, Oxygen saturation: low (Low) oxygen was not going to the blood. On an unknown date, SARS-CoV-2 test: positive (Positive) positive. Concomitant information was not provided by reporter. No treatment information was provided. Patient had 1st dose of Moderna COVID-19 vaccine in last week of Jan2021 and 2nd dose was administered 28 days after. Two weeks ago patient was diagnosed to have COVID-19 and initially had high grade fever for a few days but had to be taken to a hospital where patient was intubated because oxygen was not going to the blood and was also noted to have very low blood pressure. Patient was placed in the ICU and passed on 16-Aug-2021. Company comment: This is a case of COVID-19 infection with fatal outcome in a 67-year-old male who died about six months after receiving the second dose of vaccine. This report refers to a case of Drug ineffective for mRNA-1273, lot #unspecified (for the two doses). Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the prolonged time since the last dose of vaccine was administered and compatibility of the event of Pyrexia with a severe COVID-19 infection, this event is assessed as unlikely related to mRNA-1273. Further information was requested.; Sender's Comments: This is a case of COVID-19 infection with fatal outcome in a 67-year-old male who died about six months after receiving the second dose of vaccine. This report refers to a case of Drug ineffective for mRNA-1273, lot #unspecified (for the two doses). Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the prolonged time since the last dose of vaccine was administered and compatibility of the event of Pyrexia with a severe COVID-19 infection, this event is assessed as unlikely related to mRNA-1273. Further information was requested.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1645286
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Contracted COVID after taking the vaccine; Couldn't remember things/some short-term memory loss; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches). At the time of the report, COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were provided. Treatment information was not provided. Patient's husband believed that his wife had taken Moderna vaccine if he was not mistaken. His wife worked in the healthcare field and had to take the vaccine through her job. He had to quarantine for 2 weeks after his wife contracted COVID. He confirmed that he had no NDC, lot or expiry date for the Moderna vaccine his wife had taken. He stated that she was doing fine. However; he mentioned that his wife still had headaches but had returned to work. He reported that after contracting COVID, his wife had some kind of memory loss. If she made plans for today, she would not remember.

Other Meds:

Current Illness:

ID: 1645287
Sex: M
Age: 35
State: UT

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: has not gotten his second dose, yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose, yet) in a 36-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose, yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose, yet) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1645288
Sex: F
Age: 73
State: NJ

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm hurt; Slight headache; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 012A21A) for COVID-19 vaccination. The patient's past medical history included AFib (Tylenol to alleviate the symptoms). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Treatment information was not provided. This case was linked to MOD-2021-290795 (Patient Link).

Other Meds: TYLENOL

Current Illness:

Date Died:

ID: 1645289
Sex: M
Age:
State: IA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 2021; Test Name: HCO3; Result Unstructured Data: 24.5 mmol/L on presenting to the hospital second time; Test Date: 2021; Test Name: serum creatinine; Result Unstructured Data: baseline serum creatinine ranging from 0.9 to 1.0 mg/dL without proteinuria.; Test Date: 2021; Test Name: serum creatinine; Result Unstructured Data: serum creatinine, 1.5 mg/dL on admission; Test Date: 2021; Test Name: arterial blood gases; Result Unstructured Data: Arterial blood gas (FiO2 0.44) confirmed acute hypoxic respiratory failure on presenting to the hospital second time; Test Date: 2021; Test Name: Non-fasting glucose; Result Unstructured Data: Non-fasting glucose was 492 mg/dL; Test Date: 2021; Test Name: BNP; Result Unstructured Data: BNP, 175 pg/mL on admission; Test Date: 2021; Test Name: PaCO2; Result Unstructured Data: 30.3 mm Hg on presenting to the hospital second time; Test Date: 2021; Test Name: Chest X-ray; Result Unstructured Data: Chest X-ray did not demonstrate any acute findings; Test Date: 2021; Test Name: Chest X-ray; Result Unstructured Data: Chest X-ray now showed an interstitial opacity in the left lower lung on presenting to the hospital second time; Test Date: 2021; Test Name: D-dimer; Result Unstructured Data: D-dimer, 557 ng/mL on admission; Test Date: 2021; Test Name: hemoglobin A1c; Result Unstructured Data: hemoglobin A1c was 8.2%; Test Date: 2021; Test Name: absolute lymphocyte count; Result Unstructured Data: 150/?L (baseline 5 months prior: 550/?L) - On admission; Test Date: 2021; Test Name: pulse oximeter; Result Unstructured Data: pulse oximeter reading was 66% on ambient air on presenting to the hospital second time; Test Date: 2021; Test Name: SatO2; Result Unstructured Data: 89.7% despite supplemental oxygen on presenting to the hospital second time; Test Date: 2021; Test Name: pH; Result Unstructured Data: pH 7.49 on presenting to the hospital second time; Test Date: 2021; Test Name: PaO2; Result Unstructured Data: 55.5mm Hg on presenting to the hospital second time; Test Date: 2021; Test Name: respiratory rate; Result Unstructured Data: 30 bpm on presenting to the hospital second time; Test Date: 2021; Test Name: SARS-CoV-2 antispike antibody; Test Result: Negative; Result Unstructured Data: A SARS-CoV-2 antispike antibody was undetectable (<0.8 units) by semiquantitative immunoassay; Comments: used Elecsys Anti-SARS-CoV-2 S, ; Test Date: 2021; Test Name: SARS-CoV-2; Test Result: Positive; Result Unstructured Data: COVID-19 was confirmed with a positive nasopharyngeal swab sample by SARS-CoV-2 real-time reverse transcription-polymerase chain reaction with a cycle threshold value for target N2 of 19.5; Comments: Used Xpert Xpress SARS-CoV-2, Cepheid; Test Date: 2021; Test Name: SARS-CoV-2; Test Result: Positive; Result Unstructured Data: A repeat nasopharyngeal sample obtained 2 days after admission confirmed persistent positivity of SARS CoV- 2 by reverse transcription-polymerase chain reaction with a cycle threshold value for target N2 gene of 15.2; Test Date: 2021; Test Name:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: fatal COVID-19 infection; hypoxic respiratory failure; tachypnea/tachypneic; nonproductive cough; intermittent low-grade; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (fatal COVID-19 infection), RESPIRATORY FAILURE (hypoxic respiratory failure) and TACHYPNOEA (tachypnea/tachypneic) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Case report: Severe COVID-19 in a kidney transplant recipient without humoral response to SARS-CoV-2 mRNA vaccine series. Transplant Direct. 2021;7(9):e473 The patient's past medical history included Renal transplant (with antithymocyte globulin induction 6 years prior presented with exertional dyspnea, posttransplant course has been uncomplicated without kidney allograft rejection, chronic infection, or hospitalization.) in 2015 and Noninvasive mechanical ventilation (Shortly after admission, noninvasive positive pressure ventilation was initiated for increasing oxygen requirements.) since an unknown date. Concurrent medical conditions included End stage renal disease, IgA nephropathy, Immunosuppression (on stable maintenance immunosuppression) and Exertional dyspnea. Concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL for Immunosuppression. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (fatal COVID-19 infection) (seriousness criteria death and hospitalization prolonged), RESPIRATORY FAILURE (hypoxic respiratory failure) (seriousness criteria death, hospitalization prolonged and medically significant), TACHYPNOEA (tachypnea/tachypneic) (seriousness criterion hospitalization prolonged), COUGH (nonproductive cough) and PYREXIA (intermittent low-grade). The patient was hospitalized for 7 days due to COVID-19, RESPIRATORY FAILURE and TACHYPNOEA. The patient was treated with DEXAMETHASONE (intravenous) for COVID-19, at a dose of 6 mg once a day; REMDESIVIR (intravenous) at a dose of 100 mg once a day; PREDNISONE for Cough and Fever, at a dose of 30 milligram; PREDNISONE for Cough and Fever, at a dose of 20 milligram and PREDNISONE for Cough and Fever, at a dose of 10 milligram. The patient died on an unknown date. The reported cause of death was this case of a kidney transplant recipient who developed a fatal covid-19 infection about 11 d after completion of the sars-cov-2 mrna vaccine series and Hypoxic respiratory failure. It is unknown if an autopsy was performed. At the time of death, TACHYPNOEA (tachypnea/tachypneic), COUGH (nonproductive cough) and PYREXIA (intermittent low-grade) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bicarbonate: high (High) 24.5 mmol/L on presenting to the hospital second time. In 2021, Blood creatinine: 0.9 to 1.0 mg/dl (normal) baseline serum creatinine ranging from 0.9 to 1.0 mg/dL without proteinuria. and normal (normal) serum creatinine, 1.5 mg/dL on admission. In 2021, Blood gases: abnormal (abnormal) Arterial blood gas (FiO2 0.44) confirmed acute hypoxic respiratory failure on presenting to the hospital second time. In 2021, Blood glucose: high (High) Non-fasting glucose was 492 mg/dL. In 2021, Brain natriuretic peptide: normal (normal) BNP, 175 pg/mL on admission. In 2021, Carbon dioxide: low (Low) 30.3 mm Hg on presenting to the hospital second time. In 2021, Chest X-ray: normal (normal) Chest X-ray did not demonstrate any acute findings and abnormal (abnormal) Chest X-ray now showed an interstitial opacity in the left lower lung on presenting to the hospital second time. In 2021, Fibrin D dimer: 557 ng/ml (abnormal) D-dimer, 557 ng/mL on admission. In 2021, Glycosylated haemoglobin: high (High) hemoglobin A1c was 8.2%. In 2021, Lymphocyte count: low (Low) 150/?L (baseline 5 months prior: 550/?L) - On admission. In 2021, Oxygen saturation: low (Low) pulse oximeter reading was 66% on ambient air on presenting to the hospital second time and low (Low) 89.7% despite supplemental oxygen on presenting to the hospital second time. In 2021, PO2: low (Low) 55.5mm Hg on presenting to the hospital second time. In 2021, Respiratory rate: high (High) 30 bpm on presenting to the hospital second time. In 2021, SARS-CoV-2 antibody test: negative (Negative) A SARS-CoV-2 antispike antibody was undetectable (<0.8 units) by semiquantitative immunoassay. In 2021, SARS-CoV-2 test: positive (Positive) COVID-19 was confirmed with a positive nasopharyngeal swab sample by SARS-CoV-2 real-time reverse transcription-polymerase chain reaction with a cycle threshold value for target N2 of 19.5 and positive (Positive) A repeat nasopharyngeal sample obtained 2 days after admission confirmed persistent positivity of SARS CoV- 2 by reverse transcription-polymerase chain reaction with a cycle threshold value for target N2 gene of 15.2. In 2021, Troponin: low (Low) Troponin-I, 0.01 ng/mL on admission. In 2021, Vital signs measurement: normal (normal) Vital signs were notable for tachypnea: body temperature 36.7 ?C, blood pressure 127/83 mm Hg, heart rate 83 bpm, respiratory rate 24 bpm, and SatO2 96% on ambient air.. In 2021, White blood cell count: normal (normal) White blood cell count was 7500/?L on admission. In 2021, pH body fluid: high (High) pH 7.49 on presenting to the hospital second time. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (fatal COVID-19 infection), RESPIRATORY FAILURE (hypoxic respiratory failure), TACHYPNOEA (tachypnea/tachypneic), COUGH (nonproductive cough) and PYREXIA (intermittent low-grade) to be possibly related. Patient started to develop nonproductive cough and intermittent low-grade fevers. His symptoms gradually worsened, and 5 days before admission, he was evaluated in the emergency department. Patient was discharged with a 6 day course of glucocorticoid therapy. He was not tested for SARS-CoV-2 at that time because he had been fully vaccinated. Patient was admitted to the intensive care unit for further treatment after presenting to the hospital the second time where he was found to be tachypneic and severely hypoxic. Upon admission, his exam was notable for bibasilar crackles in lower lung fields without peripheral edema. Patient continued to decompensate and died on the seventh day after admission. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected.; Reported Cause(s) of Death: This case of a kidney transplant recipient who developed a fatal COVID-19 infection about 11 d after completion of the SARS-CoV-2 mRNA vaccine series; hypoxic respiratory failure

Other Meds: TACROLIMUS; MYCOPHENOLATE MOFETIL

Current Illness: End stage renal disease; Exertional dyspnea; IgA nephropathy; Immunosuppression (on stable maintenance immunosuppression); Noninvasive mechanical ventilation (Shortly after admission, noninvasive positive pressure ventilation was initiated for increasing oxygen requirements).

ID: 1645290
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: leg sprain; I pulled a muscle in my leg when walking; It dose not bother me all the time but sometimes it is painful; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (leg sprain), MUSCLE STRAIN (I pulled a muscle in my leg when walking) and MYALGIA (It dose not bother me all the time but sometimes it is painful) 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 LIGAMENT SPRAIN (leg sprain), MUSCLE STRAIN (I pulled a muscle in my leg when walking) and MYALGIA (It dose not bother me all the time but sometimes it is painful). At the time of the report, LIGAMENT SPRAIN (leg sprain), MUSCLE STRAIN (I pulled a muscle in my leg when walking) and MYALGIA (It dose not bother me all the time but sometimes it is painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645291
Sex: F
Age: 73
State: NJ

Vax Date: 01/28/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Arm hurt; Slight headache; Felt tired; Diagnosed with Mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), INFECTIOUS MONONUCLEOSIS (Diagnosed with Mononucleosis), HEADACHE (Slight headache) and FATIGUE (Felt tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination. The patient's past medical history included AFib. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INFECTIOUS MONONUCLEOSIS (Diagnosed with Mononucleosis). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired) had resolved and INFECTIOUS MONONUCLEOSIS (Diagnosed with Mononucleosis) outcome was unknown. No concominant medication is provided. This case was linked to MOD-2021-290723 (Patient Link).

Other Meds:

Current Illness:

ID: 1645292
Sex: F
Age: 66
State: NJ

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 97'F

Allergies:

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

Symptoms: I had chills for about 20 minutes.; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (I had chills for about 20 minutes.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (I had chills for about 20 minutes.). At the time of the report, CHILLS (I had chills for about 20 minutes.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97 (Low) 97'F. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication reported. No treatment medication reported. The patient received the 1st dose of the Moderna Covid-19 vaccine. Reported having chills for about 20 minutes. She didn't take her temperature. Her normal temperature was 97degree F. She was always low. 03Feb2021: Received the 2nd dose of the Moderna Covid-19 vaccine. No side effects to report.

Other Meds:

Current Illness:

ID: 1645293
Sex: M
Age:
State:

Vax Date: 08/13/2021
Onset Date: 08/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: felt a tiny bit under the weather/was feeling under the weather on and off; headache/had a headache which he describes as very slight, nothing crazy; with the exact same thing happening to his big toe on his right foot; felt like gout on the back or heel of his left foot; The joint was sore and not feeling right; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like gout on the back or heel of his left foot), LIMB DISCOMFORT (with the exact same thing happening to his big toe on his right foot), MALAISE (felt a tiny bit under the weather/was feeling under the weather on and off), HEADACHE (headache/had a headache which he describes as very slight, nothing crazy) and ARTHRALGIA (The joint was sore and not feeling right) 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 13-Aug-2021 at 5:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced LIMB DISCOMFORT (felt like gout on the back or heel of his left foot) and ARTHRALGIA (The joint was sore and not feeling right). On 18-Aug-2021, the patient experienced LIMB DISCOMFORT (with the exact same thing happening to his big toe on his right foot). On an unknown date, the patient experienced MALAISE (felt a tiny bit under the weather/was feeling under the weather on and off) and HEADACHE (headache/had a headache which he describes as very slight, nothing crazy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (felt like gout on the back or heel of his left foot) and ARTHRALGIA (The joint was sore and not feeling right) had resolved and LIMB DISCOMFORT (with the exact same thing happening to his big toe on his right foot), MALAISE (felt a tiny bit under the weather/was feeling under the weather on and off) and HEADACHE (headache/had a headache which he describes as very slight, nothing crazy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported

Other Meds:

Current Illness:

ID: 1645294
Sex: F
Age: 58
State: FL

Vax Date: 02/26/2021
Onset Date: 03/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 103 degrees Fahrenheit; Test Date: 2021; Test Name: Covid-19 antibody test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature increased: high (High) 103 degrees Fahrenheit. In 2021, SARS-CoV-2 antibody test: positive (Positive) Positive. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1645295
Sex: F
Age: 57
State: KY

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizziness; Pain in her arm; Felt weak/Didn't feel energetic; Didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in her arm), ASTHENIA (Felt weak/Didn't feel energetic) and FEELING ABNORMAL (Didn't feel good) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication. In 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 DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in her arm), ASTHENIA (Felt weak/Didn't feel energetic) and FEELING ABNORMAL (Didn't feel good). At the time of the report, DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Pain in her arm) had resolved and ASTHENIA (Felt weak/Didn't feel energetic) and FEELING ABNORMAL (Didn't feel good) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The treatment information was not provided. This case was linked to MOD-2021-290867 (Patient Link).

Other Meds: TYLENOL; IBUPROFEN

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am