VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1645195
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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Mild side effects after receiving a booster yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild side effects after receiving a booster yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild side effects after receiving a booster yesterday). At the time of the report, VACCINATION COMPLICATION (Mild side effects after receiving a booster yesterday) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. The patient asked if it was okay to take Tylenol. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645196
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: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment medications are reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645197
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: Arm hurt; Area where I received the shot is very hard like a big knot; Area where I received the shot is very hard like a big knot; Its always extra warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Its always extra warm), VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE INDURATION (Area where I received the shot is very hard like a big knot) and VACCINATION SITE SWELLING (Area where I received the shot is very hard like a big knot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Its always extra warm), VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE INDURATION (Area where I received the shot is very hard like a big knot) and VACCINATION SITE SWELLING (Area where I received the shot is very hard like a big knot). At the time of the report, FEELING HOT (Its always extra warm) outcome was unknown and VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE INDURATION (Area where I received the shot is very hard like a big knot) and VACCINATION SITE SWELLING (Area where I received the shot is very hard like a big knot) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not provided. The area where the patient received the shot was very hard like a big knot and its always extra warm . Treatment medication were not reported.

Other Meds:

Current Illness:

ID: 1645198
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: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Sick to my stomic; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomic) 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 ABDOMINAL DISCOMFORT (Sick to my stomic). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported.

Other Meds:

Current Illness:

ID: 1645199
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Reaction to the second; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to 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. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the second). At the time of the report, VACCINATION COMPLICATION (Reaction to the second) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient did run a reaction to the a reaction to the second. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645200
Sex: U
Age:
State:

Vax Date:
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: Sever headach; Body hurts all over; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sever headach) and MYALGIA (Body hurts all over) 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 HIV infection. 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 HEADACHE (Sever headach) and MYALGIA (Body hurts all over). At the time of the report, HEADACHE (Sever headach) and MYALGIA (Body hurts all over) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. On an unknown date, Body temperature: 98.2 (normal) Temperature 98.2. Reportedly, this was patient's 3rd shot.

Other Meds:

Current Illness: HIV infection

ID: 1645201
Sex: F
Age: 66
State: MI

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

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

Lab Data: Test Date: 20210811; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 19-Feb-2021 for Myalgia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (I had a sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Patient took her second dose on 18-FEB-2021 on left arm, lot number was 013M20A. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested This case was linked to MOD-2021-288260 (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 event, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1645202
Sex: M
Age: 69
State: OH

Vax Date: 02/14/2021
Onset Date: 05/08/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210508; Test Name: POC Glucose; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210509; Test Name: Magnesium; Test Result: Negative; Result Unstructured Data: Negative; Test Date: 20210508; Test Name: X-Ray chest; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210508; Test Name: CT Brain; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210508; Test Name: CT neck; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210508; Test Name: ECG 12-lead; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210508; Test Name: CBC; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210509; Test Name: CBC; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210509; Test Name: HGA1C hemoglobin test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210508; Test Name: INR; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210514; Test Name: MRI brain; Test Result: Negative ; Result Unstructured Data: MRI of the brain with and without contrast and a transthoracic echocardiogram; Test Date: 20210508; Test Name: Comprehensive Metabolic Panel; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210508; Test Name: PT; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210508; Test Name: COVID-19 WVUH molecular test; Test Result: Negative; Result Unstructured Data: Negative.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Bell's Palsy; felt like he was having a stroke; paralysis of the left side of his face/whole left side of his face was drooping; mouth went numb; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (felt like he was having a stroke) and FACIAL PARALYSIS (paralysis of the left side of his face/whole left side of his face was drooping) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS, AMLODIPINE and ESCITALOPRAM for an unknown indication, ROSUVASTATIN CALCIUM (CRESTOR). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (felt like he was having a stroke) (seriousness criterion medically significant), FACIAL PARALYSIS (paralysis of the left side of his face/whole left side of his face was drooping) (seriousness criterion medically significant) and HYPOAESTHESIA ORAL (mouth went numb). The patient was hospitalized for 1 day until 09-May-2021 due to BELL'S PALSY. The patient was treated with PREDNISONE at a dose of 60 mg for one week. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (felt like he was having a stroke), FACIAL PARALYSIS (paralysis of the left side of his face/whole left side of his face was drooping) and HYPOAESTHESIA ORAL (mouth went numb) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood glucose: negative (Negative) negative. On 08-May-2021, Chest X-ray: negative (Negative) negative. On 08-May-2021, Computerised tomogram head: negative (Negative) negative. On 08-May-2021, Computerised tomogram neck: negative (Negative) negative. On 08-May-2021, Electrocardiogram: negative (Negative) negative. On 08-May-2021, Full blood count: negative (Negative) negative. On 08-May-2021, International normalised ratio: negative (Negative) negative. On 08-May-2021, Metabolic function test: negative (Negative) negative. On 08-May-2021, Prothrombin time: negative (Negative) negative. On 08-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2021, Blood magnesium: negative (Negative) Negative. On 09-May-2021, Full blood count: negative (Negative) negative. On 09-May-2021, Glycosylated haemoglobin: negative (Negative) negative. On 14-May-2021, Magnetic resonance imaging head: negative (Negative) MRI of the brain with and without contrast and a transthoracic echocardiogram. Lab data Pronin-1, Type and Screen, ABO and Rh, Lipid panel, Hepatic Function panel, CT angio head, gray Top Tube, Gold Top Tube provided with Negative results. On 08May2021 around noon, the caller stated that he felt like he was having a stroke. He reported that his mouth went numb, and then two hours later the whole left side of his face was drooping. The caller stated that he had paralysis of the left side of his face only. The right side of his face was not involved. He went to the emergency room on 08May2021 around 4:00 PM to rule out if he was having a stroke. On 08May2021, the patient reported having the following tests performed while in the emergency room: POC Glucose, ECG 12-lead, CBC with differential, PT/INR, Pronin-1, Type and Screen, Comprehensive Metabolic Panel, X-Ray chest, Gray Top Tube, Gold Top Tube, CT Brain without IV contrast, CT Angio head and neck, and COVID-19 WVUH molecular lab test. All test results negative for stroke. The caller stated he was diagnosed with Bell's Palsy on 08May2021. He was given an antibiotic (unknown name) for one week and Prednisone 60 mg daily for one week as treatment. The patient was hospitalized for one night. While in the hospital on 09May2021, the patient reported having the following tests performed: HGA1C hemoglobin test, CBC with differential, Lipid Panel, Hepatic Function Panel, Magnesium, Basic Metabolic Panel, and ABO and RH. All test results negative for stroke. The caller stated that he was discharged from the hospital on 09May2021. On 14May2021, patient had an MRI of the brain with and without contrast and a transthoracic echocardiogram. The caller stated that every test he had performed was negative. Stroke was ruled out. The caller mentioned that the Bell's Palsy has only improved 5% since 08May2021. 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: VITAMINS NOS; AMLODIPINE; ESCITALOPRAM; CRESTOR

Current Illness:

ID: 1645203
Sex: F
Age: 76
State: CA

Vax Date: 02/26/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Tinnitus, mostly white noise but sometimes ringing; flu feeling for one day; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 an unknown date, the patient experienced TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day). At the time of the report, TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided.

Other Meds:

Current Illness:

Date Died: 07/23/2021

ID: 1645204
Sex: F
Age: 74
State: FL

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

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

Lab Data: Test Date: 2021; Test Name: biopsy; Result Unstructured Data: extreme vasculitis after a nerve biopsy; Test Date: 2021; Test Name: biopsy; Result Unstructured Data: muscles were debilitating; Test Date: 2021; Test Name: COVID-19; Test Result: Positive; Result Unstructured Data: positive.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of COMA (went into a coma), CARDIAC ARREST (2 days after she was diagnosed with COVID, she fell into cardiac arrest), HYPOKINESIA (couldn't get out of bed/couldn't move), ARTERIAL OCCLUSIVE DISEASE (clogged arteries in her legs), PERONEAL NERVE PALSY (foot drop), COVID-19 (acquired COVID/2 days after she was diagnosed with COVID, she fell into cardiac arrest), RALES (a little bit of crackling in her lungs), ORAL CANDIDIASIS (thrush in her mouth), ASTHENIA (completely weak/extreme weakness), PAIN (extreme pain/continued with the pain), HOSPITALISATION (she was in the hospital for a total of 131 days) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (extreme pain/continued with the pain) (seriousness criteria death, hospitalization and disability). In July 2021, the patient experienced COMA (went into a coma) (seriousness criteria death, hospitalization, disability, medically significant and life threatening), CARDIAC ARREST (2 days after she was diagnosed with COVID, she fell into cardiac arrest) (seriousness criteria death, hospitalization, disability and medically significant) and COVID-19 (acquired COVID/2 days after she was diagnosed with COVID, she fell into cardiac arrest) (seriousness criteria death, hospitalization prolonged and disability). On an unknown date, the patient experienced HYPOKINESIA (couldn't get out of bed/couldn't move) (seriousness criteria death, hospitalization and disability), ARTERIAL OCCLUSIVE DISEASE (clogged arteries in her legs) (seriousness criteria death, hospitalization and disability), PERONEAL NERVE PALSY (foot drop) (seriousness criteria death, hospitalization and disability), RALES (a little bit of crackling in her lungs) (seriousness criteria death, hospitalization and disability), ORAL CANDIDIASIS (thrush in her mouth) (seriousness criteria death, hospitalization and disability), ASTHENIA (completely weak/extreme weakness) (seriousness criteria death, hospitalization and disability), HOSPITALISATION (she was in the hospital for a total of 131 days) (seriousness criteria death and hospitalization prolonged) and PYREXIA (fever) (seriousness criteria death, hospitalization and disability). The patient died on 23-Jul-2021. The reported cause of death was Coma, Cardiac arrest, Movements reduced, Arterial occlusion, Foot drop, covid-19, Crackles lung, Oral thrush, Weakness, Pain and Fever. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) extreme vasculitis after a nerve biopsy. In 2021, Biopsy muscle: abnormal (abnormal) muscles were debilitating. In 2021, COVID-19: positive (Positive) positive. No concomitant and treatment information was provided. Patient was removed from the hospital and taken to a rehabilitation facility. Patient had a fever at that facility and a little bit of crackling in her lungs. Then patient was admitted back in the hospital for four months. They did a biopsy in the throat due to thrush in patients mouth, which the patient never had before. patient was completely weak, and couldn't find out what patient had.. After 3 months in the hospital, they found that patient had extreme vasculitis after a nerve biopsy. They gave patient a treatment to lower her vascular system; the name is unknown. patient was doing well, but then patient acquired COVID in July 2021. Two days after patient was diagnosed with COVID, and fell into cardiac arrest. patient went into a coma, then passed 3 days later on 23Jul2021. patient was in the hospital for a total of 131 days. Company Comment: This is a case of death in a 74-year-old female patient, after receiving on February, date unknown an unspecified dose of vaccine (Lot number unknown). Cause of death was coma, cardiac arrest, movements reduced, arterial occlusion, foot drop, covid-19, crackles lung, oral thrush, weakness, pain and fever. Very limited information regarding underlying medical history, concomitant medications and autopsy report was provided at this time. Further information is expected.; Sender's Comments: This is a case of death in a 74-year-old female patient, after receiving on February, date unknown an unspecified dose of vaccine (Lot number unknown). Cause of death was coma, cardiac arrest, movements reduced, arterial occlusion, foot drop, covid-19, crackles lung, oral thrush, weakness, pain and fever. Very limited information regarding underlying medical history, concomitant medications and autopsy report was provided at this time. Further information is expected.; Reported Cause(s) of Death: cardiac arrest; coma; Pain; Movements reduced; arterial occlusion; foot drop; fever; crackles lung; Oral thrush; weakness; COVID-19

Other Meds:

Current Illness:

ID: 1645205
Sex: M
Age: 22
State: FL

Vax Date: 01/08/2021
Onset Date: 08/16/2021
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: received the booster at the same time as the DTap; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) from 16-Aug-2021 to an unknown date for Diphtheria immunisation. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap) had resolved. No Information on concomitant medications were reported. No treatment details were reported. Company Comment: This is a case of Extra Dose Administered (lot #052E21A) to an immunocompromised patient with no AEs reported. Further information has been requested.; Sender's Comments: This is a case of Extra Dose Administered (lot #052E21A) to an immunocompromised patient with no AEs reported. Further information has been requested.

Other Meds: DTAP

Current Illness: Immunocompromised

ID: 1645206
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: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Symptoms from virus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms from virus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms from virus). At the time of the report, VACCINATION COMPLICATION (Symptoms from virus) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1645207
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Kinda dysfunctional; My vision is worse; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Kinda dysfunctional) and VISUAL IMPAIRMENT (My vision is worse) 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 ASTHENIA (Kinda dysfunctional) and VISUAL IMPAIRMENT (My vision is worse). At the time of the report, ASTHENIA (Kinda dysfunctional) and VISUAL IMPAIRMENT (My vision is worse) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645208
Sex: F
Age:
State: AR

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

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: cannot write, nor be left alone; use cane to walk; cannot drive; Pneumonia; Pulmonary infarction; multiple ones traveled in both lungs; blood clot in her legs all the way from the tight to the ankles; tremor in the hand and legs, face shakes like parkinsonian disease; she is confused; neurological deficit; losing function in arms and legs; losing function in arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia), PULMONARY INFARCTION (Pulmonary infarction), PULMONARY THROMBOSIS (multiple ones traveled in both lungs ), THROMBOSIS (blood clot in her legs all the way from the tight to the ankles), TREMOR (tremor in the hand and legs, face shakes like parkinsonian disease), CONFUSIONAL STATE (she is confused), NERVOUS SYSTEM DISORDER (neurological deficit), the first episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs), the second episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot write, nor be left alone), WALKING AID USER (use cane to walk) and IMPAIRED DRIVING ABILITY (cannot drive) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 010M20A) 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 22-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 PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), PULMONARY INFARCTION (Pulmonary infarction) (seriousness criteria hospitalization and medically significant), PULMONARY THROMBOSIS (multiple ones traveled in both lungs ) (seriousness criteria hospitalization and medically significant), THROMBOSIS (blood clot in her legs all the way from the tight to the ankles) (seriousness criteria hospitalization and medically significant), TREMOR (tremor in the hand and legs, face shakes like parkinsonian disease) (seriousness criterion hospitalization), CONFUSIONAL STATE (she is confused) (seriousness criterion hospitalization), NERVOUS SYSTEM DISORDER (neurological deficit) (seriousness criterion hospitalization), the first episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs) (seriousness criterion hospitalization), the second episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs) (seriousness criterion hospitalization), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot write, nor be left alone) (seriousness criteria hospitalization and disability), WALKING AID USER (use cane to walk) (seriousness criteria hospitalization and disability) and IMPAIRED DRIVING ABILITY (cannot drive) (seriousness criteria hospitalization and disability). The patient was treated with OXYGEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia), PULMONARY INFARCTION (Pulmonary infarction), PULMONARY THROMBOSIS (multiple ones traveled in both lungs ), THROMBOSIS (blood clot in her legs all the way from the tight to the ankles), TREMOR (tremor in the hand and legs, face shakes like parkinsonian disease), CONFUSIONAL STATE (she is confused), NERVOUS SYSTEM DISORDER (neurological deficit), the last episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot write, nor be left alone), WALKING AID USER (use cane to walk) and IMPAIRED DRIVING ABILITY (cannot drive) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitants and treatment medications were provided. It was reported that the nurse practitioner who used to handle about 40-50 patients per day, could not do that anymore and has been off work since 09 Apr 2021 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:

ID: 1645209
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 06/02/2021
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: Slight stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Slight stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Slight stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Slight stroke) 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. Company Comment: Very limited information regarding this event/s has been provided at this time. No further information is to be expected.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. No further information is to be expected.

Other Meds:

Current Illness:

ID: 1645210
Sex: F
Age:
State:

Vax Date:
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:

Allergies:

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

Symptoms: ""rare" side effects"; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (""rare" side effects") in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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 ADVERSE EVENT (""rare" side effects") (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (""rare" side effects") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was admitted I ICU. No concomitant drugs were reported. No treatment information was reported. Very limited information regarding this event has been provided at this time. Further information is not expected. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.

Other Meds:

Current Illness:

ID: 1645211
Sex: U
Age:
State:

Vax Date:
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: Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1645212
Sex: F
Age: 81
State: FL

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.; experienced normal side effects; lessergy for 1 or 2 days; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LISINOPRIL, VITAMIN 15, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), RUBUS IDAEUS (BERRY ACTIVE RASPBERRY KETONES) and CENTRUM JR [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COPPER;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;TH for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.) (seriousness criterion hospitalization), VACCINATION COMPLICATION (experienced normal side effects) and UNEVALUABLE EVENT (lessergy for 1 or 2 days). At the time of the report, HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.), VACCINATION COMPLICATION (experienced normal side effects) and UNEVALUABLE EVENT (lessergy for 1 or 2 days) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reportedly consumed lots of fluids as treatment. It was recommended to her that she drink Gatorade. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds: LISINOPRIL; VITAMIN 15; CALCIUM + VITAMIN D3; BERRY ACTIVE RASPBERRY KETONES; CENTRUM JR [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COPPER;CYAN

Current Illness:

ID: 1645213
Sex: F
Age:
State: LA

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: whole body hurts; aching; fever; her head is killing her; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her). At the time of the report, PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her) outcome was unknown. No concomitant medications were reported by the reporter. The events reported occurred after the second dose. No Treatment information was provided by the reporter. This case was linked to MOD-2021-268418 (Patient Link).

Other Meds:

Current Illness:

ID: 1645214
Sex: F
Age:
State: PA

Vax Date: 03/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: A staph infection; An allergic reaction (hives and swollen lips); Hives; swollen lips; Cellulitis; This spontaneous case was reported by a pharmacist and describes the occurrence of CELLULITIS (Cellulitis), STAPHYLOCOCCAL INFECTION (A staph infection), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)), URTICARIA (Hives) and LIP SWELLING (swollen lips) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criteria hospitalization and medically significant), STAPHYLOCOCCAL INFECTION (A staph infection) (seriousness criteria hospitalization and medically significant), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)) (seriousness criterion hospitalization), URTICARIA (Hives) (seriousness criterion hospitalization) and LIP SWELLING (swollen lips) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to CELLULITIS, HYPERSENSITIVITY, LIP SWELLING and URTICARIA. At the time of the report, CELLULITIS (Cellulitis), STAPHYLOCOCCAL INFECTION (A staph infection), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)), URTICARIA (Hives) and LIP SWELLING (swollen lips) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was 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.; 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:

ID: 1645215
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: paralysis side effects; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralysis side effects) 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 PARALYSIS (paralysis side effects) (seriousness criterion medically significant). At the time of the report, PARALYSIS (paralysis side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had paralysis side effects after the vaccine . Concomitant and treatment medications were not reported. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1645216
Sex: F
Age: 65
State: ME

Vax Date: 01/07/2021
Onset Date: 02/05/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210716; Test Name: Pulse rate; Result Unstructured Data: pulse was of 240

Allergies:

Symptom List: Unevaluable event

Symptoms: rapid arrhythmia; Couldn't breath, short of breath; pulse was 240; atrial fibrillation; palpitations during walking, heart started racing; This spontaneous case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), ARRHYTHMIA (rapid arrhythmia), PALPITATIONS (palpitations during walking, heart started racing), DYSPNOEA (Couldn't breath, short of breath) and HEART RATE INCREASED (pulse was 240) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included TRIAMTERENE for Blood pressure high. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (palpitations during walking, heart started racing) (seriousness criterion hospitalization). In June 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization and medically significant). On 16-Jul-2021, the patient experienced ARRHYTHMIA (rapid arrhythmia) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Couldn't breath, short of breath) (seriousness criterion hospitalization) and HEART RATE INCREASED (pulse was 240) (seriousness criterion hospitalization). The patient was treated with METOPROLOL on 16-Jun-2021 at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), ARRHYTHMIA (rapid arrhythmia), DYSPNOEA (Couldn't breath, short of breath) and HEART RATE INCREASED (pulse was 240) outcome was unknown and PALPITATIONS (palpitations during walking, heart started racing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Heart rate: 240 (High) pulse was of 240. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient stayed 3 days in ICU and discharged 3 days later. 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: TRIAMTERENE

Current Illness: Blood pressure high

ID: 1645217
Sex: M
Age:
State: FL

Vax Date: 04/01/2021
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: Test Name: blood count; Result Unstructured Data: blood counts are all normal

Allergies:

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

Symptoms: Recently diagnosed with thrombocytopenia; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thrombocytosis (he had a history of elevated platelets). On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) (seriousness criterion medically significant). The patient was treated with HYDROXYUREA ongoing since an unknown date for Thrombocytopenia, at an unspecified dose and frequency. At the time of the report, THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: normal (normal) blood counts are all normal. Patient was recently diagnosed with thrombocytopenia, which he stated is not related to the vaccine because he had a history of elevated platelets. his physician had been advising him to go see a hematologist for about a year. Concomitant medications were not provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient was recently diagnosed with thrombocytopenia which he stated is not related to the vaccine because he had a history of elevated platelets. Myelosuppression is a common side effects of the drug "HYDROXYUREA" 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. Patient was recently diagnosed with thrombocytopenia which he stated is not related to the vaccine because he had a history of elevated platelets.Myelosuppression is a common side effects of the drug "HYDROXYUREA" Further information is expected..

Other Meds:

Current Illness: Thrombocytosis (he had a history of elevated platelets)

ID: 1645218
Sex: F
Age: 39
State:

Vax Date: 04/27/2021
Onset Date: 05/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: emergency room and they gave me antibiotics in case I had cellulitis; Covid Arm; fever; burning; scratch; stretch mark; area hot to the touch; injection site swollen and red arm; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (scratch), SKIN STRIAE (stretch mark), VACCINATION SITE WARMTH (area hot to the touch), VACCINATION SITE ERYTHEMA (injection site swollen and red arm) and CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced SCRATCH (scratch) (seriousness criterion medically significant), SKIN STRIAE (stretch mark) (seriousness criterion medically significant), VACCINATION SITE WARMTH (area hot to the touch) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (injection site swollen and red arm) (seriousness criterion medically significant), VACCINATION COMPLICATION (Covid Arm), PYREXIA (fever) and VACCINATION SITE PAIN (burning). On an unknown date, the patient experienced CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis) (seriousness criterion medically significant). At the time of the report, SCRATCH (scratch), SKIN STRIAE (stretch mark), VACCINATION SITE WARMTH (area hot to the touch), VACCINATION SITE ERYTHEMA (injection site swollen and red arm), CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis), VACCINATION COMPLICATION (Covid Arm), PYREXIA (fever) and VACCINATION SITE PAIN (burning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not provided. Patient visited to the emergency room and prescribed antibiotics in case patient had cellulitis. The Emergency Room told to the patient about Corvid Arm. and also prescribed steroids. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-289518 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1645219
Sex: M
Age: 73
State: FL

Vax Date: 12/29/2020
Onset Date: 12/29/2020
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: I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (I had a sore arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (I had a sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications or treatment details were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded This case was linked to MOD-2021-289014 (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 event, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1645220
Sex: F
Age:
State:

Vax Date: 07/24/2021
Onset Date: 07/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body); The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body; had feelings of "prickers" throughout my body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body), PARAESTHESIA (had feelings of "prickers" throughout my body) and PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) 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 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body) (seriousness criterion medically significant) and PARAESTHESIA (had feelings of "prickers" throughout my body) (seriousness criterion medically significant). On 14-Aug-2021, the patient experienced PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body) and PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) outcome was unknown and PARAESTHESIA (had feelings of "prickers" throughout my body) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Two hours after patient had feelings of prickers throughout the body. It subsided after a week but returned in full force on 8/14 after a rigorous uphill hike. The pricker sensation in calves was extremely painful. 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:

ID: 1645221
Sex: M
Age: 73
State: FL

Vax Date: 12/29/2020
Onset Date: 01/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: My hearing is distorted; I had sudden hearing loss in my right ear/repeated episodes of hearing loss; My injection site arm was hot; My injection site arm itched like crazy; my injection site arm was red; My injection site arm was swollen; I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 23-Jan-2021, the patient experienced SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) (seriousness criterion medically significant), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen). On 17-Aug-2021, the patient experienced HYPOACUSIS (My hearing is distorted). At the time of the report, SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss), HYPOACUSIS (My hearing is distorted), PAIN IN EXTREMITY (I had a sore arm), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. 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. This case was linked to MOD-2021-289003 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1645222
Sex: F
Age:
State: NC

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:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210801; Test Name: antibodies; Test Result: Negative ; Result Unstructured Data: HCP made patient test for antibodies on 01Aug2021 since patient had had symptoms in January even though patient tested negative that time. Since no antibodies were detected, patient decided to vaccinate.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: sore ears, pain inside of ear; pain inside of neck; terrible aches, every part from the head to the waist that can possible hurt, hurts; Arm pain; hurts when I take a deep breath, hurts to breath; Arm is so swollen; Arm and finger are tingling; pectoral area is hurting; pain seems muscular; elbow started hurting; pain inside of head, every part from the head to the waist that can possible hurt, hurts; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (sore ears, pain inside of ear), NECK PAIN (pain inside of neck), PAIN (terrible aches, every part from the head to the waist that can possible hurt, hurts), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (hurts when I take a deep breath, hurts to breath) in a 65-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. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 16-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 EAR PAIN (sore ears, pain inside of ear), NECK PAIN (pain inside of neck), PAIN (terrible aches, every part from the head to the waist that can possible hurt, hurts), PAIN IN EXTREMITY (Arm pain), DYSPNOEA (hurts when I take a deep breath, hurts to breath), PERIPHERAL SWELLING (Arm is so swollen), PARAESTHESIA (Arm and finger are tingling), CHEST PAIN (pectoral area is hurting), MYALGIA (pain seems muscular) and ARTHRALGIA (elbow started hurting). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (sore ears, pain inside of ear), NECK PAIN (pain inside of neck), PAIN (terrible aches, every part from the head to the waist that can possible hurt, hurts), PAIN IN EXTREMITY (Arm pain), DYSPNOEA (hurts when I take a deep breath, hurts to breath), PERIPHERAL SWELLING (Arm is so swollen), PARAESTHESIA (Arm and finger are tingling), CHEST PAIN (pectoral area is hurting), MYALGIA (pain seems muscular) and ARTHRALGIA (elbow started hurting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Drug specific antibody: negative (Negative) HCP made patient test for antibodies on 01Aug2021 since patient had had symptoms in January even though patient tested negative that time. Since no antibodies were detected, patient decided to vaccinate.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication includes migraine medication. The "pain does not cross the spine, there is nothing on the right side". It all started 30' after vaccination, when patient felt some tension going to the neck, from arm to neck. When patient was 20, patient fainted when receiving tetanus shot. Also mentioned that in 2011 after receiving flu shot patient had a horrible reaction which included blisters in the cornea that popped causing lost of vision for 4 months.HCP made patient test for antibodies on 01Aug2021 since patient had had symptoms in January even though patient tested negative that time. Since no antibodies were detected, patient decided to vaccinate. Patient said that has an over active immunity system that responds strongly. Patient carries an EpiPen everywhere patient goes, but has only used it once.

Other Meds: SINGULAIR

Current Illness:

ID: 1645223
Sex: F
Age:
State: MA

Vax Date: 02/14/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Sore arm; Systemically she felt bad but not significant; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination. The patient's past medical history included Inflammatory bowel disease, Small fiber neuropathy, Diastolic heart failure and Chemotherapy from 2003 to 2004. Concurrent medical conditions included Osteoporosis. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment information was provided. This case was linked to MOD-2021-289133 (Patient Link).

Other Meds: ENTYVIO; PYRIDOSTIGMINE

Current Illness: Osteoporosis

ID: 1645224
Sex: M
Age:
State: NY

Vax Date: 02/08/2021
Onset Date: 08/15/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Diverticulitis inflammation months after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis inflammation months after second vaccine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Prostate cancer (He has been taking Xtandi for prostate Cancer for more than a year.). Concomitant products included ENZALUTAMIDE (XTANDI) for Prostate cancer. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced DIVERTICULITIS (Diverticulitis inflammation months after second vaccine) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Aug-2021 to 16-Aug-2021 due to DIVERTICULITIS. The patient was treated with CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE]) for Adverse event, at an unspecified dose and frequency and METRONIDAZOLE BENZOATE (FLAGYL [METRONIDAZOLE BENZOATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis inflammation months after second vaccine) outcome was unknown. Action taken with suspect drug was not applicable. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's advanced age and diet (Eat too many seeds) 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 event, a causal relationship cannot be excluded. However, this patient's advanced age and diet (Eat too many seeds) remains a contributory factor.

Other Meds: XTANDI

Current Illness: Prostate cancer (He has been taking Xtandi for prostate Cancer for more than a year.)

ID: 1645225
Sex: F
Age:
State: MA

Vax Date: 02/14/2021
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: Redness appeared by the injection site, half way down to the elbow; Loss of appetite; 101F fever lasted three days; chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemotherapy NOS from 2003 to 2004 and Crohn's disease. Concurrent medical conditions included Osteoporosis, Small fiber neuropathy (Autonomic small fiber Neuropathy) and Diastolic heart failure. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow) had resolved. No treatment medications were provided Patient stated that - redness pretty much went away week and a half later This case was linked to MOD-2021-289115 (Patient Link).

Other Meds: ENTYVIO; PYRIDOSTIGMINE

Current Illness: Diastolic heart failure; Osteoporosis; Small fiber neuropathy (Autonomic small fiber Neuropathy)

ID: 1645226
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: injected part if kinda hardened; injected part if kinda hardened almost to swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling). At the time of the report, VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645227
Sex: M
Age: 24
State: MI

Vax Date: 03/01/2021
Onset Date: 03/01/2021
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: RA

Lab Data: Test Name: CT scan; Result Unstructured Data: The CT scan confirmed he had a concussion.; Test Date: 202103; Test Name: Weight; Result Unstructured Data: Patient lost 10 Ibs weight due to anxiety

Allergies:

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

Symptoms: He had lost 10 lbs due to the anxiety; doctor recommended he not get the second dose; bruise on his head; Hit his head on the shower stall; Lost consciousness; concussion; anxiety; hit his head on the door; felt nauseous; Lost consciousness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of LOSS OF CONSCIOUSNESS (Lost consciousness) and the second episode of LOSS OF CONSCIOUSNESS (Lost consciousness) in a 24-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 COVID-19 in November 2020. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced the first episode of LOSS OF CONSCIOUSNESS (Lost consciousness) (seriousness criterion medically significant), CONCUSSION (concussion), ANXIETY (anxiety), HEAD INJURY (hit his head on the door) and NAUSEA (felt nauseous). On 13-Aug-2021, the patient experienced the second episode of LOSS OF CONSCIOUSNESS (Lost consciousness) (seriousness criterion medically significant), CONTUSION (bruise on his head) and HEAD INJURY (Hit his head on the shower stall). On an unknown date, the patient experienced WEIGHT DECREASED (He had lost 10 lbs due to the anxiety) and PRODUCT DOSE OMISSION ISSUE (doctor recommended he not get the second dose). The patient was treated with CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for Anxiety, at a dose of 10 mg once a day and ALPRAZOLAM for Anxiety, at a dose of 0.25 mg (he had only taken this twice). In March 2021, NAUSEA (felt nauseous) outcome was unknown. At the time of the report, last episode of LOSS OF CONSCIOUSNESS (Lost consciousness), CONCUSSION (concussion), ANXIETY (anxiety), HEAD INJURY (hit his head on the door), CONTUSION (bruise on his head), HEAD INJURY (Hit his head on the shower stall) and WEIGHT DECREASED (He had lost 10 lbs due to the anxiety) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (doctor recommended he not get the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Weight: lost 10 ibs (abnormal) Patient lost 10 Ibs weight due to anxiety. On an unknown date, Computerised tomogram: concussion (abnormal) The CT scan confirmed he had a concussion.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided Patient took first vaccine on MAR-2021 and during the night after vaccination patient waked up for restroom but felt nauseous, got to the bathroom and lost the consciousness and ambulance was called where patient was took to the emergency room ang got stiches done. Patient anxiety had became severe. Patient lost consciousness again on 13-AUG-2021 and was sitting down and passed out and hit his head on the shower stall. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. The report also refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with associated AEs reported as loss of consciousness, head injury, contusion, anxiety and weight loss.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. The report also refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with associated AEs reported as loss of consciousness, head injury, contusion, anxiety and weight loss.

Other Meds:

Current Illness:

ID: 1645228
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. No concomitant medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645229
Sex: U
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/17/2021
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: Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: High

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Flush; Body aches; Nausea; 99.5 is the highest temp; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp) 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 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp). At the time of the report, FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 99.5 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1645230
Sex: F
Age:
State:

Vax Date: 03/15/2021
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: No second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication provided. The patient had to leave the country and had missed the second dose.

Other Meds:

Current Illness:

ID: 1645231
Sex: M
Age: 59
State: FL

Vax Date: 02/24/2021
Onset Date: 02/01/2021
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: His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Liver transplant. Concurrent medical conditions included Bell's palsy since June 2021. 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. In February 2021, the patient experienced BELL'S PALSY (His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, BELL'S PALSY (His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown. Concomitant medication included Etdir. Treatment information included Gabapentin. 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. Of note, the patient has a past condition of Bell's Palsy. This is limited information has been provided at this time further information is expected This case was linked to MOD-2021-290260 (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. Of note, the patient has a past condition of Bell's Palsy. This is very limited information has been provided at this time further information is expected

Other Meds: PROGRAF; LISINOPRIL; GABAPENTIN

Current Illness: Bell's palsy

ID: 1645232
Sex: F
Age: 86
State: IN

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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: she does not have an appetite; she cannot eat/she gags whenever she tries to eat; Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (she does not have an appetite), RETCHING (she cannot eat/she gags whenever she tries to eat) and EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The patient's past medical history included Heart attack (Patient disclosed that she had a heart attack in the past so she was on a lot of medications.). Concomitant products included ATORVASTATIN, CARVEDILOL, MELATONIN, NITROFURANTOIN, ACETYLSALICYLIC ACID (ASPIRINE), TICAGRELOR (BRILINTA), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication. On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine). On 17-Aug-2021, the patient experienced DECREASED APPETITE (she does not have an appetite) and RETCHING (she cannot eat/she gags whenever she tries to eat). At the time of the report, DECREASED APPETITE (she does not have an appetite) and RETCHING (she cannot eat/she gags whenever she tries to eat) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine) had resolved. The treatment information was unknown.

Other Meds: ATORVASTATIN; CARVEDILOL; MELATONIN; NITROFURANTOIN; ASPIRINE; BRILINTA; ENTRESTO; PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]

Current Illness:

ID: 1645233
Sex: M
Age: 38
State: NM

Vax Date: 06/02/2021
Onset Date: 08/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Second dose has not been administered more than 2 months away from the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment information was reported.

Other Meds:

Current Illness:

ID: 1645234
Sex: M
Age: 0
State: CA

Vax Date: 07/15/2021
Onset Date: 07/15/2021
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:

Allergies:

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

Symptoms: Excessive sweating; Feeling feverish; Moderna Covid-19 vaccine administered to a 12 year old; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive sweating), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old) and PYREXIA (Feeling feverish) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old). On 24-Jul-2021, the patient experienced HYPERHIDROSIS (Excessive sweating). 24-Jul-2021, the patient experienced PYREXIA (Feeling feverish). On 15-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old) had resolved. At the time of the report, HYPERHIDROSIS (Excessive sweating) and PYREXIA (Feeling feverish) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were provided No treatment drugs were provided. The patient said that she brought her son to the pharmacy and the Pharmacy Technician asked the Mother if her son who was 12 years of age would like the Pfizer or the Moderna Covid-19 vaccine.. The callers son received his first Moderna Covid-19 dose on 15-Jul-2021.

Other Meds:

Current Illness:

ID: 1645235
Sex: F
Age: 71
State: NJ

Vax Date: 01/19/2021
Onset Date: 06/10/2021
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: Test Name: MRI; Result Unstructured Data: 3 tears in rotator cuff; Test Name: X-RAY; Result Unstructured Data: 3 tears in rotator cuff

Allergies:

Symptom List: Pain in extremity

Symptoms: severe anemia; white spots just on her arms and shoulders./skin hypopigmentation; lot of white cells in her urine; lot of shoulder pain; has 3 tears in his rotator cuff; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAEMIA (severe anemia), SKIN HYPOPIGMENTATION (white spots just on her arms and shoulders./skin hypopigmentation) and WHITE BLOOD CELLS URINE POSITIVE (lot of white cells in her urine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was provided by the reporter. Concomitant products included VALSARTAN and AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced ROTATOR CUFF SYNDROME (has 3 tears in his rotator cuff). On an unknown date, the patient experienced ANAEMIA (severe anemia) (seriousness criterion medically significant), SKIN HYPOPIGMENTATION (white spots just on her arms and shoulders./skin hypopigmentation) (seriousness criterion medically significant), WHITE BLOOD CELLS URINE POSITIVE (lot of white cells in her urine) (seriousness criterion medically significant) and ARTHRALGIA (lot of shoulder pain). At the time of the report, ANAEMIA (severe anemia), SKIN HYPOPIGMENTATION (white spots just on her arms and shoulders./skin hypopigmentation), ROTATOR CUFF SYNDROME (has 3 tears in his rotator cuff) and ARTHRALGIA (lot of shoulder pain) outcome was unknown and WHITE BLOOD CELLS URINE POSITIVE (lot of white cells in her urine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) 3 tears in rotator cuff. On an unknown date, X-ray: abnormal (abnormal) 3 tears in rotator cuff. The patient noticed white spots just on her arms and shoulders after they came back form vacation. On 13-Apr-2021, she went to see her primary care physician and they referred her to a dermatologist. On 29-Apr-2021, the dermatologist said that white spots were due to skin hypopigmentation and told her not to worry about it. She also had lot of shoulder pain and her doctor ordered MRI and X-Ray. She had three tears in her rotator cuff, but thought it was due to her age. On 10-Jun-2021, her doctor told her that she had severe anemia and referred her to a hematologist-oncologist, and from 23-Jun-2021 onwards she received three iron infusions (once a week). She also found lot of white cells in her urine and that was still an ongoing issue. Her doctors had never been able to tell her that what has caused her anemia and white cells in urine. 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.; 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: VALSARTAN; AMLODIPINE [AMLODIPINE BESILATE]

Current Illness:

ID: 1645236
Sex: M
Age: 59
State: CA

Vax Date: 05/07/2021
Onset Date: 05/28/2021
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: patient suffered a DVT; This spontaneous case was reported by a pharmacist and describes the occurrence of DEEP VEIN THROMBOSIS (patient suffered a DVT) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003B21A) for COVID-19 vaccination. Concomitant products included ANTICOAGULANT CITRATE DEXTROSE (ANTICOAGULATION) and APIXABAN (ELIQUIS) for an unknown indication. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DEEP VEIN THROMBOSIS (patient suffered a DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (patient suffered a DVT) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Laboratory data was mentioned as the ultrasound and result was not given. No treatment information was provided by the reporter. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: ANTICOAGULATION; ELIQUIS

Current Illness:

ID: 1645237
Sex: F
Age: 61
State: CA

Vax Date: 03/25/2021
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: Stomach was upset like nausea; Lightheaded/ somewhat dizzy; Headaches; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach was upset like nausea), DIZZINESS (Lightheaded/ somewhat dizzy), HEADACHE (Headaches) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 3 and Spinal stenosis. Concomitant products included TRAMADOL for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach was upset like nausea), DIZZINESS (Lightheaded/ somewhat dizzy), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, ABDOMINAL DISCOMFORT (Stomach was upset like nausea), DIZZINESS (Lightheaded/ somewhat dizzy), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated she did not take any medications for her symptoms but limited her diet to applesauce, bananas and rice. This case was linked to MOD-2021-289628 (Patient Link).

Other Meds: TRAMADOL

Current Illness: Chronic kidney disease stage 3; Spinal stenosis

ID: 1645238
Sex: F
Age: 62
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: I was never sick before being treated for walking pneumonia; Vertigo; Severe brain fog; Frozen shoulder in non vaccinated arm; Recently developed an acute case of bronchitis; I slept for two days; Dizziness; Bursitis; Acute case of laryngitis; Sick; Headache; Six days after each vaccine I experienced exhaustion I slept for two days/Fatigue extreme; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of ATYPICAL PNEUMONIA (I was never sick before being treated for walking pneumonia) in a 63-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. No medical history for the patient was reported. Concomitant products included VITAMIN D NOS, MAGNESIUM, FISH OIL, ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION, VITAMIN B12 NOS and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication. On 06-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 ATYPICAL PNEUMONIA (I was never sick before being treated for walking pneumonia) (seriousness criterion medically significant), PERIARTHRITIS (Frozen shoulder in non vaccinated arm), BRONCHITIS (Recently developed an acute case of bronchitis), BURSITIS (Bursitis), LARYNGITIS (Acute case of laryngitis) and ILLNESS (Sick). an unknown date, the patient experienced VERTIGO (Vertigo), FEELING ABNORMAL (Severe brain fog), HYPERSOMNIA (I slept for two days), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days/Fatigue extreme) and MYALGIA (Body ache). At the time of the report, ATYPICAL PNEUMONIA (I was never sick before being treated for walking pneumonia), PERIARTHRITIS (Frozen shoulder in non vaccinated arm), BRONCHITIS (Recently developed an acute case of bronchitis), BURSITIS (Bursitis), LARYNGITIS (Acute case of laryngitis) and ILLNESS (Sick) outcome was unknown, VERTIGO (Vertigo), FEELING ABNORMAL (Severe brain fog), HYPERSOMNIA (I slept for two days), DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Body ache) had resolved and FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days/Fatigue extreme) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment information were 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. Exception for "Atypical pneumonia": Very limited information regarding this event has been provided at this time. Further information has been requested This case was linked to MOD-2021-289683 (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. Exception for "Atypical pneumonia": Very limited information regarding this event has been provided at this time. Further information has been requested

Other Meds: VITAMIN D NOS; MAGNESIUM; FISH OIL; LEXAPRO; BUPROPION; VITAMIN B12 NOS; FIORICET

Current Illness:

ID: 1645239
Sex: U
Age:
State:

Vax Date: 07/22/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210731; Test Name: COVID-19 Molecular test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Vomiting

Symptoms: got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid) 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 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced COVID-19 (got Covid). At the time of the report, COVID-19 (got Covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications details were provided. No treatment Medications details were provided.

Other Meds:

Current Illness:

ID: 1645240
Sex: F
Age: 56
State: FL

Vax Date: 02/12/2021
Onset Date: 02/12/2021
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: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M21A) for COVID-19 vaccination. The patient's past medical history included Lymph node excision. Concurrent medical conditions included Breast cancer. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 14-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient mentioned that the first dose was administered in her left arm, and as a cancer survivor, she does no receive anything in that arm, she has no lymph nodes on that side. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter This case was linked to MOD-2021-289632 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow Up information was received on 18-Aug-2021 and Added DOB/age of patient.

Other Meds:

Current Illness: Breast cancer

ID: 1645241
Sex: M
Age: 76
State: CA

Vax Date: 05/04/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: short of breath; greater than 35 days between Covid-19 vaccinations; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (short of breath) and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003T21A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath) and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations). At the time of the report, DYSPNOEA (short of breath) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1645242
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Red marks on skin following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red marks on skin 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 07-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 ERYTHEMA (Red marks on skin following vaccination). At the time of the report, ERYTHEMA (Red marks on skin following vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medication was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1645243
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: it's toxic; 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 TOXICITY TO VARIOUS AGENTS (it's toxic) 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 TOXICITY TO VARIOUS AGENTS (it's toxic). At the time of the report, TOXICITY TO VARIOUS AGENTS (it's toxic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not reported. Other countries stopped giving the Moderna and Pfizer's vaccine because it's toxic. This case was linked to MOD21-131922 (E2B Linked Report).; Sender's Comments: MOD21-131922:

Other Meds:

Current Illness:

ID: 1645244
Sex: F
Age:
State: NY

Vax Date: 07/01/2021
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: a little rash; on my left arm, small bumps started to populate all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little rash) and VACCINATION SITE MASS (on my left arm, small bumps started to populate all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-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 RASH (a little rash) and VACCINATION SITE MASS (on my left arm, small bumps started to populate all over). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) on 11-Aug-2021 at an unspecified dose and frequency. At the time of the report, RASH (a little rash) and VACCINATION SITE MASS (on my left arm, small bumps started to populate all over) outcome was unknown. No concomitant drug information 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 company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. This case was linked to MOD-2021-289677 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up received contain no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am