VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1481748
Sex: F
Age: 23
State: OH

Vax Date: 06/26/2021
Onset Date: 06/26/2021
Rec V Date: 07/18/2021
Hospital: Y

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: hospitalized for ovarian cyst that burst; had a seizure last night; sunburn; sunburn in which she could see discoloration of white and red as if she was able to see where the vaccine moved under the skin and where the vaccine was injected and spread; small bubble blisters starting at left arm injection site covering over her breasts and up to right shoulder; felt nauseous for the first 30 minutes after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CYST RUPTURED (hospitalized for ovarian cyst that burst) and SEIZURE (had a seizure last night) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seizure. Concomitant products included ALLERGY MEDICATION. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced SUNBURN (sunburn), VACCINATION SITE DISCOLOURATION (sunburn in which she could see discoloration of white and red as if she was able to see where the vaccine moved under the skin and where the vaccine was injected and spread), BLISTER (small bubble blisters starting at left arm injection site covering over her breasts and up to right shoulder) and NAUSEA (felt nauseous for the first 30 minutes after receiving the first dose). On 28-Jun-2021, the patient experienced OVARIAN CYST RUPTURED (hospitalized for ovarian cyst that burst) (seriousness criteria hospitalization and medically significant). On 01-Jul-2021, the patient experienced SEIZURE (had a seizure last night) (seriousness criterion medically significant). The patient was hospitalized on 28-Jun-2021 due to OVARIAN CYST RUPTURED. The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) for Pain and Ovarian cyst ruptured, at an unspecified dose and frequency. At the time of the report, OVARIAN CYST RUPTURED (hospitalized for ovarian cyst that burst), SEIZURE (had a seizure last night), SUNBURN (sunburn), VACCINATION SITE DISCOLOURATION (sunburn in which she could see discoloration of white and red as if she was able to see where the vaccine moved under the skin and where the vaccine was injected and spread), BLISTER (small bubble blisters starting at left arm injection site covering over her breasts and up to right shoulder) and NAUSEA (felt nauseous for the first 30 minutes after receiving the first dose) 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. Daily allergy medication was reported as concomitant. Treatment- After sun burn Aloe Vera and Toradol for ovarian cyst burst pain. Patient experienced symptoms since receiving first dose of Moderna vaccine. Patient felt nauseous for first 30 minutes after receiving first dose and had an hour drive and went to beach after first dose and got sunburn in which patient could see discoloration of white and red as if was able to see where the vaccine moved under the skin and where the vaccine was injected and spread, small bubble blisters starting at left arm injection site covering over breasts and up to right shoulder area which developed a few hours after being in sun. Patient was hospitalized for an ovarian cyst that burst on 28Jun2021 and had history of seizures and has not had one for about 2 years and says last night 1Jul2021 had a seizure and does not know if it is related to the vaccine or not. Patient was surgically sterile. 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: ALLERGY MEDICATION

Current Illness: Seizure

ID: 1481749
Sex: M
Age: 42
State: NC

Vax Date: 01/05/2021
Onset Date: 02/25/2021
Rec V Date: 07/18/2021
Hospital: Y

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: Nonsustained ventricular tachycardia; Chest discomfort; Rash; S.O.B; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030C20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included COPD (Frequent exacerbation), Hypertension, Diabetes, Shellfish allergy and Allergy to antibiotic (Cipro allergy). Concomitant products included METOPROLOL for Arrhythmia, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for COPD, ATORVASTATIN for Hyperchloremia, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for Hypertension. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Feb-2021, the patient experienced DYSPNOEA (S.O.B) (seriousness criterion hospitalization), PALPITATIONS (Palpitations) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). On 27-Mar-2021 at 12:06 PM, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion hospitalization). On 26-May-2021, the patient experienced VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Feb-2021 due to DYSPNOEA and PALPITATIONS, then on 27-Mar-2021 due to CHEST DISCOMFORT, then on 25-May-2021 due to RASH, and then on 26-May-2021 due to VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) had not resolved. Patient reported that he visited cardiologist, primary care, emergency room multiple more times. He experienced unknown rash from beginning and continues. One of the emergency room visit on 27-May-2021 and went for palpitation, shortness breath and non sustained ventricular tachycardia was present. He admitted to hospital. He experienced rash on arm, then face, torso and now mid section and thighs have rah. Experiencing palpitation/ arrhythmias daily as well shortness of breath. Treatment information was not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes

Other Meds: LISINOPRIL HCTZ; AMLODIPINE; ATORVASTATIN; METOPROLOL; ALBUTEROL [SALBUTAMOL SULFATE]

Current Illness: Allergy to antibiotic (Cipro allergy); COPD (Frequent exacerbation); Diabetes; Hypertension; Shellfish allergy

ID: 1481750
Sex: M
Age: 73
State: GA

Vax Date: 01/16/2021
Onset Date: 02/14/2021
Rec V Date: 07/18/2021
Hospital: Y

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: Stroke, on the left side of his body; Difficulty walking; Difficulty moving his legs; Does not feel energetic; Difficulty reading after the stroke; Difficulty handling stress after the stroke; Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke, on the left side of his body), GAIT DISTURBANCE (Difficulty walking), MUSCULAR WEAKNESS (Difficulty moving his legs), ASTHENIA (Does not feel energetic), READING DISORDER (Difficulty reading after the stroke) and STRESS (Difficulty handling stress after the stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN D NOS, VITAMIN B12 NOS, ALFUZOSIN HYDROCHLORIDE (UROXATRAL), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), FINASTERIDE, MAGNESIUM ASPARTATE, POTASSIUM ASPARTATE (POTASSIUM-MAGNESIUM-L-ASPARAGINATE), UBIDECARENONE (CO Q 10 [UBIDECARENONE]), APIXABAN (ELIQUIS), FLECAINIDE, VALSARTAN and ATORVASTATIN for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Felt sick). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke, on the left side of his body) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty walking) (seriousness criterion disability), MUSCULAR WEAKNESS (Difficulty moving his legs) (seriousness criterion disability), ASTHENIA (Does not feel energetic) (seriousness criterion disability), READING DISORDER (Difficulty reading after the stroke) (seriousness criterion disability) and STRESS (Difficulty handling stress after the stroke) (seriousness criterion disability). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. On 14-Feb-2021, MALAISE (Felt sick) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke, on the left side of his body) outcome was unknown and GAIT DISTURBANCE (Difficulty walking), MUSCULAR WEAKNESS (Difficulty moving his legs), ASTHENIA (Does not feel energetic), READING DISORDER (Difficulty reading after the stroke) and STRESS (Difficulty handling stress after the stroke) had not resolved. It was reported that the patient was in the hospital and had to go to rehabilitation after the stroke. The patient was having difficulty walking and moving his legs, difficulty reading, difficulty handling stress and he does not feel energetic following the stroke. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; VITAMIN D NOS; VITAMIN B12 NOS; UROXATRAL; BYSTOLIC; FINASTERIDE; POTASSIUM-MAGNESIUM-L-ASPARAGINATE; CO Q 10 [UBIDECARENONE]; ELIQUIS; FLECAINIDE; VALSARTAN; ATORVASTATIN

Current Illness:

ID: 1481751
Sex: M
Age:
State: KY

Vax Date: 04/23/2021
Onset Date: 05/24/2021
Rec V Date: 07/18/2021
Hospital: Y

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: acute idiopathic myocarditis; 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 MYOCARDITIS (acute idiopathic myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 047B21A) for COVID-19 vaccination. Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and SIMVASTATIN for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (acute idiopathic myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (acute idiopathic myocarditis) had not 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 and treatment medication were reported. A cardiologist informed to the patient that people experienced acute myocarditis. EKG: abnormal, catheter angiogram on 24-May-2021. MRI on 25-May-2021. 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-2021-209351 (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: VITAMIN D [VITAMIN D NOS]; FISH OIL; SIMVASTATIN

Current Illness:

ID: 1481752
Sex: M
Age:
State: GA

Vax Date: 01/26/2021
Onset Date: 03/22/2021
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Heart attack; Lost alot of weight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure fluctuation. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WEIGHT DECREASED (Lost alot of weight). The patient was hospitalized from 22-Mar-2021 to 26-Mar-2021 due to MYOCARDIAL INFARCTION. The patient was treated with Rehabilitation therapy (On 01 Apr 2021, the patient was put in cardiac pulmonary rehab, currently in sixth week.) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and WEIGHT DECREASED (Lost alot of weight) outcome was unknown. No concomitant medications reported. The patient had a heart attack following stents. The patient had a cardiac catheterization on 22 Mar2021 and then was admitted to the (hospital) critical care unit (CCU) for 1 night, and then went home on 26 Mar2021. The patient may possibly have to do a total of 12 weeks of cardiac pulmonary rehab, but the patient would not know until he has his cardiologist appointment on 14 May2021. Company Comment : Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds:

Current Illness: Blood pressure fluctuation

ID: 1481753
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Active IgA nephropathy; Gross hematuria; This case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (Active IgA nephropathy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Antiphospholipid syndrome and Obesity. Concomitant products included AMLODIPINE, FUROSEMIDE, OLMESARTAN, WARFARIN and ENOXAPARIN for an unknown indication. 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 IGA NEPHROPATHY (Active IgA nephropathy) (seriousness criterion medically significant) and HAEMATURIA (Gross hematuria). At the time of the report, IGA NEPHROPATHY (Active IgA nephropathy) outcome was unknown and HAEMATURIA (Gross hematuria) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) negative. In 2021, Antineutrophil cytoplasmic antibody: negative (Negative) negative. In 2021, Antinuclear antibody: negative (Negative) negative. In 2021, Biopsy: abnormal (abnormal) IgA nephropathy among 12 glomeruli samples, 3 were globally sclerotic and 1 contained a segmental scar. The remainder had mild diffuse mesangial hypercellularity and 1 glomerulus displayed active segmental fibrinoid necrosis with mild leukocyte infiltration, rupture of glomerular basement membrane and an overlying segmental cellular crescent. their was 30% tubulointerstitial scarring and moderate arterio- and arteriosclerosis.. In 2021, Blood creatinine: 1.7 (High) 1.7 mg/dl. In 2021, Complement factor C3: negative (Negative) negative. In 2021, Complement factor C4: negative (Negative) negative. In 2021, Hepatitis B surface antigen: negative (Negative) negative. In 2021, Hepatitis C antibody: negative (Negative) negative. In 2021, IgA nephropathy: abnormal (abnormal) M1E0S1T1C1. In 2021, Immunology test: positive (Positive) global granular mesangial staining for IgA (3+), C3 (1+), kappa (2-3+), and lambda (3+). In 2021, Urine analysis: >50 (High) red blood cells per high-power field, baseline of 10-20 rbcs 7 months prior to presentation. In 2021, Urine protein/creatinine ratio: 2 (High) g/g; baseline values of 1.3mg/dl and 1.3g/g 7 months prior to presentation. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IGA NEPHROPATHY (Active IgA nephropathy) and HAEMATURIA (Gross hematuria) to be possibly related. Treatment medication not provided. Follow up received by safety on 8-Jul-21 contains no new information. 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-2021-249638, MOD-2021-249639 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Full text article received; 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: AMLODIPINE; FUROSEMIDE; OLMESARTAN; WARFARIN; ENOXAPARIN

Current Illness: Antiphospholipid syndrome; Hypertension; Obesity

ID: 1481754
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Ended up hospitalized for vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Ended up hospitalized for vertigo) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Ended up hospitalized for vertigo) (seriousness criterion hospitalization). At the time of the report, VERTIGO (Ended up hospitalized for vertigo) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported . Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1481755
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: hospital after their first dose of Moderna Covid-19 Vaccine; first Moderna Covid-19 Vaccine around 2 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of HOSPITALISATION (hospital after their first dose of Moderna Covid-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospital after their first dose of Moderna Covid-19 Vaccine) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (first Moderna Covid-19 Vaccine around 2 months ago). At the time of the report, HOSPITALISATION (hospital after their first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (first Moderna Covid-19 Vaccine around 2 months ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided. Based on reporter's causality and the available information suggesting the event hospitalization was related to underlying medical condition, causality assessed as unlikely related to mRNA-1273 vaccine. Causality for Product dose omission issue assessed as not applicable.; Sender's Comments: Based on reporter's causality and the available information suggesting the event hospitalization was related to underlying medical condition, causality assessed as unlikely related to mRNA-1273 vaccine. Causality for Product dose omission issue assessed as not applicable.

Other Meds:

Current Illness:

ID: 1481756
Sex: F
Age:
State: NY

Vax Date: 05/28/2021
Onset Date: 06/30/2021
Rec V Date: 07/18/2021
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: swollen gums; got very sick when I got the first and second shot to the point I thought I was going to die; pain is worse than having a child; cant swallow/hard time drinking water/painful talking; hand, foot and mouth disease; They said it is a virus / They also said it could be hand, foot and mouth disease.; lymph nodes are swollen; severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters; funny metallic taste; severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters; lesions in my month; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters), HAND-FOOT-AND-MOUTH DISEASE (hand, foot and mouth disease), GINGIVAL SWELLING (swollen gums), ILLNESS (got very sick when I got the first and second shot to the point I thought I was going to die), ORAL MUCOSAL BLISTERING (severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters), ORAL DISORDER (lesions in my month), ORAL PAIN (pain is worse than having a child), DYSPHAGIA (cant swallow/hard time drinking water/painful talking), DYSGEUSIA (funny metallic taste), VIRAL INFECTION (They said it is a virus / They also said it could be hand, foot and mouth disease.) and LYMPHADENOPATHY (lymph nodes are swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced MOUTH ULCERATION (severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters) (seriousness criterion medically significant), ORAL DISORDER (lesions in my month) (seriousness criterion medically significant), DYSGEUSIA (funny metallic taste) (seriousness criterion medically significant) and LYMPHADENOPATHY (lymph nodes are swollen) (seriousness criterion medically significant). On 03-Jul-2021, the patient experienced HAND-FOOT-AND-MOUTH DISEASE (hand, foot and mouth disease) (seriousness criterion medically significant) and VIRAL INFECTION (They said it is a virus / They also said it could be hand, foot and mouth disease.) (seriousness criterion medically significant). On an unknown date, the patient experienced GINGIVAL SWELLING (swollen gums) (seriousness criterion medically significant), ILLNESS (got very sick when I got the first and second shot to the point I thought I was going to die) (seriousness criterion medically significant), ORAL PAIN (pain is worse than having a child) (seriousness criterion medically significant) and DYSPHAGIA (cant swallow/hard time drinking water/painful talking) (seriousness criterion medically significant). The patient was treated with LIDOCAINE for Blisters, at an unspecified dose and frequency and AMOXICILLIN for Tooth infection, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters), HAND-FOOT-AND-MOUTH DISEASE (hand, foot and mouth disease), GINGIVAL SWELLING (swollen gums), ILLNESS (got very sick when I got the first and second shot to the point I thought I was going to die), ORAL MUCOSAL BLISTERING (severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters), ORAL DISORDER (lesions in my month), ORAL PAIN (pain is worse than having a child), DYSPHAGIA (cant swallow/hard time drinking water/painful talking), DYSGEUSIA (funny metallic taste), VIRAL INFECTION (They said it is a virus / They also said it could be hand, foot and mouth disease.) and LYMPHADENOPATHY (lymph nodes are swollen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported that she got the first Moderna COVID-19 vaccination 28 days prior to second dose. On 02-Jul-2021, she called her dentist who gave her amoxicillin for a tooth infection. She took this until she went to urgent care who told her it wasn't a tooth infection and to stop taking it. She went to urgent care on 03-Jul-2021 and the emergency room on 03-Jul-2021. On 06-Jul-2021, patient went to the doctor who told her she had lesions in mouth ulcers which look like blisters. Patient also reported that a week after Halloween of 2020 her young child had a cough. He had a COVID test which tested positive. Her and her other son were in quarantine for two weeks but they never tested them so she doesn't know if she had COVID-19 or not. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication has been reported. 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-2021-250541 (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: 1481757
Sex: M
Age: 82
State: CA

Vax Date: 02/02/2021
Onset Date: 02/06/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included exercise nerve tests with electricity. The patient has been to his hospital and has not seen any success in his treatments. 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: LISINOPRIL; AMLODIPINE; EZETIMIBE; ALOGLIPTIN; PREFORIN

Current Illness:

Date Died: 06/18/2021

ID: 1481758
Sex: M
Age: 29
State: TX

Vax Date: 06/13/2021
Onset Date: 06/18/2021
Rec V Date: 07/18/2021
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: passed away; blood in lungs; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) and PULMONARY HAEMORRHAGE (blood in lungs) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and PULMONARY HAEMORRHAGE (blood in lungs) (seriousness criteria death and medically significant). The patient died on 18-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding the events has been provided at this time. Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death

Other Meds:

Current Illness:

ID: 1481759
Sex: F
Age: 49
State: NJ

Vax Date: 07/06/2021
Onset Date: 07/06/2021
Rec V Date: 07/18/2021
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: Anaphylactic Reaction; Rapid Heart rate; Narrowing of throat; swelling of tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction), HEART RATE INCREASED (Rapid Heart rate), THROAT TIGHTNESS (Narrowing of throat) and SWOLLEN TONGUE (swelling of tongue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE for an unknown indication. On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criteria medically significant and life threatening). 06-Jul-2021, the patient experienced HEART RATE INCREASED (Rapid Heart rate) (seriousness criterion medically significant), THROAT TIGHTNESS (Narrowing of throat) (seriousness criterion medically significant) and SWOLLEN TONGUE (swelling of tongue) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of 50 mg; EPINEPHRINE for Adverse event, at a dose of 0.3 mg; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at a dose of 125 mg; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 08-Jul-2021, ANAPHYLACTIC REACTION (Anaphylactic Reaction), HEART RATE INCREASED (Rapid Heart rate), THROAT TIGHTNESS (Narrowing of throat) and SWOLLEN TONGUE (swelling of tongue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medication included "MP thyroid." Within 12 minutes of receiving the vaccine, the patient developed an anaphylactic reaction, with swelling of tongue, narrowing of the throat and a rapid heart rate. Oral diphenhydramine 50 mg and epinephrine injection 0.3mg was given to the patient by emergency medical technicians. The patient was taken in an ambulance where she received methylprednisolone sodium succinate 125 mg. She was taken to a local emergency room for treatment. In the emergency room, she was given famotidine and then discharged after observation. Approximately 12 hours later, the patient began to experience the same anaphylactic reaction again and was taken to another emergency room. The patient was treated with intravenous diphenhydramine and an epinephrine injection. She was observed in the emergency room then discharged with prescription medicine. 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: LEVOTHYROXINE

Current Illness:

ID: 1481760
Sex: M
Age: 66
State: TX

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Went to ICU with 4 blood clots in the left leg from the hip-down; Pulmonary embolism; Unable to walk; Used to go to the bathroom (pee) 3-4 times at night; Not too well; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down) and PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included High cholesterol and Nerve pain. Concomitant products included ATORVASTATIN for High cholesterol, GABAPENTIN for Nerve pain, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well). The patient was treated with Surgery (To clear blood clots) for Thrombosis. At the time of the report, THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down), PULMONARY EMBOLISM (Pulmonary embolism), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) His lungs were clear. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received the 2nd dose on 23rd or 24th of February 2021. Patient reported being in ICU for 9 days and in acute care for 2 days. Prior to the surgery to clear blood clots, the Eliquis was stopped, had staples, put tubes through for the surgery and was put back on Eliquis afterwards.; 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: ELIQUIS; ATORVASTATIN; GABAPENTIN; BABY ASPIRIN; FLOMAX [TAMSULOSIN HYDROCHLORIDE]

Current Illness: High cholesterol; Nerve pain

ID: 1481761
Sex: F
Age: 64
State: NY

Vax Date: 03/11/2021
Onset Date: 04/08/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Inflamed right inner ear; Fluid in the right ear; Loss of hearing in the Right Ear; Tinnitus Right Ear; Right Ear Hurts; Tight Inner Right Ear; Metallic Taste in the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the Right Ear) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Sinusitis. Concurrent medical conditions included Seasonal allergy and Deviated nasal septum. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Metallic Taste in the mouth). On 09-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the Right Ear) (seriousness criterion medically significant), TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear). In May 2021, the patient experienced INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear). On 08-Apr-2021, DYSGEUSIA (Metallic Taste in the mouth) had resolved. On 30-May-2021, DEAFNESS UNILATERAL (Loss of hearing in the Right Ear), INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear) had resolved. At the time of the report, TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Acoustic stimulation tests: normal (normal) her sense of hearing had come back to normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment include Drained fluid from the Ear. 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: Seasonal allergy

ID: 1481762
Sex: M
Age: 72
State: IL

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 07/18/2021
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: Feeling cold; Oxygen saturation low; Intermittent headache; Feeling unwell; Pain in arm; Cough; Phlegm; Hypoxemia; Chest cold; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOXIA (Hypoxemia) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. The patient's past medical history included Blood pressure high, Urinary tract disorder, Non-smoker and Abstains from alcohol. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for Blood pressure high, TAMSULOSIN for Urinary tract disorder. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). In June 2021, the patient experienced MALAISE (Feeling unwell), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache). In 2021, the patient experienced HYPOXIA (Hypoxemia) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm). On an unknown date, the patient experienced FEELING COLD (Feeling cold). In 2021, HYPOXIA (Hypoxemia), COUGH (Cough) and PRODUCTIVE COUGH (Phlegm) had resolved. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold), MALAISE (Feeling unwell), PAIN IN EXTREMITY (Pain in arm), FEELING COLD (Feeling cold), OXYGEN SATURATION DECREASED (Oxygen saturation low) and HEADACHE (Intermittent headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Oxygen saturation: 85 % (Low) 85. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Reporter stated that patient had other concomitant therapy of supplemental oxygen. 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: AMLODIPINE BENAZEPRIL; TAMSULOSIN

Current Illness:

ID: 1481763
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ankylosing spondylitis relapse; Wearing off effect; This spontaneous case was reported by a physician and describes the occurrence of ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) in a 66-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. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. Concurrent medical conditions included Ankylosing spondylitis. 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) had not resolved and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) to be possibly related. No further causality assessment was provided for THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). Concomitant medications were not provided. Treatment information was unknown. The event Therapeutic response shortened " was reported for the co-suspect drug humira. Company comment: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.

Other Meds: HUMIRA

Current Illness: Ankylosing spondylitis

ID: 1481764
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 07/18/2021
Hospital: Y

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: Triple vessel bypass graft; Fractured wrist/ Wrist fracture; Osteopenia; Leg pain/ Pain in extremity; Diarrhea/ Diarrhoea; Dizzy spells/ Dizziness; Pain in hip/ Arthralgia; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of CORONARY ARTERY BYPASS (Triple vessel bypass graft), WRIST FRACTURE (Fractured wrist/ Wrist fracture), OSTEOPENIA (Osteopenia), PAIN IN EXTREMITY (Leg pain/ Pain in extremity), DIARRHOEA (Diarrhea/ Diarrhoea), DIZZINESS (Dizzy spells/ Dizziness), ARTHRALGIA (Pain in hip/ Arthralgia) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Triple vessel bypass graft (Coronary artery bypass). Concurrent medical conditions included Rheumatoid arthritis. 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate free. In January 2021, the patient experienced WRIST FRACTURE (Fractured wrist/ Wrist fracture) (seriousness criterion hospitalization), OSTEOPENIA (Osteopenia) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Leg pain/ Pain in extremity) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea/ Diarrhoea) (seriousness criterion hospitalization), DIZZINESS (Dizzy spells/ Dizziness) (seriousness criterion hospitalization), ARTHRALGIA (Pain in hip/ Arthralgia) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced CORONARY ARTERY BYPASS (Triple vessel bypass graft) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CORONARY ARTERY BYPASS (Triple vessel bypass graft) was resolving, WRIST FRACTURE (Fractured wrist/ Wrist fracture), OSTEOPENIA (Osteopenia) and ARTHRALGIA (Pain in hip/ Arthralgia) had not resolved, PAIN IN EXTREMITY (Leg pain/ Pain in extremity) outcome was unknown and DIARRHOEA (Diarrhea/ Diarrhoea), DIZZINESS (Dizzy spells/ Dizziness) and NAUSEA (Nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Company comment: Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1481765
Sex: F
Age: 55
State: IL

Vax Date: 01/29/2021
Onset Date: 01/01/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Feeling anxious; Defaecation urgency; Injection site itching; Injection site hives; Injection site redness; Fever; Palpitation; ACNE; Hemorrhoidal bleeding; Bloody diarrhoea; Rectal bleeding; Fear; Constipation; Lower abdominal pain; Diarrhoea; Injection site papule; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) and RECTAL HAEMORRHAGE (Rectal bleeding) in a 55-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. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohns disease aggravated and ADALIMUMAB (HUMIRA) solution for injection for Crohns disease aggravated. The patient's past medical history included Abdominal pain lower, Diarrhea (Diarrhoea/Loose stools 2 Per day/Blood noted), Constipation and Loose stools. On 29-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram once a day. On 12-Feb-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram once a day. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ACNE (ACNE). In February 2021, the patient experienced PALPITATIONS (Palpitation) and PYREXIA (Fever). On 30-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE ERYTHEMA (Injection site redness). In 2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), FEAR (Fear), CONSTIPATION (Constipation), HAEMORRHOIDAL HAEMORRHAGE (Hemorrhoidal bleeding), ABDOMINAL PAIN LOWER (Lower abdominal pain), DIARRHOEA (Diarrhoea) and INJECTION SITE PAPULE (Injection site papule). On 29-Jun-2021, the patient experienced DEFAECATION URGENCY (Defaecation urgency). On an unknown date, the patient experienced ANXIETY (Feeling anxious). In February 2021, PYREXIA (Fever) had resolved. In 2021, INJECTION SITE PAPULE (Injection site papule) had resolved, INJECTION SITE PRURITUS (Injection site itching) had not resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), RECTAL HAEMORRHAGE (Rectal bleeding), ACNE (ACNE), DEFAECATION URGENCY (Defaecation urgency), HAEMORRHOIDAL HAEMORRHAGE (Hemorrhoidal bleeding), PALPITATIONS (Palpitation) and ABDOMINAL PAIN LOWER (Lower abdominal pain) outcome was unknown and FEAR (Fear), CONSTIPATION (Constipation), ANXIETY (Feeling anxious), DIARRHOEA (Diarrhoea), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased mmHg (High) Increased Blood Pressure was noted.. In 2021, Cardiac stress test: negative (Negative) Negative. In 2021, Echocardiogram: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No Treatment medication reported Patient was involved in Facilitated Collect Clinical Study. Manufacture Control No for Co-suspect drug.: 21K-163-3803366-00 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. Unlikely, that the events are related to the vaccine. Patient has Chiron's disease, Further information is expected. This case was linked to MOD-2021-252736 (Patient Link).; Reporter's Comments: This case was received from AbbVie.; 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. Unlikely, that the events are related to the vaccine. Patient has Chiron's disease, Further information is expected.

Other Meds:

Current Illness:

ID: 1481766
Sex: F
Age: 63
State: CA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 07/18/2021
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: nerve damage; entire body became inflamed - Huge inflammation; can't move arm/can't hold on to anything/can't move left leg/can hardly move; Shaking; Bad reaction; coagulation problem; Tremors in the head (brain); Blood pressure went to roof - high blood pressure "169"; cannot walk down; unable to work for a month and half; wrists are swollen - right knee is swollen; Feeling awful; In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts; whole-body hurts; Passing out; kidneys are shutting down; Von Willebrand disease (spelled it out on phone as"gon wille brand'l"; paralyzed; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") and PARALYSIS (paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 LOSS OF CONSCIOUSNESS (Passing out) (seriousness criteria disability and medically significant), RENAL IMPAIRMENT (kidneys are shutting down) (seriousness criteria disability and medically significant), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") (seriousness criteria disability and medically significant), PARALYSIS (paralyzed) (seriousness criteria disability and medically significant), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: 0.50 (Inconclusive) Patient stated her creatinine was 0.50. On an unknown date, Blood pressure measurement: 169 (High) high blood pressure 169. On an unknown date, C-reactive protein: 34/7 (Inconclusive) huge inflammation with c-reactive protein. C-reactive protein at 34.7. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) chest suggested no blood clots per patient. On an unknown date, Fibrin D dimer: 3.89 (Inconclusive) Patient reported that D-dimer (which was usually found after blood clot was present and was in process of breaking down). On an unknown date, Haematocrit: 32.9 (normal) normal. On an unknown date, Haemoglobin: 10.8 (Inconclusive) It was 14 before 3 week ago and was normal and 14 (Inconclusive) It was 14 before 3 week ago. On an unknown date, Monocyte count: 0.91 (High) monocytes are high. On an unknown date, Pain assessment (1-10): 10 (abnormal) hurts at 10 on pain scale from 1-10. On an unknown date, Red blood cell sedimentation rate: 69 (Inconclusive) Sedimentation rate was 69. On an unknown date, Sepsis: negative (Negative) tested negative. On an unknown date, X-ray: inconclusive (Inconclusive) right knee is swollen per x-ray. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) to be related. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient stated that she had gone to hospital on 14th and 16th of June 2021 and on 06 Jul 2021. The patient stated that her doctor told her that if she was not treated within a week or 2, she will be gone. The patient stated that due to coagulation problem, she should not have gotten the vaccine per patient and said it was her doctor's fault. The patient stated that she will have to go to ER if anything happens and stated that Moderna vaccine gave her all symptoms and the patient stated that she did not get Covid and was now scared that she will die. Company Comment: Very limited information regarding the events has been provided at this time. Additional information required. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9 Jul 2021 contain new serious and non serious events , suspect product dose details, lab data and narrative updated.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information required.

Other Meds:

Current Illness:

ID: 1481767
Sex: F
Age: 46
State: GA

Vax Date: 04/06/2021
Onset Date: 05/25/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She had enlarged heart; She had enlarged liver; She is very angry that this happened to her.; She felt as if she was dying.; Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021; Within 7 days after receiving 2nd dose, she had a stroke.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.), FEELING ABNORMAL (She felt as if she was dying.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021). At the time of the report, CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.), CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.) and FEELING ABNORMAL (She felt as if she was dying.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment medication were not reported Patient went to ER within those 7 days. Patient mentioned that her husband was also sick after receiving vaccine. Action taken with mRNA-1273 in response to the events was not applicable. As an intervention patient had 3 blood transfusions and was on ventilator Based on the current available information and temporal association between the use of the product and the start date (within 7 days) 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 (within 7 days) of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1481768
Sex: M
Age:
State: NY

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 07/18/2021
Hospital: Y

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: Anxiety directly related and due to the vaccine; I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.; his chest hurt so bad; he got sick very bad; He has elevated immunity; More than 35 days after the first dose without receiving the second dose; I felt like I was having a heart attack; my knees were aching; When I woke up the next day, felt like a truck ran me over; lost all appetite; it attacked both my knees so severely I could hardly walk; Couldn't get off my toilet seat; I can't sit in my couch; had all kind of symptoms; 101 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine) and INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) at an unspecified dose. On 22-Mar-2021, the patient experienced GENERAL SYMPTOM (had all kind of symptoms), PYREXIA (101 fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) (seriousness criterion hospitalization), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch) and ARTHRALGIA (my knees were aching). On 06-Apr-2021, the patient experienced CHEST PAIN (his chest hurt so bad) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (I felt like I was having a heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Anxiety directly related and due to the vaccine) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (he got sick very bad) and IMMUNE SYSTEM DISORDER (He has elevated immunity). The patient was hospitalized from 06-Apr-2021 to 07-Apr-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine), INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.), GENERAL SYMPTOM (had all kind of symptoms), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch), ILLNESS (he got sick very bad), IMMUNE SYSTEM DISORDER (He has elevated immunity), ARTHRALGIA (my knees were aching), PYREXIA (101 fever) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 101 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) was unknown. Patient reported that he wont get the second one, as he got sick very bad. He had elevated immunity, his antibodies level is off the charts, that was documented in his hospital. Concomitant medications was not reported . Treatment history was not 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; 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: 1481769
Sex: M
Age: 71
State: FL

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: when it stops, tremors and seizures on his leg muscles starts.; what he had could not let him function properly anymore, cannot drive, cannot scuba dive, could no longer live actively; loosing ability to walk, cannot seat upright; uncontrollable muscle cramps on his legs every 2 minutes that went on for hours and hours, huge cramps, Currently, patient is still with episodes of spasms in his left thigh and left groin; so unbearable, rated pain as 8/10, 10 being the highest; lower back and hips with strong pain; tremors; 2 days ago his shoulder joints started aching.; dull aches everywhere in his body; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (when it stops, tremors and seizures on his leg muscles starts.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (when it stops, tremors and seizures on his leg muscles starts.) (seriousness criterion medically significant), MOVEMENT DISORDER (what he had could not let him function properly anymore, cannot drive, cannot scuba dive, could no longer live actively), GAIT DISTURBANCE (loosing ability to walk, cannot seat upright), MUSCLE SPASMS (uncontrollable muscle cramps on his legs every 2 minutes that went on for hours and hours, huge cramps, Currently, patient is still with episodes of spasms in his left thigh and left groin), PAIN (so unbearable, rated pain as 8/10, 10 being the highest), BACK PAIN (lower back and hips with strong pain), TREMOR (tremors), ARTHRALGIA (2 days ago his shoulder joints started aching.) and MYALGIA (dull aches everywhere in his body). The patient was treated with IBUPROFEN for Adverse event, at a dose of 12-16 Ibuprofen depending on how bad; ACETAMINOPHEN at a dose of 500 mg twice a day; TRAMADOL at a dose of 50 mg four times per day and CELECOXIB at a dose of 200 mg once a day. At the time of the report, SEIZURE (when it stops, tremors and seizures on his leg muscles starts.), MOVEMENT DISORDER (what he had could not let him function properly anymore, cannot drive, cannot scuba dive, could no longer live actively), GAIT DISTURBANCE (loosing ability to walk, cannot seat upright), MUSCLE SPASMS (uncontrollable muscle cramps on his legs every 2 minutes that went on for hours and hours, huge cramps, Currently, patient is still with episodes of spasms in his left thigh and left groin), PAIN (so unbearable, rated pain as 8/10, 10 being the highest), BACK PAIN (lower back and hips with strong pain), TREMOR (tremors), ARTHRALGIA (2 days ago his shoulder joints started aching.) and MYALGIA (dull aches everywhere in his body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Magnetic resonance imaging: normal (normal) normal. In 2021, X-ray: normal (normal) x rays of back and hip are normal.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided by the reporter. According to reporter, the patient went to a physical therapist but reported only worsened his situation and decided not to go on with the therapy anymore. Steroids were reported as a additional treatment medication. 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: 1481770
Sex: F
Age: 25
State: TX

Vax Date: 06/01/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: seizure; shortness of breath; mucus/was throwing up everything including mucus; She had reduced appetite; upset stomach; nausea; Vomiting; felt like she was going to die, like she got hit by a car; fever; coughing; unable to move; have no energy/body is very weak/She was weak; unable to go to work, and lost her job; arm was swollen; arm was itchy; 2nd dose after 38 days; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 0110214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bacterial vaginosis. Previously administered products included for an unreported indication: FLU (Patient regularly takes the flu shot). Concurrent medical conditions included Diabetes, Asthma, Seizure, Anxiety and Arthritis. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), PROCATEROL HYDROCHLORIDE (PRO-AIR) and GLUCOSE for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), PRURITUS (arm was itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 38 days). On 09-Jul-2021, the patient experienced IMPAIRED WORK ABILITY (unable to go to work, and lost her job), MOVEMENT DISORDER (unable to move), ASTHENIA (have no energy/body is very weak/She was weak), COUGH (coughing), VACCINATION COMPLICATION (felt like she was going to die, like she got hit by a car) and PYREXIA (fever). On 10-Jul-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), SECRETION DISCHARGE (mucus/was throwing up everything including mucus), DECREASED APPETITE (She had reduced appetite), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and VOMITING (Vomiting). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and Physical therapy (breathing exercise) for Dyspnoea. On 08-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 38 days) had resolved. On 10-Jul-2021, SEIZURE (seizure), DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (arm was swollen), PRURITUS (arm was itchy) and PYREXIA (fever) had resolved. At the time of the report, IMPAIRED WORK ABILITY (unable to go to work, and lost her job), MOVEMENT DISORDER (unable to move), ASTHENIA (have no energy/body is very weak/She was weak), SECRETION DISCHARGE (mucus/was throwing up everything including mucus), COUGH (coughing), VACCINATION COMPLICATION (felt like she was going to die, like she got hit by a car), DECREASED APPETITE (She had reduced appetite), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, Body temperature: 101 (High) High. The patient reported her A1C was at 9 for at least 3 months to date. 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. Additionally, this is also a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #027D21A). Further information has been requested. This case was linked to MOD-2021-256558 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Case upgraded to serious; Patient medical history, lab data, concomitant and treatment medication, new events added, and narrative updated.; 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. Additionally, this is also a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #027D21A). Further information has been requested.

Other Meds: KEPPRA [LEVETIRACETAM]; PRO-AIR; JANUVIA; GLUCOSE

Current Illness: Anxiety; Arthritis; Asthma; Diabetes; Seizure

Date Died: 07/08/2021

ID: 1481771
Sex: M
Age: 84
State: CT

Vax Date: 07/07/2021
Onset Date:
Rec V Date: 07/18/2021
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: Cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease); Atherosclerotic Cardiovascular Disease; This spontaneous case was reported by a nurse and describes the occurrence of PARKINSON'S DISEASE (Cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease)) and ARTERIOSCLEROSIS (Atherosclerotic Cardiovascular Disease) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergy to Sinemet). On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARKINSON'S DISEASE (Cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease)) (seriousness criteria death and medically significant) and ARTERIOSCLEROSIS (Atherosclerotic Cardiovascular Disease) (seriousness criterion death). The patient died on 08-Jul-2021. The reported cause of death was parkinson's disease and Atherosclerotic cardiovascular disease. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient passed away (08Jul2021 at 4:10 PM). The HCP reported that the death certificate showed cause of death to be Parkinson's Disease secondary to ASHD (atherosclerotic heart disease). No concomitant medication details was provided. No treatment medication details was provided. Very Limited information regarding the events has been provided at this time . Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time . Further information has been requested.; Reported Cause(s) of Death: Parkinson's Disease; Atherosclerotic Cardiovascular Disease

Other Meds:

Current Illness: Drug allergy (Allergy to Sinemet)

ID: 1481772
Sex: M
Age:
State: FL

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 07/18/2021
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: Dose given was beyond the use date (BUD) of 8July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) in a 35-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 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) (seriousness criterion medically significant). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given was beyond the use date (BUD) of 8July2021) 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 information was provided by the reporter. The pharmacist reported that they had 5 refrigerated vials that went the beyond use date of 08JUL2021. Out of them 1 vial was used for 4 patients on 09JUL2021 and that was beyond the use date. The pharmacist also reported that those vials were refrigerated on 08JUN2021and are not supposed to be given after its BUD of 08JUL2021. The other 4 vials are still sealed, unused and kept for disposal. No treatment information was provided by the reporter. Company comment: This report refers to a case of Expired product administration error for mRNA-1273, with no associated adverse events. This appears to be non-serious, but RA has reported this as a serious event. However, more information is required to determine the serious criteria. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received does not contain any new information (NNI); Sender's Comments: This report refers to a case of Expired product administration error for mRNA-1273, with no associated adverse events. This appears to be non-serious, but RA has reported this as a serious event. However, more information is required to determine the serious criteria.

Other Meds:

Current Illness:

ID: 1481773
Sex: F
Age: 46
State: CA

Vax Date: 05/11/2021
Onset Date: 06/08/2021
Rec V Date: 07/18/2021
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: Low blood pressure; Sweating; Concussion; Diarrhea; Irregular menstrual cycle; Lightheadedness; Dehydrated; Heart pounding; Fever; Covid arm of left arm which was hard in between elbow and shoulder; like hives and was pink; like hives and was pink; Weakness; Eye discomfort; Fainted; Woke up covered in blood gashed forehead open above right eye; Stomach pain; Nausea; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) and HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) for Chemotherapy, VITAMIN C [ASCORBIC ACID] for an unknown indication. On 11-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) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (Nausea). On 09-Jun-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Heart pounding), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), DIARRHOEA (Diarrhea), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainted), HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye), PALPITATIONS (Heart pounding), ABDOMINAL PAIN UPPER (Stomach pain), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 67/30 (Low) 67/30. On an unknown date, Heart rate: low (Low) Low. 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-2021-253122 (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: VITAMIN C [ASCORBIC ACID]; SPRYCEL

Current Illness: Chronic myeloid leukemia

ID: 1481774
Sex: F
Age: 44
State: IL

Vax Date: 04/26/2021
Onset Date: 07/02/2021
Rec V Date: 07/18/2021
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: This spontaneous case was reported by a physician and describes the occurrence of MENINGITIS ASEPTIC (developed possible aseptic meningoencephalitis) and IMMUNE-MEDIATED ADVERSE REACTION (doctor thought that I could have hyperimmune react) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Back surgery in June 2015. Concurrent medical conditions included Depression since 2010, Chronic back pain (s/p (status post) back surgery) since 25-Jun-2015, Egg allergy (when patient was in elementary/middle school), Food allergy (spinach - severe abd pain) since 2019, Drug allergy (Reglan), Drug allergy (Fentanyl) and Acid reflux (esophageal) since 2018. Concomitant products included LANSOPRAZOLE (PREVACID) for Acid reflux (esophageal), PARACETAMOL (TYLENOL) for Back pain. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced MENINGITIS ASEPTIC (developed possible aseptic meningoencephalitis) (seriousness criterion medically significant). On 03-Jul-2021, the patient experienced MEMORY IMPAIRMENT (memory deficits), DISTURBANCE IN ATTENTION (concentration problems), MOUTH ULCERATION (mouth ulcers), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), CONSTIPATION (constipation), MUSCLE TWITCHING (muscle twitchings lower legs), BURNING SENSATION (bilateral feet burning), PERIPHERAL COLDNESS (bilateral feet coldness), DEHYDRATION (severe dehydration), VACCINATION COMPLICATION (hyperimmune reaction), VACCINATION SITE INDURATION (left arm induration), MYALGIA (myalgias), HEADACHE (pulsatile headaches) and PYREXIA (fever). On an unknown date, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (doctor thought that I could have hyperimmune react) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose administration). At the time of the report, MENINGITIS ASEPTIC (developed possible aseptic meningoencephalitis), MEMORY IMPAIRMENT (memory deficits), DISTURBANCE IN ATTENTION (concentration problems), MOUTH ULCERATION (mouth ulcers), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), CONSTIPATION (constipation), MUSCLE TWITCHING (muscle twitchings lower legs), BURNING SENSATION (bilateral feet burning), PERIPHERAL COLDNESS (bilateral feet coldness), DEHYDRATION (severe dehydration), VACCINATION COMPLICATION (hyperimmune reaction), VACCINATION SITE INDURATION (left arm induration), MYALGIA (myalgias), HEADACHE (pulsatile headaches) and PYREXIA (fever) had not resolved, IMMUNE-MEDIATED ADVERSE REACTION (doctor thought that I could have hyperimmune react) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose administration) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Body temperature: 99.7 degrees f (High) fever 99.7 degrees F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-111340, MOD-2021-111340 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received does not contain any 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.

Other Meds: TYLENOL; PREVACID

Current Illness: Acid reflux (esophageal); Chronic back pain (s/p (status post) back surgery); Depression; Drug allergy (Reglan); Drug allergy (Fentanyl); Food allergy (spinach - severe abd pain)

ID: 1481775
Sex: F
Age: 65
State: RI

Vax Date: 02/23/2021
Onset Date: 03/25/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: she was going to pass out; started feeling bad; completely cramping, laid down on the floor until the ENT; chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (she was going to pass out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Acid reflux (oesophageal), Rotator cuff injury and Thyroid disorder. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (she was going to pass out) (seriousness criterion medically significant), FEELING ABNORMAL (started feeling bad), MUSCLE SPASMS (completely cramping, laid down on the floor until the ENT) and CHILLS (chills). On 25-Mar-2021, LOSS OF CONSCIOUSNESS (she was going to pass out) had resolved. At the time of the report, FEELING ABNORMAL (started feeling bad), MUSCLE SPASMS (completely cramping, laid down on the floor until the ENT) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment products included Pantoprazole 40 mg BID (after vaccine adverse event) Concomitant products included Valsartan HCTZ 160/25 QD Patient said she was informed she might have Vasovagal response. After staying the emergency room for 6 hours all of her blood work and test came back to normal. The heartburn did not change at all. Patient's new GI doctor suggested that she might be experiencing from inflammatory response from the vaccine and suggested to stay on Pantoprazole 40 mg and double the dose. Patient then spoke with her retired GI doctor who said that the vaccine might cause weaken her system and now its compromised. Patient said that her digestive system and quality of life has been affected after the vaccination. Consent to follow up with patient and health care professional given. 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-2021-253202 (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: SYNTHROID; PANTOPRAZOLE; CRESTOR

Current Illness: Acid reflux (oesophageal); Rotator cuff injury; Thyroid disorder

ID: 1481776
Sex: F
Age: 35
State: AZ

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Relapse; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Relapse) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 CONDITION AGGRAVATED (Relapse) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to CONDITION AGGRAVATED. At the time of the report, CONDITION AGGRAVATED (Relapse) had resolved. Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. Limited information regarding the event has been provided at this time and is insufficient for causality assessment. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Live follow up received on 13-JUL-2021, contains no new information.; Sender's Comments: Limited information regarding the event has been provided at this time and is insufficient for causality assessment.

Other Meds:

Current Illness:

ID: 1481777
Sex: F
Age: 71
State: IL

Vax Date: 11/01/2020
Onset Date: 03/12/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: vomiting; Injection site redness; delirious; oral intake reduced; mobility decreased; sweating; fever; This spontaneous case was reported by a physician and describes the occurrence of DELIRIUM (delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Smoker (Former cigarette smoker) from 1970 to 1996. Concurrent medical conditions included Shellfish allergy (Hives), Allergy to antibiotic (Doxycycline- skin eruption) and Rheumatoid arthritis. Concomitant products included RISEDRONATE SODIUM (RISEDRONATE) for Bone disorder NOS, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Pain. In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever) and INJECTION SITE ERYTHEMA (Injection site redness). On 14-Mar-2021, the patient experienced VOMITING (vomiting). On 14-Mar-2021, DELIRIUM (delirious), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported.; 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: RISEDRONATE; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]

Current Illness: Allergy to antibiotic (Doxycycline- skin eruption); Rheumatoid arthritis; Shellfish allergy (Hives)

ID: 1481778
Sex: M
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: heart attack after Moderna vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attack after Moderna 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. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment was reported for the events. 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: 1481779
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain; Numbness in the right side of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) (seriousness criteria medically significant and life threatening) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) (seriousness criterion medically significant). At the time of the report, CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram head: abnormal (abnormal) Small blood clot on the left side of brain. In 2021, Magnetic resonance imaging: abnormal (abnormal) 2 others on additional on the right side of the brain. No relevant concomitant medication information provided. No relevant treatment information provided. Patient received both vaccine doses. About 3 weeks after the second dose, the patient experienced numbness in the right side of their mouth with no other signs of a stroke. Per patient, there was no apparent reason for the strokes and the diagnostics were normal. 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:

Date Died: 06/01/2021

ID: 1481780
Sex: M
Age: 72
State: NJ

Vax Date: 05/01/2021
Onset Date: 06/01/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 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 PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death

Other Meds:

Current Illness: Blood pressure; Diabetes

ID: 1481781
Sex: F
Age:
State: TX

Vax Date: 04/12/2021
Onset Date: 05/01/2021
Rec V Date: 07/18/2021
Hospital: Y

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: Legion in the brain that showed swelling; Legion in the brain that showed swelling; Only can see little bit from left eye; Had an eye stroke, affecting optic nerve; Could not see anything from right eye; Numbness in her arm and toe/developing numbness in arm and leg; Developed high blood pressure; Little bit of heavy breathing; Optic nerve split; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Could not see anything from right eye), BRAIN OEDEMA (Legion in the brain that showed swelling), CENTRAL NERVOUS SYSTEM LESION (Legion in the brain that showed swelling), VISUAL IMPAIRMENT (Only can see little bit from left eye), OPTIC NERVE DISORDER (Optic nerve split), OPTIC NEUROPATHY (Had an eye stroke, affecting optic nerve) and HYPOAESTHESIA (Numbness in her arm and toe/developing numbness in arm and leg) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 079A42A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced BLINDNESS UNILATERAL (Could not see anything from right eye) (seriousness criteria hospitalization, disability and medically significant), OPTIC NERVE DISORDER (Optic nerve split) (seriousness criteria hospitalization and disability), OPTIC NEUROPATHY (Had an eye stroke, affecting optic nerve) (seriousness criteria hospitalization, disability and medically significant) and DYSPNOEA (Little bit of heavy breathing). On an unknown date, the patient experienced BRAIN OEDEMA (Legion in the brain that showed swelling) (seriousness criteria hospitalization, disability, medically significant and life threatening), CENTRAL NERVOUS SYSTEM LESION (Legion in the brain that showed swelling) (seriousness criteria hospitalization and life threatening), VISUAL IMPAIRMENT (Only can see little bit from left eye) (seriousness criteria hospitalization and disability), HYPOAESTHESIA (Numbness in her arm and toe/developing numbness in arm and leg) (seriousness criterion hospitalization) and HYPERTENSION (Developed high blood pressure). The patient was treated with AMLODIPINE BESILATE (NORVASC) for Blood pressure high, at a dose of 10 mg; HYDROCHLOROTHIAZIDE for Blood pressure high, at a dose of 25 mg and PREDNISONE for Inflammation, at a dose of 40 mg. At the time of the report, BLINDNESS UNILATERAL (Could not see anything from right eye), VISUAL IMPAIRMENT (Only can see little bit from left eye) and OPTIC NERVE DISORDER (Optic nerve split) had not resolved and BRAIN OEDEMA (Legion in the brain that showed swelling), CENTRAL NERVOUS SYSTEM LESION (Legion in the brain that showed swelling), OPTIC NEUROPATHY (Had an eye stroke, affecting optic nerve), HYPOAESTHESIA (Numbness in her arm and toe/developing numbness in arm and leg), HYPERTENSION (Developed high blood pressure) and DYSPNOEA (Little bit of heavy breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Intraocular pressure test: pressure increased up to 26 (High) pressure increased up to 26. Concomitant product used was not provided by the reporter. A few days after getting second vaccination, this patient started to experience a little bit of heavy breathing. About a week later, when she got up she could not see anything from her right eye. She went to an Eye Specialist and was diagnosed with optic nerve may have split causing her pressure to increase to 26 and affecting both eyes. The doctor recommended she go to the ER. While at the ER, she developed high blood pressure (never had before), numbness in her arm and toe. It was recommended that she see her primary physician. Her primary physician prescribed Norvasc (amlodipine) and hydrochlorothiazide. The patient then traveled to see two eye specialist and was hospitalized for brain test, CAT scan and MRI. She was told she had a eye stroke affecting her optic nerve, developing numbness in arm and leg and a lesion in her brain was noticed that showed swelling. She was prescribed prednisone for the inflammation. Treatment included MRI, brain test, CAT scan, amlodipine, hydrochlorothiazide and prednisone. 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: 1481782
Sex: F
Age: 36
State: IL

Vax Date: 07/09/2021
Onset Date: 07/11/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Congestion of lungs; Developed sinus like infection; Shortness of breath; Coughing; Sneezing; Feels dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion of lungs) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ALPRAZOLAM (XANAX) and CLONAZEPAM (CLONOPIN) for an unknown indication. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced PULMONARY CONGESTION (Congestion of lungs) (seriousness criterion medically significant), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY CONGESTION (Congestion of lungs), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications included Sinus infection medicine along with other medications. 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: ADDERALL; XANAX; CLONOPIN

Current Illness:

ID: 1481783
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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: fainting; pain; sleep walking; dizziness; Anemia; was very thirsty/drank lots of water, around 2-3 gallons a day; three interventions on her bladder; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Bladder disorder. 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 SYNCOPE (fainting) (seriousness criteria hospitalization and medically significant), PAIN (pain) (seriousness criterion hospitalization), SOMNAMBULISM (sleep walking) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization), ANAEMIA (Anemia) (seriousness criterion hospitalization), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) (seriousness criterion hospitalization) and BLADDER DISORDER (three interventions on her bladder) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. 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: 1481784
Sex: M
Age: 60
State: FL

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 07/18/2021
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: Had a seizure, 2 other reactions like seizures; Could not breathe, has breathing problems; Was really sick; could not get out of bed for 4 days; shoulder pain; muscle pain; Felt a little nauseated; Is really fatigued, tired; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure, 2 other reactions like seizures) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Diverticulitis, Narcolepsy and Vertigo. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (Had a seizure, 2 other reactions like seizures) (seriousness criterion medically significant), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired). At the time of the report, SEIZURE (Had a seizure, 2 other reactions like seizures), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired) outcome was unknown. The patient's medical history also included an unknown syndrome (could not understand the name). Concomitant product was not reported. The patient had experienced shoulder pain, muscle pain, fannnnd had elt a little nauseated. Three and a half weeks after having the second shot , he had a seizure, was really sick, could not breathe (started after he got the seizure), and it was horrible. At the time of the report, the patient continued to have muscle pain and everything, predominantly in his upper chest, and has breathing problems; he had never smoked or anything. He also had 2 other seizures like reactions. He was really fatigued and tired. He could not get out of bed for 4 days. He went to doctor but was given no aditional treatment. At some point after he had the seizure, the patient saw his doctor. Treatment was not reported. Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.

Other Meds:

Current Illness: Blood pressure high; Diverticulitis; Narcolepsy; Vertigo

ID: 1481785
Sex: M
Age: 53
State: IL

Vax Date: 05/01/2021
Onset Date: 05/05/2021
Rec V Date: 07/18/2021
Hospital: Y

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: patient very nearly loss consciousness and fell on the floor; felt worse; malaise; light headed / dizziness; felt pressure in his chest; weakness; more fatigue/extreme fatigue; bradycardia effect / heart rate was 37 / slower heart rate; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) and BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included GABAPENTIN and SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine, MELOXICAM for Tennis elbow. On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) (seriousness criterion medically significant), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his chest), ASTHENIA (weakness) and FATIGUE (more fatigue/extreme fatigue). On 01-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). At the time of the report, LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor), BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate), FEELING ABNORMAL (felt worse), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his chest), ASTHENIA (weakness) and FATIGUE (more fatigue/extreme fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Heart rate: 37 37. On 01-Jul-2021, Blood pressure measurement: Abnormal. On 01-Jul-2021, Echocardiogram: dilation and leaky valve Dilation and leaky valve. On 01-Jul-2021, Heart rate: Normal resting heart rate was 62-64, now its 49-50. Patients standing and walking used to be 75-85, now its 58-57 (standing), 60 (walking). Patient said that over the last two months his sleeping Heart Rate was 42 to 43 and dipped down to 39 sometimes. No treatment drug details was reported. This case was linked to MOD-2021-253997 (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: GABAPENTIN; IMITREX [SUMATRIPTAN SUCCINATE]; MELOXICAM

Current Illness:

ID: 1481786
Sex: F
Age:
State: OH

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 07/18/2021
Hospital: Y

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: Nausea; 3 weeks after, the 2nd dose was given; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks after, the 2nd dose was given). At the time of the report, NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks after, the 2nd dose was given) had resolved. Concomitant medications were not reported. The patient was treated with unspecified medications for nausea. On an unknown date, the patient had nausea after the vaccination which resolved after 24 hours. 3 weeks later, the patient had the 2nd dose of the vaccine and since then had nausea. The patient was hospitalized twice due to the nausea and consulted with physician but the medications that were being given to the patient were not helping. This report refers to a case of wrong schedule of product for mRNA-1273, lot # unknown with associated AE Nausea. Very limited information regarding the event Nausea has been provided at this time. Further information is not expected. This case was linked to MOD-2021-254392 (Patient Link). Reporter did not allow further contact; Sender's Comments: This report refers to a case of wrong schedule of product for mRNA-1273, lot # unknown with associated AE Nausea. Very limited information regarding the event Nausea has been provided at this time. Further information is not expected.

Other Meds:

Current Illness:

ID: 1481787
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: collapsed on the spot when she got second vaccine; lost her hearing/Got her hearing back; lost her vision; Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later; a week later she followed up with her HCPs and primary care physician and it was determined that this was an allergic reaction to the Moderna Vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed on the spot when she got second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (collapsed on the spot when she got second vaccine) (seriousness criterion medically significant), DEAFNESS (lost her hearing/Got her hearing back), BLINDNESS (lost her vision), HYPOTENSION (Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later) and ALLERGY TO VACCINE (a week later she followed up with her HCPs and primary care physician and it was determined that this was an allergic reaction to the Moderna Vaccine). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed on the spot when she got second vaccine), DEAFNESS (lost her hearing/Got her hearing back), BLINDNESS (lost her vision), HYPOTENSION (Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later) and ALLERGY TO VACCINE (a week later she followed up with her HCPs and primary care physician and it was determined that this was an allergic reaction to the Moderna Vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Blood pressure dangerously low/Blood pressure went back to normal 20 minutes later. On an unknown date, Scan brain: normal (normal) Normal. No concomitant medication was reported. No treatment medication was reported. Company comment: Based on current available information and the temporal association between product use and the start dat of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start dat of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1481788
Sex: F
Age: 38
State: MO

Vax Date: 03/27/2021
Onset Date: 05/22/2021
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Guillain Barre syndrome; pins and needles in her feet; loss of the ability to walk; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 002B21A) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included No adverse event. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (pins and needles in her feet) (seriousness criterion hospitalization) and GAIT INABILITY (loss of the ability to walk) (seriousness criterion hospitalization). The patient was hospitalized on 24-May-2021 due to GAIT INABILITY, GUILLAIN-BARRE SYNDROME and PARAESTHESIA. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) on 26-May-2021 at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Computerised tomogram: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Lumbar puncture: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Magnetic resonance imaging: guillain barre syndrome (abnormal) Guillain Barre syndrome. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. She was moved to rehab on Memorial Day Weekend. She is still in physical therapy and has residual pins and needles. 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: 1481789
Sex: F
Age: 70
State: FL

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 07/18/2021
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: was not administered the 2nd dose of the vaccine; atrial fibrillation; afib attack/atrial fibrillation; itchy ant bite like lesions which popped on different sites of her body; itchy ant bite like lesions which popped on different sites of her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (afib attack/atrial fibrillation) and ATRIAL FIBRILLATION (atrial fibrillation) in a 70-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. No medical history was provided by the reporter. The patient's past medical history included Atrial fibrillation and Cardiac ablation on 06-Jul-2020. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ATRIAL FIBRILLATION (afib attack/atrial fibrillation) (seriousness criterion medically significant). In March 2021, the patient experienced PRURITUS (itchy ant bite like lesions which popped on different sites of her body) and SKIN LESION (itchy ant bite like lesions which popped on different sites of her body). On 04-Apr-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). On 12-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was not administered the 2nd dose of the vaccine). The patient was treated with FLECAINIDE for Adverse event, at a dose of 100 mg twice a day and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at an unspecified dose and frequency. In April 2021, ATRIAL FIBRILLATION (afib attack/atrial fibrillation) had resolved. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itchy ant bite like lesions which popped on different sites of her body) and SKIN LESION (itchy ant bite like lesions which popped on different sites of her body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (was not administered the 2nd dose of the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 04-Mar-2021, in the morning, the patient experienced had an atrial fibrillation attack and went to the emergency room (ER) where she was given medications to control it. On 04-Apr-2021, the patient had another atrial fibrillation attack and again she went to the ER. The patient had two more atrial fibrillation attacks on unspecified dates in April and she managed these at home by doubling up on her medication. Patient reports that with this, it took 6-7 hours before the atrial fibrillation got controlled. Treatment included: She had an ablation last 06Jul2021 for the atrial fibrillation. 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. Noting the history of atrial fibrillation may remain as risk factor. This report refers to a case of lack of product dose omission for mRNA-1273, lot # unknown.; 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. Noting the history of atrial fibrillation may remain as risk factor. This report refers to a case of lack of product dose omission for mRNA-1273, lot # unknown.

Other Meds: XARELTO

Current Illness:

ID: 1481790
Sex: M
Age: 19
State: CA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 07/18/2021
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: It got progressively worse & got hives; Both arms started itching, mostly the left at first; Lethargy; Soreness in left arm; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), MYALGIA (Soreness in left arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced URTICARIA (It got progressively worse & got hives) (seriousness criterion medically significant) and PRURITUS (Both arms started itching, mostly the left at first) (seriousness criterion medically significant). The patient was treated with PREDNISONE on 05-Apr-2021 at a dose of 20 milligram and PREDNISONE on 14-Apr-2021 at a dose of 10 milligram. At the time of the report, URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported by reporter. On 05 Apr 2021, the patient went to the Emergency Room and was prescribed Prednisone 20 mg 2 tabs daily for four days. The hives went away after the 4th day but came right back. On 14 Apr 2021, the patient went to the dermatologist. At that time the hives continued and were spread on quads, calves, hands and back. The dermatologist prescribed Prednisone 10mg with titrating dose over two weeks. 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-2021-254133 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; 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: 1481791
Sex: F
Age: 81
State: WI

Vax Date: 05/28/2021
Onset Date:
Rec V Date: 07/18/2021
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: Mastitis in size of "egg" and "hot"; Lipoma; turned to brown like sun burn; Received antibiotics and she had harsh reaction to it; Itchy arm; "ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"; This spontaneous case was reported by a consumer and describes the occurrence of MASTITIS (Mastitis in size of "egg" and "hot") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergy to Celebrex), Drug allergy (Allergy to Codeine), Allergy to antibiotic (Allergy to Erythromycin), Drug allergy (Allergy to Viax), Allergy to antibiotic (Allergy to Cefoxitin), Drug allergy (Allergy to Valdecoxib) and Infection. Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), VALSARTAN (DIOVAN), HYDROCHLOROTHIAZIDE, METFORMIN, TRIAMCINOLONE and AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVUNATE POTASSIUM) for an unknown indication. On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-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 MASTITIS (Mastitis in size of "egg" and "hot") (seriousness criterion medically significant), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"). At the time of the report, MASTITIS (Mastitis in size of "egg" and "hot"), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn") outcome was unknown. No relevant concomitant medications were reported. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. This case was linked to MOD-2021-214864 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.

Other Meds: AMLODIPINE; CRESTOR; DIOVAN; HYDROCHLOROTHIAZIDE; METFORMIN; TRIAMCINOLONE; AMOXICILLIN AND CLAVUNATE POTASSIUM

Current Illness: Allergy to antibiotic (Allergy to Erythromycin); Allergy to antibiotic (Allergy to Cefoxitin); Drug allergy (Allergy to Viax); Drug allergy (Allergy to Valdecoxib); Drug allergy (Allergy to Codeine); Drug allergy (Allergy to Celebrex); Infection

ID: 1481792
Sex: M
Age: 19
State: CA

Vax Date: 04/27/2021
Onset Date: 03/28/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Redness presently cover entire body; one of my eyelids is swollen; itching; I also woke up during the night & I passed out.; lethargic; had the shivers; headache; soreness in my left arm; My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine). On 27-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.) (seriousness criterion medically significant), LETHARGY (lethargic), CHILLS (had the shivers), HEADACHE (headache) and MYALGIA (soreness in my left arm). On 03-Jul-2021, the patient experienced PRURITUS (itching). On 12-Jul-2021, the patient experienced SWELLING OF EYELID (one of my eyelids is swollen). On an unknown date, the patient experienced ERYTHEMA (Redness presently cover entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) for Adverse event, at an unspecified dose and frequency and PREDNISOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.), LETHARGY (lethargic), URTICARIA (My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine), PRURITUS (itching), SWELLING OF EYELID (one of my eyelids is swollen), ERYTHEMA (Redness presently cover entire body), CHILLS (had the shivers), HEADACHE (headache) and MYALGIA (soreness in my left arm) outcome was unknown. 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-2021-254121 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; 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: 1481793
Sex: F
Age: 44
State: TX

Vax Date: 03/01/2021
Onset Date: 05/01/2021
Rec V Date: 07/18/2021
Hospital: Y

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: low blood pressure, when she stands she faints; cellulitis; tingling sharp pain in feet and toes; a high heart rate; pain in hands which moves through her body during the night/ sharp pain in her feet and toes; rash/rash in middle side back; vomiting, she can't eat gags when eating regular food; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (low blood pressure, when she stands she faints) and CELLULITIS (cellulitis) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced HYPOTENSION (low blood pressure, when she stands she faints) (seriousness criterion hospitalization), CELLULITIS (cellulitis) (seriousness criterion medically significant), PARAESTHESIA (tingling sharp pain in feet and toes), HEART RATE INCREASED (a high heart rate), PAIN IN EXTREMITY (pain in hands which moves through her body during the night/ sharp pain in her feet and toes), RASH (rash/rash in middle side back), VOMITING (vomiting, she can't eat gags when eating regular food) and PYREXIA (fever). The patient was treated with MIDODRINE for Low blood pressure, at an unspecified dose and frequency and SULFANILAMIDE (SULFA [SULFANILAMIDE]) (intravenous) for Cellulitis, at an unspecified dose and frequency. At the time of the report, HYPOTENSION (low blood pressure, when she stands she faints) and VOMITING (vomiting, she can't eat gags when eating regular food) had not resolved and CELLULITIS (cellulitis), PARAESTHESIA (tingling sharp pain in feet and toes), HEART RATE INCREASED (a high heart rate), PAIN IN EXTREMITY (pain in hands which moves through her body during the night/ sharp pain in her feet and toes), RASH (rash/rash in middle side back) and PYREXIA (fever) outcome was unknown. Concomitant medications were not reported . Treatment history includes steroid pack of pills . Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Patient was hospitalized for a period of three weeks around that time with an admitting diagnosis of low blood pressure,believed to have been brought on by her known sulfa allergy. Reporter believes to be Guillain-Barre based on the collection of symptoms and what research he had done online. 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. There is confounding by a reported medical history of sulfa allergy.; 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. There is confounding by a reported medical history of sulfa allergy.

Other Meds:

Current Illness: Sulfonamide allergy

ID: 1481794
Sex: F
Age: 33
State: FL

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: She was in the hospital; Greater than 35 days since the patient received her first Moderna Covid-19 vaccine; Swelling in right arm injection site area; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (She was in the hospital) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in right arm injection site area). On an unknown date, the patient experienced HOSPITALISATION (She was in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her first Moderna Covid-19 vaccine). At the time of the report, HOSPITALISATION (She was in the hospital), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her first Moderna Covid-19 vaccine) and VACCINATION SITE SWELLING (Swelling in right arm injection site area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information about the event hospitalization has been requested. This report refers to a case of product dose omission for mRNA-1273, lot # 037B21A.; 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 about the event hospitalization has been requested. This report refers to a case of product dose omission for mRNA-1273, lot # 037B21A.

Other Meds:

Current Illness:

ID: 1481795
Sex: F
Age:
State: OH

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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: Nausea; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, NAUSEA (Nausea) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. No concomitant medications were reported. Treatment details included unspecified medications for nausea. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-254067 (Patient Link). Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1481796
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Toxic effects of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) (seriousness criterion death). The reported cause of death was toxic effects of moderna vaccine. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. No treatment information was provided. Company comment: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Reported Cause(s) of Death: Toxic effects of Moderna vaccine

Other Meds:

Current Illness:

ID: 1481797
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Rheumatoid Arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis flare up. The patient's past medical history included Rheumatoid arthritis since an unknown date. 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. and UPADACITINIB (RINVOQ) (Oral) UNK dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Rheumatoid arthritis flare up, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not reported. Very limited information regarding this event has been provided at this time. Further information will be requested. This case was linked to US-MODERNATX, INC.-MOD-2021-197904 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information will be requested. US-MODERNATX, INC.-MOD-2021-197904:Dose 1 Case

Other Meds:

Current Illness: Rheumatoid arthritis

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm