VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1249666
Sex: F
Age: 42
State: MA

Vax Date: 03/25/2021
Onset Date: 03/30/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE HD) for Birth control. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headache) (seriousness criterion hospitalization prolonged). On 02-Apr-2021, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to CEREBRAL VENOUS SINUS THROMBOSIS and HEADACHE. At the time of the report, CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) had not resolved, and HEADACHE (headache) outcome was unknown. Not Provided, DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Computerized tomogram: abnormal (abnormal) Cerebral Venus Thrombosis in the brain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of the events included Pradaxa. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's recent history of starting back on oral contraceptives may remain a risk factor for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's recent history of starting back on oral contraceptives may remain a risk factor for this event.

Other Meds: CONTRACEPTIVE HD

Current Illness:

ID: 1249667
Sex: F
Age: 64
State: CA

Vax Date: 03/23/2021
Onset Date: 04/20/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: anaphylactic shock; difficulty breathing; faced was paralyzed; rash on arms and chest; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing) and FACIAL PARALYSIS (faced was paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008B21A) 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 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic shock) (seriousness criterion life threatening), DYSPNOEA (difficulty breathing) (seriousness criterion medically significant), FACIAL PARALYSIS (faced was paralyzed) (seriousness criterion medically significant) and RASH (rash on arms and chest). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing), FACIAL PARALYSIS (faced was paralyzed) and RASH (rash on arms and chest) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included epinephrine injection. Company comment: based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-081859 (E2B Linked Report).; Sender's Comments: based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-081859:Crossed linked

Other Meds:

Current Illness:

ID: 1249668
Sex: M
Age: 69
State: NJ

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: positive for COVID-19; unwell; fever; chills; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pneumonia. On 23-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 MALAISE (unwell), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On 31-Mar-2021, the patient experienced COVID-19 (positive for COVID-19) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to COVID-19. At the time of the report, COVID-19 (positive for COVID-19), MALAISE (unwell), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, COVID-19: positive (Positive) positive. 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. Patient was treated with Ibuprofen, Nyquil and Dayquil for the symptoms. Patient was discharged the next day. Patient was treated with antibiotics for pneumonia. Company comment: Based on the information provided including the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely. Malaise is assessed as a symptom of the infection and also assessed as unlikely. Chills, pyrexia and myalgia, although also considered as symptoms of Covid-19, are temporarily associated with the product administration and consistent with the product safety profile and thus , causality cannot be excluded. This case was linked to MOD21-079024 (Linked Report).; Sender's Comments: Based on the information provided including the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely. Malaise is assessed as a symptom of the infection and also assessed as unlikely. Chills, pyrexia and myalgia, although also considered as symptoms of Covid-19, are temporarily associated with the product administration and consistent with the product safety profile and thus , causality cannot be excluded. MOD21-079024:cross linked

Other Meds:

Current Illness: Pneumonia

ID: 1249669
Sex: F
Age: 56
State: LA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Elbow and breast she is still experiencing cellulitis in these areas; Experienced a fever of 101 degrees fahrenheit; This spontaneous case was reported by a health care professional and describes the occurrence of CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PREDNISONE for an unknown indication. On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) (seriousness criterion medically significant) and PYREXIA (Experienced a fever of 101 degrees fahrenheit). At the time of the report, CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) and PYREXIA (Experienced a fever of 101 degrees fahrenheit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (Inconclusive) 101 degrees Fahrenheit. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment for the event included the patient went through two rounds of antibiotic treatment. On 20 Apr 2021, the patient was started on prednisone. 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. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-081503, US-MODERNATX, INC.-MOD-2021-081647 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested. US-MODERNATX, INC.-MOD-2021-081503: US-MODERNATX, INC.-MOD-2021-081647:

Other Meds: PREDNISONE

Current Illness:

ID: 1249670
Sex: F
Age: 72
State: FL

Vax Date: 03/24/2021
Onset Date: 04/02/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: fell on 2april at a local Walmart; started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching; woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (tripped over a pallet and fell) and FALL (fell on 2april at a local ) in a 72-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 Surgery (surgery to repair my elbow) on 08-Apr-2021. Concurrent medical conditions included Allergy. Concomitant products included CITALOPRAM and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (tripped over a pallet and fell) (seriousness criterion medically significant) and FALL (fell on 2april at a local ) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRURITUS (started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching) and URTICARIA (woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone). The patient was treated with Surgery for Fall. At the time of the report, SYNCOPE (tripped over a pallet and fell), PRURITUS (started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching) and URTICARIA (woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone) outcome was unknown and FALL (fell on 2april at a local was resolving. 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. Treatment drugs included, Oxycodone , Zyrtec, Benadryl. Patient went to see doctor and they put on a new brace called T-form. It was reported that these hives are most likely related to oxycodone.; Sender's Comments: Based on reporter's causality (Tripped over a pallet and fell) the event is assessed as unlikely related to mRNA-1273.

Other Meds: CITALOPRAM; MULTIVITAMINS & MINERALS PLUS LUTEIN

Current Illness: Allergy

ID: 1249671
Sex: F
Age:
State: TN

Vax Date: 03/25/2021
Onset Date: 04/12/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: they did ultrasound and found a blood clot in her right leg behind the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included LIRAGLUTIDE (VICTOZA) and INSULIN GLARGINE (TOUJEO) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Ultrasound scan: found a blood clot in her right leg behind the kne (abnormal) found a blood clot in her right leg behind the knee. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included xarelto 15mg. Concomitant medication included BP medicine. Her right leg started swelling and turned red a week ago(10Apr2021). She went to the doctor on 12Apr2021 and they did ultrasound and found a blood clot in her right leg behind the knee (12Apr2021). She is scheduled to get 2nd dose on 22Apr2021. She never had blood clot before so wanted to report it. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds: VICTOZA; TOUJEO

Current Illness: Hypertension

ID: 1249672
Sex: F
Age: 50
State: VA

Vax Date: 03/02/2021
Onset Date: 03/25/2021
Rec V Date: 04/24/2021
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: COVID-19; Patient didn't receive her second dose vaccine as of day 49; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 02-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 COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient didn't receive her second dose vaccine as of day 49). The patient was hospitalized on 25-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (COVID-19) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't receive her second dose vaccine as of day 49) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: covid-19 Positive. 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 . It was unclear about the duration of hospitalization. Patient didn't receive her second dose vaccine as of day 49 due to her hospitalization.; Sender's Comments: This case concerns a 50-year-old female hospitalized with a serious unexpected event of COVID-19, and nonserious unexpected Intentional product use issue. Event onset 24 days after first dose mRNA-1273. Event outcome unknown. 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: 1249673
Sex: F
Age: 84
State: PA

Vax Date: 01/30/2021
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: TIA; Left upper lip is turned down/face does not look normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METOPROLOL for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) (seriousness criterion medically significant). The patient was hospitalized for 3 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Other concomitant medications included unspecified blood pressure medications. No treatment information reported. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-081470 (Patient Link).; Sender's Comments: Although a temporal association exist, the event of Transient ischemic attack with facial paralysis is confounded by the patient's history of Blood pressure abnormal and advanced age.

Other Meds: METOPROLOL

Current Illness: Blood pressure abnormal

ID: 1249674
Sex: F
Age:
State: KS

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Chest cold; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant and no treatment Medication was provided. This case concerns an adult female with a serious unexpected event of lower respiratory tract infection. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. 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 an adult female with a serious unexpected event of lower respiratory tract infection. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. 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: Asthma

ID: 1249675
Sex: F
Age: 49
State: OR

Vax Date: 02/26/2021
Onset Date: 04/12/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 49-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 relevant medical history provided). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 12-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. Not Provided No medical history and concomitant medications were provided. No treatment information provided. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1249676
Sex: M
Age:
State: GA

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/24/2021
Hospital: Y

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: massive blood clot in the right lung; painful knot under the skin on his arm; threw up about 20 times in 6 hours, and kept vomiting all the next day; massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him; next day when he got up and could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (massive blood clot in the right lung), PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) and THROMBOSIS (painful knot under the skin on his arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder NOS in September 2020 and Broken bones. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced GAIT DISTURBANCE (next day when he got up and could barely walk). On 26-Mar-2021, the patient experienced PULMONARY EMBOLISM (massive blood clot in the right lung) (seriousness criteria hospitalization, medically significant and life threatening). On 04-Apr-2021, the patient experienced PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (painful knot under the skin on his arm) (seriousness criterion medically significant) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day). On 19-Mar-2021, GAIT DISTURBANCE (next day when he got up and could barely walk) outcome was unknown. On 28-Mar-2021, PULMONARY EMBOLISM (massive blood clot in the right lung) had not resolved. On 04-Apr-2021, PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) had not resolved. At the time of the report, THROMBOSIS (painful knot under the skin on his arm) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day) outcome was unknown. Not Provided Treatment information provided as blood thinners (IV heparin) and antibiotics were used to treat the events. 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-2021-081632 (E2B Linked Report).; 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-2021-081632:2nd dose

Other Meds:

Current Illness:

ID: 1249677
Sex: F
Age:
State: MA

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 04/24/2021
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: infection in her abdomen, currently taking antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) (seriousness criterion medically significant). At the time of the report, ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not provided. The patient was treated with antibiotics for abdominal infection. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1249678
Sex: M
Age:
State: GA

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Left lung is beginning to hurt again; chest is killing him; can barely walk; pain all over; the knot on the arm is blood clot; knot under the skin on his arm; painful knot under the skin; nauseated; kept vomiting all the next day, threw up about 20 times; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (the knot on the arm is blood clot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken bones. Concurrent medical conditions included Autoimmune disorder in September 2020. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times). On 18-Apr-2021, the patient experienced SKIN MASS (knot under the skin on his arm) and PAIN OF SKIN (painful knot under the skin). On 19-Apr-2021, the patient experienced THROMBOSIS (the knot on the arm is blood clot) (seriousness criterion medically significant). On 20-Apr-2021, the patient experienced PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk) and PAIN (pain all over). On 17-Apr-2021, NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times) had resolved. At the time of the report, THROMBOSIS (the knot on the arm is blood clot), PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk), SKIN MASS (knot under the skin on his arm), PAIN OF SKIN (painful knot under the skin) and PAIN (pain all over) outcome was unknown. No concomitant medications were reported. Treatment for the events included Elquis and I.V heparin. This case was linked to MOD-2021-081600 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product safety profile.

Other Meds:

Current Illness:

ID: 1249679
Sex: F
Age: 95
State: NJ

Vax Date: 03/17/2021
Onset Date: 04/17/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 was reported). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) (seriousness criterion medically significant) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out). At the time of the report, PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) outcome was unknown. The 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.; 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: 1249680
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had anaphylactic reaction after 12 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination. The patient's past medical history included Back surgery. Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) outcome was unknown. Not Provided Reporter mentioned that patient has been given steroids for seven days. Treatment information was not provided. 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. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-051952 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-051952:Dose 1

Other Meds: MIRALAX

Current Illness:

Date Died: 04/18/2021

ID: 1249681
Sex: F
Age: 75
State: TX

Vax Date: 03/09/2021
Onset Date: 04/17/2021
Rec V Date: 04/24/2021
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: Found dead; Felt crappy; Wasn't feeling well; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Found dead) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal ("Patient was on blood pressure medications for the last 20 years") and Anticoagulant therapy ("Patient started on a blood thinner in January 2021"). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well). On 18-Apr-2021, FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well) outcome was unknown. The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided 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. The patient was on blood pressure medications (unspecified) for the last 20 years. She was started on blood thinner (unspecified) in January 2021. Treatment information leading up to the patient's death was not reported. Action taken with mRNA-1273 in response to the events was not applicable. A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A). Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded. However, causality cannot be established for the death as cause of death is unknown. Further information is being requested.; Sender's Comments: A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A). Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded. However, causality cannot be established for the death as cause of death is unknown. Further information is being requested.; Reported Cause(s) of Death: Found dead

Other Meds:

Current Illness: Anticoagulant therapy ("Patient started on a blood thinner in January 2021"); Blood pressure abnormal ("Patient was on blood pressure medications for the last 20 years")

ID: 1249682
Sex: M
Age: 40
State: FL

Vax Date: 03/22/2021
Onset Date: 04/19/2021
Rec V Date: 04/24/2021
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: head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely stand up; sick to his stomach; Passed out to sleep at 745 pm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Hyperthyroidism. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) (seriousness criterion medically significant). On 19-Apr-2021 at 11:30 PM, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up) and ILLNESS (sick to his stomach). On 20-Apr-2021, the patient experienced VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm), COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up), ILLNESS (sick to his stomach), VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas) had not resolved. Not Provided Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication. Treatment information was not provided. 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. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine. This case was linked to US-MODERNATX, INC.-MOD-2021-081679 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine, US-MODERNATX, INC.-MOD-2021-081679:cross link Dose 1

Other Meds: FLOVENT

Current Illness: Asthma; Hyperthyroidism

ID: 1249683
Sex: F
Age: 68
State:

Vax Date: 02/11/2021
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: Passed out; she does not remember passing out; did not wake up till 3 in the afternoon that day; she was nauseous and in the morning when she got up she was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A 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 medical history reported). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous). On 12-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous) had resolved. Concomitant medications were not provided. The patient did not remember passing out but found herself on the bathroom floor. Treatment information included bismuth subsalicylate. This case was linked to MOD-2021-081743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1249684
Sex: F
Age: 69
State: NY

Vax Date: 02/24/2021
Onset Date: 03/26/2021
Rec V Date: 04/24/2021
Hospital: Y

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: Can not eat; severe nausea; very weak; wife was aching and out of sorts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. Concurrent medical conditions included Heart disorder, Diabetic and Kidney disorder (kidney issues). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and INSULIN for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (wife was aching and out of sorts) (seriousness criterion hospitalization prolonged). On 27-Mar-2021, the patient experienced NAUSEA (severe nausea) (seriousness criterion hospitalization prolonged) and ASTHENIA (very weak) (seriousness criterion hospitalization prolonged). In April 2021, the patient experienced FOOD INTOLERANCE (Can not eat) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to ASTHENIA, MYALGIA and NAUSEA, and then on sometime in April 2021 due to FOOD INTOLERANCE. At the time of the report, MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown (Inconclusive) unknown. In 2021, Laboratory test: unknown (Inconclusive) unknown. On 27-MAR-2021, the patient had severe nausea, was very weak and went to the emergency. The patient was admitted for 3 days. Reporter stated his wife was transferred to another hospital for 7 days and then transferred to a rehab for 3 days. The patient was currently back at the first hospital with severe nausea and can not eat. The doctors who had examined the patient could not figure out from where the severe nausea coming from or how to stop it. The patient was given nausea medication. Action taken with mRNA-1273 in response to 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. This case was linked to MODERNATX, INC.-MOD-2021-081839, MOD-2021-081707 (E2B Linked Report).; 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. MODERNATX, INC.-MOD-2021-081839:Case for dose 1 MOD-2021-081707:same reporter

Other Meds: METOPROLOL; LIPITOR; ASPIRIN [ACETYLSALICYLIC ACID]; INSULIN

Current Illness: Diabetic; Heart disorder

ID: 1249685
Sex: F
Age: 53
State: SC

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/24/2021
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: side of the neck and ear ache; Nose draining; Sore Throat; Cannot swallow; Felt like hot iron stuck on the face; Eyes clumpy and hard to open mornings; Bell's Palsy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer (stage 4 of unspecified cancer). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication. 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 FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings) 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. The patient's Primary Care Physician and Oncologist recommended not to have the second dose. Treatment included prednisone for 5 days, flonase, and ice pack to open the eyes. Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose; 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: KEYTRUDA

Current Illness: Cancer (stage 4 of unspecified cancer)

ID: 1249686
Sex: F
Age: 59
State: PR

Vax Date: 03/22/2021
Onset Date: 03/29/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: red in same arm of injection; Cellulitis; It started to itch; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) 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 medical history provided.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN B NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (It started to itch). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red in same arm of injection). On 02-Apr-2021, CELLULITIS (Cellulitis), VACCINATION SITE PRURITUS (It started to itch) and VACCINATION SITE ERYTHEMA (red in same arm of injection) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information included Tylenol and Clindamycin 300. This case was linked to MOD-2021-082391 (Patient Link).; 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 events, a causal relationship cannot be excluded.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B NOS; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1249687
Sex: M
Age:
State: FL

Vax Date: 02/13/2021
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: unable to move; unable to communicate with my wife; severe back pain; still weak; got all the same reactions; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (unable to move) and COMMUNICATION DISORDER (unable to communicate with my wife) 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 (Past medical history not provided). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HYPOKINESIA (unable to move) (seriousness criterion hospitalization) and COMMUNICATION DISORDER (unable to communicate with my wife) (seriousness criterion hospitalization). On an unknown date, the patient experienced BACK PAIN (severe back pain) and ASTHENIA (still weak). The patient was hospitalized from 13-Mar-2021 to 16-Mar-2021 due to COMMUNICATION DISORDER and HYPOKINESIA. On 16-Mar-2021, COMMUNICATION DISORDER (unable to communicate with my wife) had resolved. At the time of the report, HYPOKINESIA (unable to move) had resolved and BACK PAIN (severe back pain) and ASTHENIA (still weak) had not resolved. Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-082315 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1249688
Sex: M
Age:
State: PA

Vax Date: 03/05/2021
Onset Date: 04/09/2021
Rec V Date: 04/24/2021
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: Bloody diarrhea; Ulcerative colitis; Dizziness; Feeling "very sick"; Fatigue; Fever; Chills; Headaches; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) in a 22-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 Asthma and Eczema. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion hospitalization), COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion hospitalization), DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea). On 09-Apr-2021, DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Colonoscopy: abnormal (abnormal) it appeared to be an "ulcerative colitis" on the entire colon. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication mentioned topical cream NOS for eczema. Treatment information mentioned IV Methylprednisolone and Metamizole. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Company comments This case concerns a 22-year-old female hospitalized with serious unexpected events of diarrhea hemorrhagic and colitis ulcerative, nonserious unexpected dizziness, malaise, and expected pyrexia, chills, headache, fatigue, nausea. Event onset 24 hours after second dose mRNA-1273. Serious event outcomes unknown. 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: 1249689
Sex: F
Age: 63
State: NJ

Vax Date: 04/10/2021
Onset Date: 04/11/2021
Rec V Date: 04/24/2021
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: seizure; very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) 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 was reported). On 10-Apr-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 11-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (very tired). On 12-Apr-2021 at 3:00 AM, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) and FATIGUE (very tired) outcome was unknown. No Treatment related information was reported. Patient went to bed like normal that night. Patient called a nearby family member, who took patient to her neurologist later the next day.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of seizure, and nonserious expected fatigue. Event onset 1 day after first dose mRNA-1273, with seizure occurring 2 days after vaccination. Event outcomes unknown. 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: 1249690
Sex: F
Age: 61
State: NY

Vax Date: 03/13/2021
Onset Date: 03/29/2021
Rec V Date: 04/24/2021
Hospital: Y

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: Stroke; More than 36 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 61-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. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE, ENALAPRIL and METOPROLOL TARTRATE for Blood pressure abnormal, ATORVASTATIN and EZETIMIBE for Cholesterol total abnormal NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose). The patient was hospitalized from 29-Mar-2021 to 15-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.

Other Meds: AMLODIPINE; ASPIRIN (E.C.); ATORVASTATIN; ENALAPRIL; EZETIMIBE; METOPROLOL TARTRATE

Current Illness: Cholesterol; Hypertension

ID: 1249691
Sex: F
Age:
State: NC

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she almost passed out; dizzy; fast hearth beats; sick; high fever; throwing up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she almost passed out) in a 43-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, COPD, Cholesterol, Hypertension and Cyst of kidney (Cyst in left kidney). On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (she almost passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea). At the time of the report, LOSS OF CONSCIOUSNESS (she almost passed out) had resolved and DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatments were reported. No concomitant medications were reported. Patient asked if she can receive another company's vaccine as a second dose.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of loss of consciousness, nonserious unexpected dizziness, heart rate increased, illness, and expected pyrexia, nausea, vomiting. Event onset the same day as first dose mRNA-1273. 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: Asthma; Cholesterol; COPD; Cyst of kidney (Cyst in left kidney); Hypertension

ID: 1249692
Sex: F
Age: 77
State: OH

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.

Other Meds:

Current Illness:

ID: 1249693
Sex: M
Age: 65
State: ND

Vax Date: 02/11/2021
Onset Date: 03/29/2021
Rec V Date: 04/24/2021
Hospital: Y

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: stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LOSARTAN, ATORVASTATIN, ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), COLECALCIFEROL (VIT D3), CLOPIDOGREL BISULFATE (PLAVIX), GARLIC [ALLIUM SATIVUM], LIDOCAINE, TIOTROPIUM and CYANOCOBALAMIN for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Computerised tomogram head: abnormal (abnormal) CT scan of head and was told that he had a stroke. No treatment information was provided. Additional concomitant medications included Circulant for an unknown indication. Additional diagnostic tests included magnetic resonance imaging, results not provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

Other Meds: AMLODIPINE; LOSARTAN; ATORVASTATIN; ALBUTEROL [SALBUTAMOL]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; SYMBICORT; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS; VIT D3;

Current Illness:

ID: 1249694
Sex: M
Age: 31
State: CA

Vax Date: 03/05/2021
Onset Date: 04/13/2021
Rec V Date: 04/24/2021
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: told mother he could hear voices that were not there.; wont watch movies or play games; Agitation; Nervous; Anxious; couldnt sleep; This spontaneous case was reported by a physician assistant and describes the occurrence of HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Down's syndrome. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) (seriousness criterion medically significant), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep). At the time of the report, HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatments were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events. This case was linked to US-MODERNATX, INC.-MOD-2021-075678 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events. US-MODERNATX, INC.-MOD-2021-075678:Case for first dose

Other Meds:

Current Illness: Down's syndrome

ID: 1249695
Sex: F
Age: 60
State: NY

Vax Date: 04/01/2021
Onset Date: 04/11/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: They thought they were having a stroke; Facial paresthesia; The right side of their face felt numb, like with paralysis; Their face was swollen; Right upper extremity paresthesia; Blurry vision; Dizzy; Nervous as hell; Felt like someone hit them with a gun in the right temple with Novocain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain). On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (They thought they were having a stroke) (seriousness criterion hospitalization), PARAESTHESIA (Facial paresthesia) (seriousness criterion hospitalization), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis) (seriousness criterion hospitalization), SWELLING FACE (Their face was swollen) (seriousness criterion hospitalization) and PARAESTHESIA (Right upper extremity paresthesia) (seriousness criterion hospitalization). The patient was hospitalized from 14-Apr-2021 to 19-Apr-2021 due to CEREBROVASCULAR ACCIDENT, HYPOAESTHESIA, PARAESTHESIA, PARAESTHESIA and SWELLING FACE. On 11-Apr-2021, VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: normal (normal) Normal. In April 2021, Blood test: normal (normal) Normal. In April 2021, Echocardiogram: normal (normal) Normal. In April 2021, Lumbar puncture: negative (Negative) Negative for Lyme disease. In April 2021, Magnetic resonance imaging brain: normal (normal) Normal (2x). In April 2021, Ultrasound Doppler: normal (normal) Normal. In April 2021, X-ray: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was unknown. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is requested.

Other Meds:

Current Illness:

ID: 1249696
Sex: M
Age: 76
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 04/24/2021
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: Struck down with Bell's Palsy over the weekend and was treated; Patient also experienced soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Struck down with Bell's Palsy over the weekend and was treated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included VALACYCLOVIR [VALACICLOVIR] and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Bell's palsy, APIXABAN (ELIQUIS), METOPROLOL TARTRATE, AMLODIPINE, ATORVASTATIN, CARBAMAZEPINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), PARACETAMOL (TYLENOL) and PREDNISONE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Patient also experienced soreness at the injection site). On 17-Apr-2021, the patient experienced FACIAL PARALYSIS (Struck down with Bell's Palsy over the weekend and was treated) (seriousness criterion medically significant). On 19-Mar-2021, VACCINATION SITE PAIN (Patient also experienced soreness at the injection site) had resolved. On 18-Apr-2021, FACIAL PARALYSIS (Struck down with Bell's Palsy over the weekend and was treated) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Valacyclovir and Eye drop were listed in concomitant medication for Bell's palsy. 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: ELIQUIS; METOPROLOL TARTRATE; AMLODIPINE; ATORVASTATIN; CARBAMAZEPINE; VALACYCLOVIR [VALACICLOVIR]; EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; TYLENOL; PREDNISONE

Current Illness:

Date Died: 04/18/2021

ID: 1249697
Sex: U
Age:
State: VA

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 04/24/2021
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: passed away from self inflicted injury; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTENTIONAL SELF-INJURY (passed away from self inflicted injury) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL SELF-INJURY (passed away from self inflicted injury) (seriousness criterion death). The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. 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. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Reporter did not allow further contact; Sender's Comments: Patient died of an unknown cause from a self-inflicted injury nine days after receiving second dose of Moderna Vaccine. Very limited information regarding this event has been provided at this time. Further information can not be requested.; Reported Cause(s) of Death: cause of death unknown

Other Meds:

Current Illness:

ID: 1249698
Sex: F
Age: 40
State: VT

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Stomach pain; Aslight headache before the first dose/headache was still bad; Threw up a significant amount approximately 4 ounce cup of bright red blood; Still not feeling well; Just sleeping; Not active; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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 was reported). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) (seriousness criterion medically significant), MALAISE (Still not feeling well), SOMNOLENCE (Just sleeping), SLUGGISHNESS (Not active) and HEADACHE (Aslight headache before the first dose/headache was still bad). On 20-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 04-Apr-2021, SOMNOLENCE (Just sleeping) and SLUGGISHNESS (Not active) had resolved. On 21-Apr-2021, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. At the time of the report, HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) and HEADACHE (Aslight headache before the first dose/headache was still bad) outcome was unknown and MALAISE (Still not feeling well) 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. Treatment information included acetaminophen, aspirin and caffeine, Excedrin and adult Pedialyte. On 02 Apr 2021, the patient woke up and threw up approximately 4 ounces of bright red blood. The patient's spouse called the emergency room (ER) who informed the spouse that was not uncommon, to have the patient come and recommended the patient drink adult Pedialyte and rest. The patient continued to feel unwell throughout the night. At 9:00 pm that evening, the patient was able to get up and eat. Company Comment: 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:

ID: 1249699
Sex: F
Age: 64
State: NY

Vax Date: 03/08/2021
Onset Date: 04/10/2021
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Blood Clot in the Lower Left Lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 010A21A) for COVID-19 vaccination. The patient's past medical history included Mastectomy bilateral on 20-Jan-2021 and Radiation therapy. Concurrent medical conditions included Breast cancer and Lung cancer (Has not been operated on as of yet). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) outcome was unknown. No concomitant medications reported. The patient developed a blood clot in the lower left lung, and was hospitalized. The doctor told her that because of cancer, radiation and recent mastectomy surgery she was at risk of developing blood clots. Treatment medication included apixaban for six months. 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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, a causal relationship cannot be excluded. Patient's underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.; 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, a causal relationship cannot be excluded. Patient's underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.

Other Meds:

Current Illness: Breast cancer; Lung cancer (Has not been operated on as of yet)

ID: 1249700
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 02/22/2021
Rec V Date: 04/24/2021
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: Erythema, Pruritus

Symptoms: Deep vein thrombosis; Pulmonary embolism; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012220A) 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-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL), MAGNESIUM and VITAMIN B3 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 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized for 2 days due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and DYSPNOEA (Shortness of breath) had not resolved. Not Provided The patient received Xarelto and IV blood thinner at hospital. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MOD-2021-083811 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded

Other Meds: TYLENOL; MAGNESIUM; VITAMIN B3

Current Illness:

ID: 1249701
Sex: F
Age:
State: WA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 04/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Generalized rash, flares up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (Generalized rash, flares up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not provided). In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced RASH (Generalized rash, flares up) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to RASH. At the time of the report, RASH (Generalized rash, flares up) had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was in hospital for 3 days. The patient had multiple consults and on 7 different medications. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-079683, MOD21-079684, MOD21-079685 (Linked Report).; 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. MOD21-079683:2nd Patient case report MOD21-079684:3rd patient case report MOD21-079685:4th patient case report

Other Meds:

Current Illness:

ID: 1249702
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Bilateral pulmonary embolism; DVT; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (DVT) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) outcome was unknown. The HCP got the vaccine several weeks after quarantine after that. After her second dose, she had a clotting issue which she had never had before. She experienced bilateral pulmonary embolism and DVT and was in the ICU twice. Action taken with the mRNA 1273 in response to the events was not applicable as the patient completed both the doses. Reporter did not provide the causality. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1249703
Sex: F
Age:
State: FL

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: had itching at the site of the injection/Injection site itching; This case has been upgraded to valid as there was new event has been reported after receiving the second dose of Product BNT162B2. Follow-up (16Feb2021): The initial case was missing the following minimum criteria: Upon receipt of follow-up information on 16Feb2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported herself. A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown Expiration date: unknown), second dose via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunisation. Patients' medical history included high blood pressure, cancer surgery in 1985. Patient concomitant medications were not reported. Patient stated that she guesses she received her first injection on 18Jan2021. It was reported that she was just aching with the first injection and she was alarmed when she started having itching with the second dose. Patient experienced itching at the site of the injection on 12Feb2021. The patient underwent unspecified lab test and procedures on 05Feb2021. The outcome of the event recovered in Feb2021. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1249744
Sex: F
Age: 25
State: CA

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
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: UNKNOWN

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

Symptoms: Patient received a second dose of Pfizer vaccine at 3 pm today 04/23/2021 at our store. After noticing some blood coming from the injection site patient became very worried and said she felt lightheaded. She was offered a chair to sit on but within 5 minutes of sitting down she said she was not feeling any better. While I was talking to her she seemed to have a mild seizure-like episode which lasted less than a minute. After she became alert she said her thumbs were cramping up and asked us to call 911 for her. Paramedics took her to the hospital.

Other Meds: AMOXICILLIN IBUPROFEN

Current Illness: NONE REPORTED

ID: 1249745
Sex: F
Age: 37
State: TX

Vax Date: 03/02/2021
Onset Date: 03/10/2021
Rec V Date: 04/24/2021
Hospital: Y

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: NA

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

Symptoms: Seizure a week after each shot

Other Meds: Lamictal, Prozac, birth control, trileptal

Current Illness: NA

ID: 1249746
Sex: F
Age: 37
State: NY

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies: Cephalexin as a child

Symptom List: Pain in extremity

Symptoms: On day after vaccination, developed red area size of dime at injection site, continuously grew to two inch diameter circle, swollen and hot to touch, lasting over a week, extremely tender and painful wincing to touch, appears like a cellulitis. Injection technique unknown to this writer. As of this event report, area is still tender to touch and slight swelled but swelling markedly improved and redness nearly gone. Slight faded bruising noticeable. Patient is clearly more tired, unclear if attributable to pregnancy or vaccine or combination, has become more intolerant to cold, describes overall achiness. Never any fever over course. Est date of pregnancy delivery Oct 6, 2021.

Other Meds: Flintstone complete vitamin daily Fish oil daily Cholecalciferol 5000 IU daily

Current Illness: None

ID: 1249747
Sex: F
Age: 77
State: MI

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies: possibly allergic to shell fish? asparagus,?

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

Symptoms: I had my first Moderna vaccine on February 13, and about 20 minutes later my tongue began to feel like novocaine wearing off. This lasted about two hours, and then I had no further reactions . My second shot was on March 13, and the same thing happened., tongue tingling, lasting 2 hours, then no further problems. On March 29 I woke up with lesions under my tongue, and a brief time of having difficulty moving my tongue. During the day my tongue felt strange and the lesions hurt. Since the 29th the lesions have disappeared, and each day my tongue improved. Today, April 23, I would describe my tongue as feeling like I have burned it on something hot, uncomfortable but not painful.

Other Meds: Simvastatin 20mg, amLODIpine 2.5mg, Sertraline 25mg

Current Illness: none

Date Died: 02/08/2021

ID: 1249748
Sex: F
Age: 73
State: NV

Vax Date: 01/23/2021
Onset Date: 01/01/2021
Rec V Date: 04/24/2021
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: At first my mother had a headache. Then My mother was feeling weak and could not breathe. She continued to suffer so went to the doctor to get a check up but continued to suffer and finally died on 2/8/21 due to a couple of reasons which include hypertension

Other Meds:

Current Illness:

ID: 1249749
Sex: M
Age: 34
State: TX

Vax Date: 04/20/2021
Onset Date: 04/22/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itchy red bumps

Other Meds:

Current Illness: Cold

ID: 1249750
Sex: F
Age: 30
State: IN

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 04/24/2021
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: Unknown

Symptom List: Vomiting

Symptoms: Severe swelling, redness, hardness, itching around injection site, about 3 inches in diameter.

Other Meds: Lorazepam, acyclovir, beta-glucan, vitamin D

Current Illness: None

ID: 1249751
Sex: F
Age: 34
State: PA

Vax Date: 04/16/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
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: ?COVID arm? - red, swollen, itchy lesion appeared at the injection site 7 days post vaccine.

Other Meds:

Current Illness:

ID: 1249752
Sex: F
Age: 69
State: CA

Vax Date: 02/15/2021
Onset Date: 03/14/2021
Rec V Date: 04/24/2021
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: None

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

Symptoms: Developed severe vertigo lasting over 1 month. Includes Tinnitus.

Other Meds: Allegra, occasional Tylenol, occasional Tamazepam

Current Illness: None

ID: 1249753
Sex: F
Age: 80
State: WI

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
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: Vomiting, fever, Diarrhea, headache, and blood in stool

Other Meds:

Current Illness:

ID: 1249754
Sex: M
Age: 16
State: CA

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Patient did not report any adverse events. Received his second dose of MODERNA COVID vaccination to complete his series.

Other Meds: None

Current Illness: None

ID: 1249755
Sex: F
Age: 27
State: WA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
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: Body aches, fever, nausea

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm