VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1204738
Sex: M
Age: 51
State: CA

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies: NKDA

Symptom List: Dysphagia, Epiglottitis

Symptoms: Increasing shortness of breath that gets worse when laying down. Pt came by ambulance to the ER.

Other Meds: None

Current Illness: None

ID: 1204739
Sex: F
Age: 25
State: CA

Vax Date: 04/10/2021
Onset Date: 04/12/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies: Ginger and mushrooms

Symptom List: Anxiety, Dyspnoea

Symptoms: Having the chills and hot flashes. Feeling dizzy

Other Meds: I?m taking multivitamins, vitamin D 3, hair skin and nail vitamins, Loratadine and Ziprasidone

Current Illness: Fatty Liver

ID: 1204740
Sex: F
Age: 65
State: VA

Vax Date: 04/10/2021
Onset Date: 04/12/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies: Latex, Indomethacin, Percocet

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

Symptoms: Lemon sized lump under left armpit - soft. No treatment.

Other Meds: None. Tylenol 1000 mg taken at about 11:00 pm.

Current Illness: None

ID: 1204741
Sex: F
Age: 23
State: MA

Vax Date: 04/11/2021
Onset Date: 04/12/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies: No

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Swelling thyroid, started one day after received my first shot of the Pfizer vaccine

Other Meds: No

Current Illness: No

ID: 1204743
Sex: F
Age: 20
State: GA

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies: I am allergic to Keflex

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

Symptoms: At 2:30am on April 13, I woke up with a 101-degree fever. Throughout the rest of the day I have felt chills, a headache, soreness all over my body, dizziness and overall weak. My temperature had fluctuated around 99.5-100 degrees all day.

Other Meds: Apri (birth control)

Current Illness: None

ID: 1204744
Sex: F
Age: 42
State: FL

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 04/13/2021
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: Opiates, Corn, Olive, PVC, Phthalate, Benzene, FDC Colors, etc

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

Symptoms: Woke with: Blood Clots in my left arm at injection pt and lower arm, wrist, hand. Blood Clots in my left leg, mainly calf, lower leg, ankle, some in thigh. Larger, more numerically present than in past from antihistamines. None present before Vax, allergen-free diet prevents usually.

Other Meds: Valerian, Cinnamon, Turmeric, Nattokinase-Serrapeptase

Current Illness: Endometriosis, Graves' Disease: causes RA, Allergies, Crohns,

ID: 1204745
Sex: F
Age: 69
State: MD

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 04/13/2021
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: high blood pressure; Arm bothered her; Congested; Right arm started tingling; Not feel well; Eyes are puffy/cannot see out of her eyes; headache/headache got worse; Chills/felt ice cold on one side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 69-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 Diabetes, Kidney disorder and Blood pressure increased (High Blood Pressure). On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side). At the time of the report, HYPERTENSION (high blood pressure), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: high (High) it was 175/80 after 10 minutes of receiving the vaccine. and high (High) It was 195/90 after 15 minutes of first measurement.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was hospitalized for 3 days. Treatment given was IV medication to lower blood pressure and Valium.; Sender's Comments: This case concerns a 69-year-old female with a serious unexpected event of hypertension, and nonserious unexpected eye swelling, nasal congestion, paraesthesia, malaise, limb discomfort, and expected headache, chills. Based on 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: Blood pressure increased (High Blood Pressure); Diabetes; Kidney disorder

ID: 1204746
Sex: M
Age: 70
State: IN

Vax Date: 02/04/2021
Onset Date: 02/06/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Blood oxygen level dropped down to 79%; Extreme shortness of breath at rest; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA AT REST (Extreme shortness of breath at rest) and HYPOXIA (Blood oxygen level dropped down to 79%) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Chronic obstructive pulmonary disease. Concomitant products included OXYGEN for COPD. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced DYSPNOEA AT REST (Extreme shortness of breath at rest) (seriousness criteria disability and medically significant). In March 2021, the patient experienced HYPOXIA (Blood oxygen level dropped down to 79%) (seriousness criteria disability and medically significant). At the time of the report, DYSPNOEA AT REST (Extreme shortness of breath at rest) and HYPOXIA (Blood oxygen level dropped down to 79%) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Oxygen saturation: 79 (Low) 79. No treatment information was 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.; 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: OXYGEN

Current Illness: Chronic obstructive pulmonary disease

ID: 1204747
Sex: F
Age: 70
State: NY

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 04/13/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: dehydration; temperature that I couldn't keep down; weak; difficulty breathing; spots on lungs; low blood pressure; cracked 2 crowns and 3 crowns lost from clinching jaw; cracked 2 crowns and 3 crowns lost from clinching jaw; nausea/vomiting; body aches; muscle aches; rash; vomiting; Started on fluids and lungs filled up with fluid; pancreas was being attacked- pancreatitis; septic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (Started on fluids and lungs filled up with fluid), PANCREATITIS (pancreas was being attacked- pancreatitis), SEPSIS (septic) and DEHYDRATION (dehydration) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (Started on fluids and lungs filled up with fluid) (seriousness criterion medically significant), PANCREATITIS (pancreas was being attacked- pancreatitis) (seriousness criterion medically significant), SEPSIS (septic) (seriousness criterion medically significant), DEHYDRATION (dehydration) (seriousness criterion hospitalization), BODY TEMPERATURE INCREASED (temperature that I couldn't keep down), ASTHENIA (weak), DYSPNOEA (difficulty breathing), PULMONARY MASS (spots on lungs), HYPOTENSION (low blood pressure), BRUXISM (cracked 2 crowns and 3 crowns lost from clinching jaw), TOOTH INJURY (cracked 2 crowns and 3 crowns lost from clinching jaw), NAUSEA (nausea/vomiting), PAIN (body aches), MYALGIA (muscle aches), RASH (rash) and VOMITING (vomiting). The patient was hospitalized from 20-Mar-2021 to 26-Mar-2021 due to DEHYDRATION. At the time of the report, PULMONARY OEDEMA (Started on fluids and lungs filled up with fluid), PANCREATITIS (pancreas was being attacked- pancreatitis), SEPSIS (septic), DEHYDRATION (dehydration), BODY TEMPERATURE INCREASED (temperature that I couldn't keep down), ASTHENIA (weak), DYSPNOEA (difficulty breathing), PULMONARY MASS (spots on lungs), HYPOTENSION (low blood pressure), BRUXISM (cracked 2 crowns and 3 crowns lost from clinching jaw), TOOTH INJURY (cracked 2 crowns and 3 crowns lost from clinching jaw), NAUSEA (nausea/vomiting), PAIN (body aches), MYALGIA (muscle aches), RASH (rash) and VOMITING (vomiting) outcome was unknown. No concomitant products included. Patient's treatment information include Advil, trigger point injections in neck, hot and cold packs, Lasix, antibiotics, pain meds, discharged from hospital on oxygen. 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: 1204748
Sex: F
Age: 55
State: TX

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 04/13/2021
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: pain and swelling in arms and leg; nausea; fatigue; EPILEPTIC SEIZURES; chills; pain and swelling in arms and leg; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (EPILEPTIC SEIZURES) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Mental disability and Epilepsy. Concomitant products included CARBAMAZEPINE (CARBAMAZEPIN) and PHENOBARBITAL (FENABBOTT) for Convulsion. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPILEPSY (EPILEPTIC SEIZURES) (seriousness criterion medically significant), CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain and swelling in arms and leg). On 28-Mar-2021, EPILEPSY (EPILEPTIC SEIZURES) outcome was unknown. At the time of the report, CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), PAIN IN EXTREMITY (pain and swelling in arms and leg), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company comment:Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.

Other Meds: CARBAMAZEPIN; FENABBOTT

Current Illness: Epilepsy; Mental disability

ID: 1204749
Sex: F
Age: 60
State: TX

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 04/13/2021
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: Respiratory attack; Left arm was numb; Had muscle restrictions and spasms; Pain in the back; Pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY DISORDER (Respiratory attack), HYPOAESTHESIA (Left arm was numb), MUSCLE SPASMS (Had muscle restrictions and spasms) and BACK PAIN (Pain in the back) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 30-Mar-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-Mar-2021, the patient experienced RESPIRATORY DISORDER (Respiratory attack) (seriousness criterion medically significant), HYPOAESTHESIA (Left arm was numb) (seriousness criterion intervention required), MUSCLE SPASMS (Had muscle restrictions and spasms) (seriousness criterion intervention required), BACK PAIN (Pain in the back) (seriousness criterion intervention required) and VACCINATION SITE PAIN (Pain in the arm). At the time of the report, RESPIRATORY DISORDER (Respiratory attack), HYPOAESTHESIA (Left arm was numb), MUSCLE SPASMS (Had muscle restrictions and spasms), BACK PAIN (Pain in the back) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown. Treatment provided include morphine, tramadol 50 mg and meloxicam 50 mg. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1204750
Sex: M
Age: 38
State: KY

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/13/2021
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: passed a kidney stone in his urine.; elevated temperature at night.; back pain in his left side.; throw up every hour from waves of pain/vomit every time his pain increased; nausea and vomiting that correlated to the dull burning pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (passed a kidney stone in his urine.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain). On 24-Mar-2021, the patient experienced NEPHROLITHIASIS (passed a kidney stone in his urine.) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (passed a kidney stone in his urine.), BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was included One extra strength Tylenol, three naproxens, water and Pedialyte Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1204751
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/13/2021
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: Full body rash; WBC drastically dropped to almost zero; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Full body rash) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided.). 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 RASH (Full body rash) (seriousness criterion hospitalization) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) (seriousness criteria hospitalization and medically significant). At the time of the report, RASH (Full body rash) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Physician called to report adverse reaction for her husband's co-worker who received the vaccine ten days back and developed full body rash and was hospitalized. Patient's WBC count drastically dropped(Almost zero). They were not sure if the vaccine was Moderna. Treatment details were not provided. Very limited information regarding these events has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1204752
Sex: F
Age: 75
State: MD

Vax Date: 02/04/2021
Onset Date: 02/14/2021
Rec V Date: 04/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Diagnosed with an A-Fib; She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that; A very strange thing happened; Had a very violent reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with an A-Fib) and LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) in a 75-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 Penicillin allergy and Allergy NOS (morphin). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with an A-Fib) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) (seriousness criterion medically significant), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with an A-Fib), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. Concomitant medications include natural fibroid 60 mg, Biestrogen (Hormone regulator). Treatment medication include unknown intravenous medication. Based on the current 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 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: Allergy NOS (morphin); Penicillin allergy

ID: 1204753
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 04/13/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: put on 30 pounds of water weight; Fainted; blood pressure dropped so low that she fainted; Moderna COVID-19 Vaccine reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included MACITENTAN for Primary pulmonary hypertension, WARFARIN, TADALAFIL and DILTIAZEM for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction). The patient was hospitalized on sometime in February 2021 due to SYNCOPE. At the time of the report, VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) 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. On an unspecified date in Feb-2021, the patient reported that she became very ill and hospitalized for 12 days after receiving the Moderna vaccination. She reported that her blood pressure dropped so low that she fainted. She also had had put on 30 pounds of water weight, which she is trying to get off. She reported that her doctor was aware of the hospitalization. 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. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MACITENTAN; WARFARIN; TADALAFIL; DILTIAZEM

Current Illness: Primary pulmonary hypertension

ID: 1204754
Sex: M
Age: 50
State: PA

Vax Date: 03/11/2021
Onset Date: 03/25/2021
Rec V Date: 04/13/2021
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: Cellulitis on his elbow; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis on his elbow) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CELLULITIS (Cellulitis on his elbow) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis on his elbow) 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 for the event included antibiotics. Based on the current information and the 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 information and the 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: 1204755
Sex: F
Age:
State: MI

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: could hardly breathe/hurts me to breath; Right side of chest hurt/pain on right side of the chest like muscle pulled; two weeks ago had dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (two weeks ago had dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus and Blood pressure high. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSENTERY (two weeks ago had dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled). At the time of the report, DYSENTERY (two weeks ago had dysentery), DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. At first she didn't feel bad but last night 31Mar2021, she could hardly breathe, right side of chest hurt, hurts me to breathe, pain on right side of chest like I pulled a muscle, two weeks ago had dysentery. Treatment included ointment. Patient didn't want to call doctor as her doctor would just tell her to go to the hospital. Doctor told her to get tested for COVID. Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely. Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273. Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.; Sender's Comments: Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely. Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273. Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.

Other Meds:

Current Illness: Blood pressure high; Diabetes mellitus

ID: 1204756
Sex: F
Age: 72
State: WV

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 04/13/2021
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: Hallucinations; Skin turned "yellow"; body smelled like "old Urine"; her urine was the color of "coffee"; Fever; Chills; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HALLUCINATION (Hallucinations) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 03-Dec-2020. Concurrent medical conditions included Scleroderma. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee"), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, HALLUCINATION (Hallucinations), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee") and PYREXIA (Fever) had resolved. At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The 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.; 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: Scleroderma

ID: 1204757
Sex: F
Age: 19
State: SD

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 04/13/2021
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: fatigue; difficulty swallowing.; allergic reaction; chest pain; shortness of breath; not feeling good; Weakness in Lower half of body; Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and FEELING ABNORMAL (not feeling good) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ISOTRETINOIN (ACCUTANE) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy) (seriousness criteria medically significant and life threatening), MUSCULAR WEAKNESS (Weakness in Lower half of body) and PYREXIA (Feverish). On 21-Jan-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), FEELING ABNORMAL (not feeling good) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 22-Jan-2021, the patient experienced DYSPHAGIA (difficulty swallowing.). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), FEELING ABNORMAL (not feeling good), MUSCULAR WEAKNESS (Weakness in Lower half of body), HYPERSENSITIVITY (allergic reaction), DYSPHAGIA (difficulty swallowing.), FATIGUE (fatigue) and PYREXIA (Feverish) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product included birth control. Treatment information included anti nausea pills, aspirin, epiPen, benadryl, tylenol, injection for breathing and surmonside. 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: ACCUTANE; LEXAPRO

Current Illness:

ID: 1204758
Sex: F
Age: 28
State: FL

Vax Date: 03/03/2021
Onset Date: 03/26/2021
Rec V Date: 04/13/2021
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: Bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bells palsy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included OXYBATE SODIUM (XYREM), PIMOZIDE (ORAP), METFORMIN and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FACIAL PARALYSIS (Bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bells palsy) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Treatment for the event included Amantadine and Methylprednisolone. She was on treatment for that and will be still on treatment during her 2nd dose. Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, 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 onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.

Other Meds: XYREM; ORAP; METFORMIN; EFFEXOR

Current Illness:

ID: 1204759
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/13/2021
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: really sick; chest pains; will not take the second shot; pretty bad cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (really sick) and CHEST PAIN (chest pains) in an 83-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 Asthma. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (pretty bad cold). On an unknown date, the patient experienced MALAISE (really sick) (seriousness criterion hospitalization), CHEST PAIN (chest pains) (seriousness criterion hospitalization) and TREATMENT NONCOMPLIANCE (will not take the second shot). At the time of the report, MALAISE (really sick), CHEST PAIN (chest pains), TREATMENT NONCOMPLIANCE (will not take the second shot) and NASOPHARYNGITIS (pretty bad cold) outcome was unknown. Not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's weight is 170 (units not reported). Whilst hospitalized, all laboratory tests (unspecified) were normal. Concomitant medication included unspecified medication for asthma. 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 these 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 these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Asthma

ID: 1204760
Sex: F
Age: 65
State: FL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 04/13/2021
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: Unevaluable event

Symptoms: Cold; Arm swells up after injection; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma chronic, Diabetes, Blood pressure abnormal and Lipids abnormal. Concomitant products included METFORMIN and LISINOPRIL for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Arm swells up after injection) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved and PERIPHERAL SWELLING (Arm swells up after injection) outcome was unknown. She was seen by her primary care physician who prescribed her antibiotics, name unknown. Based on the current available information and the temporal association of the product and start date of the events a causal relationship cannot be excluded.; Sender's Comments: based on the current available information and the temporal association of the product and start date of the events a causal relationship cannot be excluded.

Other Meds: METFORMIN; LISINOPRIL

Current Illness: Asthma chronic; Blood pressure abnormal; Diabetes; Lipids abnormal

ID: 1204761
Sex: F
Age: 25
State: KY

Vax Date: 02/26/2021
Onset Date: 03/29/2021
Rec V Date: 04/13/2021
Hospital: Y

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: Acute ITP; Heart rate dropped to 47; Shortness of breath; Heart rate dropped to 47; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Acute ITP), the first episode of HEART RATE DECREASED (Heart rate dropped to 47), DYSPNOEA (Shortness of breath) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-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 29-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Acute ITP) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced the first episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization prolonged) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to DYSPNOEA, HEART RATE DECREASED and IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Acute ITP) had not resolved and DYSPNOEA (Shortness of breath) and the last episode of HEART RATE DECREASED (Heart rate dropped to 47) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Platelet count: about 2000 (Low) About 2000. On 01-Apr-2021, Heart rate: dropped to 47 (abnormal) Dropped to 47. On 02-Apr-2021, Platelet count: low (Low) Low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included: steroids [also noted as dexamethasone (DECADRON)] and IV IgG. At the time of the report, the patient was being transferred to another hospital facility. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events and excluding other etiologies, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1204762
Sex: F
Age: 55
State: PA

Vax Date: 01/13/2021
Onset Date: 02/10/2021
Rec V Date: 04/13/2021
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: They think she has Guillen barre; severe neck pain and pain on the side of neck; numbness across the shoulders and down the arms and leg numbness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Intervertebral disc operation (She had a surgical procedure done year and half ago where two artificial discs were put in her neck.). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) (seriousness criterion medically significant), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever). At the time of the report, GUILLAIN-BARRE SYNDROME (They think she has Guillen barre), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever) outcome was unknown. Concomitant product use was not provided. Treatment included prednisone for 15 days and cephalexin (500mg) for 7 days (both for unknown indication) and gabapentin (for neck pain). The patient is scheduled for cervical and brain MRI and also had cervical x-ray (results not reported). The patient opted not to have spinal tap. Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded. However the event of Guillen barre has not been confirmed. Additional information has been requested; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded. However the event of Guillen barre has not been confirmed. Additional information has been requested

Other Meds:

Current Illness:

ID: 1204763
Sex: F
Age: 46
State: WA

Vax Date: 03/19/2021
Onset Date: 03/29/2021
Rec V Date: 04/13/2021
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: she has half a millimeter bump; RASH ON HANDS AND FEET; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS BULLOUS (she has half a millimeter bump) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hand, foot and mouth disease (about three years ago). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (she has half a millimeter bump) (seriousness criterion medically significant) and RASH (RASH ON HANDS AND FEET). At the time of the report, DERMATITIS BULLOUS (she has half a millimeter bump) and RASH (RASH ON HANDS AND FEET) 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. No treatment information was provided. Company comment:This case concerns a 46-year-old female with serious unexpected events of dermatitis bullous and rash. Event on set 11 days after first dose mRNA-1273. Based on 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: This case concerns a 46-year-old female with serious unexpected events of dermatitis bullous and rash. Event on set 11 days after first dose mRNA-1273. Based on 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: 1204764
Sex: F
Age: 68
State: NJ

Vax Date: 03/09/2021
Onset Date: 03/24/2021
Rec V Date: 04/13/2021
Hospital: Y

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: Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was provided

Other Meds:

Current Illness:

ID: 1204765
Sex: M
Age: 81
State: NY

Vax Date: 03/04/2021
Onset Date: 03/13/2021
Rec V Date: 04/13/2021
Hospital: Y

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: Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-Mar-2021 to 17-Mar-2021 due to COVID-19 and PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1204766
Sex: M
Age: 74
State: IL

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 04/13/2021
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: Shingles on his forehead; pneumonia; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). In March 2021, the patient experienced HEADACHE (Headache). On 30-Mar-2021, the patient experienced HERPES ZOSTER (Shingles on his forehead). At the time of the report, PNEUMONIA (pneumonia), HEADACHE (Headache) and HERPES ZOSTER (Shingles on his forehead) outcome was unknown. Not Provided 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. On 11Mar2021, he went to the urgent care and was diagnosed to have pneumonia for which he was given Doxycycline 100 mg for 10 days. For experiencing headache. He was prescribed with Valacyclovir.

Other Meds:

Current Illness:

ID: 1204767
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: rheumatoid arthritis; stress response caused her to also develop shingles; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) 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. The patient's past medical history included No adverse event (No reported medical history. ). 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 RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant) and HERPES ZOSTER (stress response caused her to also develop shingles). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis) and HERPES ZOSTER (stress response caused her to also develop shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment information not provided Very limited information regarding this event has been provided at this time. No follow up is possible This case was linked to MOD-2021-067542 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible MOD-2021-067542:Valid case

Other Meds:

Current Illness:

ID: 1204768
Sex: M
Age: 49
State: NC

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 04/13/2021
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: bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet; This spontaneous case was reported by a physician and describes the occurrence of PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history) and Biopsy. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Biopsy skin: abnormal (abnormal) Diffuse bullous pemphigoid. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant medication were not reported. 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: 1204769
Sex: M
Age:
State: CA

Vax Date: 03/13/2021
Onset Date: 03/14/2021
Rec V Date: 04/13/2021
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: Lost hearing in the left ear; Tinnitus (ringing in the left ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost hearing in the left ear) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LOSARTAN, AMOXICILLIN and PREDNISONE for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Tinnitus (ringing in the left ear)). On an unknown date, the patient experienced DEAFNESS (Lost hearing in the left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Lost hearing in the left ear) and TINNITUS (Tinnitus (ringing in the left ear)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) Hearing loss. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was taking other unspecified concomitant medications. On an unknown date, the patient went to an urgent care ear throat specialist with a chief complaint of tinnitus and had a hearing test. The patient was diagnosed with hearing loss in the left ear and was given a steroid prescription. Based on the current available information and the 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 the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

Other Meds: LOSARTAN; AMOXICILLIN; PREDNISONE

Current Illness:

ID: 1204770
Sex: F
Age:
State: FL

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 04/13/2021
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: fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting spells) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection). On 02-Apr-2021, the patient experienced SYNCOPE (fainting spells) (seriousness criterion medically significant) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainting spells), CHILLS (Chills), VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment included Tylenol. 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: 1204771
Sex: M
Age: 53
State: MA

Vax Date: 03/05/2021
Onset Date: 04/02/2021
Rec V Date: 04/13/2021
Hospital: Y

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: Blacked out dur to severe dehydration; Felt dizzy tired and went to sleep for a period of 4 - 5 hours; Drenched in sweat; Described his urine been very dark in color, almost black-ish in a way; Projectile vomiting of food; Night sweats; Diarrhea; Given ant nausea medications; Lot of fatigue; Felt pain in his at the injection site; Pain in his lower spine and hips; chills; Blacked out dur to severe dehydration; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration) and DEHYDRATION (Blacked out dur to severe dehydration) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No recorded medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration) (seriousness criterion medically significant), DEHYDRATION (Blacked out dur to severe dehydration) (seriousness criterion hospitalization), DIZZINESS (Felt dizzy tired and went to sleep for a period of 4 - 5 hours), HYPERHIDROSIS (Drenched in sweat), CHROMATURIA (Described his urine been very dark in color, almost black-ish in a way), VOMITING PROJECTILE (Projectile vomiting of food), NIGHT SWEATS (Night sweats), DIARRHOEA (Diarrhea), NAUSEA (Given ant nausea medications), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Felt pain in his at the injection site ), ARTHRALGIA (Pain in his lower spine and hips) and CHILLS (chills). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to DEHYDRATION. On 06-Apr-2021, LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration), DEHYDRATION (Blacked out dur to severe dehydration), DIZZINESS (Felt dizzy tired and went to sleep for a period of 4 - 5 hours), CHROMATURIA (Described his urine been very dark in color, almost black-ish in a way), VOMITING PROJECTILE (Projectile vomiting of food), DIARRHOEA (Diarrhea), NAUSEA (Given ant nausea medications), FATIGUE (Lot of fatigue), ARTHRALGIA (Pain in his lower spine and hips) and CHILLS (chills) had resolved, VACCINATION SITE PAIN (Felt pain in his at the injection site ) outcome was unknown. At the time of the report, HYPERHIDROSIS (Drenched in sweat) and NIGHT SWEATS (Night sweats) had not resolved. Concomitant product use was not provided by the reporter. On an unspecified date, the patient went to sleep for a period of 4 - 5 hours. Upon waking up, he was drenched in sweat. The patient's mattress, pillow and body were covered in sweat. The patient was only able to stay awake for about 2 hours and the fell back asleep for about 4 -5 hours. This cycle of being up or 2 hours and sleep for 4 - 5 hours continued throughout the weekend. By Monday (05APR2021) morning, the night sweats continued, and contacted his primary care physician, who advised him to go to the nearest emergency room. In emergency room, while diagnostic tests were undergoing. The patient's symptoms began on Friday and ended except of the night sweat which were ongoing. Treatment for the event included anti-nausea medications. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. 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:

Current Illness:

ID: 1204772
Sex: M
Age: 78
State: AZ

Vax Date: 02/09/2021
Onset Date: 03/01/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication. On 09-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. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided Treatment of these events included steroids. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: WARFARIN

Current Illness:

ID: 1204773
Sex: M
Age: 43
State: FL

Vax Date: 03/09/2021
Onset Date: 04/07/2021
Rec V Date: 04/13/2021
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: Fainting for about 30 seconds to a minute in the bathroom; Feeling dizzy; Could not stand for a while when fell; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell). On 07-Apr-2021 at 4:00 AM, the patient experienced SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) (seriousness criterion medically significant). On 07-Apr-2021, DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell) had resolved. On 07-Apr-2021 at 4:01 AM, SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) had resolved. No concomitant medications were reported. Treatment included for the events was acetaminophen. Patient reported that he felt dizzy and fainted for about 30 seconds to 1 minute in his bathroom at around 4:00 am this morning after receiving his second dose of the vaccine yesterday on 6 April 2021.Also, he could not stand for a while when fell. The patient took energy drink. Patient confirmed that the symptom was one time and it has not come back.; 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: 1204774
Sex: F
Age: 89
State:

Vax Date: 03/21/2021
Onset Date: 03/23/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). On 23-Mar-2021, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment for the event included apixaban started on 24-Mar-2021. 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: 1204775
Sex: F
Age: 53
State: FL

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 04/13/2021
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: shortness of breath; Dizziness; All side effects on safety sheet of moderna vaccine except bad rash; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No Medical History). On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), DIZZINESS (Dizziness), VACCINATION COMPLICATION (All side effects on safety sheet of moderna vaccine except bad rash) and HEADACHE (Headache). At the time of the report, DYSPNOEA AT REST (shortness of breath) and DIZZINESS (Dizziness) had resolved and VACCINATION COMPLICATION (All side effects on safety sheet of moderna vaccine except bad rash) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant drugs were not reported. Treatment drug included Tylenol.; 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: 1204776
Sex: M
Age:
State: IL

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 04/13/2021
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: felt down; redness on right arm and shoulder, redness on left arm and shoulder; itchiness on right arm and shoulder; Only first dose received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (felt down) in a male 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. The patient's past medical history included No adverse event (No relevant medical history reported). On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced FALL (felt down) (seriousness criterion hospitalization). On 27-Feb-2021, the patient experienced ERYTHEMA (redness on right arm and shoulder, redness on left arm and shoulder) and PRURITUS (itchiness on right arm and shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only first dose received). The patient was hospitalized on 21-Feb-2021 due to FALL. At the time of the report, FALL (felt down), ERYTHEMA (redness on right arm and shoulder, redness on left arm and shoulder), PRURITUS (itchiness on right arm and shoulder) and PRODUCT DOSE OMISSION ISSUE (Only first dose received) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This report refers to a case of (Product dose omission issue) for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (fall, erythema, and pruritus), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of (Product dose omission issue) for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (fall, erythema, and pruritus), a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1204777
Sex: M
Age: 64
State: MI

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I developed shingles around the outside of my left eye; painful stiffness in the injection site arm; felt a little tired; joint pain in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cataract (cataract surgery, left eye) on 26-Mar-2021. Previously administered products included for an unreported indication: SHINGRIX in 2020. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (painful stiffness in the injection site arm), FATIGUE (felt a little tired) and ARTHRALGIA (joint pain in the injection site arm). On 01-Apr-2021, the patient experienced OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) (seriousness criterion medically significant). At the time of the report, OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) had not resolved and MUSCULOSKELETAL STIFFNESS (painful stiffness in the injection site arm), FATIGUE (felt a little tired) and ARTHRALGIA (joint pain in the injection site arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment for the ophthalmic herpes zoster include sulfamethoxazole 160mg BID and valacyclovir 500mg 2 tablets TID. Company comment: Based on reporter's causality and recent history of cataract surgery the event eye herpes zoster is assessed as unlikely related to mRNA-1273. For the other events the causality cannot be excluded. On 05Apr2021, his eye Dr assessed the area with shingles and thought that the shingles was most likely due to the trauma to the eye from the surgery.

Other Meds:

Current Illness:

ID: 1204779
Sex: M
Age: 80
State: VA

Vax Date: 01/20/2021
Onset Date: 03/31/2021
Rec V Date: 04/13/2021
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: Clot blood; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medically reported history). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Clot blood) outcome was unknown. The patient was diagnosed with blood clots in legs and lung. 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: 1204780
Sex: F
Age: 87
State: MA

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Right side hearing loss; Dizziness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Right side hearing loss) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DEAFNESS (Right side hearing loss) (seriousness criterion medically significant), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DEAFNESS (Right side hearing loss), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Magnetic resonance imaging: normal (normal) normal. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1204781
Sex: F
Age: 79
State: NY

Vax Date: 02/09/2021
Onset Date: 03/09/2021
Rec V Date: 04/13/2021
Hospital: Y

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: head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown. No treatment medication was included. 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 US-MODERNATX, INC.-MOD-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (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. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose

Other Meds: KLONOPIN

Current Illness: Glaucoma

ID: 1204782
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 04/13/2021
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: Blood clot; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, THROMBOSIS (Blood clot) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) postive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included blood thinner medication. 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.; 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

Current Illness:

ID: 1204783
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Sepsis; Been 52 days for second dose of vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SEPSIS (Sepsis) 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. The patient's past medical history included No adverse event (No reported medical history). 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 SEPSIS (Sepsis) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Been 52 days for second dose of vaccine). At the time of the report, SEPSIS (Sepsis) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Been 52 days for second dose of vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported The patient was hospitalized for almost 3 weeks for sepsis after receiving first dose. At the time of report, the patient was on 52nd day since receiving first dose. Treatment information was not provided. 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:

Current Illness:

ID: 1204784
Sex: F
Age: 53
State: NJ

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 04/13/2021
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: breakthrough seizures; sinus infection; She also missed her 2nd appointment on 5APR2021 due to sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (breakthrough seizures) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seizure. On 04-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 SEIZURE (breakthrough seizures) (seriousness criterion medically significant), SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (She also missed her 2nd appointment on 5APR2021 due to sinus infection). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (She also missed her 2nd appointment on 5APR2021 due to sinus infection) had resolved. At the time of the report, SEIZURE (breakthrough seizures) and SINUSITIS (sinus infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. There were no concomitant medications reported. Treatment included antibiotics for the event sinus infection.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (seizure and sinusitis), a causal relationship cannot be excluded.

Other Meds:

Current Illness: Seizure

ID: 1204785
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: stroke; slurred speech; Almost Paralyzed (generalized weakness); headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Crohn's disease 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, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), DYSARTHRIA (slurred speech), ASTHENIA (Almost Paralyzed (generalized weakness)) and HEADACHE (headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DYSARTHRIA (slurred speech), ASTHENIA (Almost Paralyzed (generalized weakness)) and HEADACHE (headaches) had not resolved. Not Provided Concomitant product use was not provided by the reporter. Treatment information was not provided. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Crohn's disease

ID: 1204786
Sex: M
Age: 66
State: CA

Vax Date: 02/21/2021
Onset Date: 03/09/2021
Rec V Date: 04/13/2021
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: Passed out every time he stood up; Gallbladder infection; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out every time he stood up) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out every time he stood up) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Mar-2021 due to CHOLECYSTITIS INFECTIVE and LOSS OF CONSCIOUSNESS. The patient was treated with Surgery for Cholecystitis infective. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out every time he stood up) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Laboratory test: abnormal (abnormal) Gallbladder infection. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. This case concerns a 67-year-old male hospitalized with serious unexpected events of loss of consciousness and cholecystitis infective. Event onset 17 days after first dose mRNA-1273. Underwent surgery. Events resolved. Based on 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: This case concerns a 67-year-old male hospitalized with serious unexpected events of loss of consciousness and cholecystitis infective. Event onset 17 days after first dose mRNA-1273. Underwent surgery. Events resolved. Based on 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: 1204787
Sex: F
Age:
State: CO

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 04/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Pfizer Covid 19 vaccine: hives/broke out in hives/received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm; she still has "lizard skin"; has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient previously had flu vaccine and had a flu and shingles vaccine and had shingles for 3 weeks after she took the shingles vaccine. The patient received her first vaccine on 30Jan2021. On 31Jan2021, the patient ended up in ER with hives from the vaccine. She was told that she would be given Prednisone for hives but not to take it until Monday at noon. Stated that they wanted her to wait 48 hours after vaccine before she started it because it would cut it in half. She started Prednisone 40mg on Monday and did get a few more hives on Tuesday and Wednesday. She had the shot in her right arm, and all this happened on the left side of her back. She had a patch of hive of 5x6 to 8x8 on her back and on the back of her arm by her elbow and forearm. She put apple cider vinegar on her arms, and she did not itch anymore. Someone told her that this could be shingles. She stated that she got flu vaccine and got sick with flu and she took the shingles vaccine and got shingles. She could not stand in shower with the shingles but that she can with this, so she knows that it is not the shingles. The patient did not want to take the second shot on 20Feb2021 and wanted to know what Pfizer thinks. She does like to travel and hopes to soon so she wanted to know if not taking the shot could get a stipulation if they required two shots to travel. She has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming, but she knows that it is there which came on in the past week (2021). She was on Prednisone 40 mg for 5 days and she still had hives (though they are diminishing). The patient stated that she still has "lizard skin". She received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm where she had shingles. Her ER doctor told her not to take the second dose and her primary care physician told her to wait and think about it. She is wondering if she should receive the second dose. The outcome of the event hives was not recovered while the other events was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1204788
Sex: F
Age:
State: WI

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 04/13/2021
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: Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the first dose; spinal nerve damage/Spinal nerve pain; Legs are burning hot now; Pain felt in calf and thigh; Bone density test/Ultra sound bad; This is a spontaneous report from a contactable consumer(patient). An 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 01Feb2021 11:30 (Batch/Lot Number: EN5318) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included angina from 2002 and ongoing, She says she has angina, and if she would have beating problems can she take a Nitro, cholesterol, depression from 2008 to an unknown date, blood pressure, anxiety from 2018 to an unknown date, arthritis from 1998 and ongoing Illness/AE: Arthritis Onset Date: 1998-2002 Stop Date: Ongoing , hypertension from 2002 and ongoing, blood cholesterol increased from 2002 and ongoing, ongoing urinary tract infection On and off, coronary artery disease from 2005 to an unknown date On and off, Family medical history included Mother coronary artery disease Died on 18Oct1967 and Father 1936 other. Concomitant medications included amlodipine taken for blood pressure abnormal from 2017 to an unspecified stop date; atorvastatin taken for blood cholesterol abnormal from 2002 to an unspecified stop date; bupropion taken for depression from 2008 to an unspecified stop date; buspirone taken for anxiety from 2008 to an unspecified stop date; carvedilol taken for blood pressure abnormal from 2002 to an unspecified stop date, 2x a day carvedilol 12.5. On an unspecified date, the patient experienced diverticulitis arteries, had a blood clot after ultrasound, sore arm/feel sore arms after the first dose, spinal nerve damage/spinal nerve pain, legs are burning hot now, pain felt in calf and thigh, bone density test/ultrasound bad. The patient underwent lab tests and procedures which included blood test: unknown results, computerized tomogram: diverticulitis arteries- On and off, investigation: unknown results. Comments: Going to pain clinic. On always, ultrasound scan: bad on Comments: Ultrasound bad, urine analysis: unknown results on comments: on and off. Treatment received for the events sore arm/feel sore arms after the first dose and spinal nerve damage/spinal nerve pain. Outcome of all events was unknown Follow-up (29Mar2021): This is a follow-up report combining information from duplicate reports 2021138557 and 2021162095. The current and all subsequent information will be reported under manufacturer report number 2021162095.

Other Meds: AMLODIPINE; ATORVASTATIN; BUPROPION; BUSPIRONE; CARVEDILOL

Current Illness: Angina pectoris (She says she has angina, and if she would have beating problems can she take a Nitro?); Arthritis (Illness/AE: Arthritis Onset Date: 1998 2002 Stop Date: Ongoing); Blood pressure high; High cholesterol; UTI (On and off)

ID: 1204789
Sex: F
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 04/13/2021
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: Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4/six days running a 100degree fever; my blood pressure went to 170/100; my oxygen dropped to 88%; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient (non-pregnant) received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 02Feb2021 09:45 AM (at the age of 91-year-old) as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease/COPD, asthma, hypertension. The patient has no known allergies. Concomitant medications were not reported. Patient took unspecified other medications within two weeks of vaccination. No other vaccine in four weeks. Patient was not tested positive for Covid prior vaccination. On 22Feb2021 at 10:15 AM, the patient experienced vomiting, blood pressure went to 170/100 and oxygen dropped to 88%. She was in bed end of the care of her daughter for six days running a 100 degree fever. Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested positive for Covid post vaccination. No treatment was taken for events. Outcome of events was recovered in 2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm